Supplement label requirements: the five required statements, the Supplement Facts panel and the mistakes to avoid

Supplement label requirements in the US start with five required statements: a statement of identity that uses the words "dietary supplement", the net quantity of contents, a Supplement Facts panel, an ingredient list, and the name and place of business of the manufacturer, packer or distributor. Add a domestic address or phone number for adverse event reports, any major allergens, and the FDA disclaimer wherever a structure/function claim appears.

What are the FDA supplement label requirements?

FDA's Dietary Supplement Labeling Guide lists five statements every label must carry:

1. Statement of identity: what the product is, using the term "dietary supplement". The word "dietary" can be replaced by the name of the dietary ingredient, as in "calcium supplement".
2. Net quantity of contents: how much is in the container.
3. Nutrition labeling: the Supplement Facts panel.
4. Ingredient list: every ingredient that isn't already declared in the panel.
5. Name and place of business of the manufacturer, packer or distributor.

The guide is old. Its general chapter is marked "content current as of" April 1, 2005, so it predates two things every label now needs: a domestic address or phone number for adverse event reports, and sesame as a major allergen. Both are covered below with their newer sources.

Placement follows a simple split. The principal display panel is the part of the package most likely to be seen when the product is displayed for sale, and it must carry the statement of identity and the net quantity of contents. The information panel sits immediately to the right of it as the product faces the shopper, and it usually holds the rest. All required text must be prominent, conspicuous and easy to read, in letters at least 1/16 inch tall, measured on the lowercase "o".

Here is that split on a bottle, using a fictional magnesium product:

Front panel and information panel

A fictional magnesium product

The frontPrincipal display panel

The part of the package most likely to be seen when the product is displayed for sale.

• Statement of identity: "Magnesium Glycinate Dietary Supplement"
• Net quantity of contents, in the bottom 30%: "120 Capsules"
• Any structure/function claim printed here, with its disclaimer on the same panel

Immediately to the rightInformation panel

Where the rest of the required information usually goes.

• Supplement Facts panel
• "Other ingredients" directly below it
• Allergen declaration
• Name and place of business
• Domestic address or phone number for adverse event reports

What goes on the front of a supplement label?

The front panel does two jobs: it tells the shopper what the product is and how much is inside.

The statement of identity names the product and includes "dietary supplement", or a version such as "magnesium supplement" or "fish oil supplement". It is the one line a buyer must be able to find without turning the bottle.

The net quantity of contents is stated by weight, measure, numerical count or a combination. For tablets and capsules, give the number of units; the guide's example is "100 tablets". If you state a weight or volume, give both metric and US customary units. The statement goes in the bottom 30 percent of the front panel, in lines generally parallel to the base, and its minimum type size grows with the panel, from 1/16 inch on panels of 5 square inches or less up to 1/2 inch on panels over 400 square inches.

Two front-panel decisions are really claim decisions. A product name can imply a disease on its own: FDA's rule on supplement claims counts the product name, pictures and symbols among the ways to make a disease claim (21 CFR 101.93). And a structure/function claim printed on the front needs its disclaimer on the front too, because the disclaimer must appear on each panel that carries a claim.

For a direct-response brand, the front panel is also the bottle shot in every ad and VSL. Whatever a viewer can read on it is part of your claims, so review the render you use in creatives, not only the print file.

How to read a Supplement Facts panel, line by line

The panel's format is set by 21 CFR 101.36. It is titled "Supplement Facts", where packaged foods use "Nutrition Facts" (21 CFR 101.9). The title must be set larger than all other type in the panel and, unless that's impractical, across its full width, with the title and every heading in bold.

This is a panel for a fictional magnesium and ashwagandha capsule, with the rule behind each line:

The % Daily Value is plain arithmetic. FDA's Reference Daily Intake for magnesium is 420 mg for adults and children 4 and older, so 200 mg ÷ 420 mg × 100 = 47.6%, printed as 48%. Ingredients with no Reference Daily Intake or Daily Reference Value, such as botanical extracts, get the symbol instead of a percentage.

