Individuals wanting to add a new substance to a conventional food have two options for achieving regulatory compliance. They can either submit a food additive petition to FDA or notify FDA of their determination that the substance is generally recognized as safe (“GRAS”).
Under FDA’s food additive regulations, food additives require premarket approval. A “food additive” includes any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component of food or otherwise affecting the component of food. 21 U.S.C. § 321(s). Exempted from the “food additive” definition, however, are GRAS substances, i.e., “substances that are generally recognized, among experts qualified by scientific training and experience to evaluate their safety as having been adequately shown through scientific procedures . . . to be safe under the conditions of their intended use.” Id. A substance is GRAS only for a specific intended use, just as a food additive is only approved for a specific intended use.
Originally, an individual could petition FDA for permission to use a new food additive or for affirmation that a new substance is GRAS. See, e.g., 21 C.F.R. §§ 170.35, 171.1. If FDA determined that the food additive is safe or affirms that a substance is GRAS, FDA could issue a new regulation stating that determination. In 1997, however, FDA found that the GRAS affirmation petition process required too many resources, and it published a proposed rule implementing a GRAS notification process to supersede the GRAS affirmation petition process. Under the GRAS notification program, an individual can notify FDA of his or her determination that a substance is GRAS for its intended use, as opposed to petitioning FDA to affirm that the substance is GRAS for its intended use.
No regulations are issued under the GRAS notification program. Rather, FDA evaluates whether a notice has a sufficient basis for the GRAS determination and sends a letter to the notifier stating that it either: (1) does not question the basis for the notifier’s GRAS determination; or (2) concludes that the notice does not provide a sufficient basis for a GRAS determination. If the latter is true, the substance cannot be added to conventional food without a food additive petition. Because no regulation is issued, FDA maintains a GRAS notice inventory that contains information about GRAS notifications filed since 1998, including FDA’s response to the notification.
Whether someone should choose the food additive petition route or the self-GRAS determination route depends upon whether there is a general safety consensus among qualified experts. When a food additive petition is submitted to FDA, the agency typically evaluates privately held information it receives from the petitioner and then determines whether the substance is safe under its intended use. When a self-GRAS determination is made, the information about the substance is broadly available and publicized, and qualified experts outside of FDA can form the consensus that serves as the basis for the safety determination.
