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December 22, 2005

Media Inquiries:
Michael Herndon, 301-827-6242
Consumer Inquiries:


FDA Proposes New Guidance to Further Reduce Children's Risk From Lead Exposure in Certain 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The Food and Drug Administration (FDA) today issued a draft guidance that aims to further lower children's exposure to small traces of lead present in certain candies.

FDA has taken this action to significantly reduce the current guidance level for lead in food after 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.

"This new guidance level will further reduce an already minimal risk from lead exposure in candy," said Acting FDA Commissioner Dr. Andrew von Eschenbach. "Today's action is part of our ongoing effort to educate consumers, promote good manufacturing practices, and protect public health, especially the health of our young children."

FDA has always recognized that some amount of lead in food and food ingredients can occur due to unavoidable background levels present in our environment. However, the adverse health effects of elevated lead levels in children are well documented and may have long-lasting or permanent consequences. Thus FDA's goal is to reduce to the greatest extent possible the amount of lead in candy.

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;
  • Pursue avenues of outreach, such as interaction with the 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.

FDA welcomes all comments on the draft guidance. The comments will be evaluated, and then FDA will prepare a final guidance document in 2006.

Written comments on the draft guidance may be submitted up to 75 days from the date it is published. Comments should be sent to FDA's Docket Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, Md. 20852.

The draft guidance is accessible on the FDA Website at http://www.cfsan.fda.gov/~dms/pbguid2.html. 


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