U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
August, 1995; Revised February, 1996

EXEMPTIONS AND SPECIAL LABELING PROVISIONS

(21 CFR 101.9(j)) (Q R1 to Q R64)

Exemptions (Q R4 to Q R57)

• Small business exemption (## 101.9(j)(1) and 101.9(j)(18)) (Q R4 to Q R10)
• Foods which are served or sold in establishments in which foods are served for immediate consumption (# 101.9(j)(2)) (Q R11 to Q R31)
• Ready-to-eat foods not for immediate consumption (# 101.9(j)(3)) (Q R32 to Q R41)
• Foods sold from bulk containers (# 101.9(j)(16)) (Q R42 to Q R46)
• Voluntary nutrition labeling of raw fruits, vegetables and fish (# 101.9(j)(10) and #101.45) (Q R47 to Q R57)

Labeling (Q R58 to Q R64)

• Nutrition label format (# 101.9(d)) (Q R58 to Q R60)
• Gift packages (# 101.9(h)(3)) (Q R61 to Q R64)

NUTRITION LABELING OF RESTAURANT FOODS

(# 101.10)B (Q R65 to Q R90)

CONTEXT OF CLAIMS AND COVERAGE BY THE NLEA

(Q R91 to Q R153)

The Claim (Q R91 to Q R131)

• Nutrient content claims (Q R91 to Q R103)
• Health claims (Q R104 to Q R116)
• Dietary guidance (Q R117 to Q R127)
• Use of undefined terms and terms or symbols in a different context (#101.13(q)(5)(iii) (Q R128 to Q R131)

Criteria for Making a Claim (Q R 132)

Reasonable Basis Determination (Restaurant Foods) (Q R 132 to Q R145)

• Determining the nutrient content of a restaurant food (Q R132 to Q R 137)
• Adherence to the "reasonable basis" (Q R138 to Q R145)

Reference Amounts (Q R 146 to Q R149)

Reference Foods (Q R150 to Q R 153)

R1.

Question: Do all foods need to bear nutrition labeling?

Answer: No. Exemptions (or special labeling requirements) are provided for:

1. Small businesses based on gross sales (after May 8, 1995, this exemption will apply only to retailers) (# 101.9(j)(1)).
2. Low volume food products (based on the average number of full time equivalent employees (FTE's) and the approximate units of food products sold in the United States) (# 101.9(j)(18)).
3. Foods served or sold in establishments that serve food for immediate consumption (e.g., restaurants, schools, cafeterias, trains, airplanes, and retail stores such as bakeries and deli's that have facilities for immediate consumption) or that are sold for use only in such establishments (# 101.9(j)(2)).
4. Ready-to-eat foods not for immediate consumption (e.g., restaurant-type foods sold by deli's and bakeries that do not have facilities for immediate consumption) that are primarily processed at the retail location or that are portioned and packaged to the consumer's specifications (# 101.9(j)(3)).
5. Foods of no nutritional significance (e.g., plain coffee or tea) (# 101.9(j)(4))
6. Bulk foods for further manufacturing (# 101.9(j)(9))
7. Raw fruits, vegetables, and seafood (covered by voluntary program for display at retail) (# 101.9(j)(10)).
8. Custom processed fish and game meat (# 101.9(j)(11)).
9. Small packages with less than 12 square inches of available label space, (e.g., a pack of gum (# 101.9(j)(13)), provided the label provides consumers with a way to obtain nutrition information for the food, (e.g., address, phone number). If a claim is made, nutrition labeling must be provided according to # 101.9(j)(13).
10. Food sold from bulk containers, provided that nutrition information is provided at point of sale (# 101.9(j)(16)).

Most of these exemptions are contingent on the food not bearing a nutrient content claim, health claim, or other nutrition-related information on its label or labeling. This set of Questions and Answers will focus primarily on the requirements for foods served or sold in establishments with facilities for immediate consumption (# 101.9(j)(2)) and for ready-to-eat foods sold by retail establishments that do not have facilities for immediate consumption (# 101.9(j)(3)). The other exemptions in # 101.9(j) will be discussed only as they apply to foods sold in these types of establishments. Additional information about the exemptions may be found in: Title 21 of the Code of Federal Regulations; Food Labeling, Questions and Answers (Volume I, August 1993); and in the Federal Register documents cited in the preface of this document.

R2.

Question: Would foods that are exempt from nutrition labeling under # 101.9(j) also be exempt from other labeling requirements?

Answer: The exemptions in # 101.9(j) apply only to nutrition labeling requirements when the food bears no claim or other nutrition information.

R3.

Question: Would food served or sold in carry-out boxes, doggie bags, or sanitary wrappers be considered "packaged food?"

Answer: Food sold in a restaurant or other retail establishment (e.g., a bakery or delicatessen) that is sold from behind a counter and placed in a wrapper, carry-out box, or other non-durable container whose sole purpose is to facilitate handling would not be considered "packaged food" and would not need to bear a net weight statement, ingredient declaration, or the other labeling required of packaged foods. However, if consumers make their selections based on the food in its packaged form, e.g., the food is wrapped or boxed by the retailer and sold from a self-service case in a corner of a restaurant, or across the aisle from an in-store deli, the food must bear all required information.

Exemptions

Small Business Exemption (## 101.9(j)(1) and 101.9(j)(18)).

R4.

Question: Does the small business exemption apply to retailers?

Answer: Yes. The small business exemptions based on dollar sales (# 101.9(j)(1)) and on low volume sales/number of employees (proposed # 101.9(j)(18)) both apply to retailers. When a retailer meets the criteria for a small business exemption under # 101.9(j)(1), all foods packaged by the small retailer would be exempt from nutrition labeling. A low volume food product sold by a retailer would be exempt under proposed # 101.9(j)(18) if the retailer meets the criteria for a small business (e.g., less than 100 full-time equivalent employees) and the food packaged by the retailer is a low volume food (e.g., annual sales of less than 100,000 consumer units). However, if the food product bears nutritional claims or other nutrition-related information on its label or labeling, it is not eligible for either exemption.

R5.

Question: A manufacturer who qualifies for a small business exemption sells his product to a large retailer who then repacks it in the deli and places it on self-service shelves. Is the product exempt from nutrition labeling if the retailer puts the small manufacturer's name on the product?

Answer: Yes. As long as the retailer is simply repacking the food into smaller containers and placing the small business's name and address on the packaged food (i.e., the package label bears no name or logo that would tie the product to the larger retailer), the food would retain any exemption it was eligible for under ## 101.9(j)(1) or (18).

R6.

Question: In May of 1994, a small manufacturer was eligible for a small business exemption based on the gross sales criterion in # 101.9(j)(1). Can the manufacturer use the same criterion in determining whether product is exempt from nutrition labeling in May of 1995?

Answer: No. Since May 8, 1995, the exemption based on gross sales (# 101.9(j)(1)) applies only to retailers (i.e., persons who sell product directly to consumers), and the manufacturer's product would need to comply with the requirements for a low-volume product (# 101.9(j)(18)) for it to continue to be eligible for the exemption.

R7.

Question: A small retailer purchases bulk product from a large manufacturer and repacks the product for retail sale using the retailer's name and logo. Is the product exempt from nutrition labeling?

Answer: If the retailer is eligible for the exemption in # 101.9(j)(1) (based on gross sales), product purchased from a large manufacturer but repacked by the retailer would be exempt from nutrition labeling, as long as the package label bears no name or logo that would tie the product to the manufacturer. However, to be eligible for the exemption in # 101.9(j)(18), the product must also meet the definition of low volume products (based on the total number of units of the product sold by the large manufacturer in the United States).

R8.

Question: What are the requirements for the exemption from nutrition labeling for a low volume food product?

Answer: The exemption for low volume food products is based on the average number of full time equivalent employees (FTE's) and the number of units of product sold in the United States. Only those products listed with the Office of Food Labeling are eligible for the exemption. For products marketed prior to May 8, 1994, limits on FTE's and unit sales will be phased-in according to the following provisions:

Compliance
Period         FTE's   Units Sold
1995          < 300    < 400,000
1996          < 200    < 200,000
1997          < 100    < 100,000

Products initially introduced after May 8, 1994, must meet the 1997 levels, i.e., < 100 FTE's and < 100,000 units sold.

R9.

Question: Do all firms need to file with FDA for the small business exemption?

Answer: No. Firms eligible for the exemption based on gross sales and firms with less than 10 FTE's and less than 10,000 units do not have to file with the FDA. However, such firms can choose to do so voluntarily in order to establish a record that they are claiming an exemption (attachment E). Also, all importers must file.

R10.

Question: Does the small business exemption apply to restaurants?

Answer: There is a separate exemption from nutrition labeling for foods sold in restaurants of any size, provided the food does not bear a claim (#101.9(j)(2)). These foods do not need the small business exemption. However, to the extent that a restaurant distributes food products for sale outside the restaurant (e.g., through grocery stores), such products may be eligible for an exemption from nutrition labeling under the small business exemption.

Foods Which are Served or Sold in Establishments in Which Foods are Served for Immediate Consumption (# 101.9(j)(2)):

R11.

Question: If a restaurant makes a claim for one item, does it need to provide nutrition information for all the foods it serves?

Answer: No. The exemptions in ## 101.9(j)(2)(I) through (iii) apply to individual food items that are served or sold in a restaurant or similar establishment, not to the establishment. A restaurant need only provide nutrition information for those items that bear a claim. The restaurant may voluntarily provide nutrition information for restaurant foods that do not bear a claim. It should be noted that the January 6, 1993 final regulations implementing the NLEA currently apply to all forms of restaurant labeling except for menus. Thus, a claim on a menu does not trigger FDA's nutrition labeling or claims requirements. However, States are not prohibited from enforcing these requirements with respect to menus (see Q R31). Furthermore, in the FEDERAL REGISTER of June 15, 1993 (58 FR 33055), FDA published a proposal to remove the exemption for claims on menus. Should the agency publish a final regulation deleting the menu exemption, the requirements discussed herein for non-menu labeling (e.g., signs, posters, placards, brochures, banners, etc.) will apply to all forms of labeling, including menus.

R12.

Question: Are foods sold to and used by restaurants in food preparation, but not served to consumers in the package in which they are received, exempt from nutrition labeling, even if claims are made?

Answer: Yes. The exemptions in # 101.9(j)(2)(iv) for foods sold for use only in restaurants but not served directly to consumers in the package received (e.g., large quantity containers) and in # 101.9(j)(2)(v) for foods sold by a distributor who principally sells food to such facilities are not conditional on the absence of claims as are the other exemptions under # 101.9(j)(2) because the consumer will not see these package labels. However, manufacturers, packers, or distributors may wish to place nutrition information on the label of the package or case, or in a flyer in each case of product, for the benefit of the food service operator who may need such information to support any claims made to consumers in the restaurant. Likewise, the restaurateur may require nutrient content information as a condition of purchase.

R13.

Question: How does FDA define "restaurants?"

Answer: "Restaurants" include conventional full service restaurants and other establishments that offer restaurant-type services. The term "restaurant" applies broadly to establishments where food is served or sold for immediate, on-site consumption (e.g., institutional food service establishments, such as schools, hospitals, and cafeterias; transportation carriers, such as trains and airplanes; delicatessens, and catering where there are facilities for immediate consumption on the premises). The definition of "restaurant" extends to establishments where foods are generally consumed immediately where purchased or while walking away (e.g., lunch wagons, cookie counters in a mall, and vending machines, including similar foods sold from convenience stores); and food delivery systems or establishments where ready-to-eat foods are delivered to homes or offices for immediate consumption.

