How to start a supplement business: US launch checklist

To start a supplement brand in the US you don’t need FDA approval before selling, but manufacturers and distributors have initial responsibility for their products’ safety. Before launch, check whether any ingredient needs a new dietary ingredient notification, label to FDA rules, notify FDA of structure/function claims, set up serious adverse event reporting, and choose a manufacturer that follows the CGMP rule.

This checklist is for a company that will sell a dietary supplement in the US under its own brand, with a contract manufacturer making the product. It covers the federal rules that apply to you as the brand owner, each with the regulation or FDA page it comes from. It is not legal advice, and it includes planning prompts for costs and sourcing. State rules and the rules of other countries are separate.

1. Know that FDA doesn’t approve supplements before sale

Under the Dietary Supplement Health and Education Act (DSHEA), FDA does not have the authority to approve dietary supplements before they are marketed. That shifts the work onto you: manufacturers and distributors have initial responsibility for making sure their supplements are safe, and a firm making a claim must have substantiation that it is truthful and not misleading. There is no FDA approval to apply for, and no FDA approval to put on the label.

2. Check whether any ingredient needs a new dietary ingredient notification

If your supplement contains a new dietary ingredient that has not been present in the food supply as an article used for food in a form that has not been chemically altered, the manufacturer or distributor must notify FDA at least 75 days before introducing the product into interstate commerce (21 CFR 190.6). The notification must include the information on which the firm based its conclusion that the supplement will reasonably be expected to be safe. Settle this question for every ingredient before you commit to a launch date.

3. Word structure/function claims carefully

If your label makes a structure/function claim, the rules are in 21 CFR 101.93:

the manufacturer, packer or distributor must notify FDA no later than 30 days after first marketing a supplement that carries the claim;
the label must carry the disclaimer “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.”;
the disclaimer must sit next to the claim with nothing in between, or be linked to it by a symbol such as an asterisk, and appear on each panel where such a claim appears.

4. Label to FDA’s rules

The label is where most of your obligations as a brand owner show up.

Supplement Facts. A supplement offered for sale must bear nutrition labeling under 21 CFR 101.36, in a panel titled “Supplement Facts”. Draft yours with the Supplement Facts label generator and work out %DV figures with the daily value calculator.
Name and place of business. The label must name the manufacturer, packer or distributor and its place of business, including street address, city, state and ZIP code (the street address may be left off if it is in a current city or telephone directory). If the company named did not make the product, its name must be qualified with a phrase such as “Manufactured for” or “Distributed by” (21 CFR 101.5).
Adverse event contact. The label must include a domestic address or domestic phone number through which reports of serious adverse events can be received (21 U.S.C. 343(y)).

5. Set up serious adverse event reporting

Under 21 U.S.C. 379aa-1, the manufacturer, packer or distributor whose name appears on the label is the “responsible person”. It must submit any report it receives of a serious adverse event to FDA, with a copy of the label, no later than 15 business days after receiving it. A serious adverse event is one that results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect, or that requires medical or surgical intervention to prevent one of those outcomes. Decide before launch who answers the address or phone number on the label, and who files the report.

6. Check whether facility registration applies to you

Facilities that manufacture, process, pack, or hold dietary supplements must register with FDA before beginning those operations. Your manufacturer’s facility is in that group. Whether your own company is depends on whether it does any of those things at a facility of its own, such as holding stock in its own warehouse. Registration is not approval: a registration number does not mean FDA has approved or endorsed a facility.

7. Understand your CGMP obligations

The CGMP rule, 21 CFR Part 111, applies to anyone who manufactures, packages, labels or holds a dietary supplement. Contracting out manufacturing does not leave you with nothing to do: FDA said when it issued the rule that a distributor selling a contract-made supplement under its own label “has an obligation to know what and how manufacturing activities are performed”, so it can decide whether the product meets its specifications and whether to release it for distribution (72 FR 34752, at 34790).

Herbal supplement manufacturing checklist: identity and sourcing

Botanical supplements follow Part 111 too. Before requesting quotes, write down the plant name, plant part, ingredient form (whole, powdered or extract), and any extract specification. Under 21 CFR 101.4(h), botanical labels must identify the plant part; naming an herb alone may not be enough.

21 CFR 111.75 requires at least one appropriate identity test or examination for each dietary ingredient before use, unless FDA grants an exemption. A supplier certificate of analysis does not by itself replace that identity requirement. Ask how the method distinguishes your intended botanical and works on the actual material supplied.

Request supplier qualification records, lot traceability, specifications and the relevant contaminant limits. 21 CFR 111.70 covers specifications for identity, purity, strength, composition and contamination. Our purchasing checklist recommends asking which tests address the risks of your ingredient, who reviews failures and who approves a supplier change; a generic “tested” statement is not enough to compare quotes.

Plan the first production run

Choose the dosage form, serving size, packaging and target order quantity before asking for quotes. Use the supplement cost calculator with your own quoted figures, including testing and freight. Work through the manufacturer audit checklist before signing a manufacturing agreement.

For outsourced testing, browse supplement testing labs and confirm that the current accreditation scope covers the methods and materials in your test plan.

Choosing the manufacturer

Most of the items above depend on the manufacturer you choose: it makes the product to your specifications, keeps the records you need to see, and its site is what FDA inspects. How to find a supplement manufacturer walks through the search step by step, and questions to ask a supplement manufacturer lists what to ask before you sign. If you are deciding between a stock formula and your own, read private label vs custom formula supplements.

Browse manufacturers by dosage form, such as capsule, gummy or powder manufacturers, or start from all supplement manufacturers. When you have a shortlist, request quotes with the same specification for each.

Common questions

Do I need FDA approval to sell a supplement?

No. Under the Dietary Supplement Health and Education Act (DSHEA), FDA does not have the authority to approve dietary supplements before they are marketed. Manufacturers and distributors have initial responsibility for making sure their products are safe, and must be able to substantiate their claims.

Do I need to register my supplement company with FDA?

Facilities that manufacture, process, pack or hold dietary supplements must register with FDA before beginning those operations. Whether that includes your company depends on whether it does any of those things at its own facility. Registration is not approval.

What disclaimer do supplement labels need?

A label that makes a structure/function claim must carry this disclaimer: “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.” FDA must also be notified of the claim no later than 30 days after the product is first marketed.

Whose name goes on the label if a contract manufacturer makes the product?

The label must name the manufacturer, packer or distributor and its place of business. If the company named did not make the product, its name must be qualified to show its connection, for example “Manufactured for” or “Distributed by”.

Who reports adverse events, the brand or the manufacturer?

The manufacturer, packer or distributor whose name appears on the label must report serious adverse events to FDA within 15 business days of receiving the report. The label must include a domestic address or phone number through which those reports can be received.

How much does it cost to start a supplement brand?

We don’t publish cost estimates: manufacturing cost depends on the formula, dosage form, quantities and the manufacturer. Send the same specification to several manufacturers and compare their quotes.

Sources

Sources checked 2026-10-16. Company descriptions are their own statements; they are not certification verification.

Search the directory for certified or licensed manufacturers, or read how we verify each listing.