Guides · US compliance

Which health words turn a supplement listing into a drug claim, and which are lawful

A dietary supplement may describe an effect on the normal structure or function of the body. It may not claim to diagnose, treat, cure, mitigate or prevent a disease: that wording makes it a drug, and without an approval or a monograph behind it an unapproved one. Regulations were read Aug 13 to 18, 2026; examples are from FDA’s warning-letter index, fetched Aug 13 and Aug 26, 2026.

The line, as the regulation draws it

21 CFR 101.93 is titled “Certain types of statements for dietary supplements” and reaches nothing else. Subsection (f) permits a claim about the structure or function of the body; (c) requires the two-sentence disclaimer that travels with it, the one ending “This product is not intended to diagnose, treat, cure, or prevent any disease”; (g)(1) defines a disease as damage to an organ, part, structure or system, “or a state of health leading to such dysfunctioning (e.g., hypertension)”. The preamble, 65 FR 1000 (Jan 6, 2000), draws the other edge: common conditions of natural states that do not cause significant or permanent harm are not diseases, among them hot flashes, common menstrual symptoms, ordinary morning sickness, mild memory problems and hair loss with aging, and noncystic acne. Cystic acne stays a disease claim. The modifier does the work, not the noun.

Lawful structure/function	Drug claim
Supports healthy immune function	Prevents colds and flu
Maintains healthy cholesterol levels already within the normal range	Lowers cholesterol
Helps maintain healthy skin	Treats cystic acne
Promotes restful sleep	Cures insomnia
Supports heart health	Lowers blood pressure; prevents heart attacks
Helps you relax	Anti-anxiety; relieves anxiety attacks

Outside a warning, a disease named outright needs no verb: hypertension, diabetes, cancer or arthritis in a product’s copy implies an effect on it, so “Arthritis Support Formula” is a drug claim. For other conditions the verb decides, and it is wider than cures and treats: lowers, reduces, prevents, mitigates, fights and combats, and the gerund (“reducing inflammation”). “Anti-” is a form of the claim, not a denial of it: “Anti-Anxiety Calming Chews” is a drug claim, “anxiety-free travel pillow” is not.

The words FDA quoted back

FDA warning letters quote the seller’s own copy back as evidence that the product is a drug. The index quotes “Lower fasting blood sugars by 11%” and, mid-sentence, “to regulate blood sugars by strengthening the pancreas”: a blood marker beside a verb that promises movement. A letter dated Jul 9, 2026, about a nerve-support formula, quoted softer copy, each line as the letter printed it:

“Supports damaged and needy nerves.”
“R-Alpha Lipoic Acid (ALA) Protect nerves from damage…”
“…clinically proven to reduce the overall symptoms of occasional burning, tingling, and numbness by ~76%.”
“NeuropAWAY targets the cause of neuropathic pains in: head & neck, feet, static nerve, hands, arms, legs…”

The letter introduced them as “Examples of some of the claims that provide evidence that your products are intended for use as drugs”.

A warning is not a claim

Deleting text the law obliges you to print is the other mistake. A condition named in a warning is the inverse of a claim:

Proposition 65. “WARNING: Cancer risk from exposure to lead. See www.P65Warnings.ca.gov.” carries one of the short-form contents California Code of Regulations title 27, section 25603 permits. On Amazon the warning is composed from your attribute and rendered by the platform, so it does not belong in listing copy: see the Prop 65 guide.
Contraindications. “Consult your physician before use if you have diabetes or high blood pressure” is a standard supplement warning.
The disclaimer itself. It contains treat and cure, and it is what makes a structure/function claim compliant.

A warning does not license the sentence after it: “Consult your doctor. Cures arthritis.” is still a drug claim.

The OTC monograph case

Some disease wording is lawful because a regulation prescribes it. 21 CFR 333.150(b) writes the first-aid antibiotic indication as a select list: “First aid to help”, then one of prevent, decrease or reduce the risk (or chance) of, guard against, protect against; then infection, bacterial contamination or skin infection; then “in minor cuts, scrapes, and burns”. 333.350 does the same for acne: “For the”, then management or treatment, then “of acne”. The acne wording is lawful only with an active ingredient 333.310 lists, at the strength it lists: benzoyl peroxide at 2.5 to 10 percent, salicylic acid at 0.5 to 2 percent. Three things that look like proof are not:

A Drug Facts panel. 21 CFR 201.66 prescribes a format, not a wording; FDA has quoted the panel back at hand sanitisers, skin lighteners and topical anaesthetics it ruled unapproved new drugs.
A monograph ingredient. Salicylic acid peels sold at 30% and 80% name the ingredient the acne monograph lists at 0.5 to 2 percent. The strength is the giveaway, and the exports we have read carry none.
An NDC. Its labeler code is assigned by FDA under 21 CFR 207; it says nothing about whether a claim sits inside a monograph.

OTC_MEDICATION, SKIN_PROTECTANT, SUNSCREEN and TOPICAL_HAIR_REGROWTH_TREATMENT are Amazon product type names for products that are OTC drugs in the US. Declaring the type says what you sell the product as, not that the formulation is within a monograph. A row declared as a dietary supplement that prints the first-aid wording is a supplement making a drug claim: the wording is a drug’s and the declaration says the product is not one.

What to do, by what the product is

A dietary supplement. Rewrite the claim as an effect on normal structure or function, as in the table above, and carry the 21 CFR 101.93(c) disclaimer.
A conventional food, which a snack, drink or tea is even when sold as wellness. The supplement disclaimer does not apply; leave it off. A health claim on a food is lawful where FDA has authorised or otherwise permitted that claim; a nutrient-content claim, which describes what is in the food, usually does the job where it is true of the food: “high in fiber”, “good source of iron”.
A cosmetic. No disclaimer exists. A claim to affect a disease or the body’s structure or function makes it a drug under FD&C Act 201(g)(1); the wording moves to appearance or feel: “reduces the appearance of acne scars” is cosmetic, “clears acne” is a drug claim.
An OTC monograph drug. Do not delete the prescribed wording; the regulation writes it. Confirm on the product label that the active ingredient and strength are the monograph’s, and that the product carries a Drug Facts panel and the labeler’s NDC.
An EU or GB listing. Do not add the FDA disclaimer; it has no effect there. Regulation (EU) 1169/2011 Art 7(3) says food information “shall not attribute to any food the property of preventing, treating or curing a human disease”; the lawful health claims are those authorised under Regulation (EC) 1924/2006, and Great Britain keeps the same prohibition as assimilated law.

What to check

Every named condition in your copy: some are a claim on their own; for the rest, the verb beside it, anti- and lowers included.
Every disease word inside a contraindication or the disclaimer: it is not a claim, so do not rewrite it as one. The sentence after it: read on its own.
An OTC monograph product: ingredient, strength, and the product type declared in your export.

Then look at the listings themselves

Pronoia reads the title, bullets, description and keywords in your own listings export for a named condition beside a claim verb, reads the warnings and disclaimer above as warnings rather than claims, and holds monograph wording and other ambiguous rows for review rather than rendering a verdict, unless the row declares a dietary supplement. It does not flag copy like the nerve-support lines above; read that yourself. Drop the file on the scan page and it is scored in your browser, nothing uploaded, or email it to audit@trypronoia.com for an audit, free for our first sellers, one each.