Lead: On Feb. 15, 2026, Health and Human Services Secretary Robert F. Kennedy Jr. argued that a 67-year-old regulatory exemption known as GRAS has allowed food companies to introduce thousands of minimally reviewed ingredients into the U.S. food supply, contributing to a diet in which ultraprocessed items make up roughly half of what Americans eat and to rising rates of obesity and malnutrition. Kennedy cited industry estimates that the marketplace may contain between 4,000 and 10,000 ingredients not subject to full Food and Drug Administration premarket review. He said his administration will use rigorous science to reassess GRAS-designated substances and to expand access to whole foods. The claims have drawn pushback from industry groups and support from public health figures, while a related civil suit remains pending.
Key Takeaways
- GRAS exemption origins: The GRAS clause dates to 1958 and is described in recent coverage as a 67-year-old provision that lets firms self-affirm the safety of certain additives without mandatory FDA premarket approval.
- Scale of ingredients: Kennedy and others cited estimates that between 4,000 and 10,000 ingredients used in U.S. products may exist under GRAS or similar categorizations, though the precise count is unclear.
- Dietary impact: Ultraprocessed foods are estimated to make up about 50% of the average American diet and are linked by some experts to the nation’s cardiometabolic disease burden.
- Health burden: Former FDA commissioner David Kessler tied ultraprocessed products to increased rates of type 2 diabetes, hypertension, abnormal lipids, fatty liver and cardiovascular events.
- Policy response: Kennedy said his administration will reexamine GRAS classifications using ‘gold-standard’ science and is prioritizing affordability and availability of whole foods.
- Industry view: The Consumer Brands Association defended the current GRAS framework as enabling innovation and said companies follow FDA science-based evaluations.
- Legal action: Ten major manufacturers are defendants in a December lawsuit filed by the San Francisco City Attorney alleging engineered addiction and public-health harms from ultraprocessed products.
Background
The GRAS (Generally Recognized As Safe) provision was incorporated into federal law in 1958 to allow ingredients with long-standing expert consensus to enter the food supply without the same premarket review required of novel additives. That mechanism was intended to streamline the introduction of familiar substances while allowing the FDA to focus on genuinely new chemicals. Over decades the food system transformed: commodity agriculture, large-scale processing and ingredient innovation expanded the universe of additives and formulations used in packaged goods.
Public-health researchers and commentators say this structural change coincided with a dramatic rise in production and consumption of ultraprocessed foods, which industry and some policymakers value for their cost, shelf life and convenience. At the same time, critics say federal farm subsidies and supply-chain arrangements favor commodity crops such as corn and soy, which feed ingredient markets for sweeteners, starches and texturizers used in highly processed items. The intersection of regulatory exemptions, market incentives and lobbying has made GRAS a focal point for debate about food safety and nutrition policy.
Main Event
Secretary Kennedy gave a public explanation of his concerns on Feb. 15, 2026, arguing that the GRAS pathway has been exploited to introduce many ingredients without robust, independent safety evaluation. He maintained that consumers cannot readily determine whether ultraprocessed products contain substances that have undergone comprehensive government review. Kennedy signaled an intention to use the administration’s authority to reassess GRAS approvals and to rely on high-quality evidence in those reviews.
Former FDA commissioner David Kessler, who has campaigned for stronger oversight of processed foods, urged wholesale revocation of GRAS status for dozens of refined carbohydrates and sweeteners unless manufacturers can demonstrate safety and lack of contribution to obesity and metabolic disease. Kessler described ultraprocessed foods as engineered to be energy-dense and highly palatable, changing eating behavior and physiology, and compared the public-health challenge to past efforts against tobacco.
The food industry, represented by the Consumer Brands Association, countered that GRAS allows companies to innovate and that food makers comply with FDA risk-based evaluations. The American Farm Bureau Federation emphasized the role of diverse, nutrient-dense foods in a healthy diet, arguing that some shelf-stable items can contribute to balance and affordability. Meanwhile, litigation continues: a San Francisco lawsuit filed in December alleges that some manufacturers intentionally engineered addictive products and concealed harms.
