INDUSTRY LETTER

Guidance for Industry: Letter to Manufacturers, Importers, and Distributors of Imported Candy and Candy Wrappers June 1995

Final

Docket Number:: FDA-2020-D-2006
Issued by:: Guidance Issuing Office

Human Foods Program

Updated Information: Guidance for Industry - Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy December 2005; Revised November 2006

June 13, 1995

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the Office of Plant and Dairy Foods, Division of Plant Product Safety.

This letter discusses two important matters concerning candy products offered for import or imported into the U.S. that have come to the attention of the U.S. Food and Drug Adminstration (FDA):

1) findings of lead-based printing inks on candy wrappers and;
2) findings of lead in the candy itself.

Findings of Lead-Based Printing Inks on Candy Wrappers.

The FDA received an increasing number of reports from its field offices and from State and local health authorities of findings of lead-based printing inks on wrappers of imported candy products. Reports of such findings have been accompanied by expressions of concern about the potential for lead to contaminate the candy and harm children who may eat the candy, and about the potential for lead to harm children who may put these wrappers in their mouths. Because research in recent years has made us more aware of the susceptibility of children to the harmful effects of lead, the FDA shares these concerns. Therefore, in response to these reports, we wish to state our policy and to note the actions that we are taking concerning the use of lead-based inks on candy wrappers.

The use of a lead-based printing ink on a food package causes the product to be in violation of the Federal Food, Drug, and Cosmetic Act (many States also have laws that are similar) if lead from the ink contaminates or can be reasonably expected to contaminate the food, either while it is held in the package or during the act of eating (e.g., in some circumstances as a consequence of children putting the wrappers into their mouths). In such cases, the product is subject to regulatory action by this agency to prohibit its entry into the country if offered for import or, if found within domestic commerce, to remove it from the market.

The FDA is currently conducting studies to identify circumstances under which the use of lead-based inks on wrappers could result in contamination of a food such as candy. Where it can be shown that the packaging poses the potential to contaminate food, we intend to take appropriate regulatory action to ensure that these products do not reach consumers.

Generally speaking, if lead derived from a lead-based printing ink is found on the portion of the package that directly contacts food or, if such lead could be expected to migrate into the packaged food, the product would likely be regarded as being in violation of the Federal Food, Drug, and Cosmetic Act. Use of the printing ink only on the outer (non-food contact) surface of the package does not ensure that it will not contaminate the food. In one instance investigated by the State of California, a colored paper package with a thin plastic inner coating was shown to contaminate a candy product because the thin plastic coating did not function as a barrier to lead migration from the paper into the candy. We are also concerned about the potential for contamination of the food-contact surface of a packaging material by contact with the outside printed surface bearing a lead-based ink. Finished packaging films are frequently distributed to end users (e.g., candy manufacturers) in rollstock form (i.e., rolled onto cores) in which the outside and food contact surfaces of the film are in contact.

Because of these concerns and considering the fact that suitable non lead-based printing inks are available for use in food packaging, we strongly urge all candy manufacturers whose products are offered for imoprt into this country to refrain from the use of lead-based printing inks on their packaging materials. This request is consistent with the longstanding policy of this agency. It has long been our goal to reduce exposure to lead from food to the maximum extent practicable.

We hope that candy manufacturers will voluntarily take this requested action as a means to ensure that their products will not face potential regulatory action by State or Federal Authorities for lead contamination. We view this as an important matter and intend to work closely with our State counterparts in research, sharing of information, and coordinating enforcement policies.
Findings of Lead in Candy.

Levels of lead found in some imported candy products by some States and by the FDA indicate that lead contamination of the candy not attributable to the use of lead-based printing inks on packaging materials may have occurred. It is not known whether such contamination could have arisen from the use of food ingredients containing high levels of lead, from food processing equipment, from utensils used in food plants, or from some other source. The agency is gathering information that should enable it to better understand the sources of lead in candy products.

While the agency does not have a standard for the maximum permissible level of lead in candy, we have authority to take regulatory action against any food product that contains a poisonous or deleterious substance that may render the product injuious to individuals. We also have regulations that require that ingredients used to manufacture food be safe, which requires that they be of a suitable degree of purity for their intended use. Further, our regulations require that equipment and utensils used in the production of food be designed and used in a manner that precludes contamination of the food with unsafe substances.

We believe that lead levels exceeding 0.5 part per million (ppm) (See updated information) in a candy product could constitute a basis for regulatory action against the product in cases where frequent consumption of the candy by small children could be anticipated. We have always recognized that some amount of lead in foods and food ingredients can occur due to unavoidable background levels of lead present in our environment. However, we also believe that sugar, the principal ingredient in most candies, when produced under good manufacturing practices, should contain levels of lead substantially below 0.5 ppm. We are 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. Manufacturers of these types of candy products need to establish controls to ensure that the use of such ingredients does not result in unacceptable levels of lead in the candy itself.

The FDA appreciates your cooperation in these two important matters that pertain to the safety of food products largely consumed by children.

Sincerely yours,

/S/

Fred R. Shank, Ph.D.
Director
Center for Food Safety and Applied Nutrition

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