HHS:PHS:FDA:CFSAN:OC:DCP:MSB
 
5100 Paint Branch Parkway
        College Park, MD 20740-3835
 
      M-I-03-14
 
                 October 3, 2003	
 
 
TO:  		All Regional Food and Drug Directors
      Attn:  Regional Milk Specialists
 
FROM:  	Milk Safety Branch (HFS-626)
 
SUBJECT:	Labeling and Standards of Identity Questions and Answers
 
 
Following are questions and answers concerning Labeling and Standard of Identity
issues raised at recent Regional Milk Seminars and Special Problems in Milk
Protection Courses.
 
Copies of this memorandum are enclosed for distribution to Regional Milk
Specialists, State Milk Regulatory Agencies, State Laboratory Evaluation
Officers and State Milk Sanitation Rating Officers in your region. This
memorandum should be widely distributed to representatives of the dairy industry
and other interested parties and also will be available on the FDA Web site at
http://www.cfsan.fda.gov at a later date.
 
If you would like an electronic version of this document prior to it being
available on the CFSAN Web Site, please e-mail your request to
Robert.Hennes@cfsan.fda.gov.
 
 
 
 
	/ss/								/ss/
 
 
Norris A. Robertson, Jr.,			      CAPT Robert F. Hennes, RS, MPH, Chief	
Milk Sanitation Officer			      Milk Safety Branch			
Milk Safety Branch					
 
 
 
 
 
 
 
LABELING AND STANDARDS OF IDENTITY
QUESTIONS AND ANSWERS
 
 
1.	 PMO-Sections 1 and 4 and Appendix L.
 
Can dimethylpolysiloxane, a defoamer, be added to milk sold as milk?
 
No. Dimethylpolysiloxane cannot be added to milk (of any fat level) that is sold
as "Milk".  (Refer to 21 CFR 173.340)
 
Can dimethylpolysiloxane be added to milk used to make standardized lowfat
yogurt?
 
Yes.  Dimethylpolysiloxane may be added as a defoaming agent to milk that is
used to make standardized lowfat yogurt, provided it meets the requirements
listed under 21 CFR 173.340 and 130.8.
 
Section 173.340 allows for the addition of dimethylpolysiloxane in the
processing of food, and its use is considered safe if present at a level that
results in the food, i.e., yogurt, containing no more than 10 parts per million.
 
Section 130.8 allows a food to conform to the standard of identity for that
particular food even if it contains an ingredient not provided for in the
standard of identity, provided that: 1) the ingredient is introduced in the
standardized food as a result of its addition to another ingredient permitted by
the standard of identity for that food, and 2) the ingredient qualifies as an
incidental additive in non-standardized foods in accordance with 21 CFR 101.100.
 
In the case of adding dimethylpolysiloxane to lowfat yogurt, it meets the first
requirement stated above, if it is introduced into lowfat yogurt as part of
lowfat milk.  It also qualifies as an incidental additive under 21 CFR
101.100(a)(3)(ii)(c), if it is added to the food for its technical or functional
effect during processing, but does not have a functional or technical effect in
the finished food, lowfat yogurt, and is present in insignificant amounts in the
finished food.
 
2.	PMO-Sections 1 and 4 and Appendix L.
 
How should a dried blended product of nonfat milk and lactose reduced
ultra-filtered (UF) milk be labeled?
 
We recommend that the product be labeled as "DRIED BLEND OF NONFAT MILK AND
ULTRA-FILTERED, LACTOSE REDUCED, NONFAT MILK".  A label such as "High Protein
Nonfat Dry Milk Powder" is not acceptable to FDA. This dried blended product
does not meet the standard of identity for Nonfat Dry Milk and therefore cannot
be labeled as such.  (Refer to 21 CFR 131.125)  However, the amount of protein
contained in the dried blended product could be placed below the product
identification, i.e., "?? % Protein".
 
Can a dried blended product of nonfat milk and lactose reduced ultra-filtered
(UF) milk be labeled Grade "A", and if so, in what Grade "A" products can it be
added to as an ingredient?
 
If this dried blended product is derived from Grade "A" milk, it can be labeled
as Grade "A" and can be IMS Listed.  It should be listed as Code 27 in the IMS
List. However, very few standards of identity for Grade "A" products allow UF
milk to be added. Many standards of identity do not allow for any ingredient
except "milk".  If the standard of identity only allows for "milk", this dried
blended product is not "milk" and cannot be added.  There are products that
provide for the addition of optional dairy ingredients and other optional
ingredients.  This dried blended product may be appropriate in these Grade "A"
products.  However, whenever this dried blended product is used, it must be
declared in the ingredient statement of the finished food.
 
