• An Environmental Defense Fund review found the FDA has consistently failed to enforce a 2016 rule requiring assessment of the cumulative health effects of food additives, allowing hundreds of chemicals into the food supply without this crucial scientific review.
• The current GRAS system allows companies to "self-certify" ingredients as safe without mandatory FDA notification, a process critics say lacks transparency and rigorous science.
• New legislative efforts, like a bill from Rep. Frank Pallone, seek to abolish this self-certification and replace it with an FDA pre-approval system for all new GRAS ingredients.
• Health freedom advocates and supplement industry experts warn that such a sweeping change would act as a de facto ban on many safe, natural supplement ingredients, raising costs, reducing competition, and granting the FDA overly broad powers.
• They argue the real problem is not the GRAS pathway itself but the FDA's risk assessment approach, which has approved numerous controversial additives, and that reform should focus on transparency and targeting truly harmful substances without creating insurmountable barriers for beneficial nutrients.

GRAS reforms are necessary, but current proposals may miss the mark entirely

For decades, the American food supply has been a living, breathing experiment. The 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetics Act was meant to be a guardrail, stipulating that additives must be proven safe by qualified scientific experts. The GRAS designation emerged as a pragmatic solution for ingredients with a long history of safe use, like vinegar or baking soda. But in 1997, the system shifted dramatically. To manage a growing tide of new substances, the FDA replaced a mandatory petition process with a voluntary notification system. Companies were now merely "invited" to inform the FDA of their own safety determinations. They could, and often did, simply declare an ingredient GRAS based on their own review and begin selling it, with no requirement for public disclosure or independent scientific scrutiny.

The consequences of this trust-based system have been profound. A 2010 report by the Natural Resources Defense Council identified 398 chemicals that had been self-certified as GRAS without FDA review over a 13-year period. The Environmental Defense Fund’s more recent analysis paints a starker picture: in a review of 900 safety certifications, only one considered the cumulative health effects of additives in what was deemed a "meaningful" way. This neglect is significant because humans are not exposed to chemicals in isolation. We consume a cocktail of additives daily, from preservatives in bread to emulsifiers in salad dressing, and their interactive, building effects over a lifetime are largely a mystery. The FDA’s own 2016 rule was supposed to correct this, mandating that cumulative impacts be considered. Yet evidence suggests this requirement has been gathering dust, a casualty of shifting administrative priorities.

A legislative cure that could be worse than the disease

The mounting evidence of systemic failure has catalyzed calls for reform, with HHS Secretary Robert F. Kennedy Jr. identifying the elimination of dangerous additives as a priority. The legislative response, however, has sparked deep concern among natural health proponents. The bill introduced by Representative Frank Pallone seeks to eliminate the self-affirmed GRAS pathway entirely. Instead, it would force companies to submit detailed notifications to the FDA and wait for a formal "no objection" letter before using any new GRAS ingredient. This transforms GRAS from a streamlined recognition of established safety into a pre-market approval gauntlet, with the FDA as the sole gatekeeper.

Jonathan Emord, General Counsel for the Alliance for Natural Health USA, critiques the approach. “Regrettably, Congressman Frank Pallone’s bill eliminates all future self-GRAS but grandfathers all prior self-GRAS determinations, leaving in the market the very subset of unsafe food additives in need of removal,” he said. The bill, he argues, is both “underinclusive and overinclusive,” failing to directly target demonstrably unsafe additives while creating new burdens for safe ones.

The alarm bells are ringing loudest for the dietary supplement and natural products industry. The GRAS pathway is not just for synthetic food dyes and preservatives; it is the primary legal route for introducing countless vitamins, minerals, amino acids, and botanical extracts into both foods and supplements. Creating a mandatory, resource-intensive pre-approval process would disproportionately burden smaller, innovative companies, potentially leaving only the largest corporations able to navigate the regulatory maze. The result could be a dramatic shrinkage in consumer choice, stripping shelves of safe, health-promoting options. It is, as critics have described, a classic case of throwing the nutrient-rich baby out with the regulatory bathwater.

The peril of power without principle

Further stoking anxiety are provisions in the reform bill that grant the FDA expansive new authority. The agency would be empowered to retroactively demand a GRAS notice for any ingredient already on the market, opening the door to campaigns against disfavored substances. Many fear natural supplements that compete with pharmaceutical products would be first in line for such scrutiny. Perhaps more fundamentally, the bill requires the FDA to reassess existing GRAS ingredients for potential hazards like carcinogenicity without explicitly mandating that these assessments consider the intended dose and use.

This shift away from the age-old toxicological principle that “the dose makes the poison” is a dangerous pivot, according to Emord. “This bill invites all new food additives to be assessed for carcinogenicity and mutagenicity without regard to dose,” he explained. This approach mirrors the European Union’s application of the “precautionary principle,” which has led to bans and severe restrictions on nutrient levels in supplements, often based on theoretical risks at extremely high doses rather than real-world usage. Applying this principle to nutrients, which have known benefits at appropriate doses, could see essential substances like selenium or certain vitamins deemed unsafe because they are toxic at levels no consumer would ever encounter.

The push for reform exposes a painful irony. Many of the additives most criticized by health advocates—artificial colors like Red 40 and Yellow 5, preservatives like BHA and potassium bromate—were not sneaked in via the self-GRAS loophole. They were formally approved by the FDA itself through its own review processes. This suggests the core issue may be the agency’s underlying risk assessment models and its tolerance for certain chemicals, not merely the existence of the self-certification pathway. A truly effective reform, therefore, would need to address the scientific benchmarks for safety itself, not just the paperwork required to meet them.

Sources include:

ANH-USA.org

EnergyCommerceHouse.gov [PDF]

Enoch, Brighteon.ai