How to start a supplement brand

Does the FDA approve dietary supplements before they are sold?

No. The FDA does not have the authority to approve dietary supplements for safety and effectiveness, or to approve their labels, before they are sold (FDA 101: Dietary Supplements). Instead, the companies that make and sell them are responsible for evaluating the safety and labeling of their products before they go on the market. If your brand name is on the bottle, that responsibility is yours, even when someone else makes the product.

A product is a dietary supplement when it is taken by mouth, is not presented as a conventional food, is labeled as a dietary supplement, and contains one or more dietary ingredients. FDA's labeling guide lists them:

• a vitamin or a mineral
• an herb or other botanical
• an amino acid
• a dietary substance people use to supplement their diet
• a concentrate, metabolite, constituent, extract or combination of any of these

Supplements come as tablets, capsules, soft gels, gel caps, powders, bars, gummies and liquids. What you say about a product matters as much as what is in it: a product presented for the treatment, prevention or cure of a disease generally meets the definition of a drug instead, which brings a very different set of rules.

Who is responsible when a contract manufacturer makes my supplement?

FDA's current good manufacturing practice (CGMP) rule for supplements, 21 CFR part 111, covers anyone who manufactures, packages, labels or holds a dietary supplement. Most new brands hire a contract manufacturer, and the rule still reaches them. FDA's small business guide to the rule gives the example of a distributor who has a manufacturer make a supplement and sells it under its own label: that distributor has an obligation to know what manufacturing is done and how, so it can decide whether the finished product meets its specifications and whether to approve and release it.

In practice, that means a brand owner should:

• write down the specifications for each product: what it contains, how much, and how pure it must be
• choose a manufacturer that works under part 111 and agree in writing who does which step
• review what the manufacturer did for each batch before deciding to release it for sale
• keep the records that show those decisions

Facilities that manufacture, pack or hold food, which includes dietary supplements, must register with the FDA and renew every other year between October 1 and December 31 of each even-numbered year. Your manufacturer registers its own facility. FDA's registration questions and answers say a broker who does not manufacture, process, pack or hold food does not have to register; if you store inventory yourself, check whether your location counts as holding food.

Do I need to tell the FDA about my ingredients?

Only for a new dietary ingredient: one that was not marketed in the United States before October 15, 1994. For a supplement that contains one, the manufacturer or distributor must send the FDA a notification at least 75 days before the ingredient is introduced into interstate commerce (How to Submit Notifications for a New Dietary Ingredient).

The date is what matters, not how familiar an ingredient sounds. If you want something novel, such as a newly developed extract, ask your manufacturer whether it was marketed in the United States before October 15, 1994 before you commit to a formula, and allow for the 75 days if it was not.

What must go on a supplement label?

FDA's Dietary Supplement Labeling Guide lists five required statements:

1. the statement of identity, which uses the term "dietary supplement" (or a word for the ingredient, such as "calcium supplement")
2. the net quantity of contents
3. nutrition labeling, in a Supplement Facts panel that gives the serving size, the servings per container and each dietary ingredient's amount
4. the ingredient list, in descending order of predominance by weight
5. the name and place of business of the manufacturer, packer or distributor

The statement of identity and the net quantity go on the principal display panel, the part of the label most likely to be seen at the shelf. When your brand is named but someone else made the product, the name is qualified with a phrase such as "Manufactured for" or "Distributed by". The label also needs a domestic address or domestic phone number where you can receive reports of serious adverse events.

What claims can I make about my supplement?

Supplements may carry structure/function claims: statements that describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the human body. Each one needs this disclaimer, prominently and in bold type: "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." You must also notify the FDA no later than 30 days after you first market the supplement with the claim (Notifications for Structure/Function Claims).

Advertising, social posts and influencer content count too. The Federal Trade Commission's Health Products Compliance Guidance says health claims must be backed by competent and reliable scientific evidence. A claim you cannot support with studies of your ingredient, at your dose, is a claim to leave out.

What happens if a customer reports a serious problem?

The manufacturer, packer or distributor whose name appears on the label must send the FDA every serious adverse event report it receives, no later than 15 business days after receiving it, and keep the records of each report for six years (FDA's adverse event reporting questions and answers). Decide before launch who reads the inbox and phone line on your label, and agree with your manufacturer how you will share reports and batch information.