FDA recently published a new guidance document related to maximum levels of lead in candy likely to be eaten frequently by small children. It includes guidance for industry as well as likely enforcement measures.
This guidance provides a recommended maximum lead level of 0.1 ppm in candy likely to be consumed frequently by small children. FDA considers the recommended maximum lead level to be achievable with the use of good manufacturing practices in the production of candy and candy ingredients and to be protective of human health. For additional discussion of the background and rationale underlying this recommended level, see “Supporting Document for Recommended Maximum Level for Lead in Candy Likely to Be Consumed Frequently by Small Children” (http://www.cfsan.fda.gov/~dms/pbcandy2.html).
In addition to announcing the recommended maximum lead level, FDA is rescinding the previous 0.5 ppm guideline for considering enforcement action against candy products likely to be consumed frequently by small children. FDA is prepared to take enforcement action against any candy product containing lead at levels that may pose a health risk. Further, FDA is reiterating its enforcement policy toward the use of lead-based ink on candy wrappers as originally stated in its 1995 letter to the industry on this subject.
FDA considers the issuance of this guidance to be a prudent public health measure consistent with the Agency’s policy of reducing lead levels in the food supply to reduce consumers’ lead exposure to the lowest level that can be practicably obtained.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
To view the complete guidance document, see http://www.cfsan.fda.gov/%7Edms/pbguid3.html.