R14.

Question: Are all foods that are sold in restaurants or from other facilities such as vending machines and that do not bear a claim exempt from nutrition labeling?

Answer: No. The exemptions in ## 101.9(j)(2)(I) through (iii) are limited to (1) ready-to-eat foods served in restaurants and in other establishments in which food is sold for immediate human consumption and (2) foods sold for sale or use only in such establishments. Commercially packaged foods such as soft drinks in cans, bags of potato chips, and candy bars that may be sold in restaurants and vending machines but that are also sold through other retail outlets(e.g., grocery stores) must bear nutrition labeling, regardless of whether or not they bear a claim (subject, of course, to the low volume product and small business exemptions).

R15.

Question: Are foods that are served aboard airlines required to have nutrition labeling?

Answer: Food served aboard airplanes and other common carriers is exempt from nutrition labeling under # 101.9(j)(2)(ii) provided it does not bear a claim.

R16.

Question: A restaurant serves a salsa that was commercially manufactured under the restaurant's brand name. The restaurant also offers a bottled salsa for sale to patrons for later use. The food does not bear a claim. To be eligible for an exemption under # 101.9(j)(2), does it matter whether the food is served for immediate consumption or whether it is sold in packaged form?

Answer: No. The exemptions in ## 101.9(j)(2)(I) through (iii) cover foods that are served or sold in restaurants and similar establishments, regardless of whether they are sold in packaged form provided their sale is limited to restaurant establishments. However, FDA strongly encourages that products such as the bottled salsa bear nutrition labeling when they are sufficiently standardized to do so.

R17.

Question: A bottled salsa sold in a restaurant is also sold through conventional retail outlets. The food does not bear a claim. Must the food bear nutrition labeling?

Answer: Yes. The exemption in # 101.9(j)(2)(iii) for foods sold in restaurants specifies that the food be sold only in restaurants. Because the sale of the salsa is not limited to restaurants, both products (i.e., restaurant and retail) must bear nutrition labeling under # 101.9. The exceptions to this requirement would be (1) foods that are packaged differently for use in restaurants compared to the food sold at other retail locations, e.g., catsup, soy sauce, and other condiments packed in decorative containers for table service, and (2) products covered by the small business or low volume products exemptions.

R18.

Question: Would foods sold in a gift shop attached to a restaurant or food items sold from a counter across the aisle from the cash register in a truck stop be considered "restaurant foods?"

Answer: If the retail area is located in close proximity to the restaurant, e.g., across the aisle from the area where food is served, and if it is not operated independently from the restaurant, it could be considered part of the restaurant establishment and the foods sold therein may qualify for the "restaurant food" exemption. However, any food item whose sale is not limited to restaurants would not be a restaurant food and, therefore, would not be eligible for the exemption in # 101.9(j)(2)(iii).

R19.

Question: Could you elaborate on the types of foods sold in vending machines that are exempt from nutrition labeling?

Answer: Foods that are prepared or dispensed by a vending machine (e.g., soda, coffee, soup, or popcorn that is dispensed into a cup) would be analogous to foods served in a restaurant and, therefore, would be exempt from nutrition labeling requirements provided the food does not bear a claim (# 101.9(j)(2)(ii)). Vending machine foods sold in packaged form (e.g., a salad or sandwich prepared in a commissary) that are similar to foods sold in restaurants are exempt from nutrition labeling requirements under # 101.9(j)(2)(iii) provided the food does not bear a claim and it is not sold through other retail channels (e.g., grocery stores). The exemption for food sold in restaurants and similar establishments, including vending machines, extends to commercially manufactured foods that have been specially packaged for sale only in such establishments. However, FDA strongly encourages that foods that are sufficiently standardized to bear nutrition labeling (e.g., individual serving size cans of soup) do so.

R20.

Question: Could you elaborate on the types of foods that are sold from convenience stores but that would be exempt from nutrition labeling because they are similar to restaurant foods?

Answer: FDA has stated that the exemption from nutrition labeling for such foods should be limited in scope and that some enforcement decisions will need to be made on a case-by-case basis. Generally, however, the foods covered by this exemption must be of the type served in restaurants or similar establishments (i.e., ready-to-eat, sold for immediate human consumption). Such foods would be expected to be non-standardized (e.g., prepared in a commissary kitchen similar to a restaurant or cafeteria kitchen where foods are assembled by hand and subject to individual product variations) and to have a short shelf-life. Examples of such foods would include: sandwiches; single-serving packages of salads, pies, and puddings; and soups and beverages dispensed into cups, that are in direct competition with foods served in restaurants and that are generally consistent with the above criteria. In contrast, this exemption would not extend to foods that are not ready-to-eat or are not for immediate consumption. As discussed in response to question R32, there is a separate exemption from nutrition labeling for ready-to-eat foods not for immediate consumption (e.g., ready-to-eat foods that are processed or prepared at the location from which they are sold but that are sold for later use (# 101.9(j)(3)). Where the food sold in a convenience store is sufficiently standardized to bear nutrition labeling, it should do so, unless otherwise exempt.

R21.

Question: If an exempt sandwich sold in a vending machine or convenience store includes a single serving unit of a condiment, such as mayonnaise, must nutrition labeling be provided on the mayonnaise packet?

Answer: Foods that are eligible for the exemption from nutrition labeling under # 101.9(j)(2), including sandwiches sold from lunch wagons, vending machines, and convenience stores, are exempt in their entirety. Therefore, a mayonnaise packet packaged with a sandwich is also exempt as long as its label does not bear a claim or other nutrition information.

R22.

Question: Would a single serve package of a condiment be exempt from nutrition labeling if it is served on its own, e.g., placed in a bowl on a table?

Answer: Yes. Food that is served in a restaurant or similar establishment is exempt from nutrition labeling provided that the food does not bear a claim (## 101.9(j)(2)(i) and (ii)). Condiments in single serve packages placed in a bowl on a table in a full service restaurant or in a container on a lunch counter or vending facility for consumers to use at their discretion, would be eligible for these exemptions. Likewise, condiments served in larger, multi-serving containers would also be eligible for the exemption under ## 101.9(j)(2)(i) or (ii) provided the food does not bear a claim.

R23.

Question: A single-serve package of a condiment is served or sold in restaurants. It is commercially manufactured, packaged, and labeled. The package label bears a claim. How should nutrition labeling be accomplished for the food?

Answer: In the August 18, 1993, technical amendments (58 FR 44020), FDA amended # 101.9(j)(13)(i)(B) to permit individual serving-size packages of food for use in restaurants and similar situations to use the minimum type size allowed under # 101.2(c)(5) of one thirty-second inch for nutrition labeling provided that the packages have a total area available to bear labeling of 3 square inches or less. If, despite this provision, a small package still cannot comply with nutrition labeling requirements, the person responsible for labeling is advised to write the Office of Food Labeling, FDA (HFS-150), requesting alternative means of compliance in accordance with 101.9(g)(9). (See Q R66 and R67.)

R24.

Question: A restaurant serves a food that is commercially manufactured, packaged, and labeled. The food is served to consumers in the form it was purchased by the restaurant, e.g., individual serving size packages of condiments are placed in a bowl for consumer use. Would FDA hold the restaurant that serves the food responsible if the label of the food does not meet FDA's requirements, for example, if a package of salad dressing bears a "lowfat" claim but fails to bear nutrition information?

Answer: FDA requires that the label of a food sold in packaged form identify conspicuously the name and place of business of the manufacturer, packer, or distributor (# 101.5). The firm that is so identified is generally the firm that is responsible for insuring that the food is properly labeled.

R25.

Question: Must a restaurant food be ready-to-eat to be exempt under # 101.9(j)(2)?

Answer: Not necessarily. The exemptions for foods served in restaurants and in similar establishments (## 101.9(j)(2)(i) and (ii)) imply that the food is ready-to-eat and is served for immediate consumption. However, a restaurant may also sell foods for carry-out that are not ready-to-eat, e.g., a pizza that is only half cooked or a pie that is frozen. Further, foods sold for use in restaurants may be used as ingredients in the foods a restaurant prepares but are not, themselves, ready-to-eat. Thus, the exemptions for foods sold for sale or use only in restaurants (## 101.9(j)(2)(iii) and (iv)) and for foods sold by a distributor who principally sells food to such facilities (# 101.9(j)(2)(v)) are not limited to ready-to-eat foods.

R26.

Question: Company X operates a large chain of restaurants with different facilities and services at each establishment based on the size of the establishment. Larger establishments have facilities for consuming food on the premises, sell food for "carry-out," and offer home delivery services. Some of the company's smaller retail establishments have no on-site eating facilities and all food sold is for "carry-out" or home delivery. Are the foods sold from these establishments exempt from nutrition labeling under # 101.9(j)(2)?

Answer: In the above example, all foods served in the larger restaurant establishment would be exempt from nutrition labeling provided the food does not bear a claim. Foods sold for carry-out or home delivery from larger establishments (i.e., establishments with facilities for immediate consumption of the food) would also be exempt provided the food does not bear a claim and sale of the food is limited to restaurant-type establishments. Foods sold by an establishment with no tables and chairs would still be eligible for the exemption provided that the food is ready-to-eat and is generally consumed immediately where purchased or while walking away (e.g., pizza sold from a walk-up counter in a mall). This exemption extends to foods sold by establishments that have facilities for delivering ready-to-eat foods to homes and offices for immediate consumption. Ready-to-eat "carry-out" foods would be similar to home-delivery foods, with the consumer doing the delivering, provided the foods are sold for immediate consumption.

R27.

Question: In the preceding example, most of the smaller establishments owned by Company X (i.e., establishments that offer only carry-out and home delivery service) cook, assemble, and otherwise prepare the food on-site. However, a few of the very small locations sell ready-to-eat food for immediate consumption that is prepared at a central commissary and shipped to the retail location. Are these foods still exempt from nutrition labeling under the restaurant food exemption if they do not bear a claim?

Answer: Yes, provided the foods meet the general criteria for restaurant foods, i.e., they are ready-to-eat and sold for immediate consumption. Although foods served or sold in restaurants are frequently prepared on-site, this is not a requirement for this exemption. (There is a separate exemption in # 101.9(j)(3) for restaurant-type foods that are ready-to-eat, not for immediate consumption, and prepared at the retail location from which they are sold (see Q R32)).

R28.

Question: Would a ready-to-eat food that is normally sold for immediate consumption by a small carry-out restaurant lose its exemption from nutrition labeling if consumers occasionally purchase the food for later use? For example, if a consumer purchases an extra pizza at lunch-time and takes it home for dinner that night or the next day.

Answer: If a food is consistent with the general requirements for the exemption for restaurant foods, it would not automatically lose its exemption because of a limited number of sales that are different from normal practice. When determining whether a food qualifies for an exemption from nutrition labeling, and which exemption applies, FDA would consider how the food would most often be reasonably expected to be sold (e.g., for immediate consumption).

R29.

Question: Do restaurant foods that make claims need to comply with the same requirements as foods from other sources?

Answer: Restaurant foods that bear a claim must comply with the same definitions for nutrient content claims or qualify to bear health claims under the same authorizing regulations as foods from other sources. At the same time, FDA is providing a measure of flexibility in how restaurateurs determine the nutrient content of their food (e.g., "reasonable basis" for believing a food meets the definition of a claim), and how they communicate this information to consumers (e.g., in a brochure or notebook) (# 101.10). These provisions are discussed in sections II and III of this document.

R30.

