July 20, 2006
Note to: Suppliers or Vendors of Soft Vinyl Lunchboxes:
The Food and Drug Administration (FDA) is directing this letter to manufacturers and suppliers of soft vinyl lunchboxes marketed in the United States. Based on testing performed by the Consumer Product Safety Commission (CPSC), we have learned that the interior polyvinyl chloride (PVC) linings of certain flexible lunchboxes contain lead (Pb)1. We believe that the source of the lead is likely to be lead-containing compounds used as adjuvants in the manufacture of PVC. Because neither lead nor lead compounds are authorized for use in the manufacture of PVC food-contact articles such as lunchboxes, and some migration of lead to food as a result of such use may reasonably be expected, we urge companies to refrain from marketing such lead-containing lunchboxes.
While the amount of lead that may transfer to food from these lunchboxes is likely to be relatively small, 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 elevated lead levels in children are well-documented and may have long-lasting or permanent consequences. Because lead accumulates in the body, these effects can occur even at low exposure levels, and may include delayed mental and physical development, and learning deficiencies.
Any component of these lunchboxes that is reasonably expected to become a component of food is potentially a food additive, subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, substances that are reasonably expected to migrate to food because of their intended use are defined as food additives (FD&C Act Section 201(s)) if they are not prior sanctioned or generally recognized as safe (GRAS) for their use. All food additives are required to undergo FDA premarket approval in accordance with Section 409 of the FD&C Act. However, neither lead nor any lead compound is authorized for use in PVC food-contact material.
According to the CPSC data, a small amount of the lead present in the interior linings of the lunchboxes is transferable by a swipe test. This implies that a small amount of lead may reasonably be expected to transfer to food that contacts the interior lining and could be deemed to be an unsafe food additive within the meaning of section 409 of the FD&C Act, and therefore adulterated within the meaning of section 402(a)(2)(C) of the statute. Therefore, the lunchboxes containing the lead compounds may be subject to enforcement action.
As always, manufacturers and suppliers are encouraged to consult with the agency regarding the regulatory status of component substances of food-contact articles, including those that may be under consideration as alternatives to lead compounds.
Please do not hesitate to contact us if you have any questions concerning this matter.
Laura M. Tarantino, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
1 Unpublished data. See US Consumer Product Safety Commission Q&As: Vinyl Lunch Boxes.