Six in 10 U.S. adults take supplements, and the FDA doesn’t approve them first

Key takeaways

• In federal survey data from August 2021 to August 2023, 60.2% of U.S. adults had used a dietary supplement in the past 30 days, up from 53.8% a decade earlier.
• Under U.S. law, a supplement is something you swallow, labeled as a supplement, that contains vitamins, minerals, herbs, amino acids, probiotics or similar ingredients.
• The FDA does not approve supplements, their labels or most of their claims before they go on sale, and companies decide how much of each ingredient goes in a serving.
• Companies must follow manufacturing rules and forward reports of serious reactions to the FDA within 15 business days, and since 2011 the FDA can order a recall.
• The label “dietary supplement” tells you how a product is regulated, not whether it works, so check the evidence for each ingredient before you buy.

How many dietary supplements are for sale in the United States? Nobody knows for sure. That includes the federal agency that regulates them.

In 2009, the Government Accountability Office (GAO), Congress’s watchdog, reported that the Food and Drug Administration (FDA) had no authority to make supplement companies tell it what products they sell¹. Roughly 4,000 products were on shelves when the category was created in 1994; an industry source put the 2008 figure near 75,000¹.

In 2019, then-FDA Commissioner Scott Gottlieb said more than 50,000 products were for sale, and possibly 80,000 or more². Over the same 25 years, he said, the industry had grown from about $4 billion to more than $40 billion².

Meanwhile, the bottles moved into most homes. In May 2026, the National Center for Health Statistics (NCHS) reported that 60.2% of U.S. adults had used a supplement in the past 30 days³.

If you value self-care and prevention, you may be one of them. This article explains what the legal category includes, who checks what before and after a product reaches the shelf, and how to use that knowledge. Our history of natural health movements tells how the 1994 law behind the category came to pass.

“Dietary supplement” is a legal label for things you swallow

Scientists sort nutrients and plants by chemistry. U.S. law sorts products by how they are made, sold and labeled. A “dietary supplement” is a legal category, and the FDA spells out its edges⁴.

To count, a product must pass three tests⁴:

• You swallow it. Creams, ointments and anything you inhale are not supplements, even when they contain the same herbs.
• It contains a dietary ingredient. Think amino acids, plants and plant extracts, vitamins and minerals, plus substances such as enzymes and probiotics. Mixes and concentrated forms of these qualify as well.
• It’s labeled as a supplement. The label must say “dietary supplement” or a version such as “iron supplement.”

Supplements come as pills, capsules, softgels, gummies, liquids and powders⁴. Teas and bars can qualify too. The catch: the product can’t be pitched as everyday food or as a stand-in for a whole meal⁴. That’s why two protein bars on the same shelf can fall under different rules.

There’s one more boundary. An ingredient first approved as a drug generally can’t be sold as a supplement later, unless it was sold as a food or supplement first⁴.

Six in 10 adults use one, and the share climbs with age

The NCHS numbers come from the National Health and Nutrition Examination Survey (NHANES). It asks a sample of Americans, chosen to represent the nation, what supplements they took in the past 30 days³.

From August 2021 to August 2023, use was common at every adult age, and it rose steadily with age³:

Age group	Used any supplement	Used two or more	Used four or more
All adults 20 and older	60.2%	38.7%	15.4%
20–39	46.3%	23.4%	6.4%
40–59	60.3%	38.5%	14.7%
60 and older	75.9%	56.4%	26.5%

Source: NCHS Data Brief No. 561, 2026³.

Women used supplements more than men, 66.1% versus 53.9%³. About 35.7% of children and teens up to age 19 used one, too³.

The trend points up. Adult use rose from 53.8% in 2013–2014 to 60.2%, and the share taking two or more products rose from 30.9% to 38.7%³.

One caution: earlier surveys asked these questions in people’s homes, but the 2021–2023 round asked them by phone, to limit COVID-19 exposure³. NCHS adjusted its weighting for people who didn’t complete the phone interview³. Even so, in our view, it’s wise to treat the trend as approximate.

