Import Alert 33-10

"Detention Without Physical Examination of Candy Due to Lead"

NOTE:

The revision of this Import Alert dated 3/12/2010 lowers the level at which FDA will consider regulatory action for products found to contain lead to 0.1ppm, removes some of the consumption calculation as determined by CFSAN, and updates the guidance section. Changes are bracketed by asterisks (***).


*** Since 1994, when an imported candy product from Mexico was found to be contaminated with lead, FDA has tested candy products to determine if the products contain lead at levels which may pose a health risk to consumers.

Sources of excessive lead levels in candy that have been identified include ingredients such as mined salt with high levels of naturally occurring lead, chili prepared from unwashed peppers, and packaging/packing materials, such as wrappers printed with lead based ink and lead glazed ceramic bowls.

While incidents of lead contamination due to packing or packaging materials have not occurred since the mid-1990s, findings or elevated lead levels in candy products containing chili are still occurring.

In 1995, FDA initially provided guidance in this import alert that it would consider action against candy products that exceeded 0.5ppm lead. The 1995 guidance was established based upon an estimated daily candy consumption of 21 grams. FDA later determined that for candy products with sizes substantially larger than 21 grams, children are likely to consume the entire product in one eating occasion and therefore revised this import alert to indicate that it would consider taking action against candy products with 0.5ppm of lead or less when consumption of the entire product would result in a lead intake of 10 micrograms or greater.

Recent findings indicate that adverse effects occur at lower blood lead levels than previously determined. In order to continue to provide adequate protection to children who consume candy products, FDA has determined the Agency may consider action against candy products which contain lead in excess of 0.1ppm.

FDAs Center for Food Safety and Applied Nutrition issued the document Guidance to Industry - Lead in Candy Likely to Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy in October, 2009. FDA is revising this Import Alert accordingly. ***

*** Districts may detain without physical examination, all products from the manufacturers and/or shippers identified on the Red List of this alert.

Surveillance sampling of other candy products is indicated. If the wrapper is considered to be a possible source of elevated lead levels, both the candy and wrapper should be analyzed for lead.

When Districts collect samples of candy which are found to be violative for lead through laboratory analyses, a recommendation for detention without physical examination and background information should be forwarded to DIOP. DIOP will coordinate with CFSAN for concurrence.

In order to consider regulatory action, one of the following conditions must be met:

Analysis of the candy shows greater than 0.1 ppm lead; or, Evidence exists that lead has migrated from the wrapper/container to the Candy

Districts should consider that each candy may present a different situation with regard to the potential for regulatory action. For example, the following considerations may be relevant:

Is there both an inner and outer wrapper? If there is an inner wrapper, does it act as a barrier to lead migration?

Is there ink on any surface that may come in contact with the candy? Is the ink on the inner or outer surface of the wrapperL?

For additional sampling and analytical guidance, refer to Compliance Program Guidance Manual 7304.019 Toxic Elements in Food and Foodware, and Radionuclides in Food and Guidance to Industry - Lead in Candy Likely To Be Consumed Frequently By Small Children: Recommended Maximum Level and Enforcement Policy. ***

For questions on issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301-796-6600.

All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.

See attachment

The article is subject to refusal of admission pursuant to Section 801(a)(3), in that the article appears to bear or contain a poisonous or deleterious substance, lead which may render it injurious to health [Adulteration, Section 402(a)(1)];

***OASIS charge code - POISONOUS***

and/or

The article is subject to refusal of admission pursuant to Section 801(a)(3), in that the article appears to bear or contain a food additive, lead, that is unsafe within the meaning of Section 409 [Adulteration 402(a)(2)(C)]."

***OASIS charge code - UNSAFE ADD***

and/or

The article is subject to refusal of admission pursuant to Section 801(a)(3), in that its container (paper wrapper) is composed in part of a poisonous or deleterious substance, lead, which may render the contents injurious to health [Adulteration, Section 402(a)(6)];

***OASIS charge code - CONTAINER***