FDA Intends to Issue Guidance Document on Imported Candy Products Containing Lead
The Food and Drug Administration (FDA) has posted to its Web site a letter to inform manufacturers, importers and distributors of imported candy that the FDA intends to publish at a future date a guidance document that will reduce its guidance level for considering enforcement action against candy products containing lead.
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FDA's 1995 guidance specified an 0.5 ppm guideline for lead in candy. The FDA explains that in 1995, it issued a letter advising manufacturers, importers, and distributors of imported candy that where frequent consumption of candy products by small children could be anticipated, it would consider taking regulatory action against candy with lead levels that exceeded 0.5 parts per million (ppm). The FDA notes that the 0.5 ppm guideline was, at that time, equivalent to the Food Chemicals Codex (FCC) specification for lead in sucrose (sugar), the main ingredient in candy.
New developments since 1995. Since it issued its 1995 letter, the FDA states that the FCC specification for lead in sucrose has been reduced from 0.5 ppm to 0.1 ppm.
Since 1995, FDA states that it has also learned that certain ingredients often used in candy products imported into the U.S. may be a source of avoidable lead exposure. These ingredients include chili powder and tamarind, which are used in candies marketed to the U.S. Hispanic population.
In addition, FDA states that it is concerned that there may be certain manufacturing processes or conditions that contribute to elevated lead levels in candy, such as the drying of raw ingredients in areas with high levels of airborne lead, storing ingredients in improperly glazed ceramic vessels that may leach high levels of lead into the product, and grinding ingredients under conditions that may result in lead contamination.
(FDA sources state that it is not yet known how much the guidance level will be reduced, as various factors must be considered in making this determination. For example, in its 1995 guidance the FDA states that it is aware that some candies contain significant amounts of lesser refined ingredients, such as chili powder, that may have higher levels of lead than highly refined ingredients like sugar.
FDA sources have also stated that the date of publication of the new guidance has not yet been set.)
Candy found containing harmful levels of lead continues to be subject to regulatory action.In its letter the FDA states that even absent revised guidance on lead levels, under U.S. law, any food product, including candy, is subject to regulatory action if the FDA finds that the food contains harmful levels of lead or that it is manufactured under conditions that may cause the food to become contaminated with lead in a manner that could present a health risk to consumers.
FDA letter (dated 03/25/04) available at http://www.cfsan.fda.gov/dms/pbltr.html
FDA 1995 guidance (dated 06/13/95) available at http://www.cfsan.fda.gov/dms/pbguid.html