FDA & Supplement Claims

Mad Muscle sells dietary supplements. Dietary supplements are regulated by the U.S. Food and Drug Administration (FDA) as a category of food, not as drugs. This page explains what that means for the claims you read on this site and on our labels.

The disclaimer, and why it appears

Wherever this site describes what an ingredient does — “citrulline malate for pump”, “beta-alanine for endurance”, “supports joint health” — that is a structure/function claim. It describes the role of a nutrient or dietary ingredient in supporting the normal structure or function of the body.

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), a supplement may carry these claims without FDA pre-approval, provided three things are true: the seller holds substantiation that the claim is truthful and not misleading, the claim is accompanied by a specific disclaimer, and the seller notifies FDA of the claim no later than 30 days after first marketing the product with it.

Every such claim on this site is marked with an asterisk that links to this disclaimer, which is the wording FDA requires:

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

That sentence is set out in 21 CFR 101.93(c). Its placement, boldface type and minimum size are also set by regulation, not by preference.

What a structure/function claim is not

A structure/function claim is not a disease claim. A disease claim states or implies that a product diagnoses, mitigates, treats, cures or prevents a disease, and a product bearing one is regulated as a drug. FDA draws the line at the disease itself: “helps build lean muscle” describes a normal body function, while “treats muscle wasting” names a disease and would not be lawful on a supplement label.

We write to the first standard. If you find copy anywhere on this site that reads as a disease claim, tell us and we will correct it.

Substantiation

Advertising for supplements is separately overseen by the Federal Trade Commission (FTC), which requires health-related claims to be supported by competent and reliable scientific evidence. FTC's Health Products Compliance Guidance (December 2022) treats randomised, controlled human trials as the most reliable form of that evidence for health-benefit claims.

The claims we make are deliberately narrow: we describe the ingredients in each product, the amounts where the label publishes them, and the role those ingredients play. We do not claim results, timelines, or outcomes for any individual.

Doses and labels

Where this site prints a number — 5,000 mg of citrulline malate per serving in Pump, 24 g of protein per serving in Whey, 75% protein by weight — that figure comes from the product label. The Supplement Facts panel on the tub is the authoritative source for the product you receive. Formulations and flavours can change; always read the panel on the container in your hand.

This is not medical advice

Nothing on this site is medical advice, and no member of Mad Muscle staff is acting as your clinician. Our founder is a licensed physical therapist, and that informs how these products are formulated, but it does not create a treating relationship with you.

Talk to your physician before using any dietary supplement if you are pregnant or nursing, taking prescription medication, managing a medical condition, or preparing for surgery. These products are not intended for anyone under 18. Products containing caffeine should be counted against your total daily caffeine intake.

Reporting a problem

If you experience an adverse event you believe is related to one of our products, stop using it and contact your healthcare provider. Please also tell us at madmusclesupplements@gmail.com so we can record it.

You may report adverse events directly to FDA through MedWatch, the agency's safety reporting program, at fda.gov/medwatch or by calling 1-800-FDA-1088.

Sources

  • 21 CFR 101.93 — Certain types of statements for dietary supplements (disclaimer wording, placement, type size, notification, and the definition of a disease claim).
  • Federal Food, Drug, and Cosmetic Act, section 403(r)(6) — the statutory basis for these claims and for the boldface disclaimer.
  • FDA, Structure/Function Claims — substantiation and the 30-day notification requirement.
  • FDA, Letter to the Dietary Supplement Industry on the DSHEA Disclaimer, 11 December 2025 — enforcement discretion on the “each panel” placement requirement only; the requirement to link the disclaimer to each claim is unchanged.
  • FTC, Health Products Compliance Guidance, December 2022 — the evidence standard for health-related advertising claims.

This page is provided for transparency and is not legal advice.