FDA’s legal authority to check U.S. export documentation questioned
The U.S. Food and Drug Administration will consider in a proposed rulemaking whether to revise its regulations for inspecting export records held by American food and cosmetic companies.
A petition filed on June 17 on behalf of the Cosmetic, Toiletry, and Fragrance Association questioned the agency’s legal authority under the FDA Export Reform and Enhancement Act to inspect export documentation. The petition claimed that U.S. exporters do not have to demonstrate compliance with foreign law. Instead, the FDA must show that the U.S. exporter violated foreign laws.
The industry group’s petition pointed out that it’s “common industry practice to manufacture products in the United States that contain ingredients or levels of ingredients approved or permitted by foreign countries but not by FDA.”
The industry group is concerned that if the FDA enforced the burden-of-proof requirements of its export recordkeeping rule companies would be forced to prepare “tens of thousands” of affidavits just for Canada and Mexico alone, and “new affidavits would be required for every product variation and every label change.”
The industry group warned the FDA that the affidavits “would simply drive food and cosmetic manufacturers abroad.”
The FDA stands behind its legal authority to inspect export documentation. “It could be extremely difficult for us to determine a food or cosmetic company’s compliance with the act’s export provisions if we could not inspect export records,” the agency said. “Without access to such records, our enforcement … of the act would likely depend on information submitted voluntarily to us, and it is hard to rely on a company to provide information about itself that would indicate a possible violation of federal law.”
The FDA will take industry comments regarding the advance notice of proposed rulemaking through Aug. 16. For instructions for submitting comments on-line, access: http://www.fda.gov/dockets/ecomments.