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🇺🇸 United States

FDA & FTC rules for supplement brands, explained.

In the US your label must be truthful, your claims substantiated, and your product made to cGMP standards - or you risk warning letters, seizures and import alerts.

FDA & FTC (United States) regulation hero
Region
United States
Enforced by
FDA · FTC
Applies to
Supplements & foods in the US
Framework
DSHEA · 21 CFR 111
What it is

Claims now require evidence.

In the US, dietary supplements are regulated under DSHEA. The FDA oversees labeling and manufacturing; the FTC polices advertising. Together they require that what's on the label is truthful and not misleading, and that every claim is backed by competent, reliable evidence.

Manufacturing must follow cGMP (21 CFR 111) - identity, purity, strength and composition all have to be verified. “Clinically dosed” and “third-party tested” mean nothing to a regulator without the data to support them.

The standard is simple: your label must match what's in the bottle, and your claims must be provable.
FDA & FTC (United States) what is it
What you must do

What compliance asks of you.

1
Truthful, accurate labeling

Label content must match the product - actual ingredient identity, amounts and potency.

2
Substantiate every claim

Structure/function claims need competent, reliable scientific evidence on file.

3
cGMP testing

Identity, purity, strength and contaminant testing under 21 CFR 111.

4
Required disclaimers

Structure/function claims carry the FDA disclaimer; claims can't imply disease treatment.

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Why it matters

Why this matters for your brand.

FDA warning letters

Public letters demanding corrective action - often the first step before harder enforcement.

Seizure & import alert

Mislabeled or adulterated products can be seized, and import alerts can block your goods at the border.

FTC action on claims

Unsubstantiated marketing claims can trigger FTC penalties and mandated refunds.

From requirement to proof

How the shield covers you.

You need to
Prove the label matches the bottle
Defacto delivers
Independent assay of identity, potency & purity
You need to
Substantiate a marketing claim
Defacto delivers
Lab-verified data, published and clickable
You need to
Show contaminants are controlled
Defacto delivers
Heavy-metal & contaminant screening on file
What we believe
Rebuilding trust in commerce.

At Defacto, we believe transparency is the fix for a broken trust layer. We built the verification infrastructure - independent labs, PhD review and a public report - so brands and shoppers can see exactly what's inside.

FAQ

Questions brands often ask us.

No - supplements aren't pre-approved. Responsibility sits with the brand to ensure labels are truthful and products are safe and compliant. That makes independent proof your strongest defense.

The FDA focuses on the label and manufacturing; the FTC focuses on advertising claims. Both require substantiation.

Current Good Manufacturing Practice (21 CFR 111) requires verification of identity, purity, strength and composition for every batch.

We independently test the exact product, verify the label against the lab result, screen for contaminants, and publish it - the evidence FDA and FTC expect you to hold.

Statements about how an ingredient affects the body's structure or function (e.g. 'supports immune health'). They need substantiation and must carry the FDA disclaimer, and they can't imply disease treatment.

Yes. Mislabeled or adulterated products can be seized, and import alerts can block goods at the border. Warning letters often come first.

No. You can use any ISO/IEC 17025- or similar accredited lab. What matters is independent testing of the actual product and keeping the evidence on file.

The FTC can pursue penalties and mandated refunds for claims that aren't backed by competent, reliable evidence - even if the label itself is fine.

Once accredited lab results are reviewed and approved, publishing verified claims with Defacto takes minutes - most brands go live the same day.

Turn compliance into a selling point.

Independent lab data, published on your product page - the evidence regulators want and the proof customers trust.

This page is general information, not legal advice. Regulations change and enforcement varies by market - confirm specifics with qualified counsel.

Founder call

Have a chat with the founders.

Jonas Karosas Jonas KarosasFounder & CEO
Deivydas Daugela Deivydas DaugelaFounding COO

You made it this far. That probably means you care about trust as much as we do. Book a founder call and let's see whether Defacto is the right fit for your product.

  • A look at how verification works for your catalog
  • Real examples from brands like yours
  • A clear, honest answer on cost and timing

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