USA - NATIONWIDE: An Introduction to Food & Beverages: Regulatory & Litigation

The GRAS System at a Crossroads: What Industry and Legal Stakeholders Need to Know

On March 10, 2025, HHS Secretary Robert F. Kennedy Jr. directed the acting FDA commissioner to explore rulemaking that could eliminate the self-affirmed pathway for substances classified as “Generally Recognized as Safe” (GRAS). Currently, food companies can independently determine a substance’s GRAS status based on publicly available scientific data and expert consensus—without notifying the FDA. Kennedy’s directive would require companies to notify the FDA before marketing any GRAS substances.

This move comes amid a broader shift at the FDA toward more proactive regulation, reflected in recent actions to reevaluate fluoride levels in bottled water, update nutrient standards for infant formula, and restrict certain color additives. These initiatives signal a growing willingness to challenge established industry practices and general increased FDA scrutiny over food safety standards.

However, overhauling the GRAS pathway faces significant challenges: the FDA’s authority is limited by statute, Congressional approval would likely be required, and industry opposition is expected to be strong. Given these hurdles, the FDA may find it more practical to focus on banning or reviewing specific high-risk ingredients rather than revamping the entire GRAS framework.

Background: a history of GRAS

The GRAS concept originated in the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FDCA). While this law empowered the FDA to regulate food additives for safety, Congress recognized that many substances—like salt and spices—had long histories of safe use. To avoid unnecessary regulation, Congress created the GRAS exemption, allowing these substances to bypass the formal food additive approval process.

• On December 9, 1958, the FDA published the first official GRAS list, now codified in the Code of Federal Regulations (CFR Parts 182, 184, and 186).
• In 1969, the FDA removed cyclamate salts from the GRAS list after studies linked them to cancer risks. This spurred President Nixon to order a comprehensive review of all GRAS substances based on modern scientific standards.
• The FDA responded with a petition-based process for manufacturers to seek GRAS confirmation. However, this process was slow and resource-intensive, sometimes taking up to six years per petition.
• By 1982, the FDA suspended active GRAS reviews, handling petitions only on a case-by-case basis.
• In 1997, the FDA introduced a voluntary GRAS notification program to ease burdens and speed up reviews. Companies could notify the FDA of their GRAS determination, which the FDA would review within about five months.
• The 2016 rule formalized this process and reaffirmed that companies could still self-affirm GRAS status without notifying the FDA, as long as their determination is based on scientific evidence and expert consensus.

FDA authority and legislative constraint

The FDA’s rulemaking authority is derived from the FDCA and other statutes enacted by Congress. While the FDA can issue regulations to enforce these laws, its power is limited to what Congress explicitly grants. It cannot impose new statutory requirements, remove existing exemptions, or fundamentally change a statute’s intent without Congressional approval. The key question is whether requiring FDA approval for all GRAS substances would effectively eliminate the GRAS exemption.

This issue goes to the heart of the FDA’s statutory authority and the legislative intent behind GRAS—an issue the FDA has addressed and found beyond its authority. In the 2016 GRAS rulemaking, the FDA noted it lacks “express statutory authority” to mandate premarket notification. When Congress created the premarket approval system for food additives in 1958, it deliberately excluded GRAS substances from the definition of “food additive,” reflecting Congress’s intent that certain substances need not undergo FDA premarket review.

The FDA has acknowledged that manufacturers may independently determine GRAS status without notifying the agency. Its authority is limited to clarifying scientific standards for GRAS determinations, not requiring FDA approval for all GRAS substances. Doing so would effectively redefine “food additive” and close the GRAS exemption—changes that require amending the FDCA.

Congress reaffirmed its intent to preserve the GRAS pathway in the 1997 FDA Modernization Act (FDAMA), which mandated notification for food-contact substances but did not extend this to GRAS substances.

Legislative and regulatory challenges

Eliminating the GRAS exemption would require new legislation, involving drafting, committee scrutiny, congressional debate, and presidential approval. On the FDA’s part, any major change requires formal rulemaking under the Administrative Procedure Act, including public notice and comment periods. Both routes face significant challenges:

• Industry Pushback: Food manufacturers and lobbyists argue mandatory approvals would increase costs, disrupt supply chains, and stifle innovation—especially harming small businesses. Legal challenges over authority and constitutionality could delay changes for years.
• Cost vs. Benefit: The FDA and policymakers would weigh public health benefits against the economic burden created by compliance costs, testing expenses, and product development delays, and possible market consolidation.
• FDA Capacity: The agency’s resources are limited. Reviewing every GRAS substance would overwhelm staff, slow approvals, and strain budgets. Historical experience, such as President Nixon’s directive for a comprehensive GRAS review, highlights the immense operational challenge such an undertaking poses.
• Political Climate: Current regulatory priorities lean toward reducing regulatory burdens and fostering a business-friendly environment. Executive Order 14192, titled “Unleashing Prosperity Through Deregulation,” requires federal agencies to eliminate at least ten existing regulations for every new one introduced.

Color additives: a common misunderstanding

HHS Secretary Kennedy cited concerns about Red 40, Yellow 5, and Yellow 6, but these are not GRAS substances. Color additives must be FDA-approved before use. The fact that some dyes, like Red Dye No. 3, have been banned despite prior approval shows even tightly regulated substances face ongoing safety debates. Eliminating self-affirmed GRAS status would not address concerns related to additives already under strict FDA oversight.

State vs. federal regulation

Some states (e.g., West Virginia) have banned certain food dyes citing health risks, even though the FDA considers them safe. This patchwork of state regulations complicates compliance and creates confusion over which scientific standards and rules apply.

Instead of eliminating self-affirmed GRAS determinations, a more effective strategy may be ongoing, rigorous scientific evaluation coupled with stronger FDA enforcement. Regular updates and safety reviews can help ensure food substances remain safe, regardless of whether companies notify the FDA.

What should companies do now?

The GRAS system remains unchanged for now—but the regulatory landscape is shifting. Companies relying on self-affirmed GRAS should:

• strengthen their scientific safety data with up-to-date research;
• be prepared to conduct additional studies if new safety concerns arise; and
• monitor regulatory and legal developments closely to anticipate changes.

Proactively preparing will help avoid costly disruptions and maintain consumer trust as discussions about food safety continue to evolve.