A major doctors’ group is calling for Congress to give the Food and Drug Administration (FDA) sweeping new power over dietary supplements. If they get their way, the vitamins, minerals, botanicals, probiotics, and specialty formulas millions of Americans rely on could be treated more like drugs than foods. Action Alert!
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THE TOPLINE
- The American College of Physicians is urging Congress to impose drug-style premarket approval, mandatory registration, and expanded FTC oversight on dietary supplements—a move that could reduce access to higher-dose, specialized, and innovative products.
- Supplements are already regulated under federal manufacturing, labeling, and safety laws. Rather than granting the FDA sweeping new powers, Congress should require the agency to use its existing authority more effectively against adulteration, contamination, hidden drug ingredients, and fraudulent claims.
- ACP’s safety case relies on adverse-event totals without adequate context, while mandatory product listing and pharmaceutical-level evidence standards could become tools to eliminate lawful products and censor truthful health information.
What ACP Is Demanding
The American College of Physicians (ACP) released a new position paper in Annals of Internal Medicine calling for Congress to “modernize” the Dietary Supplement Health and Education Act of 1994 (DSHEA). ACP wants supplements to undergo FDA registration and premarket approval, including products already on the market. It also calls for more Federal Trade Commission (FTC) policing of supplement marketing.
ACP says its recommendations are needed because more than half of American adults use supplements, while only about a quarter use products recommended by a healthcare professional. ACP also argues that some products may contain unlisted ingredients, unsafe dosages, illicit substances, or interact with medications.
No one at ANH-USA is defending adulterated products, hidden drug ingredients, false labels, or fraudulent disease claims. Bad actors should be removed from the market, period. And both FDA and FTC already have ample regulatory tools at their disposal to make this happen.
But ACP’s central proposal, a drug-style premarket approval system, would decimate consumer access to safe, natural products that millions of Americans rely on.
Premarket Approval Would Crush Consumer Choice
Drug pre-market approval costs can be recovered because drugs often receive strong patent protection and market exclusivity. Nutrients, herbs, and other natural substances generally cannot be patented in the same way. Requiring supplement makers to produce drug-style evidence before selling ordinary natural products would favor giant corporations with compliance departments and deep pockets. Smaller innovators would be pushed out. Higher-dose, practitioner-grade, niche, and personalized products would be most vulnerable.
The result would not be “better supplements.” It would be fewer supplements, more standardized formulas, less innovation, and fewer options for consumers trying to manage their health naturally. The USA would also lose its status as the global capital for research and development of dietary supplements.
Supplements Are Already Regulated
One of the most misleading talking points in supplement policy is that supplements are “unregulated.” They are not.
Dietary supplement manufacturers are subject to FDA current good manufacturing practice rules. These rules apply to companies that manufacture, package, label, or hold dietary supplements.
The real question is whether the FDA is using its existing authority effectively to address adulteration, contamination, illegal drug ingredients, and other bad actors. There have been periods when the agency appeared to tolerate the worst abuses in the supplement industry, seemingly in the hope that mounting problems would build support for repealing DSHEA and expanding the FDA’s power over supplements.
What we oppose is using a few bad apples to justify giving FDA sweeping new authority over the entire supplement market. This is the same playbook we see being used against homeopathy and peptides: use isolated examples of bad products or bad actors to justify an attack on an entire sector.
The “Safety” Argument Needs Context
ACP cites adverse event reports to argue that current regulation is inadequate. But raw adverse event counts do not tell us how dangerous supplements are as a category.
One 2023 narrative review cited in ACP’s paper reported 79,071 adverse events related to dietary supplements between 2004 and 2021 (about 4,651 per year on average). That number sounds alarming until we ask the basic scientific questions: How many people used supplements during that period? How many doses were consumed? How many reports were serious, and how many were mild (transient flushing or nausea)?
A safety rate requires a denominator. Let’s do some quick math. If half of American adults use supplements, that’s about 135 million people. With an average of 4,651 adverse events per year, that means that 0.0034 percent of supplement users experience an adverse event. By contrast, about 8.3% of people receiving primary care experienced an adverse drug reaction. In other words, primary care drug reactions are 2,441 times more common than supplement adverse events.
The FTC Is Already in Overdrive
ACP also wants more FTC resources to police supplement marketing, especially online and on social media. But the FTC is already aggressively expanding its reach to censor supplement benefits: something we’re pushing back on in the courts.
A National Database Could Become a Hit List
ACP’s proposed national supplement database also sounds benign. Transparency is good. But a mandatory product listing system can quickly become a tool for elimination.
ANH has warned for years that Senator Dick Durbin’s mandatory product listing proposal would give FDA a ready-made map of the supplement marketplace: ingredients, dosages, labels, and product identities. That could allow the agency to target high-dose supplements, supplements that compete with drugs, or products caught in FDA’s overbroad “new dietary ingredient” dragnet. ANH has also warned that mandatory listing could accelerate attacks on higher-dose supplements used by integrative doctors and informed consumers.
Consumers should not have to fear that a “database” is the first step toward disappearing the products they rely on.
An Assault on Your Health Freedom
The FDA and FTC already have tools to act against adulteration, misbranding, illegal disease claims, contamination, and deceptive marketing. Congress should demand better enforcement against real violations, not hand regulators a sweeping premarket approval system that would make supplements less accessible, less diverse, and more expensive.
ANH-USA will continue fighting attempts to turn supplements into drugs by another name. We will oppose premarket approval, mandatory product listing schemes that threaten access, and agency censorship of truthful health information.
Action Alert!
