Senator Marshall Introduces GRAS Reform Bill

GRAS Background

Under the Federal Food, Drug, and Cosmetic Act (FFDCA), any “food additive” added to a food is considered unsafe, rendering the finished food legally adulterated, unless the specific use for which it is added to the food has been authorized by FDA pursuant to a food additive regulation.¹ However, this statutory definition of a “food additive” expressly excludes substances that are generally recognized as safe (GRAS) based either on (a) common use in food before 1958 or (b) scientific procedures.² The law currently allows an entity to pursue a GRAS determination in one of two ways: (a) through self-affirmation or (b) by submitting a voluntary GRAS Notification to FDA.

GRAS Listing Requirement

Under the proposed legislation, any food containing a food substance marketed on a GRAS basis would be deemed adulterated under the FFDCA Section 402(a) clause (2)(C) unless the substance is included on a list maintained by FDA or the substance is under review by FDA and the agency has not yet made a final determination regarding its safety. Notably, the bill would require all GRAS ingredients to be included on the newly created list and would not exempt, for example, commonly used foods (e.g., fruits, vegetables, honey, nuts, grains), flavors covered by a monograph issued by the Flavor Extract Management Association (FEMA), GRAS food contact substances, or substances that are the subject of a GRAS regulation or voluntary GRAS notification. As a result, any food containing a substance that is not the subject of a food or color additive regulation or food contact notification or that is not a prior-sanctioned ingredient would be deemed adulterated if the substance is not included on FDA’s list of GRAS substances. The bill would require FDA to promulgate rules to establish the procedures to “establish and maintain a publicly accessible list” of GRAS substances within two years of enactment.³

1. Notice and Listing Timeline

The proposed legislation would allow any person to file with FDA a “notice” proposing inclusion of any food substance on the list of GRAS substances. Notices for substances marketed on the basis of GRAS prior to the bill’s enactment must be submitted no more than two years after the bill’s enactment. Notices for new substances must be submitted at least 120 days prior to the first use of the food substance.

After receiving a notice, the agency would have 180 days to either add the food substance to the list of GRAS substances or make a preliminary determination to exclude the substance from the list. The bill would require a notice proposing inclusion of such substance on the list and does not provide any details on what, if any information, must be included in the initial notice. Notably, the bill states, “If the Secretary does not make a preliminary determination to exclude a food substance [within 180 days], such food substance shall be deemed to be added to the list [of GRAS substances.]” In other words, agency inaction would be deemed an approval of the GRAS substance.

2. Excluded or Delisted Substances

If FDA makes a preliminary determination to exclude a substance from the GRAS list, any person using the substance would be required to submit one of three responses within 180 days of the preliminary exclusion: (1) a request that the agency reconsider the exclusion, including “any additional information the [agency] may request” to determine the substance’s safety (e.g., a GRAS dossier); (2) a food additive petition under FFDCA Section 409; or (3) a phase-out plan.

The agency would make a final determination of a substance’s safety only upon receiving a request to reconsider. However, as noted above, the bill provides that any substance undergoing final review by the agency would not be deemed adulterated while still under review.

The above procedure for excluded or delisted substances would also apply to removals from the list pursuant to the post-market assessment procedure, discussed below.

Changes to Other Provisions

The bill would modify several FFDCA provisions, most notably the definition for food additives in FFDCA Section 201(s) (21 U.S.C. § 321(s)) and the conditions of adulterated food in FFDCA Section 402(a)(2)(C) (21 U.S.C. § 342(a)(2)(C)).

1. Food Additive Definition

The definition of “food additive” would be revised to remove the existing GRAS clause and add “a food substance generally recognized as safe” as an exception to the definition of “food additive.” A “food substance generally recognized as safe” would in turn be defined as

any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use, except that such term does not include [food additives, pesticide chemical residues, pesticide chemicals, color additives, prior sanctioned ingredients, new animal drugs, or dietary ingredients]

The proposed language largely tracks the type of substances that are included in the existing definition of food additive, including food contact substances. The definition would provide greater flexibility for the use of radiation by including it in the definition of a GRAS substance while the existing definition treats all sources of radiation as food additives.

2. Adulteration Provision

The “adulteration” provision would be modified by providing that food is adulterated if it bears or contains “a food substance generally recognized as safe that is not included on the list maintained by [FDA] . . . or is under review.”

Post-market Assessment of Food Additives, Color Additives, and GRAS Substances

The proposed legislation includes a provision that would allow FDA to conduct a post-market review of any food additive, color additive, or GRAS substance if the agency receives a petition from a citizen or a notice from a state government detailing concerns about a substance’s safety, or if FDA itself determines a substance presents a safety concern. After review, the agency could amend or revoke any food or color additive usage regulation. For GRAS substances, the agency could determine the substance to be a “food additive” and remove it from the GRAS substances list that would be created by the legislation.

The bill would require FDA to prioritize citizen petitions and state government notices for substances “for which clear and convincing scientific evidence supports the concerns raised in the petition or notice.” The agency would be required to publish a “request for safety information” in the Federal Register for any substance subject to the agency’s post-market review.

The proposed legislation also includes limitations on the agency’s post-market review process. First, the bill would require that any determination, final action, or re-evaluation related to post-market review must be subject to notice and comment rulemaking and must be reviewed and recommended by “individuals serving in positions in the Food and Drug Administration under career appointments and who have relevant scientific and regulatory expertise.” Second, the bill states clearly that review authority cannot be delegated to “an individual occupying a position for which appointment is made by the President” or to any FDA employee not serving a career appointment.

Preemption

The bill does not contain language that would expressly preempt states from establishing requirements for food additives, color additives, or GRAS substances that differ from the federal requirements. It is unclear whether the provision that allows states to submit a petition seeking FDA review of an authorized food or color additive or listed GRAS substance ultimately would be given some type of preemptive effect by the courts.

Next Steps

We will continue to monitor the status of this legislation. As a reminder, no changes have been made to the law or regulations regarding GRAS. As such, it is still appropriate for companies to market ingredients on the basis of a GRAS determination.

Please let us know if you have questions.