1. Lead in Candy FDA Overview Michael E. Kashtock, Ph.D. U. S. Food and Drug Administration Center for Food Safety and Applied Nutrition

2. Early history of the problem In 1994 the state of California found ppm levels of lead in a powdered Mexican candy that had migrated from the wrapper. Findings were f/u to an EBLL investigation. In 1994 the state of California found ppm levels of lead in a powdered Mexican candy that had migrated from the wrapper. Findings were f/u to an EBLL investigation. CA and FDA tested many other Mexican candy products at that time looking for candy contamination from lead ink used on wrappers CA and FDA tested many other Mexican candy products at that time looking for candy contamination from lead ink used on wrappers

3. Early history of the problem (cont’d) More candy with lead ink on wrappers was found, but none in which the ink (lead) migrated into the food More candy with lead ink on wrappers was found, but none in which the ink (lead) migrated into the food Testing was showing higher levels of lead than expected in the candy proper, 0.05 vs. 0.2 ppm Testing was showing higher levels of lead than expected in the candy proper, 0.05 vs. 0.2 ppm Ultimately we learned that unwashed chili used as an ingredient was the principal source of lead Ultimately we learned that unwashed chili used as an ingredient was the principal source of lead FDA issued 1995 “policy letter” addressing lead in candy and use of lead ink on candy wrappers FDA issued 1995 “policy letter” addressing lead in candy and use of lead ink on candy wrappers

4. Current Policy Lead from wrapper - FDA will take regulatory action against any candy product with lead based ink on the wrapper if the ink migrates into the candy (1995 letter) Lead from wrapper - FDA will take regulatory action against any candy product with lead based ink on the wrapper if the ink migrates into the candy (1995 letter) Non-wrapper lead - FDA will consider taking regulatory action against any candy product containing 0.5 ppm, or more lead (1995 letter to industry) Non-wrapper lead - FDA will consider taking regulatory action against any candy product containing 0.5 ppm, or more lead (1995 letter to industry) In 2004 FDA revised the 1995 policy to state that it would consider regulatory action if a labeled serving of candy contained 10 or more micrograms of lead. In 2004 FDA revised the 1995 policy to state that it would consider regulatory action if a labeled serving of candy contained 10 or more micrograms of lead.

5. Current Policy (cont’d) FDA has not found additional Mexican candy products with lead based ink which can migrate into the candy FDA has not found additional Mexican candy products with lead based ink which can migrate into the candy If we find lead based ink on a candy wrapper that doesn’t migrate into the candy, we inform the CPSC If we find lead based ink on a candy wrapper that doesn’t migrate into the candy, we inform the CPSC If we find a candy product that exceeds the current guideline, we would likely remove from the market and place future shipments on DWPE If we find a candy product that exceeds the current guideline, we would likely remove from the market and place future shipments on DWPE

6. Current guideline, 0.5 ppm When established in 1995, was equivalent to the FCC limit for lead in sucrose and HFCS at the time When established in 1995, was equivalent to the FCC limit for lead in sucrose and HFCS at the time FDA believed at the time that lead levels well below 0.5 ppm were achievable in candy if produced under GMP FDA believed at the time that lead levels well below 0.5 ppm were achievable in candy if produced under GMP Most candy products then and now were/are << 0.5 ppm; currently most are < 0.1 ppm Most candy products then and now were/are << 0.5 ppm; currently most are < 0.1 ppm Seen as an interim level that would be lowered at a future time Seen as an interim level that would be lowered at a future time FCC level for sucrose and HFCS eventually lowered to 0.1 ppm FCC level for sucrose and HFCS eventually lowered to 0.1 ppm

7. FDA Current Activities FDA stated its intent to lower its guidance level for lead in candy in March 2004 FDA stated its intent to lower its guidance level for lead in candy in March 2004 OCR Series ran in April 2004 OCR Series ran in April 2004 FDA published draft guideline for a 0.1 ppm recommended maximum level for lead in candy in December 2005 FDA published draft guideline for a 0.1 ppm recommended maximum level for lead in candy in December 2005 75 Day comment period to end March 13 75 Day comment period to end March 13 To be followed by final guidance To be followed by final guidance

8. Enforcement Considerations FDA has an ongoing monitoring program for Mexican candy at the border; we detain candy with potentially harmful levels of lead. FDA has an ongoing monitoring program for Mexican candy at the border; we detain candy with potentially harmful levels of lead. Focus sampling on high chili, high salt candies Focus sampling on high chili, high salt candies Current enforcement threshold is 10 micrograms per labeled serving of candy, e.g., for 35 g serving ~ 0.3 ppm lead Current enforcement threshold is 10 micrograms per labeled serving of candy, e.g., for 35 g serving ~ 0.3 ppm lead Current enforcement policy will change once the guidance is finalized Current enforcement policy will change once the guidance is finalized

9. Enforcement Considerations Statement in the guidance that it is not an “enforcement guideline” Statement in the guidance that it is not an “enforcement guideline” Under new guidance we will consider taking enforcement action at levels as low as can be legally substantiated down to 0.1 ppm Under new guidance we will consider taking enforcement action at levels as low as can be legally substantiated down to 0.1 ppm The enforceable level may be higher than 0.1 ppm for candy likely to be consumed in small amounts The enforceable level may be higher than 0.1 ppm for candy likely to be consumed in small amounts