Upcoming changes to food regulations under Secretary Kennedy’s leadership could have a seismic impact on your supplement access. Act now before it’s too late. Action Alert!
THE TOPLINE
- Proposed changes to the FDA’s GRAS (Generally Recognized as Safe) rules—backed by RFK Jr.’s push to clean up junk and ultra-processed foods—could create a sweeping pre-approval system that threatens access to thousands of safe, natural supplement ingredients.
- While reform is needed to curb harmful additives, past FDA decisions show the agency has approved questionable synthetic ingredients—raising concerns that new authority could unfairly target natural products instead.
- This is a pivotal moment for health freedom: without public pushback, regulatory overreach could restrict supplement access under the guise of food safety reform.
This is a supplement red alert! What we believe are probably well-intentioned efforts to rid the food system of bad ingredients could end up casting a much wider net that sweeps up safe, natural products right along with the bad actors. We must make our voices heard to prevent a supplement crackdown.
Ultraprocessed Foods in the Crosshairs
The statistics paint a grim picture. A pitiful 12.2% of American adults are metabolically healthy, while 74% are overweight or obese. There are many reasons behind the failing health of our nation, and the prevalence of ultra-processed foods (UPFs) is certainly one of them. Health Secretary RFK Jr. has rightly made UPFs a focus of his tenure, which is why reforming food regulations has been a priority for him. But, as the saying goes, the road to Hell is paved with good intentions.
What is “GRAS”?
What’s happening is that the FDA, under RFK Jr.’s direction, is about to propose changes to the rules for how certain food ingredients can come to the market. The pathway in question is called the “Generally Recognizes as Safe”(GRAS) designation and has been in place since 1958. It was designed to prevent unnecessary regulatory burdens on ingredients that had a well-established safety record. (You can read our white paper on GRAS reform for more background.)
There are several signs that HHS is preparing to release its plan for GRAS reform imminently, one of them being the broadcast last Sunday of a “60 Minutes” segment with interviews both of RFK Jr. and former FDA Commissioner Dr. David Kessler. The angle? While each has a contrasting view on many issues, especially vaccines, both have found common ground over GRAS rules that they say have provided a loophole exploited by Big Food. Kennedy and Kessler each argued on “60 Minutes” that self-GRAS has been the regulatory mechanism used by Big Food to expose millions of Americans to the UPFs that underlie the country’s metabolic health crisis. Part of their analysis, we uphold, is right on target, but we also propose that ditching self-GRAS will not only fail to eliminate UPFs from the market, it will also create an unmanageable backlog for FDA and wipe from the market a huge number of health-promoting supplements, functional foods, and medical foods. We expressed all of this in our press release issued on February 17 that you can read at the link below.
Over time, the GRAS designation evolved, and the FDA allowed companies to independently declare an ingredient as GRAS with no transparency—meaning neither the FDA not any independent scientists have been able to review the scientific basis on which companies declare their ingredients to be safe. This process, known as self-affirmed GRAS (“self-GRAS” for short), has enabled unscrupulous companies to place unsafe ingredients in the food supply.
But it also happens to be how thousands of safe, natural ingredients come to the market—in foods, functional foods, medical foods, and the supplements you care about.
As we mentioned above, the FDA’s proposed new rule on GRAS has yet to be released, but we’re concerned it may follow some of the legislative reforms we’ve previously reviewed and install what is essentially an FDA pre-approval system that doesn’t effectively differentiate between safe, natural compounds with a long history of safe use and the bad ingredients designed to get us addicted to junk. The result? The FDA may remove a few harmful additives, but at the same time a host of natural ingredients due to an ill-conceived application of the precautionary principle: a classic example of “throwing the baby out with the bathwater.”
Common Misconceptions
We often hear the point raised that the European Union only has a few hundred legal food additives compared to the thousands in the US considered GRAS—mostly self-GRAS—but this is an apples-to-oranges comparison. In Europe, “food additives” are largely defined as technological additives governed under a specific framework, while many other ingredients are regulated under general food law.
We’ve also shown how several of the prime examples of food additives with questionable safety records have actually come to market via FDA’s formal GRAS approval pathway, not as self-GRAS. Additives like Red 40, Yellow 5, BHA, sodium nitrite, aspartame, and potassium bromate, to name a few, were all reviewed and approved by the FDA.
One of the reasons 60 Minutes interviewed former FDA Commissioner David Kessler is because he has issued a Citizen Petition to revoke the GRAS status of processed and refined sweeteners and starches for their role in the obesity epidemic. Dr. Kessler’s petition details how the FDA formally reviewed the GRAS status of many of these ingredients in the 1980s. The agency’s conclusion? “[The] available data support the view that sugars do not have a unique role in the etiology of obesity.” Further, “Sugars have not been shown to present an increased risk of diabetes or coronary heart disease in this population.” That’s right: the FDA, when given the option to review the data through its formal GRAS approval process, determined that these ultra-processed ingredients were perfectly safe. And we want to give this agency authority over thousands of more additives? While still pretending the self-GRAS pathway is the problem and therefore needs to be eliminated despite it being the primary regulatory mechanism to get safe and beneficial ingredients to market?
The Real Risk: Regulatory Overreach
History tells us the likely outcome of handing the FDA pre-market authority over GRAS ingredients. The bad stuff used by Big Food to get us hooked on junk gets the green light, while safe natural products with a history of safe use get stuck in FDA purgatory. We’ve seen countless times how the agency has a knee-jerk distrust of natural products, probably because they compete with pharmaceutical drugs for your healthcare dollars and drugs are the FDA’s cash-cow.
The agency can’t seem to stand the idea of Americans making informed choices for their health that don’t involve buying expensive drugs that have the agency’s stamp of approval.
This is why we’ve developed a rational system for GRAS reform that protects natural ingredients, provides real transparency, and weeds out ingredients that pose a real risk to our health.
A Defining Moment for Health Freedom
This is a pivotal moment that could determine whether Americans continue to have access to the natural products they rely on for their health—or whether those products are slowly strangled by regulatory red tape.
We all agree that harmful, ultra-refined, synthetic or bioengineered additives designed to fuel addiction and drive chronic disease have no place in our food supply. But we must not allow a legitimate effort to clean up the food system to become a backdoor assault on supplements and natural health products.
The future of supplement access is not guaranteed. It depends on whether Americans who value health freedom stand up now.
Action Alert!
