Why Aren't Dietary Supplements Regulated?

Woman holding supplement bottle

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Americans aren’t shy about reaching for dietary supplements. According to research from the Council on Responsible Nutrition, 73% of U.S. adults regularly take over-the-counter supplements—and there’s no shortage of products to choose from. Whether you want to build muscle, increase your libido, or just feel a cold coming on, there’s a supplement marketed toward just about every health purpose.

Many people find these pills, powders, and tinctures helpful for improving health, but there’s a concerning issue underlying the supplement industry. Dietary supplements are only minimally regulated by the Food and Drug Administration (FDA), mostly after they hit the market. For this reason, safety issues often go unidentified, and it can be difficult to know whether supplements really contain what they say. In fact, numerous studies have found illegal stimulants and pharmaceutical-grade drugs in over-the-counter supplements.

The question remains: why are dietary supplements so minimally regulated, and what can you do to ensure that what you see is what you get? Read on for answers.

What Products Are Considered Dietary Supplements?

According to the FDA, the term “dietary supplement” is defined as “a product intended for ingestion that, among other requirements, contains a ‘dietary ingredient’ intended to supplement the diet.” The “dietary ingredient” in these products could be a vitamin, mineral, botanical, herb, amino acid, microbial (i.e. probiotics), or other substance suitable for human consumption. (It could also feature any combination of these ingredients.)

Dietary supplements come in a wide variety of formats, like pills, powders, tinctures, liquids, and gummies. All supplements must declare themselves as such with a label including the word “supplement.”

Who Regulates Dietary Supplements?

Because dietary supplements are considered foods, they lie within the FDA’s jurisdiction for labeling and ingredients. However, the FDA’s oversight of these products is minimal. When Congress passed the Dietary Supplement and Health and Education Act of 1994 (DSHEA), it prohibited manufacturers from marketing adulterated or misbranded products. But it’s the responsibility of the manufacturer, not the FDA, to determine that their products are both safe and accurately labeled. The FDA may only remove a product from the market if it’s found to be adulterated or misbranded after going to market.

In short, anyone can sell supplements that make health claims without having to prove correctness. This means that plenty of ineffective and even unsafe items make it onto U.S. grocery shelves and online stores every year.

Issues with Lack of Regulation

Clearly, the lack of regulation around dietary supplements causes some major problems for consumers. Here are three primary concerns.

Unsafe Products Available on the Market

Multiple studies have examined the contents of over-the-counter supplements with alarming results.

A 2018 study that investigated supplements that went to market between 2006 and 2016 found that 20% of those intended for sexual enhancement, weight loss, and muscle building contained more than one unapproved ingredient. Another study from 2021 looked at the contents of 17 sports and weight loss supplements and found nine prohibited stimulants. The safety of these stimulants in humans is unknown. It’s possible that consumers are getting more than they bargain for, with potentially dangerous outcomes.

Lack of Efficacy of Products

Besides knowing your supplement is safe, you probably also want to know that it will actually do what it claims. Yet this is another lingering question around many pills, bars, gummies, and more.

Because manufacturers don’t have to prove the efficacy of their products, many ineffective supplements are allowed to reach consumers. A 2018 report, for example, determined that, of three memory supplements studied, two of them contained none of the active ingredient they claimed.

Loss of Consumer Trust

The more consumers learn how minimally supplements are regulated, the less trust they’re likely to have in these products. This is unfortunate, since some products genuinely do provide safe, effective ingredients for various health purposes. It may also undermine trust in the FDA and public health organizations in general.

How Consumers Can Advocate for Themselves

You’re not without options for choosing a supplement that’s the real deal. Start with a look through Verywell’s supplement methodology. This big-picture explainer walks you through our supplement recommendation process, plus offers tips on making safe choices for yourself.

Additionally, it’s always smart to check labels for an indication of third-party testing. Labels from organizations like NSF, USP, BSGC, and Informed Sport let you know that a manufacturer elected to have their products verified with high-quality testing by impartial outside eyes.

The U.S. Department of Defense also offers an interactive seven-question tool to help you determine whether a supplement is a good option. And the FDA keeps a searchable database of products known to commit health fraud. Try searching for a product before shelling out your cash.

Finally, to make a good supplement choice, trust your own common sense and powers of observation. If a pill makes outlandish claims (like that you’ll drop 10 pounds or look 10 years younger in a week), it’s probably too good to be true.  

A Word From Verywell

Though many supplements are in fact legitimate, it doesn’t hurt to approach these products with some healthy skepticism. Besides doing your own research on a supplement before taking it, you can always discuss it with a healthcare provider or pharmacist.

Frequently Asked Questions

  • When did the FDA stop regulating supplements?

    Landmark federal legislation regarding dietary supplements was passed under the Dietary Supplement and Health and Education Act of 1994. This ruling established that supplement manufacturers were responsible for verifying the safety and accuracy of their own products and gave the FDA authority to take action against supplements only after they hit the market.

  • Do supplements need FDA approval?

    Supplements do not require FDA approval to be sold in the U.S. market. The FDA only intervenes to remove a supplement if it has been proven to be unsafe or mislabeled.

  • What tools can I use to tell if a supplement is safe?

    Not knowing whether a dietary supplement is safe can be a scary thing. To protect yourself against shady supplements, you can employ a few tools. First, look for an indication of third-party testing (such as an NSF, BSGC, Informed Sport, or USP label). You can also use the Department of Defense’s Operation Supplement Safety tool, which takes you through a questionnaire to determine the likelihood of a supplement’s safety.

6 Sources
Verywell Fit uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Center for Responsible Nutrition. 2020 CRN Survey Reveals Focus on Vitamins and Minerals.

  2. Tucker J, Fischer T, Upjohn L, Mazzera D, Kumar M. Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration WarningsJAMA Netw Open. 2018;1(6):e183337. doi:10.1001/jamanetworkopen.2018.3337

  3. Cohen PA, Travis JC, Vanhee C, Ohana D, Venhuis BJ. Nine prohibited stimulants found in sports and weight loss supplements: deterenol, phenpromethamine (Vonedrine), oxilofrine, octodrine, beta-methylphenylethylamine (BMPEA), 1,3-dimethylamylamine (1,3-DMAA), 1,4-dimethylamylamine (1,4-DMAA), 1,3-dimethylbutylamine (1,3-DMBA) and higenamine. Clin Toxicol (Phila). 2021 Nov;59(11):975-981. doi: 10.1080/15563650.2021.1894333.

  4. FDA. Questions and Answers on Dietary Supplements.

  5. FDA. Dietary Supplements.

  6. U.S. Government Accountability Office. Memory Supplements: Results of Testing for Selected Supplements.

By Sarah Garone, NDTR
Sarah Garone, NDTR, is a freelance health and wellness writer who runs a food blog.