This product may not be appropriate for other milk products, for example, dry
curd cottage cheese and sour cream.  The standard of identity for dry curd
cottage cheese (21 CFR 133.129) provides for the use of specific dairy
ingredients.   These dairy ingredients are sweet skim milk, concentrated skim
milk and nonfat dry milk.  (Refer to 21 CFR 133.129(b)(2))  The dried blended
product would not qualify.  The standard of identity for sour cream (21 CFR
131.160) permits the use of only pasteurized cream as the basic ingredient. It
provides for the optional use of safe and suitable ingredients that improve
texture, prevent syneresis, or extend the shelf life of the product.  (Refer to
21 CFR 131.160(b))  This dried blended product does not meet these stipulations
required for optional ingredients.
 
3.	PMO-Sections 1 and 4 and Appendix L.
 
The Grade "A" dried powder blend, trade name "Culture Mate", ingredient
statement lists "hydrolyzed casein".  However, the blend sheets indicate that
"whey protein hydrolysate" is used. Would this situation be a labeling violation
that we should address?
 
Yes.  Whey protein hydrolysate and hydrolyzed casein are two distinct and
separate ingredients, the names of which cannot be used interchangeably.
Section 102.22 requires protein hydrolysates to be named using the specific
source of the protein.  Therefore, if the manufacturer used the ingredient "whey
protein hydrolysate" in the "Culture Mate" premix as shown in the blend sheet,
then the ingredient statement of this food must declare this ingredient as "whey
protein hydrolysate," and not as "hydrolyzed casein" as is currently being
identified.
 
 
The Milk Safety Branch (MSB) would recommend that the State Regulatory Agency
work with the company to get the label corrected within a reasonable period of
time.  MSB would also recommend that such violations found on a rating or check
rating of the blending plant be indicated as a labeling violation and the
appropriate corresponding value be taken from Number 3, Part III of the "Report
of Enforcement Methods".
 
4.	PMO-Sections 1 and 4 and Appendix L.
 
Is a milk product labeled "Fat Free Half-and-Half " properly labeled?
 
Yes.  A milk product can be labeled "Fat Free Half-and-Half" provided it meets
the requirements of 21 CFR 131.180, 21 CFR 130.10, and 21 CFR 101.62. This would
be a food that uses a standardized name and a nutrient content claim per the
provisions in 21 CFR 130.10.
 
5.	PMO-Section 4	
 
Is the labeling term "Extra Rich" allowed on a whole milk package where the milk
has a milkfat content of 5 percent?
 
No.  The standard of identity for milk provides for a minimum milk fat content
of 3.25 percent.  (Refer to 21 CFR 131.110)  Therefore, a whole milk product
with a milkfat content of 5 percent is still the standardized food "milk".
 
The claim "Extra Rich" explicitly and implicitly characterizes the level of
nutrients in this food and therefore must comply with the laws and regulations
governing nutrient content claims.  Nutrient content claims may only be used, if
they are authorized.  The term "Extra Rich" is not authorized by regulation or
by the act and; therefore, cannot be used on a food label in a nutrient context.
 
 "Extra" is an authorized nutrient content claim.  (Refer to 21 CFR 101.54(e))
However, this claim may not be used to describe the level of fat in a food.
"Extra" may be used to describe the level of protein, vitamins, minerals,
dietary fiber or potassium, provided, in part, that the food contains at least
10 percent more of the Reference Daily Intake (RDI) or Daily Reference Value
(DRV) of the specified nutrient per Reference Amount Customarily Consumed
(RACC).
 
 "Rich in" is also an authorized nutrient content claim.  (Refer to 21 CFR
101.54(b))  This claim may be used to describe the level of a nutrient with an
established RDI or DRV, provided, in part, the food contains 20 percent or more
of the RDI or DRV of the specified nutrient per the RACC.  (Refer to 21 CFR
101.54(b))    While "Rich in" was not originally intended to cover the nutrient
"fat", 21 CFR 101.54(b) does not specifically prohibit a "Rich in Fat" claim.
However, in order for a product to claim that it is "Rich in Fat", it would have
to contain at least 13 grams of fat per reference amount customarily consumed.
The reference amount for milk is 240 mL (1 cup).  (Refer to 21 CFR 101.12)
Would a whole milk product with a milkfat content of 5 percent require a
statement regarding the percentage of milkfat in the product?
 
No.  However, we recognize that firms may want to distinguish 5 percent fat milk
from 3.25 percent fat milk.  We would not object to a factual claim, such as,
"5% fat" to make this distinction.  In addition, we would not object to a
fanciful term in conjunction with the declaration of the percentage fat,
provided that the fanciful term does not explicitly or implicitly characterize
the level of fat in this food.  (Refer to 21 CFR 101.3(b))
 
6.	PMO-Appendix L.
 
Is vitamin addition to milk optional or required?
 