Question: When are the labeling requirements for restaurant foods effective? Answer: The effective dates vary depending on the type of claim being made, the size of the restaurant, and the type of labeling that bears the claim. "Small restaurants" are defined as "firms with 10 or fewer establishments." Larger restaurants have more than 10 establishments. The effective dates FDA established are:

• May 8, 1993, for health claims in non-menu labeling in larger restaurants;
• May 8, 1994, for health claims in non-menu labeling in small restaurants;
• May 8, 1994, for nutrient content claims in non-menu labeling in larger restaurants;
• May 8, 1995, for nutrient content claims in non-menu labeling in small restaurants;

Thus, all of these requirements are in effect.

R31.

Question: Can a State require restaurant foods to bear nutrition labeling even if the food is exempt under Federal requirements?

Answer: Yes. The NLEA provided for Federal preemption of State and local requirements that are not identical to the Federal requirement in a number of key areas of food labeling (section 403A(a) of the act). However, sections 403A(a)(4) and (5) of the act provide that State requirements of the type required by 403(q) (nutrition labeling) and 403(r)(1) (claims) would not be preempted for foods that are exempt from the Federal requirements. Thus, even though claims on menus are not currently subject to NLEA, States would be free to apply nutrition labeling and claims requirements to claims on menus. Furthermore, because the act exempts restaurant foods that do not bear a claim from mandatory nutrition labeling, State requirements for the nutrition labeling of such foods would not be preempted. The act also exempts restaurant foods that bear a claim from certain disclosure and referral statements. Thus, State requirements of this type would not be preempted. (The first volume of Questions and Answers, August 1993, N95, incorrectly stated that a State would need to submit a petition, and receive a favorable response to that petition, in order to enforce State requirements for the nutrition labeling of restaurant foods).

Ready-to-eat Foods Not for Immediate Consumption (# 101.9(j)(3)):

R32.

Question: I own a "gourmet-take-away" store. Many of the items sold in the store are ready-to-eat, similar to foods served in restaurants. However, the foods are not usually purchased for immediate consumption. Must these foods bear nutrition labeling?

Answer: It depends. Section 101.9(j)(3) exempts the types of ready-to-eat foods that would have been exempted by ## 101.9(j)(2)(i) or (ii) (i.e., ready-to-eat foods that are served in restaurants and similar establishments and that do not bear a claim) had it not been for the requirement that the food be sold in an establishment that has facilities for immediate consumption. To be eligible for the exemption in # 101.9(j)(3), restaurant-type foods that are sold by retail establishments that do not have facilities for immediate consumption must be: (1) similar to foods served in restaurants, (2) ready-to-eat, (3) primarily processed or prepared at the retail establishment from which they are sold, and (4) not offered for sale outside such establishment. Accordingly, ready-to-eat food that is prepared on-site, and that is sold only from such retail location, is exempt from nutrition labeling under # 101.9(j)(3) provided that it does not bear a claim, regardless of whether or not there are facilities for on-site consumption. Foods that are prepared elsewhere but are portioned and packaged to consumer specifications at retail would fulfill the prepared on-site criterion.

R33.

Question: To be exempt from nutrition labeling under # 101.9(j)(3), foods must be ready-to-eat. Are cold entrees, such as lasagna or pizza, considered ready-to-eat even though they are generally eaten hot?

Answer: As long as the food is fully cooked, it is considered ready-to-eat. For example, a pizza with a raw crust that requires cooking before consumption would not be "ready-to-eat." However, a pizza that is cooked and then cooled would be. While most customers would be expected to reheat the food before consumption, it would not be necessary that they do so.

R34.

Question: Could you elaborate on which foods sold from delis and bakeries that do not have facilities for immediate consumption of food (including independent deli's and bakeries and the deli or bakery cases of retail stores) are exempt from nutrition labeling under # 101.9(j)(3)?

Answer: Foods sold from behind deli and bakery service cases, where the customer must make a selection and indicate the amount of the item desired, are exempt unless the food bears a claim or other nutrition information. When claims or other nutrition information are given, nutrition labeling needs to be displayed clearly at the point-of-purchase. When the deli or bakery foods that are regulated by FDA are packaged for self-service, they are only exempt from nutrition labeling if the product was primarily processed or prepared on-site, and no claims are made for the product. If the food is primarily processed or prepared on the premises from which it is sold, it is exempt from nutrition labeling, regardless of how it is sold (i.e., from behind the counter or pre-portioned packages from a self-service shelf).

R35.

Question: Would bread baked at the retail location qualify as "primarily processed or prepared on-site," if the bakery is using dough that was pre-formed at a different location? What if the bakery adds icing to a cake that was baked elsewhere?

Answer: To meet the criterion for being "primarily processed or prepared on-site," the food must be augmented on site in a manner that changes the nutritional profile of the food, i.e., filling, icing, enrobing. Foods that are assembled on-site meet this criterion even though some components of the food (e.g., the bread or cheese used in a sandwich) were prepared elsewhere. Similarly, cakes that are custom decorated at the retail location are exempt, even if the cake was baked elsewhere. Garnishing (e.g., adding sesame seeds to bread dough) would fall under the definition of "primarily processed or prepared on-site" if the added food changes the nutritional profile of the finished product. In contrast, if a food is merely portioned on-site or if pre-formed dough or pre-scaled/-molded dough is simply thawed or merely proofed and baked at the retail location, the product is not "primarily processed or prepared on-site," and nutrition labeling is required.

R36.

Question: Is nutrition labeling required for orange juice that is freshly squeezed in the produce section of the retail store?

Answer: No, this product is produced on the premises from raw oranges available in the retail section of the store. It may be collected in containers brought in by consumers or containers available from the retail store. The product need not have nutrition labeling.

R37.

Question: Must cheeses that are cut into slices or wedges and packaged in retail establishments bear nutrition labeling?

Answer: Cheese is generally not processed or prepared on the premises. Therefore, unless it is sold from behind the deli counter, i.e., portioned to consumer specifications, it would not qualify for an exemption under # 101.9(j)(3). When pre-portioned, wrapped, and put out on a self-service counter, it is a packaged food and must meet all labeling requirements.

R38.

Question: Must slices of cheesecake that are cut and packaged in retail establishments bear nutrition labeling?

Answer: If the cheesecake is primarily processed or prepared on the premises, or if it is sold from behind the deli counter, it is exempt under # 101.9(j)(3). If it does not meet either of these criteria, it must bear full labeling. As with cheese, when pre-portioned, wrapped, and put out on a self-service counter, it is a packaged food and must meet all labeling requirements.

R39.

Question: A deli purchases 6 and 8 lb loaves of bread that it cuts and sells by unsliced, random weight portions. Is nutrition labeling required for the bread, and if so, how can the deli declare "Serving size" and "Servings per container" for the unsliced, random weight portions? Answer: Nutrition labeling would be required on the cut pieces when they are packaged and put out on a self-service shelf, or if claims are made on the product when sold from behind the counter. When labeling is required, the serving size for the unsliced bread should be based on the reference amount (e.g., "2 oz (56 g/1 inch slice)"), and the "Servings per container" could say "varied," so that the same nutrition label could be used on all random weight portions.

R40.

Question: Is nutrition labeling required for foods sold in a salad or soup bar in a retail store?

Answer: Unpackaged ready-to-eat foods available for self-service from salad and soup bars in a retail store (i.e., a grocery store that does not have facilities for immediate consumption) are generally exempt under # 101.9(j)(3) since the foods are of the type often sold from a service counter or deli case and are portioned to consumer specifications (even though it is the customer, not store personnel, who is portioning the food item). This exemption includes ready-to-eat food, not for immediate consumption, that is primarily processed or prepared at the retail location from which it is sold, regardless of whether it is sold wrapped or self-service. If the food is ready-to-eat and is sold for immediate consumption, it may also qualify for the restaurant food exemption, even if it is sold from a retail establishment with no facilities for immediate consumption. (See, e.g., foods sold in convenience stores that are in direct competition with restaurant foods (Q R13)). The above exemptions are dependent on the food not bearing a claim or other nutrition information. If a claim is made (e.g., "low fat pasta salad"), or when other nutrition information is provided, the above exemptions are lost, and nutrition information must be provided.

R41.

Question: When party platters of vegetables and dip or cheeses are made up in the deli or produce section of a retail store, must the platters bear nutrition labeling? On vegetable platters, does it make a difference if the dip is prepared in the store or is a commercially prepared product?

Answer: Platters prepared or assembled at a retail location and sold from such retail location are exempt under # 101.9(j)(3), regardless of whether the platter includes a commercially processed food component, such as a dip. In contrast, platters that are prepared in a central commissary and shipped to the retail store must bear nutrition labeling (except platters containing only fresh fruits or vegetables that are exempt under the voluntary nutrition labeling program # 101.9(j)(10)).

Foods Sold from Bulk Containers (# 101.9(j)(16)):

R42.

Question: How should nutrition labeling be accomplished for foods sold from bulk containers?

Answer: Section 101.9(j)(16) allows foods sold from bulk containers to display the required nutrition information on the outside of the container or on posters, counter cards, tags, or similar measures. The containers these foods are put into when sold to the consumer do not need to bear nutrition labeling as long as the required nutrition information is displayed at point-of-purchase (i.e., plainly in view by the bulk containers).

R43.

Question: If a bulk food is repacked at the retail level and sold in packaged form instead of from the bulk container, do the individual packages have to carry nutrition labeling?

Answer: Yes. When foods are received by a retail store in bulk form and repacked for sale to consumers as a packaged food, the package must meet all mandatory labeling requirements.

R44.

Question: When placing nutrition labeling on bulk foods, how should the number of servings per bulk container be declared?

Answer: The number of servings in a bulk container will vary according to the fill of the container, and such a number is of little or no usefulness to consumers. Thus, FDA intends to propose in the Federal Register the possible use of the term "varied" or other options for expressing servings per container in this situation. Pending such rulemaking, FDA would be unlikely to object to a statement that the "Servings per container" are "varied" on bulk food containers or on random weight portions of foods repackaged by the retailer.

R45.

Question: Who is responsible for providing nutrition information for bulk foods?

Answer: The retailer is responsible for displaying the nutrition information in the required format on or adjacent to the bulk container. The information may be obtained/provided by either the supplier or retailer. The decision as to who actually develops the information is up to those parties involved.

R46.

Question: If a co-op sells bulk foods directly to consumers or consumer groups, must the bulk container bear nutrition labeling?

Answer: Yes. Subject, of course, to the exemptions for small businesses and low volume products.

Voluntary Nutrition Labeling of Raw Fruits, Vegetables and Fish (# 101.9(j)(10) and # 101.45):

R47.

Question: Will posting of nutrition labeling for all raw fruit, vegetables, and fish be required?

Answer: No. The program is voluntary as long as there is substantial compliance by the retail food industry. FDA is required to survey every two years to see if a substantial proportion of retailers are providing nutrition labeling for the 20 most frequently consumed fresh vegetables, fruits, and raw fish.

R48.

Question: What are the 20 most frequently consumed raw vegetables, fruits, and fish? Are they determined on a regional basis?