Industry surveys report even higher numbers. In 2023, the Council for Responsible Nutrition (CRN), a trade association that calls itself the supplement industry’s leading one, said 74% of U.S. adults took supplements⁵. Its online poll of 3,192 adults, run by the research firm Ipsos, counted seasonal and occasional users⁵.

The federal survey counts only the past 30 days, which helps explain the gap.

Supplement, drug or medical food: three rulebooks

The same capsule shape can hold three very different kinds of product. What decides the category is the product’s purpose and how it’s sold.

Category	What it’s for	Key rule	Can it claim to treat a disease?
Dietary supplement	Adds to the diet; not meant to replace food3	No FDA approval of the product, label or most claims before sale4	No. Selling it to treat or prevent a disease makes it a drug in the eyes of the law4
Drug	Treats, cures or prevents disease4	Unlike supplement makers, drug makers must prove safety before marketing6	Yes; a disease claim is what makes a product a drug4
Medical food	The dietary management of a disease with special nutritional needs7	Made for use under a physician’s supervision7	It is meant for one disease’s dietary management, by definition7

The medical food definition comes from a section of the Orphan Drug Act⁷. It covers food made to be consumed or given enterally, meaning into the digestive tract, under a physician’s supervision⁷. The condition must have special nutritional needs that have been established by medical evaluation⁷. A powder marketed for “brain health” doesn’t become a medical food by borrowing the phrase.

Who checks what, before and after a bottle reaches the shelf

This is the whole system on one page. It’s the part most shoppers never see.

Stage	What the law requires	Who is responsible
Before sale: the product	No FDA approval of safety, effectiveness, labels or most claims46	The company
Before sale: new ingredients	A notice to FDA at least 75 days ahead, with safety evidence, for ingredients not sold before Oct. 15, 1994, unless already in the food supply in unaltered form4	The company files; FDA reviews the notice
Before sale: the factory	Register the facility with FDA; follow manufacturing rules on identity, purity, quality, strength and composition4	The company; FDA inspects
On the label	The words “dietary supplement,” a Supplement Facts panel, the firm’s name and a U.S. address or phone number for reporting serious reactions4	The company; FDA reviews after sale
After sale: safety	Forward serious adverse event reports to FDA within 15 business days and keep all reports for 6 years8	The company named on the label
After sale: enforcement	Inspections, marketplace checks, import exams, warning letters and recalls2411	FDA
Advertising	Regulated by the Federal Trade Commission4	The company; the FTC enforces

A few details in that table matter more than they look.

The new-ingredient rule depends on a list that doesn’t exist. The FDA says there is no authoritative list of ingredients sold in supplements before October 15, 1994⁹. Companies decide for themselves whether an ingredient is “new.” If a required notice is never filed, the product is adulterated, meaning illegal to sell, as a matter of law⁹.

Manufacturing rules arrived in 2007. The FDA published its supplement good manufacturing practice rule on June 25, 2007¹⁰. At the time, the agency’s best estimate was about 1,460 firms that made, packed or held supplements¹⁰. The rules cover identity, purity, quality, strength and composition, but the FDA does not test products before they’re sold⁴.

No law caps the dose. Companies set serving sizes and ingredient amounts without FDA approval⁴. Our article on supplement stacks shows how that adds up when you take several products.

“Serious” has a precise meaning. A law signed on December 22, 2006, requires companies to report serious adverse events⁸. A serious event is one that leads to death, a life-threatening episode, a hospital stay, lasting disability or a birth defect, or that needs medical care to prevent one of those⁸.

Forced recalls are new and rare. When GAO reported in 2009, the FDA had no power to order a recall and relied on companies to act voluntarily¹. It had banned only one supplement ingredient, ephedra, in 2004¹.

The FDA Food Safety Modernization Act of 2011 gave the agency mandatory recall power¹¹. In April 2018, the FDA said it had used that power for the first time to protect people from contaminated food¹¹. The target was kratom products tainted with Salmonella, after the company refused repeated requests to recall them voluntarily¹¹.

