FDA Reminds Food Manufacturers About FD&C Act Requirements

WASHINGTONThe U.S. Food and Drug Administration (FDA) on Jan. 14 issued a guidance as a strong reminder to manufacturers and distributors of conventional foods about Federal Food, Drug, & Cosmetic Act (FD&C Act) requirements for substances added to conventional foods, including beverages.

The guidance, published in the Federal Register, also reminded dietary supplement manufacturers and distributors that the same requirements apply to certain substances that are added to dietary supplements; namely, those that are not dietary ingredients as defined in the FD&C Act.

The Guidance for Industry: Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements" states: We are concerned that some of the novel substances that are being added to conventional foods, including beverages, may cause the food to be adulterated because these added substances may not be GRAS for their intended use and are not being used in accordance with a food additive regulation prescribing conditions of safe use. In addition, some substances that have been present in the food supply for many years are now being added to conventional foods at levels in excess of their traditional use levels or in new types of conventional foods. This trend raises questions as to whether these higher levels and other new conditions of use are safe."

FDA makes clear that if a substance is not generally recognized as safe (GRAS) by qualified experts for its intended use in food and does not qualify for any of the other exemptions from the food additive definition, it is a food additive. Many substances intentionally added to beverages and other conventional foods are food additives that require premarket approval based on data demonstrating safety. Usually, these data are submitted to FDA in a food additive petition, although the agency may also approve a food additive on its own initiative without first receiving a petition. FDA issues food additive regulations specifying the conditions under which an additive has been demonstrated to be safe and, therefore, may be lawfully used. Any unapproved food additive used in a beverage or other conventional food causes the food to be adulterated under the FD&C Act. Adulterated foods cannot be legally imported or marketed in the United States.

If a substance is GRAS under the conditions of its intended use in food, it is exempt from the definition of a food additive, and thus, from pre-market approval. For a particular use of a substance to be GRAS, there must be both evidence of safety and a basis to conclude that this evidence is generally known and accepted by qualified experts. In addition, under the second part of the GRAS standard, the scientific evidence to establish the safety of the substance for its intended use must be generally available, and there must be a basis to conclude that consensus exists among qualified experts about the safety of the substance for its intended use.