Answer: The 20 foods for each group are identified in # 101.44. The same list is to be used nationwide. Vegetables: Potato, iceberg lettuce, tomato, onion, carrot, celery, sweet corn, broccoli, green cabbage, cucumber, bell pepper, cauliflower, leaf lettuce, sweet potato, mushrooms, green onion, green (snap) beans, radishes, summer squash, and asparagus. Fruits: Banana, apple, watermelon, orange, cantaloupe, grapes, grapefruit, strawberries, peach, pear, nectarine, honeydew melon, plums, avocado (California), lemon, pineapple, tangerine, sweet cherries, kiwi fruit, and limes. Fish: Shrimp, cod, pollack, catfish, scallops, Atlantic/coho salmon, flounder, sole, oysters, orange roughy, Atlantic/Pacific and jack mackerel, ocean perch, rockfish, whiting, clams, haddock, blue crab, rainbow trout, halibut, and lobster. On July 18, 1994 (59 FR 36379), FDA proposed that the list for the 20 most frequently consumed raw fish be modified to read as follows: Shrimp, cod, pollack, catfish, scallops, salmon (Atlantic/coho, chum/pink, sockeye), flounder/sole, oysters, orange roughy, mackerel (Atlantic/Pacific), ocean perch, rockfish, whiting, clams, haddock, blue fish, rainbow trout, halibut, lobster, and swordfish.

R49.

Question: Can retailers provide nutrition labeling for raw fruit, vegetables, and fish that are not among the top 20 items?

Answer: Yes. The names and descriptions of these foods should clearly identify them as distinct from the foods among the most frequently consumed list for which FDA has provided data (# 101.45(c)(1)). Nutrition labeling values for foods not on FDA's lists are subject to the compliance provisions of # 101.9(g).

R50.

Question: How does FDA define "raw fruit and vegetables" for the voluntary nutrition labeling program? Are fresh herbs and nuts included under the voluntary nutrition labeling program if they are sold in the produce section of retail stores?

Answer (revised 2/96): The NLEA provides for voluntary nutrition labeling of "raw agricultural commodities and raw fish." The act defines "raw agricultural commodities" as any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing. Therefore, fruit and vegetables that receive little or no processing and no heat treatment, regardless of whether the fruit and vegetables are waxed, are subject to the voluntary program. In addition, for ease of administration the agency has chosen to draw a practical line in terms of retail selling practices and program implementation by including raw fruit and vegetables that are sold in the producesection and that are peeled, trimmed, cut and/or packaged with no added ingredients (e.g., carrot sticks, mixed salad greens) in the voluntary program when no claims are made for the product. When claims are made, nutrition labeling is required on the package unless the the required nutrition information is provided on a poster or other means as specified in # 101.45. Accordingly, fresh herbs and nuts (e.g., walnuts, peanuts) that have no added ingredients, such as salt, and that are sold in the produce section would be exempt from nutrition labeling under the voluntary program. However, when shelled or unshelled nuts or produce are processed in a manner other than mixing with other raw produce items, peeling, trimming , or cutting, (e.g., dried fruit, roasted nuts, frozen melon balls), nutrition labeling is required under # 101.9.

R51.

Question: Is nutrition labeling still voluntary on packages of raw vegetables or fruits when processed foods, such as salad dressings and croutons, are added to the package?

Answer: When processed foods, such as salad dressings or croutons, are added to packages of raw vegetables or fruits, the product is considered to be a multi-ingredient processed packaged food and is no longer part of the voluntary program. Therefore, nutrition labeling is mandatory for the entire contents of the package. (Subject, of course, to the exemption for ready-to-eat food that is primarily processed or prepared at the retail location and the small business exemptions.)

R52.

Question: Would the packaged salad with dressing be considered ready-to-eat if consumers have to open the package of dressing and add it to the salad greens themselves?

Answer: Because restaurant salads may be served with the dressing on the side or the croutons in a side package, packages of salads prepared in the retail establishment would be considered ready-to-eat when the only preparation needed by the consumer is adding the dressing or croutons. In contrast, products that require a significant amount of assembly or preparation (e.g., a pizza kit) would generally not be considered ready-to-eat.

R53.

Question: I understand that adding salad dressing to a package of greens makes the food a multi-ingredient processed food and nutrition labeling is required for the entire contents of the package. Does the requirement change if the packaged salad contains a packet of salad dressing that already bears nutrition labeling?

Answer: No. Nutrition labeling is still required for both the greens and the salad dressing. However, # 101.9(h)(1) allows separately packaged ingredients that are intended to be eaten at the same time to be labeled individually or with a composite value. Therefore, the greens and salad dressing can be labeled individually. If the nutrition label on the packet is visible at the point of purchase, the information on the dressing need not be reprinted on the outer bag.

R54.

Question: Is nutrition labeling required for candied or caramel apples sold in the produce department?

Answer: Yes. These products are multi-ingredient processed food products. Therefore, nutrition labeling is mandatory.

R55.

Question: Is nutrition labeling required for raw, frozen fish that are packed or repacked by the retailer and sold in the frozen food section of the retail store?

Answer: Raw single-ingredient fish that are packaged by the retailer, whether fresh or frozen, fall under the voluntary nutrition labeling program. However, for the retail store to be in compliance with the voluntary program, the nutrition labeling information must be available at point of purchase (i.e., be displayed in close proximity to the product) of both the fresh and frozen fish. It may be necessary for some retail stores to display signs/brochures with the nutrient data for fish in the frozen food section as well as the fresh fish section of the store. In contrast, raw frozen fish that are packaged by a manufacturer (e.g., packaged in a box with a printed label and brand name) come under the mandatory nutrition labeling program.

R56.

Question: Is nutrition labeling required for crab meat that is canned and pasteurized, but not shelf-stable?

Answer: Pasteurized crab meat that is not shelf-stable and is sold on ice or refrigerated is included under the voluntary nutrition labeling program, whereas canned crab meat that is shelf-stable must bear nutrition labeling.

R57.

Question: Are steamed shrimp exempt from nutrition labeling if they are purchased from a manufacturer and repacked in the retail store for sale from either the fresh fish or deli counters? Would it make a difference if the retailer adds a seasoning mix when steaming the shrimp or if a cocktail sauce is added to the package?

Answer: Plain, thermally processed shelled or unshelled lobster, crab, and shrimp are included in the voluntary nutrition labeling program when sold in either the fresh fish or deli sections of the store. However, consistent with earlier answers for fruit and vegetable products, when a food is composed of more than one ingredient, some of which are not included in the voluntary program (such as a seasoning mix or cocktail sauce), it must bear nutrition labeling. These added ingredients would generally alter the nutrient content of the product so that the nutrient values posted for the voluntary program would no longer accurately represent the finished product. However, if the finished product meets the criteria for a ready-to-eat food, primarily processed and prepared at the location from which it is sold (e.g., steamed, spiced shrimp prepared in-house), it may be exempt from nutrition labeling under # 101.9(j)(3) (see Q R32).

Labeling

Nutrition Label Format (# 101.9(d)):

R58.

Question: We package fresh tomatoes and want to put nutrition labeling on the package. Should we follow the guidelines for the voluntary program for raw fruit, vegetables, and fish (# 101.45) or the nutrition labeling format required by # 101.9?

Answer: When providing nutrition information on the package, even when nutrition labeling is otherwise voluntary, the information should be presented in a format that is consistent with the format requirements in # 101.9(d).

R59.

Question: We produce a cookie assortment containing various percentages of 6 different cookies. What nutrition format should be used?

Answer: The manufacturer may choose to use: (1) a separate Nutrition Facts label for each variety of cookie in the package, (2) an aggregate label (i.e., a single Nutrition Facts panel including nutrient content information and % Daily Values in separate columns for each variety), or, (3) if it is likely that one person would eat an assortment of the cookies at the same time, a composite label that provides one set of nutrition information based on a weighted average of all of the cookies in the assortment.

R60.

Question: I use a single box to package a variety of different products (e.g., cherry pie, apple pie, cheese cake, etc.). The box is partially pre-labeled, i.e., it bears nutrition labeling in the aggregate format for all possible products. When product is packaged, I print the identity statement for the food on the principal display panel. Must the Nutrition Facts panel be marked or highlighted at the time of packaging to indicate which product is in the package? Answer: No, the statement of identity on the principal display panel along with the statement of identity above each column of nutrient values in the aggregate Nutrition Facts panel will provide adequate information for the consumer to determine which nutritional values in the aggregate label apply to the contents of the package.

Gift Packages (# 101.9(h)(3)):

R61.

Question: What is the correct way to label a gift basket that contains a variety of foods, candies, and liquors of various sizes? Does nutrition labeling have to be provided for each individually wrapped product, and are such packages considered multi-packs?

Answer: Nutrition labeling of gift food packages is addressed in # 101.9(h)(3) which:

1. allows nutrition information to be placed on labeling inside the package,
2. provides for standardized serving sizes when there is no reference amount appropriate for the variety of foods in the gift pack,
3. allows number of servings per container to be listed as "varied,"
4. allows nutrition information to be given as a composite for categories of foods in the gift pack that have similar dietary uses and similar nutritional characteristics (e.g., assorted chocolate candies, assorted cheeses), and
5. does not require declaration of nutrients in free promotional items or items used in small quantities to enhance the appearance of the gift package.

The required nutrition information for different foods may be put on a brochure or package insert using the aggregate display illustrated in # 101.9(d)(13)(ii). Listing the servings per container as "varied" allows use of the same nutrition label on packages of varied sizes. If some individually wrapped food items in the gift pack bear nutrition labeling, that information need not be repeated with the nutrition information provided for the unlabeled foods, e.g., on the outside of the gift pack or on a package insert. Further, the labeling of all malt beverages, regardless of alcohol content, and of liquors and wines containing 7 percent or more by volume of alcohol is regulated by the Bureau of Alcohol, Tobacco, and Firearms (BATF). BATF does not require that the products it regulates bear nutrition labeling.

R62.

Question: A retailer assembles gift packages containing a mixture of prepackaged and pre-labeled foods from the following categories: (1) Food items in packages that bear Nutrition Facts in accordance with # 101.9, (2) packages with less than 12 square inches of available label space that contain a phone number where nutrition information may be obtained, (3) packages labeled before May 8, 1994, with the old nutrition label format, and (4) packages labeled before May 8, 1994, that do not bear nutrition labeling. What are the nutrition labeling requirements for gift packages containing these foods when the gift package is assembled after August 8, 1994?

Answer: Gift packages that are assembled after August 8, 1994, are required to bear nutrition labeling in accordance with current labeling regulations. The following rules apply to the above categories:

1. When individual food packages within a gift package bear complete nutrition labeling, the nutrition information need not be repeated on the outer wrapper or in a package insert, even when such means are used to convey nutrition information on other products within the gift package.
2. Available label space is not an issue for most gift packages since the required information may be placed on the larger outer wrapper or in a package insert. Therefore, when packages with less than 12 square inches of available label space are added to a gift package, the nutrition information should be obtained from the manufacturer and placed on or within the gift package. Free promotional items and items used in small quantities to enhance the appearance of the gift package are excused from this requirement (# 101.9(h)(3)(v)).
3. Because, in part, the old nutrition label does not provide all of the nutrition information now required on nutrition labeling (e.g., percent Daily Value), those labels cannot be used in lieu of the new nutrition labels. However, the agency will not object to the use of packaged foods that bear the old nutrition label in gift packs assembled after August 8, 1994, provided that the gift pack provides nutrition labeling on the outer wrapper or in a package insert that meets the requirements of new # 101.9.
4. Nutrition labeling must be placed on the outer wrapper or on a package insert for all foods in a gift package (except free promotional items and items used in small quantities to enhance the appearance of the gift package) that do not bear the required nutrition information on the package label. This is true for foods packaged before May 8, 1994, or anytime after that date, when they are incorporated in a gift package.

R63.

Question: Is nutrition labeling required for fresh fruit included in a gift package?

Answer: Nutrition labeling is not required when the entire package is made up of fresh fruits (which fall under the voluntary nutrition labeling program) or when the fruit is packed with other processed foods that are intended to be eaten separately. However, if the fruit is included as one part of a kit with more than one ingredient, and some of the other ingredients are not subject to the voluntary labeling exemption, nutrition labeling is required (e.g., apples and caramel sauce).

