Starting a supplement brand: the steps at a glance
| Step | What you do | The rule behind it |
|---|---|---|
| 1. Product | Check that it is a dietary supplement, not a food or a drug | 21 U.S.C. 321(ff) |
| 2. Ingredients | Check each dietary ingredient for new dietary ingredient status | 21 U.S.C. 350b · 21 CFR 190.6 |
| 3. Manufacturing | Make it under dietary supplement cGMP, in a registered facility | 21 CFR 111 · 21 CFR 1.225 |
| 4. Claims | Substantiate them, add the disclaimer, notify FDA | 21 CFR 101.93 |
| 5. Label | Statement of identity, Supplement Facts, other ingredients, net quantity, contact for adverse events | 21 CFR 101.36 |
Step 1: is your product a dietary supplement?
The legal definition decides which rulebook you follow, so settle it first. A dietary supplement is a product meant to supplement the diet that contains at least one dietary ingredient, is taken by mouth, and is labeled as a dietary supplement.
- Dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance that adds to total intake, or a concentrate, metabolite, constituent, extract or combination of these
- Forms: tablet, capsule, powder, softgel, gelcap, liquid or another form meant to be swallowed
- Not presented as a conventional food or as the only item of a meal or diet
- Not an approved drug ingredient, unless it was sold as a supplement or food first
A gummy with vitamin D, a capsule of ashwagandha root extract and a scoop of creatine powder all fit. A drink named and canned like a soda usually does not: FDA treats products presented as beverages as conventional foods, even when they carry a Supplement Facts panel.
Step 2: check every ingredient for NDI status
The law treats dietary ingredients that were already marketed in the US before a cutoff date set in the law differently from newer ones. A newer one is a new dietary ingredient (NDI). FDA keeps no authoritative list of the older ingredients, so it is up to you to determine the status and keep the proof.
- No notification is needed if the supplement only contains dietary ingredients that have been in the food supply as an article used for food, in a form that has not been chemically altered
- Otherwise, the manufacturer or distributor sends FDA a notification with the safety evidence at least 75 days before the product enters interstate commerce
- The notification names the ingredient (with the Latin binomial for botanicals), the amount per serving, the conditions of use on the label, and the history of use or other evidence of safety
- FDA keeps the notification confidential for 90 days after the filing date, then puts it on public display, except trade secrets
- No reply from FDA is not a finding that the ingredient is safe
Step 3: manufacturing under 21 CFR 111
Most new brands hire a contract manufacturer. Part 111 still reaches you: it covers anyone who manufactures, packages, labels or holds a dietary supplement. These are the records and checks it asks for, and what to ask your manufacturer to show you:
| Requirement | What it means | Rule |
|---|---|---|
| Identity test | At least one test or examination to confirm the identity of every dietary ingredient before it is used | 111.75(a)(1) |
| Specifications | Specs for components, in-process steps, the finished batch, packaging and labels | 111.70 |
| Master manufacturing record | One per formula and per batch size, so every batch comes out the same | 111.205 |
| Batch production record | A new one every time a batch is made | 111.255 |
| Reserve samples | Kept from every lot of packaged and labeled product you distribute | 111.83 |
| Record keeping | 1 year past the shelf life date, or 2 years after the last batch is distributed | 111.605 |
The facility that makes, packs or holds your product also registers with FDA before it starts, like any food facility.
Step 4: claims you can make
Supplements may carry structure/function claims, like "supports healthy bones", if you have evidence that the claim is truthful and not misleading. A claim that the product treats, cures, mitigates or diagnoses a disease makes it a drug in FDA's eyes, and so does a disease prevention claim that is not an authorized health claim. A structure/function claim brings three duties:
- Print FDA's disclaimer next to the claim, or link the two with a symbol like an asterisk
- Set the disclaimer in bold type at least 1/16 inch tall
- Notify FDA of the claim no later than 30 days after you first market the product with it
Advertising is a separate track: FDA points supplement companies to the Federal Trade Commission, which primarily regulates advertising. Our label maker does not review claims, so check each one against the rules before it goes on the bottle.
Step 5: the supplement label
FDA's summary of what a dietary supplement label must carry fits on one hand:
- A product name with "dietary supplement", or the type of ingredient in its place, like "iron supplement" or "herbal supplement"
- Who made, packed or distributed it: the firm's name and place of business
- A Supplement Facts panel with serving size, servings per container and each dietary ingredient
- An "other ingredients" list for the ingredients not declared in the panel
- The net quantity of contents
- A domestic address or phone number for reporting serious adverse events
The serving size names the form: "2 Capsules", "1 Scoop (8 g)", "1 Gummy". FDA says there is no law or rule that limits the serving size or the amount of an ingredient per serving; that is your call, within the safety and cGMP rules.
Make your Supplement Facts panel
Our Supplement Facts mode is built for exactly this step. Enter the amount per serving and it does the rest:
- Vitamins and minerals with their source, like "Zinc (as zinc citrate)", in the order FDA sets, each with its % Daily Value
- Botanicals with the part of the plant, like "Ashwagandha root extract"
- Proprietary blends with the total weight and the ingredients from most to least
- Other ingredients below the panel
- Exports for print and design: an actual-size vector PDF, SVG and a 600 dpi PNG that drop straight into your bottle artwork
The preview is free. A label costs $29 one time and stays editable for 2 years: handy when your manufacturer changes a capsule size or a source.
Make your Supplement Facts label →