Monday, March 29, 2010

FDA Issues ‘Import Alert’ for Labeling Violations: Many Non-U.S. Firms Affected

(, LLC)

On March 09, 2010, U.S. Food & Drug Administration (FDA) issued Import Alert #99-20, “Detention Without Physical Examination of Imported Food Products Due to Nutritional Labeling Education Act (NLEA) Violations” (IA 99-20) FDA enforces all laws and regulations related to “Front of Package” labeling and Nutritional Facts Panels. This applies to both imported and domestic products. According to Benjamin L. England, of, LLC, despite NLEA being issued in 1994, “…the new Import Alert makes it clear FDA is substantially increasing its enforcement of food manufacturers and importers, under this statute. FDA will stop importers from selling products with illegal claims on their labels.”

Many manufacturers have already been placed on Import Alert #99-20, being charged with the simplest violation that the FDA can target; labeling violations. In order for a product or manufacturer to be placed on IA 99-20 – which automatically detains the product at the Customs Port of Entry even without physically examining the product – the product need only “appear” to violate NLEA. According to the alert, when FDA first discovers a product or manufacturer has violated NLEA, FDA may issue a Release “with comment” which instructs the importer that the violation must be remedied on future shipments. “In our experience,” stated Mr. England, “FDA often just refuses the product” resulting in expensive delays and shipping charges for the importer. IA 99-20 indicates that if the importer violates NLEA after the first offense, then FDA will place the importer on the import alert, which will cause the importer’s products to be Detained Without Physical Examination and ultimately refused entry into the United States.

Manufacturers under Import Alert #99-20 have been charged pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act: “(the product) appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required nutritional information,” “bears an unauthorized nutrient content/health claim,” and/or “fails to bear required information (e.g. juice percentage, names of each ingredient and names of color additives).” Read more here.