R64.

Question: I assemble gift packs using prepackaged foods manufactured by other companies. Labeling on my part is limited to adding a "Contents List" which includes my company name and address. The gift pack is featured in the same manner in my catalogue. While some of these products have nutrition labeling, some do not because the manufacturers have a small business exemption and no claims are made. Am I responsible for providing nutrition labeling for the items that do not carry nutrition information?

Answer: Nutrition labeling must be made available for all foods in a gift pack unless the packer, as well as the manufacturer, qualifies for a small business exemption. Section 101.9(h)(3)(i) allows for the added nutrition information to be placed on an insert in the gift pack rather than on each package label.

R65.

Question: I understand that foods served or sold in restaurants are exempt from nutrition labeling if they do not bear a claim. Once they bear a claim, the restaurant must provide nutrition information upon request for the food that bears the claim. Does a restaurant have to use the Nutrition Facts format to provide nutrition information?

Answer: No. FDA is not requiring full nutrition labeling for restaurant foods, nor is it requiring that nutrition information be presented in the Nutrition Facts format. Because restaurant foods tend to be prepared or sold differently from foods from other sources, FDA has amended # 101.10 to provide a number of flexibilities for restaurants in how they determine the nutrient content of a food (e.g., using data base analysis or other reliable sources of nutrient information) and in how this information may be presented to consumers (e.g., in various formats and by reasonable means, such as in a flier or notebook) (January 6, 1993, 58 FR 2302 at 2410).

R66.

Question: Which foods can take advantage of the flexible provisions of # 101.10 (Nutrition labeling of restaurant foods)?

Answer: Section 101.10 was established to provide flexibility to restaurants and similar establishments when it is the restaurateur who is responsible for determining nutrient content or providing nutrition labeling for foods that are served or sold in such establishments. The nutrition labeling provisions in # 101.10, and discussed herein, also extend to the restaurant-type foods described in # 101.9(j)(3) provided they meet the requirements of that section (i.e., they are: similar to foods served in restaurants, ready-to-eat, not for immediate consumption, and prepared or processed primarily at the retail location from which they are sold).

R67.

Question: Can a commercial food manufacturer use the nutrition labeling provisions of # 101.10 (Nutrition labeling of restaurant foods) for foods that he/she manufactures, packages, and labels for sale or use in restaurants? Would it matter if the food was sold only in restaurants?

Answer: No. Section 101.10 was established to provide flexibility to restaurants and similar establishments when it is the restaurateur, not a manufacturer, who is responsible for determining nutrient content or providing nutrition labeling for food sold in such establishments. Consistent with the agency's treatment of commercially packaged fresh fish and nuts (Q R50 and R55), when a manufacturer or packer labels a packaged food, including foods sold only in restaurants, the nutrition information must be presented according to the requirements in # 101.9 (Nutrition Facts) and would be judged by the compliance criteria of that section. The exception would be foods sold for use in restaurants but not served to consumers in the package in which they are received (e.g., large, institutional size containers) (## 101.9(j)(2)(iv) and (v)). Because such foods are exempt from nutrition labeling requirements, even if they bear a claim, voluntary nutrition labeling may be presented for these foods by any reasonable means, including those provided for in # 101.10.

R68.

Question: Does nutrition information have to appear on the same labeling that bears a nutrient content claim or health claim? For example, would a claim for a food listed on a placard require nutrition information on the placard also?

Answer: No. Section 101.10 requires that nutrition information be available upon request. It may appear on the same or different labeling from that which bears the claim. It may be presented in various forms, including those specified in # 101.45 (e.g., displayed at point of purchase by an appropriate means, such as affixing it to the food, by posting a sign, or by making the information readily available in a brochure, notebook, or leaflet, in close proximity to the foods), Nutrition Facts (# 101.9), and by other reasonable means (# 101.10).

R69.

Question: A restaurant prepares and sells a number of foods that bear a claim, including an ice cream sandwich made with "low fat ice cream." The ice cream sandwich may be served for immediate consumption or it may be wrapped and sold from a self-service cold case in the restaurant. The wrapped sandwiches sold from a self-service case bear a claim on the package label. The restaurant provides consumers, upon request, with a brochure containing nutrient content information, according to # 101.10, for the foods it serves for immediate consumption that bear claims. Can the restaurant use the same brochure to meet nutrition labeling for the wrapped ice cream sandwich that bears a claim on its label or does it have to put Nutrition Facts on each package? Answer: Foods that are served or sold in restaurants and similar establishments may bear nutrition information according to # 101.10, even if the food is sold in packaged form and a claim or other nutrition information appears on the package label provided the food is labeled by the restaurateur.

R70.

Question: How may nutrition information be presented for restaurant-type foods that are primarily processed or prepared at the retail location from which they are sold when that location does not have facilities for immediate consumption? Please address salads prepared and sold in-house in your answer.

Answer: Many restaurant-type foods (i.e., ready-to-eat but not for immediate consumption) that are prepared at the same retail location from which they are sold have similar needs for flexible nutrition labeling as foods served or sold by restaurants (e.g., the foods are generally hand assembled and, therefore, subject to individual product variations). Thus, the general provisions of # 101.10 discussed in this section are available to restaurant-type foods that meet the criteria set out in # 101.9(j)(3). For example, if a grocer prepares and sells a "low fat" potato salad in-house, nutrition labeling must, at a minimum, provide information on the fat content of the food. This information would be available to the grocer from his/her reasonable basis determination that the food meets FDA's definition for the claim. Nutrition information for a restaurant-type food that bears a claim must be available to consumers upon request and may be presented by reasonable means (e.g., in a brochure or posted at point of purchase).

R71.

Question: Can a restaurant provide nutrition information to consumers orally, or must it be presented in written form?

Answer: Nutrition information for restaurant and restaurant-type foods may be provided by any reasonable means, including orally. A statement from a waiter, for example, that a "low fat" meal contains less than 10 grams of fat will serve as the functional equivalent of full nutrition labeling. In such a case, however, the restaurant should also have nutrition information in writing, as a back-up, to ensure that the information communicated by the staff is valid.

R72.

Question: I understand that nutrition information for packaged foods must be provided for the food "as packaged." Information for the nutrient values of the food "as prepared" is voluntary and would be listed in a second column. What is the basis for nutrition labeling of a food served in a restaurant (not in packaged form), the uncooked ingredients or the prepared food?

Answer: Nutrition information must be provided on the basis of the food as packaged or purchased by the consumer (# 101.9(b)(9)). Thus, nutrition labeling of a ready-to-eat food served in a restaurant or similar establishment would be based on the nutrient content of a single serving of the finished product as it is marketed for purchase by consumers.

R73.

Question: Which nutrients should a restaurant include in nutrition labeling?

Answer: At a minimum, restaurants must provide information on the nutrient that is the basis for the claim, e.g., "low fat, this meal contains 10 grams of fat."

R74.

Question: How does a restaurant determine which nutrients are the basis for a claim, i.e., which nutrients must be included in nutrition labeling?

Answer: Nutrients that are the basis for a claim include all nutrients that are relevant in determining whether a food meets the definition for a claim. For example, fat claims are based on the fat content of a food. Thus, nutrition information for a "low fat" food must include information on the level of fat in the food bearing the claim. Cholesterol claims are based on the cholesterol content of the food and are allowed only when a food contains 2 grams or less saturated fat per reference amount (2 grams or less saturated fat per 100 grams of food for meals and main dish products). Thus, nutrition information for a food bearing a cholesterol claim must include information on both the cholesterol and the saturated fat content of the food. Health claims include both the general health claims requirements (i.e., that disqualifying levels not be exceeded) and the nutrient requirements for the specific claim (see Q R109). This information (e.g., information about the level of the nutrients that are the basis for the claim) should be readily available to a restaurant from its determination that the food conforms to the definition of a claim. (Definitions for nutrient content claims and requirements for health claims are summarized in attachments B, C, and D of this document.)

R75.

Question: If a restaurant wants to provide information on additional nutrients, e.g., nutrients that are not the basis for a claim, can it do so?

Answer: Yes. While the provision of information on nutrients that are the basis for a claim is the minimum requirement for nutrition labeling of restaurant foods, FDA encourages restaurants to provide consumers with as much information on the nutrient content of the food as possible.

R76.

Question: If a restaurateur chooses to voluntarily provide nutrition labeling for a food that is otherwise exempt, how may this be accomplished?

Answer: Generally, the restaurateur may provide voluntary nutrition information according to the options available to foods that bear a claim, i.e., # 101.9 (Nutrition Facts), # 101.45 (voluntary program for raw fruits, vegetables, and fish), or # 101.10 (reasonable means). For example, a restaurateur may choose to provide nutrient content information in a statement such as "Garden salad with grilled chicken, contains 390 calories, 8 g fat, and 13 mg cholesterol." Because nutrition labeling requirements are triggered by a nutrient content claim, health claim, or other nutrient content information, the food would no longer be exempt from nutrition labeling. However, this information can itself serve as the functional equivalent of nutrition labeling, and no additional labeling would be required.

R77.

Question: Would FDA consider a telephone number to be a reasonable means of providing nutrition information for a food sold in a restaurant or other vending facility and which makes a claim?

Answer: No. Once a food bears a claim, nutrition information must be readily accessible to consumers, e.g., on the label attached to the food or in labeling at point of purchase. Vending machine foods that are sold in packaged form should have required labeling on the product visible to the consumer prior to purchase or be otherwise displayed at point of purchase. With respect to foods prepared or processed by the vending machine (e.g., soup dispensed into a cup), the mandatory information may be displayed on the vending machines.

R78.

Question: Must a restaurant include % Daily Values in its nutrition labeling?

Answer: Not necessarily. Nutrition information may be presented in a variety of formats. However, the agency considers % Daily Values to be very important information and encourages such a declaration whenever practicable. If a restaurant chooses to use the Nutrition Facts format, labeling must contain all information, including % Daily Values, required for the chosen format.

R79.

Question: Can a restaurant present nutrition information in a modified version of the Nutrition Facts format? For example, can nutrition information be presented in a format that resembles the Nutrition Facts but that contains elements that were modified or eliminated compared to the requirements of # 101.9?

Answer: No. As stated in response to Q R65, a restaurant may choose to present nutrition information in a variety of formats. FDA would not object to a restaurant food bearing nutrition information according to the different Nutrition Facts formats set out in # 101.9 (e.g., the simplified format, the shortened format, an aggregate display, or a linear display) so long as labeling contains all required elements of the chosen format and it meets the requirements of # 101.10 (i.e., it includes information on the nutrient that is the basis for the claim).

R80.

Question: FDA's requirements for the Nutrition Facts format are fairly specific with respect to type style, type size, and placement. Does the agency have similar requirements for nutrition labeling of restaurant foods? Answer: It depends on the format used. Nutrition labeling for restaurant foods may be presented in various formats, including Nutrition Facts (# 101.9), following the format established for raw fruit, vegetables, and fish (# 101.45), and by other reasonable means (e.g., a statement such as "low fat, this food contains no more than 3 grams of fat" in a brochure or notebook) (# 101.10). Consistent with its flexible approach towards restaurant food labeling, FDA has not established standardized type size or placement requirements in # 101.10. Labeling that is easily accessible to consumers, that contains all required nutrition information, and that is presented clearly and legibly, would be generally consistent with the "reasonable means" provision of # 101.10.

R81.

