S-2341-119
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sponsored by Edward Markey (D-MA)
What it does
This bill would require all food additives to either receive formal FDA approval or be covered by a GRAS (Generally Recognized as Safe) notification submitted within two years of enactment that the FDA has not objected to. It would end the current system under which manufacturers can self-determine that an additive is GRAS without notifying the FDA at all. The FDA would be required to review at least 50 GRAS notifications per year until all have been assessed, to regularly reassess previously approved additives, and to publish written determinations with reasoning. The bill would also make substances classified as toxic or carcinogenic permanently ineligible for GRAS status.
Who benefits
Consumers broadly, who would gain greater assurance that food additives have undergone federal review. Public health advocates and researchers who have raised concerns about the self-affirmed GRAS loophole. Manufacturers whose additives have already received formal FDA approval, who would face a more level competitive playing field. Smaller food companies that already comply with stricter notification requirements. Children and vulnerable populations (pregnant women, immunocompromised individuals) who may be disproportionately exposed to food additive risks. State food safety regulators who currently fill gaps left by federal inaction.
Who is hurt
Food manufacturers and ingredient suppliers who currently rely on self-affirmed GRAS determinations without FDA notification, and who would face new compliance costs and potential product reformulation. The FDA itself would face a significant administrative burden, requiring substantial new resources to review hundreds of existing GRAS notifications on a mandatory annual schedule. Small and mid-sized food producers with limited regulatory staff may face disproportionate compliance costs. Consumers could see modest food price increases if manufacturers pass along reformulation or compliance costs. Additive suppliers whose products are reclassified as toxic or carcinogenic would lose market access entirely.
Supporters argue
Supporters argue that the current GRAS system has a fundamental structural flaw: manufacturers can introduce additives into the food supply based solely on their own safety determination, with no requirement to ever inform the FDA. A 2010 Government Accountability Office report found that the FDA cannot ensure the safety of all GRAS substances because it lacks basic information about which additives are in use. Supporters further argue that making toxic and carcinogenic substances categorically ineligible for GRAS status closes a gap that has allowed some substances with known hazard profiles to remain in the food supply, and that mandatory annual review targets create accountability where none currently exists.
Opponents argue
Opponents argue that the bill imposes a sweeping new regulatory mandate without providing the FDA with the funding or staffing necessary to execute it — the agency already faces a backlog of hundreds of unreviewed GRAS notifications under the current voluntary system. They contend that requiring FDA review of every additive before market use could significantly slow product innovation and create bottlenecks that disadvantage U.S. food manufacturers relative to foreign competitors. Opponents also argue that the two-year window for submitting legacy GRAS notifications is operationally unrealistic given the large number of substances currently in use, and that the bill's broad definitions of "toxic" and "carcinogenic" could sweep in substances that pose negligible risk at typical dietary exposure levels.
Constitutional context
Congress has broad authority to regulate food safety under the Commerce Clause (Art. I, §8, cl. 3), as food additives are articles of interstate commerce. The FDA's implementing regulations would face heightened judicial scrutiny under Loper Bright v. Raimondo (2024), which eliminated automatic deference to agency interpretations — courts would independently assess whether FDA determinations on specific substances fall within the statutory authority this bill grants.
Checks and balances
The executive branch (FDA) gains significant new authority to approve, object to, or revoke GRAS status for food additives; checks include mandatory public comment periods, written reasoning requirements, congressional oversight, and post-Loper Bright judicial review of FDA determinations.
Historical precedent
The Food Additives Amendment of 1958 established the original pre-market approval framework and created the GRAS exemption, but no subsequent legislation has attempted to mandate comprehensive FDA review of all existing GRAS determinations at this scale.