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July 20, 2006
As published in the June 29 Federal Register, the Food and Drug Administration (FDA) is requesting comments concerning the establishment of program priorities in the Center for Food Safety and Applied Nutrition (CFSAN) for fiscal year (FY) 2007. As part of its annual planning, budgeting, and resource allocation process, CFSAN is reviewing its programs to set priorities and establish work product expectations. This Federal Register notice has been published to give the public an opportunity to provide input into the priority- setting process. CFSAN is interested, in part, in comments regarding the broad program areas that its stakeholders believe should continue to be a priority in FY 2007 as well as suggestions for new program areas or activities that should be added as a high priority for FY 2007. Written or electronic comments are due by August 28, 2006. Information for providing comments is provided in the Federal Register notice.
The Food and Drug Administration (FDA) has issued a letter directed to the manufacturers and suppliers of soft vinyl lunchboxes marketed in the United States as a result of recent testing performed by the Consumer Product Safety Commission (CPSC) that disclosed that the interior polyvinyl chloride (PVC) linings of certain flexible lunchboxes contain lead. It is believed that the source of the lead is likely to be lead-containing compounds used as adjuvants in the manufacture of polyvinyl chloride (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, the FDA is urging companies to refrain from marketing such lead-containing lunchboxes.
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 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.
The letter issued is available on the FDA's Center for Food Safety and Applied Nutrition's (CFSAN) website (Letter to Manufacturers and Suppliers Concerning the Presence of Lead in Soft Vinyl Lunchboxes).
