Lead in CandyLead in CandyFDA OverviewFDA OverviewMichael E. Kashtock, Ph.D.Michael E. Kashtock, Ph.D.

U. S. Food and Drug AdministrationU. S. Food and Drug Administration

Center for Food Safety and Applied Center for Food Safety and Applied NutritionNutrition

Early history of the problemEarly history of the problem

In 1994 the state of California found In 1994 the state of California found ppm levels of lead in a powdered ppm levels of lead in a powdered Mexican candy that had migrated Mexican candy that had migrated from the wrapper. Findings were f/u from the wrapper. Findings were f/u to an EBLL investigation.to an EBLL investigation.

CA and FDA tested many other CA and FDA tested many other Mexican candy products at that time Mexican candy products at that time looking for candy contamination from looking for candy contamination from lead ink used on wrapperslead ink used on wrappers

Early history of the problem (cont’d)Early history of the problem (cont’d)

More candy with lead ink on wrappers was More candy with lead ink on wrappers was found, but none in which the ink (lead) found, but none in which the ink (lead) migrated into the foodmigrated into the food

Testing was showing higher levels of lead than Testing was showing higher levels of lead than expected in the candy proper, 0.05 vs. 0.2 ppmexpected in the candy proper, 0.05 vs. 0.2 ppm

Ultimately we learned that unwashed chili used Ultimately we learned that unwashed chili used as an ingredient was the principal source of as an ingredient was the principal source of leadlead

FDA issued 1995 “policy letter” addressing FDA issued 1995 “policy letter” addressing lead in candy and use of lead ink on candy lead in candy and use of lead ink on candy wrapperswrappers

Current PolicyCurrent Policy

Lead from wrapperLead from wrapper - FDA will take - FDA will take regulatory action against any candy regulatory action against any candy product with lead based ink on the product with lead based ink on the wrapper if the ink migrates into the candy wrapper if the ink migrates into the candy (1995 letter)(1995 letter)

Non-wrapper leadNon-wrapper lead - FDA will consider - FDA will consider taking regulatory action against any candy taking regulatory action against any candy product containing 0.5 ppm, or more lead product containing 0.5 ppm, or more lead (1995 letter to industry)(1995 letter to industry)

In 2004 FDA revised the 1995 policy to In 2004 FDA revised the 1995 policy to state that it would consider regulatory state that it would consider regulatory action if a labeled serving of candy action if a labeled serving of candy contained 10 or more micrograms of lead.contained 10 or more micrograms of lead.

Current Policy (cont’d)Current Policy (cont’d)

FDA has not found additional Mexican FDA has not found additional Mexican candy products with lead based ink which candy products with lead based ink which can migrate into the candycan migrate into the candy

If we find lead based ink on a candy If we find lead based ink on a candy wrapper that doesn’t migrate into the wrapper that doesn’t migrate into the candy, we inform the CPSCcandy, we inform the CPSC

If we find a candy product that exceeds If we find a candy product that exceeds the current guideline, we would likely the current guideline, we would likely remove from the market and place future remove from the market and place future shipments on DWPEshipments on DWPE

Current guideline, 0.5 ppmCurrent guideline, 0.5 ppm When established in 1995, was equivalent to When established in 1995, was equivalent to

the FCC limit for lead in sucrose and HFCS at the FCC limit for lead in sucrose and HFCS at the timethe time

FDA believed at the time that lead levels FDA believed at the time that lead levels well below 0.5 ppm were achievable in well below 0.5 ppm were achievable in candy if produced under GMPcandy if produced under GMP

Most candy products then and now were/are Most candy products then and now were/are << 0.5 ppm; currently most are < 0.1 ppm<< 0.5 ppm; currently most are < 0.1 ppm

Seen as an interim level that would be Seen as an interim level that would be lowered at a future timelowered at a future time

FCC level for sucrose and HFCS eventually FCC level for sucrose and HFCS eventually lowered to 0.1 ppmlowered to 0.1 ppm

FDA Current Activities FDA Current Activities

FDA stated its intent to lower its guidance FDA stated its intent to lower its guidance level for lead in candy in March 2004level for lead in candy in March 2004

OCR Series ran in April 2004OCR Series ran in April 2004 FDA published draft guideline for a 0.1 FDA published draft guideline for a 0.1

ppm recommended maximum level for ppm recommended maximum level for lead in candy in December 2005lead in candy in December 2005

75 Day comment period to end March 1375 Day comment period to end March 13 To be followed by final guidanceTo be followed by final guidance

Enforcement ConsiderationsEnforcement Considerations

FDA has an ongoing monitoring program for FDA has an ongoing monitoring program for Mexican candy at the border; we detain Mexican candy at the border; we detain candy with potentially harmful levels of lead. candy with potentially harmful levels of lead.

Focus sampling on high chili, high salt Focus sampling on high chili, high salt candiescandies

Current enforcement threshold is 10 Current enforcement threshold is 10 micrograms per labeled serving of candy, micrograms per labeled serving of candy, e.g., for 35 g serving ~ 0.3 ppm leade.g., for 35 g serving ~ 0.3 ppm lead

Current enforcement policy will change once Current enforcement policy will change once the guidance is finalizedthe guidance is finalized

Enforcement ConsiderationsEnforcement Considerations

Statement in the guidance that it is Statement in the guidance that it is not an “enforcement guideline”not an “enforcement guideline”

Under new guidance we will consider Under new guidance we will consider taking enforcement action at levels taking enforcement action at levels as low as can be legally as low as can be legally substantiated down to 0.1 ppmsubstantiated down to 0.1 ppm

The enforceable level may be higher The enforceable level may be higher than 0.1 ppm for candy likely to be than 0.1 ppm for candy likely to be consumed in small amountsconsumed in small amounts