The GRAS system at a crossroads

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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.

Legislative and Regulatory Processes for Modifying the GRAS System

To amend the FDCA and eliminate GRAS, Congress follows an extensive process that includes drafting, committee review, debate, voting, and presidential approval. Similarly, any change from the FDA will require formal rulemaking under the Administrative Procedure Act, which involves publishing a proposed rule, allowing public comments, and issuing a final rule based on feedback. Through either avenue, both the FDA and Congress would face many challenges:

• Industry resistance and lobbying efforts:
  • Powerful lobbying groups would resist eliminating self-GRAS, citing increased costs and supply chain disruptions. This could lead to delays through political debates, legal challenges, and potential legislative actions, further hindering the FDA’s efforts to implement any such proposed rule. Furthermore, legal challenges from industry stakeholders on constitutional grounds could tie up the proposed rule in litigation for years, further delaying its implementation and possibly forcing revisions or abandonment of the proposal.
• Cost-benefit analysis:
  • A cost-benefit analysis would be needed to weigh public health benefits against the economic burden on the food industry. Eliminating self-GRAS would increase compliance costs, testing expenses, and product development delays, particularly harming smaller companies and startups, potentially stifling innovation and consolidating market power among larger manufacturers.
• FDA’s resource burden:
  • Shifting safety assessments to the FDA would require more staff, funding, and scientific review capacity, leading to longer approval times, increased costs, and internal resistance due to resource constraints, undermining the FDA’s efficiency. Historical precedent, such as President Nixon’s call for a comprehensive GRAS review, shows that reviewing every GRAS substance would be burdensome given current staffing and budgetary constraints.
• Executive Order 14192 and the Trump administration’s focus:
  • Executive Order 14192, titled “Unleashing Prosperity Through Deregulation” mandates that for every new regulation issued, federal agencies must identify and eliminate at least ten existing regulations. Eliminating self-GRAS would also contradict the current administration’s stance on reducing regulatory burdens and promoting business-friendly policies.

Color Additives and the GRAS Misconception

In an announcement video posted on X, the HHS Secretary specifically mentioned concerns over Red 40, Yellow 5, and Yellow 6 in the U.S., misclassifying them as “generally recognized as safe” (GRAS). However, color additives are not classified under GRAS, as they are all subject to FDA approval. Under the FDCA, all color additives, as well as new uses for listed color additives, must be approved by the FDA before they can be used in foods, drugs, cosmetics, or certain medical devices, or applied to the human body. There is no GRAS provision for color additives within the statutory definition. This distinction is critical, as it underscores a common misconception about the regulatory framework surrounding these substances and highlights ongoing challenges in achieving scientific consensus. Even FDA-approved substances, such as artificial colorants, may face conflicting scientific assessments as new research emerges—Red Dye No. 3, for example, was recently banned. Thus, many of the most pressing public health concerns regarding food additives, such as food dyes, cannot be resolved simply by eliminating the self-GRAS process.

State Bans and the Need for Ongoing Safety Evaluation

State actions, such as West Virginia’s recent ban on these color additives, further complicate public discourse. States have the authority to impose stricter regulations based on their own health and safety concerns, even when substances are federally approved. While the FDA may deem these dyes safe, some states, citing studies linking the dyes to behavioral issues in children, have opted to impose bans. This creates a fragmented regulatory environment, where food manufacturers must navigate a patchwork of regulations.

The underlying scientific and regulatory conflict persists, regardless of whether self-GRAS is eliminated. The tension between state and federal regulation complicates efforts to ensure consistent and reliable food safety standards. A more effective solution may not be the elimination of self-affirmed GRAS, but rather a continuous, rigorous scientific evaluation of potentially harmful substances. This approach should include regular inspection and consistent enforcement by FDA to ensure that all substances used in food products are safe, even for those that have not been formally notified to the FDA.

What Companies Should Do Now: Preparing for Potential Legal and Regulatory Challenges in the GRAS System

At this stage, nothing has changed. The self-affirmed pathway for GRAS is far from being eliminated. Challenges related to FDA rulemaking authority, industry resistance, and resource limitations will delay any major changes to the current framework. However, companies may encounter increased litigation and heightened regulatory scrutiny, particularly for those that have self-affirmed GRAS for certain substances. To prepare for potential legal and regulatory challenges, companies that have self-affirmed GRAS status can:

• Review and strengthen safety dossiers:
  • Ensure that the scientific data supporting each self-affirmed GRAS substance is comprehensive, up-to-date, and robust enough to withstand legal and regulatory challenges.
• Conduct additional studies if needed:
  • Be prepared to conduct additional studies to address emerging safety concerns or evolving public health debates that could arise.
• Monitor and prepare for regulatory and legal changes:
  • Regularly review internal processes to ensure compliance with existing regulations and proactively prepare for potential future changes to avoid disruptions and maintain customer confidence.

Questions?

If you have any questions about GRAS, Food Additives, Color Additives, New Dietary Ingredient Notifications, contact Talati Law Firm PLLC at ashish@talati-law.com.