Question: Data base analysis indicates that a food contains 277 calories, 464 mg sodium, 39.22 g protein, and 5.81 g fat per serving. Can a restaurant use the same numbers that are generated by data base analysis (or provided in a cookbook or other source of nutrient content information) directly in its nutrition labeling?

Answer: Yes. However, labeling that declares nutrient values in a way that implies an unwarranted degree of accuracy could be misleading. To avoid the impression of unwarranted accuracy, as well as to make nutrition labeling easier for consumers to review and understand, restaurants are strongly encouraged to follow the rounding rules set out in # 101.9(c) (see attachment A). To be consistent with these rules, the above values should be declared as 280 calories, 460 mg sodium, 39 g protein, and 6 g fat.

R82.

Question: If an airline provides passengers with a special meal upon request (e.g., a "low sodium" meal), would this be a claim subject to the NLEA? How can nutrition labeling be accomplished?

Answer: If, in response to a special request, the airline provides a special meal and represents that the food or meal is, for example, "low sodium," "reduced sodium," or "low in fat," the airline is making a nutrient content claim for the food, and the food must meet the definition for the claim. Nutrition information must be provided for the nutrient amounts that are the basis for the claim (e.g., "low fat, this meal contains 10 grams of fat") and may be provided by reasonable means (e.g., on the back of a card wrapped with the meal identifying the meal as a special request or in a binder available from the flight attendants).

R83.

Question: Is a restaurant required to provide information on the amounts of nutrients that are not the basis for a claim? For example, if a food bears a "low fat" claim but the sodium content of the food exceeds a certain level, does the restaurant need to include sodium in its nutrition labeling?

Answer: FDA encourages restaurants to provide as much nutrition information as possible to consumers. However, the NLEA exempts restaurant foods from the referral and disclosure statements that must appear on the principal display panel of a packaged food if the food bears a claim and it contains a nutrient (i.e., fat, saturated fat, cholesterol, or sodium) at a level greater than the disclosure levels set out in # 101.13(h). Further, FDA's regulations provide that, in a restaurant situation, information on the nutrients that are the basis for the claim may serve as the functional equivalent of full nutrition labeling. Thus, in the above example, information about the fat content of the food bearing a "low fat" claim would serve as the functional equivalent of full nutrition labeling.

R84.

Question: Can a restaurant present nutrition information for an item based on an optional form of serving or preparation? For example, if it serves a grilled chicken breast with the skin attached, can it provide nutrient content information on the basis of the chicken with the skin removed?

Answer: As stated in response to Q R72, nutrition information must be presented for a food based on the form in which the food is served or sold to consumers. The restaurant may, however, voluntarily provide a second set of information based on an optional method of preparation or serving, e.g., the chicken breast with skin removed. If a claim is made for a food, and the food or meal only meets the definition of the claim based on an optional method of preparation (e.g., if the food may be prepared, on request, with half the oil normally used), this fact must be clearly communicated to consumers.

R85.

Question: I understand that nutrient content information should be based on the labeled serving size for a food. In a restaurant situation, labeled serving size would be the same as an actual or portioned serving, e.g., the amount of food provided by the restaurant in a single serving. What basis should a restaurant use for nutrition labeling if it has no control over serving size? For example, how should a restaurant declare the nutrient content of items offered in a self-service soup and salad bar?

Answer: Even if it is not the restaurant that portions a food, the restaurant may still have a logical frame of reference for serving size. For example, if a restaurant provides patrons with containers or serving utensils that have a given capacity (e.g., soup bowls, salad dressing ladles) and if it is reasonable to expect that consumers may fill the containers to capacity, the restaurant should base nutrient content information on of the amount of food the container could hold. However, if a food bears a claim, it must meet the definition for the claim based on its reference amount, regardless of labeled serving size (see Q R146). Nutrient content information for discrete items available at a self-service salad bar, e.g., muffins, whole fruit, or slices of bread, should be declared on the basis of the number of unit items that is closest to the reference amount for the food (# 101.19(b)(2)(ii)).

R86.

Question: FDA has stated that a restaurant may present nutrition information in a statement such as "contains X amount of a nutrient." Does labeling also need to specify serving size, e.g., does it need to list the weight of the food or meal?

Answer: It depends. FDA encourages restaurants to provide as much nutrition related information as possible, including information on serving size. However, consistent with the agency's flexible approach to nutrition labeling on restaurant foods, FDA will accept labeling that provides nutrition information for a single serving of a food or meal that does not specifically state serving size provided omission of this information does not result in labeling that is false or misleading. For example, if a menu lists the items available in a restaurant followed by a description of the food or meal and information on the fat and calorie content of the food, consumers could reasonably expect that the nutrient content information is declared on a per serving basis, and they will be able to relate this information to the quantity of food they are served. On the other hand, there may be situations in a restaurant where consumers would not have an appropriate frame of reference for nutrition information unless the serving size used as a basis for the information is specified, for example, when a food is available in more than one serving size (e.g., soup sold by the cup and by the bowl) or when serving size varies (e.g., items from a self-service soup and salad bar where the consumer controls portion size). Furthermore, if nutrition labeling is presented in a format that has requirements for declaring serving size (e.g., Nutrition Facts), nutrition labeling must contain all required elements of the chosen format.

R87.

Question: Should a restaurant provide nutrition information on a "per serving" basis, or can the information be declared by other units or measures, such as "per item" or "per unit?" For example, if a restaurant sells whole pizza and pizza by the slice, how should nutrition information be declared?

Answer: Generally, nutrition information should be presented on a per serving basis. Nutrition information on a per unit basis could be appropriate when a single unit may also be a single serving. However, the basis for the information must be clearly communicated to consumers. It is especially important that the basis be declared when a food is available in more than one size serving, e.g., pizza that is available whole and by the slice, or soup that is available by the cup or by the bowl. The restaurant may provide additional information, such as "8 slices per medium 16-inch pizza, 1 slice contains..." to help consumers put nutrition information in context. Conversely, it would be misleading to present the information on a per item basis when a serving generally contains more than one item of the food, for example, if a single serving of cookies contains more than one cookie.

R88.

Question: Can a restaurant provide nutrition information on a per item basis when the item is significantly larger than FDA's reference amount for the food? For example, the reference amount for muffins is 55 g. If a restaurant serves a muffin that weighs 165 g (three times as big as the reference amount) can it still treat the muffin as a single serving?

Answer: If a unit weighs 200 percent or more of the reference amount set out in # 101.12(b), it may be labeled as a single serving provided it is reasonable to expect that the food would be consumed in a single sitting.

R89.

Question: For packaged foods, the actual amount of naturally occurring vitamins, minerals, and protein must be at least 80 percent of the values that are declared on the label, whereas the actual calorie, carbohydrate, and sodium contents may not exceed the labeled values by more than 20 percent. Will FDA apply these same compliance criteria to the nutrient content information declared on labeling for restaurant foods?

Answer: No. The above compliance criteria (# 101.9(g)) were established to account for natural variations in the nutrient content of commercially manufactured and packaged foods that are subject to chemical analysis to determine compliance. These criteria ensure that values declared in the Nutrition Facts panel for nutrients such as vitamins and minerals are not over-declared, and that nutrients such as calories and fat are not under-declared, compared to actual amounts that are determined by chemical analyses. The standard that restaurant foods must meet is that a restaurateur have a "reasonable basis" for believing a claim or other nutrition information is valid. Thus, FDA will not subject restaurant foods to chemical analysis to determine whether nutrient levels are properly declared. Rather, FDA will be assessing whether the restaurant's basis for a claim or other nutrition information is, or is not, reasonable. For example, if a restaurant claims a meal is "low fat," FDA would look at the recipe, calculations, and any other information used by the restaurant in determining whether the meal meets the definition of "low fat," i.e., that it contains no more than 3 g fat per 100 g of food.

R90.

Question: Can a restaurant provide nutrition information for different components of a single food or meal separately? For example, can it provide one set of nutrient content information for a salad and a second set of information for the salad dressing if the dressing is served on the side?

Answer: Nutrition information for different components of a food or meal can be presented separately when the components are served separately (e.g., for a sauce or dressing served on the side), or where the components are separate entities, e.g., a steak, baked potato, and green vegetable, even if the components are served together. It could be misleading, however, to present nutrition information separately for mixed components where the consumer could not reasonably be expected to separate them, e.g., if the dressing is served on the salad.

The Claim

Nutrient content claims:

R91.

Question: What is a nutrient content claim? Could you provide some examples?

Answer: A nutrient content claim is any statement about a food product that directly, or by implication, characterizes the level of a nutrient in the food (# 101.13(b)). Thus, nutrient content claims include direct statements about the level (or range) of a nutrient in a food, e.g., "low sodium," "reduced fat," or "contains 100 calories." An implied nutrient content claim is any claim that: (1) describes the food, or an ingredient in the food, in a manner that suggests that a nutrient is absent or present in a certain amount, e.g., "no tropical oils" or (2) suggests that the food, because of its nutrient content, may be useful in maintaining healthy dietary practices when the claim is made in conjunction with an explicit nutrient content claim, e.g., "healthy, contains 3 grams of fat."

R92.

Question: Would use of terms such as "Nutritious," "Wholesome," "Best choice," or "Good for you" on the label or labeling of a food subject the food to the claims requirements?

Answer: It depends on the context in which the term is used. When a term such as "Wholesome" or "Nutritious" is used in a context that does not render it an implied claim (e.g., "Nutritious foods, prepared fresh daily" or "Made with wholesome ingredients"), it is not subject to the claims requirements. On the other hand, FDA may consider the term to be used in a nutritional context if it appears in association with an explicit or implicit claim or statement about a nutrient. In statements such as "Nutritious, contains 3 grams of fiber," "Best choice, contains 200 mg sodium," or "Good for you, contains 5 grams of fat," the terms are implied nutrient content claims and the foods bearing the claims must meet the requirements for a claim defined by FDA for the nutrient that is the subject of the claim (# 101.65(d)(1)). For example, a food bearing the claim "Good for You, contains 5 grams of fat," would have to meet the requirements for one of the fat claims, defined in # 101.62 (e.g., "low fat") if it is to not misbrand the food.

R93.

Question: What are the requirements for a restaurant food and its labeling when the food bears a statement about the amount or percentage of a nutrient in the food?

Answer: Statements about the amount or percentage of a nutrient in a food (e.g., "10% protein" or "less than 3 grams of fat per serving") may be made without further qualification if the food meets the definition for a claim (i.e., if the food is "low" in, "reduced," or a "good source" of the subject nutrient (# 101.13(i) and # 101.62(b)(6)). If the nutrient content of a food is not consistent with the definition of a claim, the food may still bear such a statement characterizing the level of a nutrient provided the statement is followed by a disclaimer, e.g., "Only 200 mg sodium, not a low sodium food." If the statement does not in any way qualify the level of a nutrient (e.g., "100 calories" or "5 grams of fat"), a disclaimer is not required.

R94.

Question: Section 101.10 provides that nutrition labeling for restaurant foods may be presented in a statement such as "low fat, contains less than 10 grams of fat." Can a food that does not qualify for a claim provide nutrition information using a similar statement, e.g., "this meal contains less than 20 grams of fat?"