The government’s own reviewers have described the gaps

The system’s weak spots aren’t a secret. Government reviewers have named them for years.

Consider underreporting. In the first 10 months of 2008, 948 supplement reaction reports reached the FDA¹. Yet the agency itself figured that supplements cause more than 50,000 adverse events a year, which means most never get reported¹.

Resources were thin, too. Supplement programs drew about 4% of the FDA food center’s resources in fiscal 2006 and 2007¹. From 2002 through 2008, FDA inspectors visited zero supplement makers overseas¹.

GAO urged the FDA to seek authority to make companies list their products and labels with the agency¹. In 2019, Gottlieb said a mandatory listing could bring significant benefits, noting that some stakeholders had suggested changing the law².

In 2026, the FDA signaled another round of changes. Its Human Foods Program listed “Dietary Supplement Oversight Modernization” among its 2026 priorities, citing the market’s rapid growth and the more than 30 years since the 1994 law¹². The February 2026 plan promised final guidance on the safety and identity information that new-ingredient notices must contain, plus ways to speed FDA’s reviews of them¹².

The agency also called a public meeting, set for March 27, 2026, on what should count as a dietary ingredient in the first place¹³. Its agenda covered proteins, enzymes, microbes and new ways of making existing ingredients¹³.

These are plans and open questions, not finished rules. Check the FDA’s supplement pages for updates before relying on any change.

The legal category says nothing about whether a product works

“Dietary supplement” describes a rulebook. It doesn’t describe results. Products in the same legal category can sit at opposite ends of the evidence scale.

Example	Evidence level	What the research shows
Folic acid for anyone who could become pregnant	Strong evidence	The U.S. Preventive Services Task Force (USPSTF), an independent expert panel, recommends a daily supplement with 400–800 mcg14
Cocoa flavanol extract for heart health	Promising but early	In the COSMOS trial of more than 21,000 adults, total heart events didn’t drop significantly, though a secondary measure, heart deaths, looked better; our companion article has the details. Mars Edge, a nutrition unit of Mars, Inc., helped fund the trial alongside NIH and supplied the cocoa pills15
Multivitamins to prevent heart disease or cancer in healthy adults	Not enough evidence	The USPSTF found too little evidence to recommend for or against them14
Beta-carotene or vitamin E pills to prevent heart disease or cancer	Evidence says no, or unsafe	The USPSTF recommends against both; beta-carotene raised lung cancer risk in smokers and people exposed to asbestos at work14

Our companion article on food versus supplements goes nutrient by nutrient. Later articles in this series cover deficiencies, recommended intakes, upper limits, labels and product forms.

A system built on choice puts more of the checking on you

Many natural-health readers prize the freedom to choose their own products without a prescription. The 1994 law protects that freedom. Supplements reach you quickly and often cheaply, without the safety proof a drug maker must supply before sale⁶.

The trade-off is that much of the checking happens after you buy. The FDA states plainly that it doesn’t approve supplements before they’re sold⁴. NIH’s Office of Dietary Supplements (ODS) adds that companies don’t have to prove their products work⁶.

Respecting that freedom means using it well. This six-step check takes about 10 minutes.

Before you buy: a six-step check

1. Name the job. Write down why you want it: a diagnosed shortfall, a life stage such as pregnancy, or a clinician’s advice. “General health” is a weak reason to spend money.
2. Look up the ingredient, not the brand. NIH’s ODS fact sheets and NCCIH’s herb pages summarize the research in plain language.
3. Read the label like a regulator. Look for the words “dietary supplement,” a Supplement Facts panel and a U.S. address or phone number⁴. A promise to treat or cure a disease is a red flag, because only drugs may legally make that claim⁴.
4. Check your medicines. Supplements can interact with prescriptions, sometimes seriously, so ask a pharmacist or clinician first⁶.
5. Weigh the quality signals. An independent seal suggests the product was made properly and is free of harmful contaminants, but it doesn’t prove safety or benefit⁶. Our article on third-party testing explains what each seal checks.
6. Keep a record. Note the product, lot number, dose and start date. ODS offers a free form for tracking your supplements and medicines⁶.

