Letter to Manufacturers, Importers, and Distributors of Imported Candy

To: Manufacturers, Importers and Distributors of Imported Candy

This letter is to inform you of actions the Food and Drug Administration (FDA) intends to take to reduce further the potential exposure of children to lead from candy products.

It has been a longstanding objective of the FDA to reduce, to the extent practicable, consumer exposure to lead from foods. The adverse health effects of the elevated lead levels in children are well-documented and may have long-lasting or permanent consequences. These effects can occur even at low exposure levels, and may include delayed mental and physical development, and learning deficiencies. Because lead accumulates in the body, exposures to even small amounts of lead can contribute to the overall level of lead in the blood and to the subsequent risk of adverse health effects.

Over the years, the FDA has pursued the goal of reducing foodborne lead exposure through a variety of means, including setting mandatory lead limits for certain foods, establishing non-binding guidance levels for lead in foods, and encouraging voluntary industry action to reduce consumer exposure to lead from food. Some of these efforts have been progressive in nature, as improved manufacturing methods have enabled the FDA to reduce previously established lead limits to provide a greater margin of public health protection.

In 1995, the FDA issued a letter (available at http://www.cfsan.fda.gov/~dms/pbguid.html), advising manufacturers, importers, and distributors of imported candy that where frequent consumption of candy products by small children could be anticipated, the agency would consider taking regulatory action against candy with lead levels that exceeded 0.5 parts per million (ppm). 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. The FCC is a compendium published by the Food and Nutrition Board of the Institute of Medicine, National Academy of Sciences, which contains food-grade specifications for food ingredients; in most cases, these specifications are eventually incorporated into relevant FDA regulations.

Since we issued our 1995 letter, the FCC specification for lead in sucrose has been reduced from 0.5 ppm to 0.1 ppm. Since 1995, we have 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, we are 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.

Because we believe that it is in the interest of public health to continue to work toward reducing the levels of lead in food, including candy, we intend to publish at a future date a guidance document that will reduce our guidance level for considering enforcement action against candy products containing lead.

In closing, we remind you that it is your responsibility to ensure that foods you produce, import, or distribute for the U.S. market comply with all relevant FDA laws and regulations. Importantly, 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.

Any questions about this matter should be directed to Dr. Michael E. Kashtock at 301-436-2022.