Three lines deserve a second look:

Botanicals, blends and sources

Each with its line from the fictional panel above

BotanicalsProprietary blendsSources

Botanicals

Botanicals must name the part of the plant the ingredient comes from (root, leaf, seed), and their common names follow the reference book Herbs of Commerce (21 CFR 101.4).

Ashwagandha root extract 300 mg

Proprietary blends

Proprietary blends may keep individual amounts private, but the total weight of the blend's ingredients must be shown and the ingredients listed in descending order by weight.

Evening Blend 450 mg: L-theanine, lemon balm (leaf)

Sources

Sources of nutrients can sit in the panel in parentheses, as in "Magnesium (as magnesium glycinate)". A source that isn't named in the panel must appear in the ingredient list.

Magnesium (as magnesium glycinate) 200 mg

That ingredient list is headed "Ingredients", or "Other ingredients" when some ingredients are already identified in the panel. It must include the ingredients that aren't dietary ingredients, and the rule names excipients, fillers, artificial colors, artificial sweeteners, flavors and binders as examples. The capsule shell counts.

Which allergens must a supplement label declare?

Allergen labeling under the Food Allergen Labeling and Consumer Protection Act of 2004 covers dietary supplements, not only foods (FDA on food allergies). There are now nine major food allergens: milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. Sesame was added by the FASTER Act, signed on April 23, 2021, and the change took effect on January 1, 2023.

Each allergen's food source must appear at least once, in one of two ways: in parentheses after the ingredient's name, or in a "Contains" statement immediately after or next to the ingredient list. For three groups you must name the specific item: the type of tree nut, the species of fish and the species of Crustacean shellfish. "Fish oil" alone doesn't do it.

Allergens can hide in parts of a formula nobody thinks of as ingredients: a softgel shell, the oil carrying a fat-soluble vitamin, a flavor, a coating. Ask your manufacturer for an allergen statement on every raw material, excipients included, and keep it with the label file.

Do supplement labels need an address or phone number for adverse events?

Yes. The Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 added section 403(y) to the Food, Drug, and Cosmetic Act: a supplement marketed in the US must carry a domestic address or a domestic phone number through which the company can receive reports of serious adverse events. FDA's guidance is direct about the consequence: without it, the supplement is misbranded. The requirement applies to every supplement labeled on or after December 22, 2007 (FDA guidance).

The name and place of business is a separate requirement, and it matters for brands that use a contract manufacturer. If the company named on the label didn't make the product, the name must be qualified, for example "Manufactured for ___" or "Distributed by ___". The address must include the street address, city, state and ZIP code, and the street address can be left out only if the business is listed in a current city or telephone directory (21 CFR 101.5).

Here is where FDA's 2005 guide sits among the rules that came after it:

FDA's 2005 guide and the label rules around it

1. 2004Allergen labeling law (FALCPA)Major food allergen labeling, which FDA applies to dietary supplements too.
2. April 2005Dietary Supplement Labeling GuideFDA's plain-English reference, still useful but older than everything below.
3. 2006Adverse event reporting lawAdds section 403(y): a domestic address or phone number on the label.
4. Dec 22, 2007Contact requirement appliesTo every supplement labeled on or after this date.
5. Apr 23, 2021FASTER Act signedSesame becomes the ninth major food allergen.
6. Jan 1, 2023Sesame labeling takes effectNine major allergens to declare.

When does a supplement label need the FDA disclaimer?

Whenever the label carries a structure/function statement: a claim about how a nutrient or ingredient affects the structure or function of the body, such as "supports normal muscle function". Three rules come with it, all in 21 CFR 101.93:

1. The wording is fixed. For one statement: "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." For more than one, it begins "These statements have not been evaluated".
2. Placement and type. The disclaimer sits right next to the claim with nothing in between, or is linked to it by a symbol such as an asterisk, in which case it is set off in a box. It appears on every panel that carries a claim, in bold type no smaller than 1/16 inch.
3. Notification. No later than 30 days after the product is first marketed, the manufacturer, packer or distributor must notify FDA of the statement.

