Supplement advertising rules: FTC and DSHEA in 2026

General information, not legal advice. Talk to a regulatory attorney before you finalize claims for a product.

U.S. supplement advertising rules come from two places: DSHEA and FDA rules control what can go on your label, while the FTC controls what your ads, website, emails and influencers say and expects the same honesty everywhere. If you’re a founder writing your own copy or briefing creators, these are the parts that matter most in 2026.

Two regulators, one test: is it true, and can you prove it?

The Dietary Supplement Health and Education Act of 1994 (DSHEA) amended the Federal Food, Drug, and Cosmetic Act. It sets out what supplement labels and labeling may say without FDA premarket approval. The FTC looks at advertising: your website, paid social, podcast reads, marketplace product pages and creator posts.

They overlap in practice. A claim that is fine on the bottle can still be deceptive in a TikTok video if the video suggests more than the label does or more than your evidence supports.

What DSHEA lets you say on a label

Structure/function claims, not disease claims

DSHEA allows structure/function claims, which describe how a nutrient or dietary ingredient affects the normal structure or function of the body. Under section 403(r)(6) of the FD&C Act, you don’t need FDA approval for these claims. You do need substantiation showing they are truthful and not misleading.

You can’t say or imply that the product diagnoses, treats, cures or prevents a disease. For example:

• “Supports normal muscle function” is a structure/function claim.
• “Relieves arthritis pain” or “lowers blood pressure” is a disease claim, and that makes it a drug claim.

Implied disease claims count too. A before-and-after image, a product name or a hashtag can push an acceptable claim over the line.

The 30-day notification

The manufacturer, packer or distributor named on the label must notify the FDA no later than 30 days after first marketing a product with a structure/function claim. The notice includes the claim text and is signed by someone who certifies that the company has substantiation. A notification is a filing, not an approval, so you can’t market it as “FDA reviewed.” The procedures are in the FDA Dietary Supplement Labeling Guide, Chapter VI.

The disclaimer, and what changed recently

Any structure/function claim must come with this exact text: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

The existing regulation, 21 CFR 101.93(d), says the disclaimer must appear on every label panel that carries such a claim. On December 11, 2025, the FDA sent a letter to the industry about this:

• It said it intends to exercise enforcement discretion on the every-panel placement rule.
• It said it does not intend to relax the rest. The disclaimer still has to be on the label and linked to each claim, usually with an asterisk.

As of September 2026, the FDA had not finalized a rule making this change. In May 2026 the Council for Responsible Nutrition (CRN) filed a citizen petition asking for clarity and quick rulemaking. Keep the disclaimer and the asterisk link on everything, and watch for a final rule before redesigning packaging.

What the FTC expects behind every claim

Competent and reliable scientific evidence

In December 2022, the FTC replaced its 1998 supplement guide with the Health Products Compliance Guidance. Health benefit and safety claims for supplements, foods and other health products need “competent and reliable scientific evidence,” and the guidance treats randomized, controlled human clinical trials as the general standard. A few details catch small brands out:

• Animal and test-tube studies carry limited weight for predicting effects in people.
• Quality beats quantity. There’s no set number of studies, but replication adds weight.
• Fit matters. Research on an ingredient at one dose doesn’t automatically support your product at a different dose, form or combination.
• Epidemiological evidence is accepted only when experts accept it as a substitute for RCTs and RCTs aren’t feasible.

Implied claims count

The FTC identifies every claim a reasonable consumer would take from the ad, not only the literal words. If you have evidence for “reduces snoring” and your ad suggests the product helps with sleep apnea, that is a separate claim needing its own evidence. Stock photos, product names, “doctor recommended” badges and a creator’s personal story all add implied claims.

Traditional use claims

“Used for centuries in Ayurvedic practice” is not a free pass. If a traditional-use claim suggests a health benefit without scientific support, the ad has to clearly say the evidence is lacking. The traditional product also has to match yours in ingredients, dose and form.

Influencers, testimonials and reviews

This is where most wellness brands get into trouble: the content comes from someone else, but the legal exposure is still yours.

