Food Products That Are or Contain an Unsafe Food Additive

Why FDA issued it

This import alert has been developed for food products, including dietary supplements, that have been imported or offered for import into the United States that are adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. � 342(a)(2)(C)(i)] in that they are or contain any food additive that is unsafe within the meaning of section 409 of the FD&C Act [21 U.S.C. � 348]. A food additive is defined in section 201(s) of the FD&C Act as any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its' becoming a component of a food or otherwise affecting the characteristics of a food. This includes any substance intended for use in the producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding of food; and including any source of radiation for s

Quoted from the “Reason for Alert” section of the FDA page for 99-45, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.