Answer: No. As stated in response to the preceding question, phrases such as "less than (X amount of nutrient)" are implied claims and can only be used for a food that meets the definition of a claim. Statements such as "contains less than 10 grams of fat" can be used in situations where, according to a restaurateur's reasonable basis determination, a food or meal meets the criteria for a claim (e.g., "low fat") but where he/she may not know the exact amount of the nutrient present. When a restaurateur is presenting nutrition information for a food that does not meet the definition for a claim, and the nutrient values determined using a reasonable basis include some variability (e.g., due to hand assembly of food items), he/she may wish to say "approximately" to indicate that the nutrient values may not be precise. Furthermore, depending on the context in which it is used, the term "contains" may itself be a nutrient content claim. A statement such as "contains fiber" is a claim that a food is a "good source" of fiber. (See attachment B). However, in a statement that includes a quantitative declaration, e.g., "contains 2 grams of fiber," the amount of fiber in the food is characterized by the quantitative declaration, "2 grams," and the term "contains" is a simple verb, not a nutrient content claim.

R95.

Question: Can a restaurant provide information on "percent calories from fat" for a restaurant food or meal? Answer: General dietary guidelines recommend a diet that derives no more than 30% of calories from fat. Because a meal is comprised of a number of items from different food groups, and because it contributes a significant proportion of the daily diet, FDA would not object to labeling that provides information about percent calories derived from fat in a meal. Conversely, FDA stated in the claims final rules that this information (e.g., percent calories from fat) would not be useful for individual food items. The agency is concerned that, because a diet that is consistent with dietary guidelines may be comprised of a variety of foods, highlighting percent calories from fat for individual food items may be misleading. Consequently, FDA discourages labeling that presents fat and calorie content as "percent calories from fat" for individual food items.

R96.

Question: Can a restaurant call an item "relatively low fat," "very low fat," "extra light," or "almost fat free?"

Answer: No. Only those claims, or their synonyms, that are specifically defined in the regulations may be used (attachment B). All other claims are prohibited (# 101.13(b)).

R97.

Question: Would use of the term "Fresh" trigger the nutrition labeling requirements of the NLEA?

Answer: No. FDA addressed the use of the term "Fresh" to describe foods that are unprocessed or unpreserved in the same issue of the Federal Register in which the claims final rules appeared. However, "Fresh," as defined in # 101.95, is not a nutrient content claim or a health claim and use of the term does not trigger nutrition labeling requirements.

R98.

Question: Could FDA elaborate on the types of statements about ingredients in a food that would be an implied nutrient content claim?

Answer: A statement highlighting the presence or absence of an ingredient, where the ingredient is associated with the level of a nutrient, would be an implied nutrient content claim. Long recognized ingredient-nutrient relationships include: sugar and calories, oils and total fat, tropical oils and saturated fat, and whole grain or bran and dietary fiber. The statement "Contains oat bran," for example, implies that a food is "a good source of dietary fiber."

R99.

Question: I make a pizza with "low fat cheese." Even though my pizza is not "low fat" can I make a nutrient content claim about the cheese?

Answer: The agency considers a product that makes an express claim ("free," "low," "good source," or "high") about an ingredient in a product to be an implied relative claim about the product itself. For example, a claim that a pizza is "made with low fat cheese" is an implied claim that the pizza is at least "reduced in fat" compared to a similar pizza. Such a claim would be prohibited if the product did not meet the criteria for the relative claim ("less" or "more" of a nutrient) that it implied. In addition, for such an implied relative claim, the accompanying information required for relative claims would also be required (e.g., 25% less fat than regular pizza, contains ____g fat, regular pizza contains ____g fat). However, consistent with FDA's flexible approach, the agency would not object to the quantitative comparison information appearing on nutrition labeling if the labeling that bears the claim does not have sufficient space to accommodate the full statement.

R100.

Question: Would a statement such as "contains no dairy ingredients" be an implied claim?

Answer: A statement that is not presented in a nutrient context, such as statements to facilitate avoidance (e.g., "contains no dairy ingredients"), information about characterizing ingredients or ingredients perceived to add value (e.g., "contains real butter"), and ingredients that do not serve nutritive purposes (e.g., "no preservatives") would not be an implied nutrient content claim.

R101.

Question: When would a statement about the way a food is prepared be an implied nutrient content claim?

Answer: The statement would be an implied nutrient content claim if it highlights a preparation method that affects the nutrient content of a food (# 101.65). For example, "made only with vegetable oil" implies that, because vegetable oil was used instead of animal fat, the food is "low in saturated fat" or "cholesterol free." On the other hand, a statement about a preparation method that affects the character of a food but that does not characterize the nutrient content of a food, e.g., "made with fresh fruit" or "prepared fresh daily" would not be an implied claim. Terms such as "broiled," "fried," or "steamed" would not subject a food to the nutrient content claims requirements if they are part of a food's identity statement, e.g., "baked potato," "steamed shrimp," or "fried zucchini," or are used solely to identify different categories of food. In addition, labeling that bears a statement such as "available broiled or fried" in the context of providing optional preparation methods for a food would not, by itself, be an implied nutrient content claim. However, a statement such as "donuts, baked not fried" that highlights the preparation method in a way that consumers may assume that the food, because of the way it was prepared, has less or more of a nutrient would be an implied claim.

R102.

Question: If the name of a restaurant establishment contains a term that may, in some contexts, be an express or implied claim (e.g., "Cafe Lite" or "Skinny Haven"), would FDA require the foods sold in the establishment to meet the definition for a claim, and if so, would all the foods sold in the establishment be expected to comply?

Answer: The name of an establishment is not necessarily a claim for the foods sold by the establishment. If, for example, "Cafe Lite" is the name of a restaurant, but the term is not being used to describe the foods sold by the restaurant (e.g., the name of the restaurant is not printed on labeling that describes the selections offered by the restaurant), it would not be a claim for the food. Further, if the name of the restaurant appears on labeling but is used in a context other than as a nutrient content or health claim (e.g., use of the term "Lite" to describe smaller portions or "Skinny" because it is the proprietor's nick-name), the term would not be a claim subject to the NLEA. Conversely, if the name of the establishment is used to describe the foods served in the restaurant and the term is used in a nutrient context (e.g., "Cafe Lite" appears prominently on labeling and is accompanied by fat or calorie content claims), the foods that bear the claim must be clearly distinguishable from food items that do not. For example, selections that meet the requirements for a "light" claim may be highlighted by the use of a symbol or different type style and a footnote explaining that the highlighted items are light in fat or calories, or sodium.

R103.

Question: What if a restaurateur is having difficulty determining whether a statement is an implied claim?

Answer: Some statements clearly are implied nutrient content claims while other statements clearly are not. Situations where the agency has been able to determine that a statement would or would not constitute an implied claim are set out in # 101.65. In many cases, however, whether a label statement is an implied claim can only be determined on a case-by-case basis, considering the entire label and the context in which the claim is made. In determining whether a statement is, or is not, an implied claim, FDA would consider both the restaurateur's intent and the consumer's likely perception of a statement.

Health claims:

R104.

Question: What is a "Health Claim?"

Answer: A health claim is a reference on the label or in the labeling of a food that directly, or by implication, including 'third party' references, written statements, symbols, or vignettes, characterizes the relationship of a nutrient or substance to a disease or health related condition (# 101.14(a)(1)). While a nutrient content claim refers to a level or range of a nutrient in a food, a health claim includes two elements, i.e., a reference to a nutrient or substance and a reference to a disease or health related condition. Labeling that links a specific food to a statement such as "Heart Healthy" contains both the substance element (reference to a specific food) and the disease-condition element (implied reduction in risk of heart disease) of a health claim. Health claims may be used on the label or labeling of a food only if claims about the nutrient-disease relationship involved have been authorized by FDA in a regulation.

R105.

Question: What health claims are approved?

Answer: Approved health claims for recognized nutrient-disease relationships include:

• Calcium and osteoporosis (# 101.72),
• Dietary fat and cancer (# 101.73),
• Sodium and hypertension (# 101.74),
• Dietary saturated fat and cholesterol and the risk of heart disease (# 101.75),
• Fiber-containing grain products, fruits, and vegetables and cancer (# 101.76),
• Fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and the risk of heart disease (# 101.77),
• Fruits and vegetables and cancer (# 101.78), and
• Folate and neural tube defects (# 101.79).

R106.

Question: What is an implied health claim?

Answer: Implied health claims include those statements (e.g., "Heart Healthy"), symbols (e.g., a heart symbol), vignettes, or other forms of communication that suggest that a relationship exists between the presence or level of a substance in the food and a disease or health-related condition (# 101.14(a)(1)).

R107.

Question: I understand that health claims may be used only if claims about the nutrient disease-relationship in the claim have been authorized by FDA. Which of the health claims that have been approved by FDA relate the nutrient content of a food to reduced risk of heart disease?

Answer: FDA has approved two claims regarding the nutrient content of a food and reduced risk of heart disease. The first is for foods that are "low" in saturated fat, cholesterol, and total fat (# 101.75). The second is for fruits, vegetables, and grain products that contain fiber (# 101.77).

R108.

Question: When would a heart symbol on restaurant labeling be an implied health claim?

Answer: Whether a heart symbol is an implied health claim will depend on the context in which it is used. FDA advises that most of the perceptions about heart symbols fall under the regulatory regime of a health claim. For example, use of a heart symbol in association with a nutrient content claim (e.g., a claim about saturated fat or cholesterol) could imply that the food, because of its nutrient content, may be useful in reducing the risk of developing a disease or health-related condition, specifically, heart disease. Use of a heart symbol or similar logo in this context would trigger the health claims requirements that a food meet the definition of an approved claim, and that it bear nutrition labeling. Further, use of a heart symbol alone, i.e., in the absence of a statement explaining its use, could be misleading. Alternatively, when a symbol is clearly being used in a context other than to highlight nutrient or health-related benefits of a food, e.g., a heart symbol followed by a statement such as "You'll love our home-made pies and cakes!" it would not be an implied claim. Further, a heart symbol may be used to identify items that are consistent with the dietary recommendations of a health professional association when labeling bears a statement explaining such use (e.g., the symbol is repeated in a footnote followed by a statement such as "these items are consistent with AHA guidelines," without triggering the claims requirements provided labeling does not bear another statement, phrase, symbol, or logo that would cause the heart symbol to be a claim in the context of the entire label (see Q R122).

R109.

Question: What are the nutrient-content requirements for a food to bear a health claim? Answer: First, a serving of the food or meal must contain less than the specified levels of four disqualifying nutrients: fat, saturated fat, cholesterol, and sodium (# 101.14(a)(5)). Second, without fortification, the food must contain at least 10 percent of the Daily Value for at least one of the following six nutrients: vitamin A, vitamin C, calcium, iron, fiber, or protein. Third, in addition to these general requirements, the food must meet the specific criteria listed in the regulation for each approved claim. For example, a food bearing a claim that links a diet low in total fat to the risk of some cancers (# 101.73) must also meet the definition for "low fat."

R110.

Question: What are disqualifying levels?

Answer: Disqualifying levels are those levels of total fat, saturated fat, cholesterol, or sodium in a food above which the food will be disqualified from making a health claim (# 101.14(a)(5)). For individual food items, these levels are per reference amount customarily consumed and per serving (or, in the case of foods with reference amounts of 30 grams or less or 2 tablespoons or less, per 50 grams). Values for meals and main dish items are per serving. Any one of these levels, e.g., per reference amount or per serving, will disqualify a food from making a health claim (see attachment D).

R111.

Question: How should a health claim be presented?

Answer: Generally, all health claims must:

• Be complete, truthful, and not misleading,
• Use "may" or "might" to express the relationship between a substance and a disease, and
• Indicate that the risk of disease depends on many factors.

An example, or model, of a health claim that meets these informational requirements is "While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease." Restaurateurs are not required to use model health claims verbatim. However, the labeled claim must contain all the required elements.

R112.

Question: Would a claim such as "Heart Healthy" or "Heart Fest" fulfill the informational requirements for a health claim?

