With a new administration preparing to take office, the dietary supplement industry is buzzing with speculation about how its potential policies and priorities could reshape the regulatory landscape and influence the marketplace. The administration’s slogan, “Make America Healthy Again,” signals fresh opportunities for companies in the nutrition, dietary supplement and wellness sectors.
But there is also significant debate over the U.S. Food and Drug Administration’s (FDA) self-affirmed process for Generally Recognized as Safe (self-GRAS) regulations—the rule that allows manufacturers to independently determine if a food ingredient is safe based on publicly available scientific evidence or a history of safe use—and it’s a debate that has the potential to take center stage in the new administration.
The President-elect’s nominee for Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr., has indicated protecting the public from harmful chemicals and food additives is a top priority. The President-elect has backed this priority stating, “HHS will play a big role in helping ensure that everybody will be protected from harmful chemicals, pollutants, pesticides, pharmaceutical products and food additives that have contributed to the overwhelming Health Crisis in this Country.”
Additionally, on Sept. 25, 2024, Kennedy posted a video titled "Enough is Enough,“ questioning the safety of various FDA-approved food additives. The video criticized Democrats for not banning these substances, as European countries have done, and promised the new administration would take action to protect American children from harmful chemicals in our food supply.
That same day, the FDA held a public meeting to discuss developing a systematic process for conducting post-market assessments of chemicals in food, including those considered GRAS. Consumer groups, the Environmental Working Group (EWG) and the Center for Science In the Public Interest (CSPI) collectively voiced concerns that the food supply in the U.S. is overloaded with toxic chemicals and criticized the self-GRAS regulation process for enabling the food industry to introduce potentially unsafe ingredients.
Another concerned consumer group, the Natural Resources Defense Council (NRDC) authored a 2014 report, "Generally Recognized as Secret“, which highlighted the Council’s issues with the self-GRAS regulation, identifying companies that were marketing products using chemicals that were self-affirmed by their experts to have met federal safety standards. The NRDC has also previously highlighted concerns about certain dietary supplement ingredients entering the market without adequate safety data, noting that ingredient manufacturers might be using self-GRAS determinations to avoid notifying the FDA, citing ingredients like Epigallocatechin-3-gallate (EGCG), Theobromine and Gamma-amino butyric acid (GABA).
While the NRDC argues the process allows manufacturers to make safety determinations without sufficient oversight, it overlooks the critical safeguards and mechanisms that are in place to ensure safety, which is firmly rooted in similar safety principles that guide FDA’s evaluations. While the dietary supplements and natural product industries might not be as affected as other industries by a proposed ban of artificial color additives, they must consider the precedent and potential broader implications that might stem from pushing for the elimination of the self-GRAS regulation.
The self-GRAS regulation has historically balanced innovation and public health protection by allowing safe food ingredients to enter the market while reducing regulatory bottlenecks.
It’s also important to consider the international context as advocates leverage Europe as a model for protecting consumers from unsafe food ingredients. European countries that have already banned certain food additives, raising concerns about the safety of several common dietary supplement ingredients that are still widely used and popular in the U.S., are facing scrutiny in countries like France and Germany, the largest and most influential countries in the European Union.
Collectively, these actions highlight a potential slippery slope: While the dietary supplement industry might not be directly or initially concerned about bans on artificial colors, it could soon find itself facing calls for bans on dietary ingredients that have been sold for decades without safety concerns through a call to end the self-GRAS regulation. With many of these arguments against self-GRAS regulation ignoring market forces and scientific integrity, it’s important to state that in today’s consumer-driven market, trust is paramount. Which is why responsible companies invest heavily in resources needed to ensure safety in order to maintain reputation and consumer trust.
In fact, CHPA’s Dr. Jay Sirois recently authored a paper published in a peer-reviewed journal outlining the importance of a robust approach to establishing safety for supplement ingredients, components and finished products, and notes how the responsible members of industry already employ best practices for the evaluation of ingredients, the manufacturing process and even monitoring for adverse events.
With that said, these arguments certainly underscore the need for a balanced approach that protects public health and is rooted in science, and that in 2025 and beyond, we should expect the unexpected. While the new administration’s focus on banning harmful food additives could benefit public health, it also brings into consideration questions about the future of self-GRAS regulation and its potential impact on the dietary supplement industry. Balancing innovation, industry responsibility, and public health protection will be crucial as these debates unfold.
