RFK Jr.’s GRAS Crackdown Could Transform the U.S. Food and Supplement Markets

Health Secretary Robert F. Kennedy Jr. is taking aim at one of the most powerful yet least understood regulatory shortcuts in U.S. food policy: the Generally Recognized as Safe (GRAS) designation. This decades-old system, originally designed for everyday staples like vinegar and baking soda, now serves as the gateway for the vast majority of new additives in America’s food supply.

If Kennedy succeeds in his reform push, the fallout could be seismic — disrupting both the processed food industry and the dietary supplement market.

What is the GRAS Loophole?

The GRAS pathway was created in 1958 so companies could add common, historically safe ingredients to foods without forcing the FDA to spend time reviewing what everyone already knew was harmless.

Over time, however, the scope of GRAS has expanded dramatically:

• Companies can self-certify an ingredient as safe without formal FDA approval.
  
  

• There’s no public database requiring disclosure before market entry.
  
  

• The FDA only intervenes if safety concerns emerge after the fact.
  
  

According to the Environmental Working Group, 99% of all new chemicals introduced into U.S. foods since 2000 have entered via the GRAS pathway — meaning the vast majority have never undergone FDA’s formal safety review process.

Kennedy has criticized the system as “innocent until proven guilty” regulation and in March 2025 ordered the FDA to revisit the rules.

Supplements in the Crosshairs

While Kennedy’s public messaging targets ultra-processed food companies, his proposed GRAS overhaul could hit the supplement industry just as hard — if not harder.

For decades, supplement makers have used GRAS as a regulatory backdoor:

1. Introduce a new compound in a food product.
   
   

2. Self-certify its safety under GRAS.
   
   

3. Repurpose the same compound for use in supplements without going through the FDA’s supplement ingredient review process.
   
   

One infamous case is apoaequorin, a jellyfish protein marketed in the memory supplement Prevagen. The ingredient failed FDA supplement safety reviews twice — yet still entered the market after the manufacturer self-certified it under GRAS for food products.

Critics say this “regulatory shopping” has turned GRAS into a wild west system that undermines the supplement safety framework entirely.

Kennedy’s Political Tightrope

Here’s where things get politically complicated.

During his 2024 presidential campaign, Kennedy pledged to expand supplement access and protect the wellness industry from what he called “aggressive suppression” by regulators. His inner circle includes prominent natural health and supplement advocates.

But dismantling GRAS without carve-outs for supplements could slow — or even block — the release of new products in the very market he has championed. Approval timelines could stretch for years, and innovation could stall in categories like herbal blends, nootropics, and plant-based nutraceuticals.

Industry Pushback and Policy Proposals

Industry groups are already lobbying for middle-ground solutions, including:

• Preserving GRAS for low-risk products while requiring public disclosure of all new dietary supplement ingredients.
  
  

• Creating tiered review systems where only higher-risk compounds trigger full FDA evaluations.
  
  

Meanwhile, food safety advocates want the opposite — mandatory FDA review for every GRAS determination, past and future.

Congress is also getting involved:

• Two Democratic senators have introduced legislation to end GRAS self-certification entirely.
  
  

• A House companion bill is expected soon, signaling bipartisan interest in reform.
  
  
  

What’s at Stake for American Food Policy

The outcome of this regulatory fight will have long-term consequences far beyond grocery store shelves:

• For consumers: Stronger oversight could mean safer foods and supplements — but also fewer new products and higher prices.
  
  

• For the food industry: Reform could require overhauling product development pipelines and ingredient sourcing strategies.
  
  

• For supplement makers: Loss of GRAS could push smaller companies out of the market if they can’t afford lengthy approval processes.
  
  

Kennedy now faces a classic Washington dilemma: satisfy public health advocates without alienating a loyal political base in the wellness industry.

The Bottom Line

Robert F. Kennedy Jr.’s push to reform the GRAS designation could be one of the most consequential food policy changes in decades. If his overhaul survives industry pushback and congressional debate, it could reset the balance between market freedom and consumer protection in the United States.

Whether you work in food manufacturing, dietary supplements, or consumer advocacy, now is the time to watch this battle closely — because the rules that emerge will define how new ingredients enter the U.S. market for years to come.