Analysis & Implications
Regulatory change to GRAS would alter how thousands of ingredients are reviewed and could impose new data and compliance costs on manufacturers. If the administration requires independent premarket review for broad classes of additives, product reformulation and reformulation lead times could affect prices and shelf availability, particularly for low-cost, shelf-stable goods that serve food-insecure populations. Policymakers will face a trade-off between tightening safety and nutrition oversight and preserving affordability and supply stability.
From a public-health economics perspective, stronger oversight could reduce long-term medical costs linked to diet-related chronic diseases, but those savings would materialize unevenly and over years. Redistributional effects are probable: smaller manufacturers may struggle to fund new safety studies, while larger firms could absorb costs more easily. That dynamic raises questions about competitive fairness, potential consolidation, and the role of public funding for ingredient safety evaluation.
Internationally, changes to U.S. GRAS practice could ripple through trade and manufacturing: U.S. standards often influence global ingredient markets and labeling norms. Importers and exporters may face uncertainty if the U.S. requires additional safety dossiers for substances previously self-affirmed. Conversely, a shift toward stricter review could spur innovation in whole-food alternatives and ingredient transparency, altering market demand.
Comparison & Data
| Metric | Reported Value |
|---|---|
| Share of diet that is ultraprocessed | ~50% |
| Age of GRAS exemption (as reported) | 67 years |
| Estimated number of ingredients cited | 4,000–10,000 |
| Share of Americans overweight/obese | ~70% |
The table summarizes widely cited figures from recent statements: roughly half of caloric intake comes from ultraprocessed items, GRAS traces to a mid-20th-century law characterized in coverage as a 67-year-old exemption, and experts have offered wide ingredient estimates. These numbers frame the policy debate but do not substitute for a comprehensive inventory or epidemiological causal proof. Detailed regulatory and health-economics modeling would be required to estimate the net effects of policy change on prices, consumption, and health outcomes.
Reactions & Quotes
Officials and experts framed the issue in stark terms, while industry echoed calls for science-based oversight.
“There is no way for any American to know if a product is safe if it is ultraprocessed.”
Robert F. Kennedy Jr., Health and Human Services Secretary
Kennedy used this phrasing to explain why he believes a reassessment of GRAS is necessary and to justify plans for new, rigorous reviews. He emphasized affordability and consumer information as policy goals rather than blanket regulation.
“They trigger overeating. They deprive us of any sense of fullness.”
Dr. David Kessler, former FDA Commissioner
Kessler framed ultraprocessed foods as biologically impactful, linking texture and formulation to overeating and metabolic disease. He is petitioning for removal of GRAS status on several refined carbohydrates pending safety proof.
“The GRAS process enables companies to innovate to meet consumer demand.”
Consumer Brands Association (industry statement)
The trade group defended the status quo as consistent with FDA’s science- and risk-based approach, arguing that industry conducts evaluations before products reach the marketplace.
Unconfirmed
- The exact number of ingredients currently in U.S. products that have been designated GRAS is not publicly verified and remains an estimate between 4,000 and 10,000.
- Allegations that manufacturers deliberately engineered addiction are central to the San Francisco lawsuit but remain claims that have not been adjudicated in full and are therefore not proven.
- The specific list of GRAS substances that would be targeted for revocation, if any, has not been published and would depend on future agency determinations.
Bottom Line
The controversy over GRAS highlights a deeper tension in U.S. food policy: balancing innovation, affordability and convenience against independent safety review and population health. Secretary Kennedy’s proposed reassessment aims to increase transparency and place more ingredients under government scrutiny, a move that could reshape how processed foods are made and marketed. Industry groups caution that such changes could raise costs and disrupt supply chains, while public-health advocates predict long-term health gains.
For readers, the near-term effects will hinge on regulatory choices and legal outcomes: whether the administration narrows the GRAS pathway, whether courts interpret the pending litigation in ways that broaden liability, and whether Congress or federal agencies allocate resources for independent safety testing. The debate will likely continue through scientific review, rulemaking and litigation, and its outcomes will have practical implications for what ends up on grocery shelves and at what price.
Sources
- CBS News / 60 Minutes reporting — News coverage of Kennedy, Kessler and industry responses
- U.S. Food and Drug Administration (FDA) — Official information on GRAS regulatory framework
- Consumer Brands Association — Industry trade group statement and resources
- American Farm Bureau Federation — Comments on diet and agriculture policy
- San Francisco City Attorney — Office handling the December lawsuit (official/legal)