Answer: No. An implied claim such as "Heart Healthy" does not contain the required elements discussed in response to the preceding question. Terms such as "Heart Healthy" would need to be accompanied by additional information to be sufficiently informative.

R113.

Question: If additional information is needed to make a claim such as "Heart Healthy" fully informative, how should it be presented, and where must it appear relative to the implied or abbreviated claim?

Answer: The additional information should appear adjacent to the implied or abbreviated claim. If a number of foods bear an abbreviated claim, the additional information, (e.g., the full health claim as described in response to question R111), may appear adjacent to each abbreviated claim or adjacent to the most prominent claim. If the foods that bear an abbreviated health claim are grouped together in a box or other section of the labeling, the full health claim may appear once within that section. Alternatively, where any graphic material or statement that constitutes an express or implied claim (e.g., "Heart Healthy"), the abbreviated claim may be followed in immediate proximity by the reference statement, "See ______ for information about the relationship between _____ and _____" informing consumers where the additional information may be found (# 101.14(d)(2)(iv)). Thus, the information required to be in the full health claim may appear elsewhere on the same or different labeling as the implied claim. In a restaurant, labeling that bears an abbreviated health claim may bear a statement such as "See your server for information about the relationship between (insert nutrient or substance) and (insert disease or health-related element)" if the full claim appears in labeling (e.g., a brochure or notebook) that is used by a restaurant to convey nutrition information.

R114.

Question: Can a restaurant communicate useful nutrition-related information to consumers in a way other than a nutrient content or health claim?

Answer: Yes. Restaurants may offer alternative selections whose value in the diet may be recognized without elaboration, e.g., raw vegetables, steamed vegetables, a grain dish, a fresh fruit plate, or pasta with a tomato based sauce instead of a cream sauce. Optional preparation or serving methods may also be highlighted by statements such as "may be prepared with half the oil on request," "smaller portions," or "dressings and sauces available on the side," provided the statement about an ingredient or preparation method does not make an implied claim about the nutrient content of the food.

R115.

Question: A number of food service establishments provide foods for special dietary use, e.g., health resorts that serve food that is useful in reducing or maintaining body weight or hospitals that provide food to help regulate sodium intake. Would such food be subject to the nutrient content claims requirements if its label or labeling bears a statement about the use of the food in a special diet? Answer: It depends. There is a separate set of requirements for foods for special dietary use in 21 CFR part 105. A claim made solely to identify a food that meets a particular dietary need that exists by reason of a physical, physiological, pathological, or other condition as described in part 105 would generally not be a nutrient content claim (# 101.65(b)(6)). Thus, a claim such as "Use as part of a weight reduction program" that identifies the special diet of which the food is intended to be a part would not, by itself, be a nutrient content claim. However, if the claim about the use of the food in a special diet is used in a context that highlights a nutritional aspect of the food that is relevant to the general population (e.g., it is accompanied by a "low sodium" or "low calorie" claim), the food and its labeling would be subject to the nutrient content claims requirements.

R116.

Question: Are statements that are not covered by the NLEA subject to any other requirements?

Answer: Yes. Statements outside the coverage of the NLEA are still subject to the requirements in the law that they must be truthful and not misleading.

Dietary Guidance:

R117.

Question: What are "dietary guidelines?" How does dietary guidance differ from a nutrient content claim?

Answer: Dietary guidelines are general dietary guidance for good health made publicly available by recognized governmental or private health professional organizations (e.g., the U.S. Surgeon General, the National Academy of Sciences, the U.S. Department of Agriculture, the Department of Health and Human Services, the American Dietetic Association, the American Heart Association, and the National Cancer Institute). Dietary guidance provided by third parties other than health professional organizations would need to be consistent with the recommendations of recognized dietary authorities. Dietary guidelines generally promote moderate intake of nutrients such as sodium, fat, and saturated fat and increased consumption of grains, fruits, and vegetables. Dietary guidance is a group of general recommendations based on a total diet (e.g., "Eating 5 fruits and vegetables a day is an important part of a healthy diet"). Conversely, a nutrient content claim is a claim about the nutrient content of a particular food (e.g., "low fat, this meal contains 10 grams of fat"). Claims about a food that suggest that the food, because of its nutrient content, may be useful in maintaining healthy dietary practices and that are made in conjunction with an explicit claim or statement about a nutrient (e.g., "Healthy, contains 3 grams of fat") are implied nutrient content claims (# 101.65(d), see attachment C).

R118.

Question: Can a restaurant say that an individual food or meal meets dietary guidelines when guidelines are based on recommendations for a total diet?

Answer: It depends, in part, on the specific recommendations of the particular group. The Surgeon General's Dietary Guidelines for Americans, for example, recommend a diet with "moderate calorie intake, less than 30 percent of calories from fat, less than 10 percent of calories from saturated fat, emphasis on vegetables, fruit, and grain products, and moderate use of sugars and sodium." While a variety of foods may make-up a total diet, it may also be possible to identify a food or meal that can be part of a diet consistent with these recommendations.

R119.

Question: The recommendations in the dietary guidelines of a number of professional health organizations include specific levels for intake of a nutrient based on total daily consumption. For example, the American Heart Association guidelines include the recommendation that Americans consume no more than 3000 mg of sodium and no more than 300 mg of cholesterol per day. How can nutrient values for recommended minimum or maximum daily intake be related to an individual food or meal?

Answer: When converting a value based on daily intake to a value that is appropriate for an individual food or meal, the recommended daily intake must be divided by an appropriate factor. Consumers generally eat three meals and several snacks a day. Because a single meal constitutes approximately 25% of the daily diet, dividing the daily value for a nutrient by a factor of 4 may be appropriate for determining the contribution of the level of that nutrient in a single meal towards a daily diet. Thus, a meal containing no more than 750 mg of sodium (3000 mg/day X 1/4 daily food intake = 750 mg) could be incorporated into a diet consistent with the American Heart Association's guidelines for sodium. A recommended value for daily consumption would need to be divided by a larger number, such as 8 for a main dish and 16 or 20 for an individual food item since a greater number of individual foods may be consumed in the course of a day.

R120.

Question: Is there a simple way to identify foods that should not be highlighted as part of a diet consistent with dietary guidelines?

Answer: Yes. If a food contains a nutrient at a level that exceeds the disqualifying levels in the general health claims requirements set out in # 101.14(a)(5) (attachment D), it would be difficult for a consumer to incorporate such food into a diet consistent with generally accepted guidelines for a healthy diet. Although a healthy diet is composed of a variety of foods with different nutrient profiles and could include such foods, a claim that such a food would be a useful part of a diet consistent with dietary recommendations would be misleading if the food that bears the claim is not helpful in reaching dietary goals.

R121.

Question: Can a restaurant make a claim that a meal "is consistent with dietary guidelines" if the nutrient profile of the meal is consistent with some, but not all, of the guidelines established by a particular organization? For example, can a restaurant say a meal is consistent with dietary guidelines based on, e.g., the fat content of the meal without regard to the level of other nutrients, such as sodium and cholesterol?

Answer: Generally, if a meal bears a claim that it is consistent with the dietary guidelines of a health professional organization, its nutrient content must be consistent with all the parameters of the guidelines of the organization. If the level of another nutrient in the meal (e.g., sodium) is not consistent with the dietary guidelines referred to, a claim that the meal is consistent with dietary guidelines would be misleading. (While statements about general dietary recommendations do not by themselves trigger specific nutrition labeling requirements, FDA would expect that a restaurant have available, as part of its reasonable basis for believing a food is consistent with dietary recommendations, information on the level of all nutrients associated with the recommendations of the organization.) Furthermore, statements that single out recommendations for a particular nutrient, e.g., "meets dietary guidelines for fat," may be a claim about the nutrient content of the food (and therefore subject to the requirements for claims), rather than a statement offering general dietary guidance.

R122.

Question: Could FDA elaborate on how restaurants can present information that a food or meal meets general dietary guidelines without making a nutrient content claim or a health claim?

Answer: Statements that a food or meal meets the dietary guidelines of a health professional organization or other recognized dietary authority will be considered dietary guidance and not a nutrient content claim or health claim, provided the statement is limited to general dietary guidance and does not characterize the level of a nutrient in the food (# 101.13(q)(5)(iii)). The National Cancer Institute's recommendation, for example, that "eating 5 fruits and vegetables a day is a good way to achieve a healthy lifestyle," is general dietary guidance. Restaurants may use a heart symbol to indicate food items that are consistent with the recommendations of a health professional organization such as the American Heart Association. However, information from such programs presented in labeling in a context that includes an explicit or implicit health claim (e.g., a statement such as "meets insert association name guidelines for a 'Heart Healthy' diet" or "meets the National Cancer Institute recommendations for fiber") will subject the food to the health claims requirements. If a food bears a claim, it must comply with the requirements for the claim. If a restaurant wants to provide information as dietary guidance and not a health claim, it should not give undue emphasis to terms or symbols that could be an implied claim. Restaurants are encouraged to use alternative terms or symbols, e.g., a star or a check mark instead of a heart, to identify items that may not comply with the health claims requirements. If the name or logo of a third party reference is likely to be an implied claim when seen in conjunction with an individual food or meal, and the food or meal does not comply with the requirements for the claim, care should be taken to separate the reference from individual foods. It may be possible, however, for labeling to bear a statement such as "This restaurant has been a paying member of (insert program name) since 1994" provided such statement refers to the establishment, not a food, and it is less prominent (in size, type style, and placement) compared to other statements that refer to the food.

R123.

Question: Would a statement that a meal can be part of a diet that is consistent with the dietary guidelines of a health professional organization be regulated as a health claim if the name of the organization includes a reference to a disease or health-related condition?

Answer: It depends. Reference to the organization will be regulated as a health claim if, within the context of the total labeling, it implies a relationship between a nutrient or substance and a disease or health-related condition. Conversely, some groups have a history of providing general dietary guidance for good health such that consumers would not automatically assume that the name of the organization or its logo implies association with the disease-related element of a health claim. Thus, reference to these groups and their guidelines (e.g., the U.S. Department of Agriculture/Department of Health and Human Services food pyramid, the American Heart Association, or the National Cancer Institute), would not constitute a health claim provided that the guidelines are general dietary recommendations (compared to dietary recommendations for individuals with a specific disease or health related condition) and reference to the organization contains no other reference to a substance or health-related condition.

R124.

Question: Can labeling that identifies items that are consistent with general dietary guidelines also provide consumers with nutrition-related information about the guidelines? Would this information be considered a nutrient content claim?

Answer: Restaurant labeling may provide information about the guidelines of a professional health organization. Whether the information is regulated as a nutrient content claim or as dietary guidance will depend on the context in which it is presented. If nutrient information is directly linked to a particular food or meal (e.g., "this meal derives no more than 30% of its calories from fat"), the information would be a nutrient content claim (see Q R121). However, if the information merely presents the guidelines of a health professional organization without making a statement about the nutrient content of a particular food, the information would not be a nutrient content claim. For example, labeling that highlights items that may be part of a diet that is consistent with all guidelines of a particular group may bear a footnote stating "Highlighted items are consistent with the general dietary recommendations of (insert name of health professional organization). These guidelines are (describe all nutrient recommendations that comprise the group's guidelines)."

R125.

Question: What is a 'third party' reference?

Answer: It is a reference on product labeling or advertising, made through a name or logo, linking a product to a person or organization that is independent of the product's manufacturer, seller, or distributor (the first party), or the consumer (the second party). The third party may be a State or local health department or consumer service agency, health professional organizat