The disclaimer doesn't make a disease claim acceptable. A statement becomes a disease claim when it says, directly or by implication, that the product diagnoses, mitigates, treats, cures or prevents a disease, and the implication can come from a symptom, the product name, a picture or a cited study. Claims linking a substance to a disease, such as a reduced risk of one, belong to a separate category, health claims, which follow their own FDA rules (chapter VI of the labeling guide).

Side by side, the difference looks like this:

Structure/function statement or disease claim?

Fictional label lines

Allowed with the disclaimerStructure/function statement

• Supports normal muscle function
• Supports relaxation
• Helps maintain healthy sleep

Not allowed as a structure/function claimDisease claim

• Lowers high blood pressure
• Prevents migraines
• A product name that implies a disease
• A cited study on treating a disease, used to suggest the product does it

The full list of disease-claim criteria, and how to rewrite a borderline line so it stays a structure/function statement, has its own post:

Label claims vs page claims: keep them consistent

The rules above govern the label. Your VSL, ads and sales page are advertising, where the FTC's evidence standard for health claims applies; our post on supplement advertising rules covers it. Buyers see the page and the bottle within days of each other, and anyone checking your claims, from a regulator to an ad reviewer, can put them side by side.

Five rules keep them in step:

• Same formula, same numbers. The ingredients, forms and amounts on the page match the Supplement Facts panel, per the same serving size.
• Same directions. If the label says two capsules a day, the video doesn't say one is enough.
• Same claim language. The video's claims stay inside what you could print on the label, and the disclaimer appears on the page wherever those claims do.
• Current bottle shots. The label visible in your creatives is the version you ship.
• One change, everywhere. A reformulation updates the label, the page, the VSL and the ads together.

In RevvyScales, an Ingredients content section puts the formula on the page (content blocks) and the legal footer holds your disclaimer (legal footer), so update both whenever the label changes. For claims, testimonials and disclosures in the video itself, see the VSL compliance guide.

Supplement label mistakes to check for

Each of these is cheap to fix on a proof and expensive after a print run:

1. "Dietary supplement" missing from the statement of identity.
2. Compound weight instead of nutrient weight, such as 500 mg declared for magnesium when 500 mg is the weight of the magnesium glycinate.
3. A botanical without its plant part.
4. A proprietary blend without a total weight, or with its ingredients out of order.
5. An incomplete "Other ingredients" list. The capsule, flow agents, colors and flavors all belong there.
6. No domestic address or phone number for adverse event reports.
7. A vague or missing allergen: "fish oil" without the species, or a sesame ingredient left undeclared.
8. A claim on the front with its disclaimer only on the back.
9. A product name that implies a disease.
10. Amounts nobody has tested. The panel promises what is in every bottle, so tie it to lot testing; our post on reading a certificate of analysis shows what to check.

If you sell into California, the label may also need a Proposition 65 warning, a separate state rule covered in Prop 65 for supplements.

A pre-print supplement label checklist

Run this against the final proof, not the design file, and keep a signed copy on file:

Before the label goes to print

• Statement of identity on the front panel, with "dietary supplement" in it
• Net quantity in the bottom 30% of the front panel: a count, or metric and US units
• "Supplement Facts" title larger than all other type in the panel, headings in bold
• Amounts per serving and % Daily Values checked against FDA Reference Daily Intakes
• Plant part named for every botanical; total weight shown for every blend
• "Other ingredients" right below the panel, capsule and excipients included
• All nine major allergens checked, with the specific nut, fish or shellfish named
• Name and place of business, qualified with "Manufactured for" or "Distributed by" if needed
• Domestic address or phone number for adverse event reports
• Exact disclaimer, in bold, on every panel that carries a claim
• No claim, name or image that implies a disease
• Label, VSL, ads and sales page say the same thing

0 of 12 done

Then file the structure/function notification within 30 days of launch, and re-check the label whenever the formula, the manufacturer or the claims change. If you are earlier in the process, how to start a supplement company puts the label in order with everything else.