THE WHAT? The US Food and Drugs Administration has issued a proposed rule to amend the color additive regulations to increase the fees for certification services.
THE DETAILS Under the Federal Food, Drug, and Cosmetic (FD&C) Act, certain color additives must be certified by the FDA for use in food, drugs, cosmetics, and medical devices. The FDA analyzes samples from each batch of color additive received from a manufacturer and verifies that it meets composition and purity specifications. Certification is performed before the color additives are permitted to be used in products marketed to U.S. consumers. Manufacturers pay fees, based on the weight of each batch, and these fees support the FDA’s color certification program.
If passed, the proposed rule would impose a 10 cent per pound increase on the charge levied for certification, the first rise since 2005 when the current schedule became effective.
THE WHY? The FDA said that an increase is necessary to cover increased operating costs in order to ensure the color certification program continues to operate at the high level of quality and efficiency that industry expects.