Disclose material connections where people can’t miss them

The FTC revised its Endorsement Guides in June 2023. Any material connection, including payment, free product, affiliate commissions, discount-code revenue and employment, has to be disclosed clearly and conspicuously: difficult to miss and easy to understand. On social media the disclosure has to be “unavoidable.” These placements don’t meet it:

• A disclosure in the creator’s bio
• A disclosure behind a “more” tap
• “#ad” buried among a dozen other hashtags

The disclosure belongs in the post itself, in the first lines of the caption and spoken or on screen in video.

The updated guides also make clear that brands can be liable for what their endorsers say, and the FTC’s companion guidance expects brands to monitor their influencers. Signing a contract and never checking the posts doesn’t protect you.

Testimonials are claims too

If a creator says your magnesium “fixed my anxiety,” that can read as a disease claim, and it is your claim. The FTC’s health guidance treats testimonials like claims you make directly, so you need scientific evidence behind them. If a testimonial shows results better than buyers can generally expect, a “results not typical” footnote doesn’t fix it: you have to clearly disclose typical results. Two habits help:

• Give creators a short list of approved claims and banned phrases.
• Review the script and the edit before anything goes live.

The Consumer Reviews and Testimonials Rule

The FTC finalized a rule in August 2024 banning the sale and purchase of fake reviews and testimonials, and letting the agency seek civil penalties against knowing violators. It prohibits:

• Reviews that misrepresent whether the reviewer had a positive or negative experience, or used the product at all
• Incentives that depend on a review being positive (or negative)
• Undisclosed reviews written by company insiders or their immediate relatives

In December 2025, the FTC sent warning letters to 10 companies under this rule. Law firm commentary in 2026 describes it as an active enforcement priority.

What getting it wrong costs in 2026

Following OMB guidance, the FTC left its civil penalty amounts unchanged for 2026 and kept the 2025 levels. Under the review rule, that means up to $53,088 per violation. Because each fake review or non-compliant post can count as a separate violation, the total adds up quickly. FTC orders in health cases can also include consumer refunds and stricter substantiation requirements that last for years.

Private litigation adds risk. Trade press has reported class-action lawsuits over things as technical as where the DSHEA disclaimer sits on a label.

A claims workflow a small brand can actually run

You don’t need a compliance department, but you do need a process. This is the one we set up with health and wellness brands:

1. Build a claims matrix. List each claim, the approved wording, the supporting studies, the dose used in them, and where the claim may appear (label, site, ads, creators).
2. Match the dose. If the amount per serving doesn’t match what the evidence used, rewrite or drop the claim.
3. File the FDA notification within 30 days of first marketing any new structure/function claim on labeling, and keep a copy.
4. Use one disclaimer system across packaging, product pages and ad landing pages.
5. Write a creator brief with approved claims, banned words (“cure,” “treat,” “heal,” condition names), and how to place the disclosure.
6. Pre-approve and monitor creator content, and keep dated screenshots.
7. Audit reviews. Remove insider reviews or label them clearly, and stop any incentive that depends on a positive rating.

At JADX, claims, packaging copy, landing pages and paid creative are handled by one team using one system, so a claim approved for the label is worded the same way in a Meta ad. If you want an outside check on what your site, ads and social accounts currently claim, our free Marketing X-Ray flags the riskiest wording first.

FAQ

Do structure/function claims need FDA approval?

No. You notify the FDA within 30 days of first marketing the claim, but the agency doesn’t approve it. You still need evidence that the claim is truthful and not misleading, and you must use the DSHEA disclaimer.

Is the DSHEA disclaimer still required on every label panel in 2026?

The regulation still says so. However, since December 2025 the FDA has said it will exercise enforcement discretion on the every-panel placement while it considers changing the rule. The disclaimer itself and the link to each claim are still required.

Are we responsible for what a paid influencer says?

Yes. Under the Endorsement Guides, the brand can be liable for deceptive creator content and for missing disclosures. The FTC expects brands to brief, review and monitor creators.

Can we use customer testimonials about health results?

Yes, but each testimonial counts as a claim that needs scientific evidence, and one that mentions a disease turns your marketing into a disease claim. If the results are better than typical, you must clearly disclose what buyers can generally expect. You also can’t publish fake reviews or ones that depend on positive sentiment.

What’s the maximum FTC civil penalty in 2026?

The FTC kept its 2025 penalty levels for 2026. Under the Consumer Reviews and Testimonials Rule, that is up to $53,088 per violation.