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• Content META

  Title	The GRAS system at a crossroads
  ID	8336357
  External ID	7696037024
  Author	Ashish R. Talati, Niyati Patel
  Published Date	April 10, 2025, 7:33 p.m.
  Summary	HHS and FDA consider major changes amid legal and industry pushback. On March 10th, 2025, HHS Secretary Robert F. Kennedy Jr. instructed the acting FDA commissioner to explore potential rulemaking to
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  URL	https://www.nutritionaloutlook.com/view/the-gras-system-at-a-crossroads
  Sentiment	Negative: 0.04128    Neutral: 0.92045    Positive: 0.03828
  Relevance	0.00490

• Content Details

  Content ID	5641603
  Key	90d8dee2-6f76-46a7-af5d-a64ed6d43265
  Content	HHS and FDA consider major changes amid legal and industry pushback. On March 10th, 2025, HHS Secretary Robert F. Kennedy Jr. instructed the acting FDA commissioner to explore potential rulemaking to eliminate the self-affirmed pathway for establishing a substance as Generally Recognized as Safe (GRAS). Under the current GRAS system, companies can independently determine that a substance is safe for use in food without requiring formal FDA approval, as long as there is consensus among qualified experts. Eliminating this pathway would require companies to notify the FDA before marketing substances as GRAS—a rule that the FDA has previously acknowledged exceeds its statutory authority. Regardless, any attempt to change the GRAS framework is likely to face significant challenges, including strong industry resistance and resource constraints, making both rulemaking and broader legislative reform difficult to achieve. Past attempts to review all GRAS substances have proven cumbersome, and some of the most concerning substances, such as color additives, are already excluded from the self-GRAS process. Given these challenges, the FDA may be better served by focusing its efforts on identifying and banning the highest-risk substances rather than eliminating the self-GRAS pathway entirely. Background: History of GRAS The concept of GRAS dates back to the passage of the Food Additives Amendment to the FDCA (Federal Food, Drug, and Cosmetic Act) in 1958. The act gave the FDA the authority to regulate food additives to ensure they are safe for human consumption. However, recognizing that many substances used in food (example common spices, salt) had long been safely consumed, Congress created the GRAS exemption, allowing certain substances to bypass the food additive approval process. 1958: Background: History of GRAS The concept of GRAS dates back to the passage of the Food Additives Amendment to the FDCA (Federal Food, Drug, and Cosmetic Act) in 1958. The act gave the FDA the authority to regulate food additives to ensure they are safe for human consumption. However, recognizing that many substances used in food (example common spices, salt) had long been safely consumed, Congress created the GRAS exemption, allowing certain substances to bypass the food additive approval process. December 9, 1958 : FDA Published GRAS List The FDA first published a list of generally recognized as safe (GRAS) substances in the Federal Register of December 9, 1958. This list came to be called the GRAS list. The current GRAS list appears as Parts 182, 184, and 186 of the Code of Federal Regulations (CFR). 1969 : FDA Removes Cyclamate; Nixon Orders Comprehensive Review The FDA removed cyclamate salts from the GRAS list after studies linked them to an increased risk of bladder cancer in laboratory animals. In response, President Nixon ordered the FDA to reassess the safety of all GRAS substances under modern scientific standards to ensure they remained safe. 1970 : Comprehensive GRAS Review The FDA launched a full-scale review of all presumed GRAS substances. This involved evaluating the scientific evidence supporting each substance’s safety and determining if it should retain GRAS status. The FDA introduced a petition-based process, allowing manufacturers to seek confirmation of GRAS status. However, the process was highly time-consuming, taking up to 6 years (72 months) for the FDA to respond to a single petition. 1982: Suspension of Active GRAS Reviews After more than a decade, the FDA determined that the petition-based GRAS review process was unsustainable. The agency stopped conducting active GRAS reviews but continued to respond to petitions on a case-by-case basis when submitted by manufacturers. 1997 : Proposed Rule for Voluntary GRAS Notification To reduce the regulatory burden and accelerate the review process, the FDA introduced a voluntary GRAS notification program through a proposed rule. Under this system, companies could independently determine that a substance was GRAS based on publicly available scientific evidence and the consensus of qualified experts. Companies could notify the FDA of their determination, and the FDA would evaluate the evidence. If the FDA had no questions or objections, the company could proceed with marketing the substance without waiting for formal FDA approval. The FDA took about an average of 5 months (162 days) to respond. The FDA believed this would encourage companies to notify them rather than relying solely on self-affirmation. 2016: FDA Issues GRAS Final Rule Formalizing the Notification Procedure The FDA issued the GRAS final rule formalizing the GRAS notification program, clarifying that GRAS status must be supported by publicly available evidence and the consensus of qualified experts. The FDA retained the right to challenge a substance’s GRAS status if new scientific evidence raised safety concerns. However, companies could still market substances as GRAS without notifying the FDA, provided they could demonstrate expert consensus on safety. FDA’s Rulemaking Authority FDA’s rulemaking authority is derived from the FDCA and other statutes enacted by Congress. The FDA has the authority to issue regulations and guidelines to implement and enforce the provisions of these laws, but its rulemaking power is limited to the scope of authority expressly granted by Congress. The FDA cannot unilaterally impose new statutory requirements, eliminate existing exemptions, or fundamentally change the intent and purpose of a statute without Congressional approval. Here, the primary question remains: would requiring FDA approval for all GRAS substances effectively dismantle the GRAS exception altogether? This issue touches on the broader statutory authority of the FDA and the legislative intent behind the creation of the GRAS exception—an issue the FDA has previously addressed and concluded is beyond their statutory authority. During the 2016 GRAS rulemaking, some commenters urged the FDA to require companies to notify the agency when concluding that a substance is GRAS. In response, the FDA stated that it does not have “express statutory authority” to mandate GRAS notifications. The FDA explained that when Congress established the premarket approval requirement for food additives in the 1958 amendment, it deliberately excluded substances that are GRAS under their intended use from the definition of “food additive.” This exclusion reflected Congress’s determination that certain substances intentionally added to food do not need FDA premarket approval to ensure safety. The FDA, in both its 1997 proposed rulemaking and 2016 rulemaking, has acknowledged that manufacturers have been able to independently determine GRAS status without notifying the FDA, as permitted by statute. Thus, the FDA only has statutory authority to modify or clarify the criteria for determining GRAS status and the scientific basis for such determinations. Requiring FDA approval for all GRAS substances would effectively redefine “food additive” under the FDCA and close the GRAS exemption—something that would require an amendment to the FDCA. Furthermore, Congress’s intent to maintain the GRAS exception was reinforced by the Food and Drug Administration Modernization Act (FDAMA) of 1997, which amended Section 409 of the FD&C Act to create a mandatory food-contact notification program for human food. Yet, Congress did not amend section 409 to require a mandatory premarket GRAS notification process.
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  Publisher Name	Nutritional Outlook (#7595)
  Publisher URL	nutritionaloutlook.com
  Description	None
  Trust Flow Score	20
  Citation Flow Score	42

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  Data Source Name	Quantexa News (#5)
  Data Source Type	news
  Data Source URL	https://app.aylien.com/dashboard
  Description	Welcome to Quantexa News API — the most powerful way to aggregate, filter, and integrate global news data into your apps and models.
  Weight	10