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Selling dietary supplements in the US

In the US, dietary supplements are regulated by the FDA under the Dietary Supplement Health and Education Act of 1994. There is no approval before sale: firms are responsible for the safety and labelling of their products before marketing, and the FDA acts after a product reaches the market. Manufacturing follows 21 CFR Part 111.

Updated · Each section links to the official source it comes from

Main law
Dietary Supplement Health and Education Act of 1994
Approval before sale
None: firms answer for safety and labelling
Manufacturing
CGMP under 21 CFR Part 111
New ingredients
A new dietary ingredient notification
Claims
Structure/function claims are notified to the FDA

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Is any ingredient a new dietary ingredient that needs notifying? Read more
  2. 2What has to be on the label, and are the major allergens declared? Read more
  3. 3Are the claims structure/function claims, and notified? Read more
  4. 4Is it made, packed, labelled and held under 21 CFR Part 111? Read more
  5. 5Does it come in from outside the US? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

Advertising claims

What the FTC expects of health claims in supplement marketing.

  • Advertising must be truthful and not misleading, and objective claims need adequate substantiation before they are made; health benefit and safety claims generally need competent and reliable scientific evidence.
  • Advertising includes packaging and labelling, websites, social media and influencer marketing, and anyone who takes part in the marketing can be liable.
  • The guidance replaced the FTC's 1998 advertising guide for dietary supplements. It is guidance, not a safe harbour.

How we help: Compliant Always keeps the evidence behind each claim with the product, so the label, the website and the substantiation file say the same thing. Ask about this

Ingredients and safety

What a supplement firm owes before it sells.

  • Manufacturers and distributors may not market adulterated or misbranded supplements, and are responsible for evaluating the safety and labelling of their products before marketing.
  • The FDA can take action against an adulterated or misbranded supplement after it reaches the market.
  • New dietary ingredients have an FDA premarket notification process.

How we help: Compliant Always keeps the evidence behind each ingredient with the product, and shows which ones carry a notification. Ask about this

Current good manufacturing practice

How supplements are made, packed, labelled and held.

  • 21 CFR Part 111 applies to anyone who manufactures, packages, labels or holds a dietary supplement, including one made by one firm and packaged or labelled by another.
  • It also applies to supplements imported or offered for import into the US.

How we help: Compliant Always keeps specifications, certificates of analysis and batch records together, organised the way Part 111 asks for them. Ask about this

Import and facilities

Registration, prior notice and supplier verification.

  • Facilities that make, process, pack or hold food, supplements included, for consumption in the US register with the FDA and renew every other year.
  • Importers give prior notice of shipments and follow a Foreign Supplier Verification Program for each food and foreign supplier.

How we help: Compliant Always keeps your foreign suppliers' documents by product and supplier, and shows which registrations and certificates lapse first. Ask about this

Who answers for what

WhoWhat they answer forHow we help
Brand or distributorThe safety and labelling of what it markets, and its claims.Label and claims checked, with the safety evidence behind them.
Contract manufacturerCGMP under Part 111 for what it makes, packs, labels or holds.Certificates of analysis and batch records kept together, ready for a brand's audit.
Ingredient supplierThe identity of the ingredient and, where it applies, its new dietary ingredient status.Specifications and certificates collected once and shown to each customer that asks.
ImporterPrior notice and supplier verification.Foreign suppliers' documents read and dated, by product and supplier.

Federal and state

Federal agencies set the national rules. States can add their own: California's Proposition 65, for example, can call for a warning on a product sold there.

Retailers and marketplaces often ask for more than the law does, such as test reports by lot or third party certificates.

Questions businesses ask

Do dietary supplements need FDA approval before sale?
No. Under DSHEA, supplement firms are responsible for evaluating the safety and labelling of their products before marketing. The FDA can act against an adulterated or misbranded supplement after it reaches the market.
What is a new dietary ingredient notification?
A premarket notification to the FDA for certain dietary ingredients in supplements. The FDA publishes the process, guidance and instructions for submitting one.
Who has to follow 21 CFR Part 111?
Anyone who manufactures, packages, labels or holds a dietary supplement, including supplements made by one firm and packaged or labelled by another, and supplements imported into the US.
Do structure/function claims need to be notified?
Yes. The FDA has a notification process for structure/function and related claims in dietary supplement labelling.
Does the FDA approve supplement labels?
No. The FDA does not pre-approve labels. The firm is responsible for a label that meets the requirements.
Which allergens must a supplement label declare?
The nine major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame.
Does a supplement facility register with the FDA?
Facilities that make, process, pack or hold food for consumption in the US, supplements included, register with the FDA and renew every other year.
What does an importer of supplements have to do?
Give prior notice of shipments, and follow a Foreign Supplier Verification Program for each food and foreign supplier.
Do state rules apply to supplements?
They can. California's Proposition 65, for example, can call for a warning, and retailers and marketplaces often ask for test reports and certificates beyond the law.
Who regulates supplement advertising in the US?
The FTC covers advertising, including packaging, websites, social media and influencers, under its Health Products Compliance Guidance. Health claims generally need competent and reliable scientific evidence before they are made.
How does Compliant Always help with selling in the US?
Our team reads the rules for the markets you sell in. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches federal sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

Name the product and the markets you sell in. We will come back to you with what applies in the US and what your paperwork needs to show.

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