US Regulation of Herbal Supplements: DSHEA, FDA and the FTC
How US law treats herbal supplements: what DSHEA changed, what FDA does and does not review, who polices advertising, and what the label disclaimer means.
Content last updated . This page has not been medically reviewed.
Safety first. Natural products can cause side effects and interact with medicines. Read herb safety and interactions before you use anything on this page.
Short answer. In the United States, herbal products sold as dietary supplements are not approved by the FDA before they are sold. The company is responsible for safety and for truthful labeling, and the FDA can act mostly after a problem appears. [1][2] That is why a label is not a guarantee of what is in the bottle. [2]
How the sources define the terms
- DSHEA. The Dietary Supplement Health and Education Act of 1994, which defined "dietary supplement" and "dietary ingredient". The FDA says "dietary ingredient" includes vitamins and minerals, herbs and other botanicals, and amino acids, among others. [1]
- New dietary ingredient (NDI). An ingredient that was not marketed in the United States before October 15, 1994. [1]
- Structure/function claim. A claim about effects on a structure or function of the body, as opposed to a claim to treat a disease. [1]
- Disclaimer. The required statement that the FDA has not evaluated a claim, and that the product is not intended to diagnose, treat, cure or prevent any disease. [1]
Who does what
| Question | What the sources say | Source body |
|---|---|---|
| Is a supplement approved before sale? | No. Under DSHEA, FDA does not have authority to approve dietary supplements before they are marketed. [1] | FDA |
| Are claims approved? | FDA generally does not approve supplement claims or other labeling before use. [1] | FDA |
| Who must show a product is safe? | Generally, a firm does not have to give FDA its safety evidence before or after marketing, except for a new dietary ingredient, which needs a notification at least 75 days before marketing. [1] | FDA |
| Does FDA test products before sale? | No. FDA does not test dietary supplements before they are sold to consumers. [1] | FDA |
| Manufacturing quality | FDA regulations require current good manufacturing practices to help ensure identity, purity, quality, strength and composition. [1] | FDA |
| When can FDA act? | In general, FDA is limited to postmarket enforcement. [1] NCCIH says FDA can act against adulterated or misbranded supplements only after the product is on the market. [2] | FDA, NCCIH |
| Advertising | The FTC and FDA share jurisdiction over marketing; the FTC has primary responsibility for claims in all forms of advertising. [3] | FTC |
| Amounts per serving | The FDA says there are no laws or regulations limiting the serving size of a supplement or the amount of an ingredient in it. [1] | FDA |
Claims on labels
- A company that makes a structure/function claim must have substantiation that the claim is truthful and not misleading. [1]
- The label must carry a disclaimer that FDA has not evaluated the claim. [1] The wording says the product is not intended to diagnose, treat, cure or prevent disease because only a drug can legally make such a claim. [1]
- The FTC says advertising must be truthful and not misleading, and advertisers must have adequate substantiation for all objective product claims. [3]
- Label claims on supplements are therefore best read as marketing claims unless a clinical source supports them. Research on a herb is covered on each herb's own page, for example turmeric and ginkgo.
What this means in practice
The sources describe a system in which responsibility starts with the manufacturer. FDA's own statement is that manufacturers and distributors have initial responsibility for ensuring their supplements meet safety standards, and that FDA enforces when they do not. [1] NCCIH adds a warning that what is on the label may not be what is in the product: the FDA has found prescription drugs, including anticoagulants such as warfarin, in products sold as supplements. [2]This is a statement about the US system. A herb sold as a supplement and a herb registered as a medicine in the EU or UK sit under different rules; see traditional herbal registration.
Limits and uncertainty
- We read the FDA's question-and-answer page, NCCIH's consumer page and the FTC's compliance guidance. We did not read the text of the statute, so details of wording are the agencies' own summaries.
- Proper evidence not found, in the pages we read, for how many herbal supplements are on the US market, or how many are tested after sale.
- State laws and rules for other claims (such as health claims, which need FDA review) were not covered in detail here.
Safety and who should ask a clinician
Because supplements are not reviewed before sale, check product quality and contamination and quality testing and certifications. Ask a pharmacist or clinician about interactions with medicines, pregnancy and breastfeeding, children, liver or kidney conditions, and surgery. Report side effects: the FDA says it evaluates adverse event reports from consumers and health care providers. [1] See side effects and reporting. A fuller overview is on how supplements are regulated.Frequently asked questions
Does the FDA approve herbal supplements?
No. Under DSHEA, the FDA does not have the authority to approve dietary supplements before they are marketed. [1]
Who checks that a herbal supplement is safe?
The manufacturer or distributor has initial responsibility for safety. FDA can take action after a product is on the market. [1][2]
What does "This statement has not been evaluated by the FDA" mean?
It means the FDA has not evaluated that claim. The law requires the disclaimer when a structure/function claim is made. [1]
Who polices supplement advertising?
The FTC and FDA share jurisdiction over marketing, and the FTC has primary responsibility for advertising claims. [3]
Is there a limit on how much of an herb a supplement can contain?
The FDA says no law or regulation limits the serving size of a supplement or the amount of an ingredient in a serving. [1] A pharmacist or clinician can help judge a product for a person.
References
- U.S. Food and Drug Administration (FDA). Questions and Answers on Dietary Supplements. Read 2026-10-23.
- National Center for Complementary and Integrative Health (NCCIH). Using Dietary Supplements Wisely. Read 2026-10-23.
- U.S. Federal Trade Commission (FTC). Health Products Compliance Guidance. Read 2026-10-23.