Vitamin addition to milk is optional.  (Refer to 21 CFR 131.110)  The standard
for "milk" allows for the optional addition of vitamins A and D.  However, if
vitamins A and D are added, they must be present at levels required in the
standard, i.e., 2000 IU for vitamin A and 400 IU for vitamin D per quart.
(Refer to 21 CFR 131.110(b))
 
Is vitamin addition to lowfat, reduced fat or skim milk optional or required?
 
Vitamin addition to lowfat or reduced fat milk is required to replenish any
reduction in essential nutrients caused by the removal of the fat.  (Refer to 21
CFR 130.10(b))  However, vitamin addition to lowfat, reduced fat or skim milk,
beyond replenishing any reduction in essential nutrients caused by the removal
of the fat, is also optional.
 
Section 130.10 specifies that standardized foods that are modified to make
nutrient content claims, i.e. lowfat or reduced fat, must not be nutritionally
inferior to the standardized food.  Nutritional inferiority means any reduction
of an essential nutrient present in a measurable amount, i.e. at least 2% of the
Daily Reference Value per Reference Amount Customarily Consumed.  In the case of
milk, vitamin A, for example, is an essential nutrient that is lost by partially
or completely removing the fat portion, and that meets the "measurable amount"
requirement.  Therefore, vitamin A is required to be added to lowfat, reduced
fat and skim milks at a level needed to replace that lost by removing the fat
portion of unfortified whole milk.  (Refer to 21 CFR 130.10 (b))  If vitamin D
is present in a measurable amount in unfortified whole milk (i.e., at least 8 IU
per 240 mL), vitamin D must be added back in an amount needed to replace that
lost by removing the fat portion to produce lowfat, nonfat, or skim milk. (Refer
to 21 CFR 130.10 (b))
 
The addition of any nutrients, including vitamins A and D, over and above that
needed to restore the levels lost during processing of lowfat, reduced fat or
skim milk is optional and depends on the nutrient content claim made on the
label.  For example, if these milks made relative claims on the labels; such as,
"fortified", "enriched", or "added" with respect to vitamin A and/or D content,
they would need to meet the requirements of 21 CFR 101.54(e).
 
7.	PMO-Appendix L. 		
 
Can menhaden oil be used in Grade "A" dairy products?
 
Yes.  However, the use on menhaden oil in dairy products is determined by
section 184.1472 and the standard of identify of the particular standardized
food. Menhaden oil is currently allowed in several dairy products, including
cheese products and frozen dairy products, at specific maximum levels of use.
(Refer to 21 CFR 184.1472 and relevant definitions in 21 CFR 170.3.)
 
Specifically, can menhaden oil be used in Yogurt?
 
No.  "Yogurt" may not contain menhaden oil as the standards for "yogurt",
"lowfat yogurt", and "nonfat yogurt" (21 CFR 131.200, 21 CFR 131.203 and 21 CFR
131.206, respectively) do not provide for the addition of menhaden oil.  (Refer
to 21 CFR 170.10)  However, menhaden oil is considered GRAS and is allowed in
yogurt-based non-standardized products at a maximum level of use of 4.0%.
(Refer to 21 CFR 184.1472)
 
Menhaden oil is permitted in yogurt-based non-standardized products, but not in
"yogurt" because per 21 CFR 170.10, simply because a food additive/GRAS
regulation permits the addition of an ingredient in a food, it does not imply
that the ingredient may be used in a standardized food, unless it is recognized
as a permitted ingredient in the applicable food standard(s).  Therefore, given
that the standards for "yogurt", "lowfat yogurt", or "nonfat yogurt" do not
provide for the addition of menhaden oil, this ingredient is not permitted in a
product that is named "yogurt", "lowfat yogurt", or "nonfat yogurt".  However,
because this ingredient is a safe and suitable substance for use in the yogurt
category of foods, it may be added to non-standardized yogurt products (i.e., a
non-standardized yogurt-based beverage) as specified by 21 CFR 184.1472.
 
In 2002, FDA proposed to amend 184.1472. (Refer to 67 Federal Register 8744
(February 26, 2002)).  Among other things, FDA proposed to allow menhaden oil in
"milk products" (a food category defined in 21 CFR 170.3 (n)(31), which
encompasses yogurt-based non-standardized products) at a maximum level of use of
5.0%.  The proposed rule indicates that the intended use of menhaden oil is as a
substitute for other edible fats or oils.  However, this is only a proposed
rule, and is not currently in effect. Note, as explained above, the current
regulation permits the use in this category of foods at a maximum level of use
of 4%.
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M-I-03-14	6	October 3, 2003