If something goes wrong, stop taking the product and contact your clinician. Then report it through the FDA’s Safety Reporting Portal at safetyreporting.hhs.gov⁴⁸. The FDA’s general contact line is 1-888-INFO-FDA (1-888-463-6332)⁴. Report misleading ads to the Federal Trade Commission⁶. For trouble breathing, a seizure or collapse, call 911.

Questions readers ask

The bottom line

A dietary supplement is defined by law, not by science: something you swallow, labeled as a supplement, that contains a vitamin, mineral, herb, amino acid or similar ingredient. Most U.S. adults now take at least one, and the share rises with age.

The rules give you wide access and put more of the checking on you. Companies answer for safety and labels, while the FDA mostly steps in after sale. Name your reason, check the evidence for the ingredient, read the label closely, clear it with your medicines and report any problem.

Related reading

• Why supplement labels say ‘supports’ and never say ‘cures’
• Third-party tested says what’s in the bottle, not that it works
• The supplement facts panel and the blend that hides your dose
• From a $20 herbal patent to a $6.8 trillion wellness economy
• Vitamin pills mostly failed big prevention trials, though a few still earn their place

Sources

1. U.S. Government Accountability Office. “Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding” (GAO-09-250). GAO, January 2009. gao.gov
2. U.S. Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight. FDA, 2019 (page undated; the text marks 25 years since the 1994 law).
3. Stierman B, Couch CA, Gahche JJ, Mishra S. “Dietary Supplement Use: United States, August 2021–August 2023.” NCHS Data Brief No. 561, National Center for Health Statistics, May 2026. cdc.gov
4. U.S. Food and Drug Administration. “Questions and Answers on Dietary Supplements.” FDA, content current as of August 27, 2026. fda.gov
5. Council for Responsible Nutrition (industry trade association). Press release on the 2023 CRN Consumer Survey on Dietary Supplements (three-quarters of Americans take supplements). October 5, 2023. crnusa.org
6. NIH Office of Dietary Supplements. “Frequently Asked Questions (FAQ).” National Institutes of Health, accessed October 2026. ods.od.nih.gov
7. U.S. Food and Drug Administration. “Medical Foods Guidance Documents & Regulatory Information.” FDA, content current as of March 1, 2023. fda.gov
8. U.S. Food and Drug Administration. “Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements” (under the Dietary Supplement and Nonprescription Drug Consumer Protection Act). FDA, revised September 2013. fda.gov
9. U.S. Food and Drug Administration. “New Dietary Ingredients in Dietary Supplements: Background for Industry.” FDA, content current as of February 9, 2023. fda.gov
10. U.S. Food and Drug Administration. Notice of draft guidance on dietary supplement adverse event reporting (Docket No. 2007D-0388), citing the dietary supplement good manufacturing practice final rule (72 FR 34752, June 25, 2007). Federal Register, vol. 72, p. 58313, October 15, 2007. govinfo.gov
11. NBC News. “FDA Forces Mandatory Recall of Kratom, Says It’s a First.” April 2018. nbcnews.com
12. U.S. Food and Drug Administration. “Human Foods Program 2026 Priority Deliverables.” FDA, February 10, 2026. fda.gov
13. U.S. Food and Drug Administration. “FDA Announces Public Meeting on Dietary Supplement Innovation and Scope of Dietary Ingredients.” HFP Constituent Update, March 3, 2026. fda.gov
14. U.S. Preventive Services Task Force. “Vitamin, Mineral, and Multivitamin Supplementation to Prevent Cardiovascular Disease and Cancer: US Preventive Services Task Force Recommendation Statement.” JAMA, 2022;327(23):2326–2333. uspreventiveservicestaskforce.org
15. Brigham and Women’s Hospital (news release via ScienceDaily). “Trial Testing Cocoa Flavanol Supplement Shows Promise for Reducing Cardiovascular Risk” (on Sesso HD et al., American Journal of Clinical Nutrition, 2022). March 16, 2022. sciencedaily.com