The dietary supplement industry is at the centre of a regulatory debate. The American College of Physicians (ACP) has published a position paper calling for a modernization of the U.S. Dietary Supplement Health and Education Act (DSHEA), arguing that the current regulatory framework should do more to protect consumers and strengthen confidence in dietary supplements.
While acknowledging that dietary supplements can provide important health benefits, the ACP believes greater emphasis should be placed on safety, quality and scientific substantiation before products reach consumers.
Calls for stronger oversight
Published in the Annals of Internal Medicine, the ACP's position paper outlines ten recommendations aimed at improving oversight of dietary supplements in the United States. Among the most significant proposals are the introduction of a premarket registration and approval process, enhanced post-market surveillance, mandatory recall authority for the U.S. Food and Drug Administration (FDA), and the creation of a national database linking dietary supplement ingredients to scientific evidence, health outcomes and potential drug interactions.
According to the ACP, these measures would improve transparency throughout the industry while ensuring products entering the market meet consistent standards for safety and quality.
Greater focus on scientific evidence
The ACP argues that, unlike pharmaceuticals and many food additives, dietary supplements are generally not evaluated for safety before becoming commercially available. At the same time, supplement use continues to grow. More than half of U.S. adults report using dietary supplements, with many consumers making purchasing decisions without consulting healthcare professionals.
The organization also points to adverse event reports submitted to the FDA between 2004 and 2021, suggesting that stronger premarket evaluation and improved post-market monitoring could help identify potential risks earlier.
Beyond safety, the ACP is calling for stronger scientific substantiation of product claims. The organization recommends that manufacturers support health claims with robust, peer-reviewed clinical research demonstrating both safety and efficacy. Evidence on appropriate dosages, pharmacokinetics, pharmacodynamics and toxicology should also play a greater role in building consumer confidence.
Industry divided on proposed changes
The ACP's recommendations have received a mixed response from industry organizations.
The Council for Responsible Nutrition (CRN) agrees that consumer safety, transparency and product quality should remain top priorities. However, the organization argues that many of the concerns raised by the ACP are already addressed under existing legislation. Rather than introducing pharmaceutical-style premarket approval, CRN believes regulators should focus on stronger enforcement of current rules.
The Natural Products Association (NPA) has taken a similar position, stating that the existing regulatory framework provides adequate oversight when properly enforced. The organization also emphasizes the important role dietary supplements play in supporting public health and consumer wellness.
What does this mean for the industry?
While opinions differ on how dietary supplement regulation should evolve, one thing is becoming clear: expectations around quality, transparency and scientific substantiation continue to rise. Regulators, healthcare professionals and consumers alike are placing greater value on products supported by reliable evidence and manufactured to consistently high standards.
For supplement brands, this means that investing in quality assurance, traceability and evidence-based product development is no longer just a competitive advantage — it is becoming an essential part of doing business.
At IQ Production, we closely follow regulatory developments and evolving market expectations to help our partners navigate a rapidly changing industry. By focusing on scientifically substantiated ingredients, reliable sourcing and high-quality manufacturing, brands can not only prepare for future regulatory changes but also strengthen consumer trust in an increasingly competitive dietary supplement market.
