FDA Issues Draft Guidance on Lead Levels in Candy

The Food and Drug Administration (FDA) today issued a draft guidance that aims to further lower children's exposure to small traces of lead present in certain candies (see Guidance for Industry: Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy).

FDA has taken this action to significantly reduce the risk of potential exposure of children to lead from certain types of Mexican candy products.Testing of certain types of Mexican candy products showed evidence of lead contamination at levels above those presently allowed. The new guidance level that is proposed is 0.1 part per million (ppm) of lead, significantly lower than the current guidance level of 0.5 ppm.

While most domestic and imported candies contain lead levels of 0.1 ppm or less, data that FDA gathered through sampling imported candy from Mexico and other information received by FDA revealed that certain ingredients often used in these candy products may be a source of avoidable lead exposure. These ingredients include chili powder and certain types of salt, which are used in these candies. Examples of these products include lollipops coated with chili, and powdery mixtures of salt, lemon flavor, and chili powder sold as a snack item.

In addition, FDA is concerned that there may be certain manufacturing processes or conditions that contribute to elevated lead levels in some of these candies, such as packing products or storing ingredients in improperly glazed ceramic vessels that may leach high levels of lead into the product.

To protect consumers, FDA will:

• Continue to closely monitor the lead levels in Mexican candy and other domestic and imported candy products, work with our Mexican counterpart regulatory agencies, and take appropriate regulatory action;
• Work with candy industry to increase industry's awareness about certain process modifications that will reduce the levels of lead in candy products; and
• Continue to assist state and local officials in their efforts to reduce exposure to lead in candy.

Comments and suggestions regarding this draft document should be submitted within 75 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number 2005D-0481.

Office of Food Safety, Defense, and Outreach

CFSAN Web site: http://www.cfsan.fda.gov/