MAHA's leader, RFK Jr., has directly targeted the GRAS pathway. He laid out his intentions in a post on X, emphasizing the need for stricter pre-market regulation and post-market assessment.
“I am directing the FDA commissioner to start the process of changing the rules to eliminate the self-affirmed GRAS pathway for new ingredients. I am also calling on the @US_FDA and @NIH continue to conduct and improve post-market assessments of GRAS chemicals currently in our food so we can rapidly identify the compounds that are making Americans so sick, and so that American consumers and regulators can make informed decisions. This is an important step in our pursuit to Make America Healthy Again.”
The GRAS Standard
Ingredients that are added to our food and/or beverages have to go through FDA approval or be GRAS. GRAS is defined as:
“... any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, …”
Ingredients evaluated based on publicly available information and found to be safe fall into this category as do those with a history of safe use prior to 1958. Companies can self-determine that an ingredient is GRAS and then voluntarily submit their information about the ingredient to the FDA for follow up. However, under the self-affirmation process, companies are not required to go to the FDA and can instead go straight to market with a new ingredient in a product.
“FDA is closing the GRAS loophole that allows untested ingredients and chemicals into the food supply without notice to the FDA or public.”
— RFK Jr.
This exact structural problem, however, is replicated and arguably amplified in the regulation of dietary supplements, which have been strangely excluded from this MAHA-driven conversation.
The Supplement Loophole
According to the FDA’s website, while supplements are treated closer to food than drugs, they aren’t regulated like either.
“FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products….
- Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of the Federal Food, Drug, and Cosmetic Act as amended by DSHEA and FDA regulations.
- FDA has the authority to take action against any adulterated or misbranded dietary supplement product after it reaches the market.”--FDA on Dietary Supplements
Supplement companies are allowed to operate in a similar way to the GRAS loophole: self-affirmation and over reliance on post-market assessment. It’s the exact same problem as GRAS and it impacts a lot of Americans taking supplements. If you care about ingredients being demonstrated as safe before they hit the market, then this is another obvious loophole to close.
According to RFK Jr., he doesn’t blame the food companies. They, like the supplement companies ’re just acting in the ways that we’ve allowed. So let’s change what’s permissible. While the GRAS pathway allows untested ingredients into the food supply, the Dietary Supplement Health and Education Act allows entire products onto the market with similar self-affirmation. Yet, there has been no mention of regulating supplements or looking into what’s actually in supplement products.
MAHA Hypocrisy
I agree with Secretary Kennedy, we should close the self-affirmation loophole. Blocking the pathway for ingredients to go to market with virtually no oversight is a sensible step. But, if the concern is ingredients going to market why stop at food and beverage? The system for dietary supplements operates on the exact same principles: it relies on companies voluntarily reporting and, largely, post-market assessment. Yet, there has been no mention of regulating supplements or looking into what's actually in them.
If RFK Jr is so concerned and passionate about what’s in our food and what we’re putting in our bodies, then why the silence on supplements?. If MAHA was consistent, they would care just as much about supplements, however, supplements are big money for a lot of MAHA people. So is the silence so surprising?
The selective outrage over similar policies is very telling. If MAHA is at all serious, then change the way that supplements are (not) regulated along with GRAS. The silence on supplements strongly suggests the movement's motivations are not purely about public health, but hypocritically about politics, financial incentives, and/or targeting specific industries.
Katie Suleta, DHSc, MPH
Katie Suleta is a regional director of research in graduate medical education for HCA Healthcare. Her background is in public health, health informatics, and infectious diseases. She has an MPH from DePaul University, an MS in Health Informatics from Boston University, and has completed her Doctorate of Health Sciences at George Washington University.
