Dietary supplement label and claim checks for US and EU sales

Last updated: 17 October 2026. Rules differ by ingredient and product. Confirm each point with the authority or a regulatory specialist.

A supplement label has to agree with the formula behind it, and every claim on it has to be allowed in the market where it is sold. The US and the EU handle claims very differently. This guide lists what each side asks for and the mismatches to look for.

US: the Supplement Facts panel.

21 CFR 101.36 requires nutrition labeling on a dietary supplement unless an exemption applies. The eCFR text sets these points:

• The heading "Supplement Facts" is larger than all other text on the panel and bold, and the information sits inside a box.
• The serving size uses a term suited to the form, such as tablets, capsules or packets, and "Servings Per Container" appears unless the net quantity already states it.
• Vitamins, minerals and other nutrients with established reference values appear under "Amount Per Serving" with a "% Daily Value" column. The amount is the weight of the ingredient itself, not of its source compound.
• Other dietary ingredients are listed by common or usual name in metric units, with an asterisk for "Daily Value not established".
• A proprietary blend is labeled as such, shows the total blend weight and lists its components in descending order by weight.
• A source can appear in parentheses, for example "Calcium (as calcium carbonate)". A source that does not appear on the panel goes in an ingredient statement outside it.

US: structure and function claims.

21 CFR 101.93 covers statements about how a supplement affects the structure or function of the body.

• The manufacturer, packer or distributor must notify FDA within 30 days after first marketing a product with such a statement. A responsible individual signs the notice and certifies that the firm has substantiation that the statement is truthful and not misleading.
• 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." A plural version may be used for several statements.
• The disclaimer sits next to the statement, or is linked to it by a symbol such as an asterisk. It appears on each label panel with a statement, in bold type no smaller than one sixteenth of an inch, and is boxed if it is not adjacent.
• A disease claim is not permitted as a structure and function statement. A product that bears one is regulated as a drug unless the claim is an authorized health claim for which the product qualifies.

EU: the food supplements directive.

Directive 2002/46/EC sets the harmonised rules. The Commission says:

• Annex I lists the vitamins and minerals that may be used, and Annex II lists the permitted substances that may be used as their sources. Products containing vitamins or minerals not in Annex II have been prohibited since 1 August 2005.
• When the page was read, the Commission had not presented a proposal for EU-wide maximum or minimum amounts. Check national rules in each destination.
• Under Article 10, a Member State may require the person placing a supplement on its market to notify the competent authority, which can include sending a copy of the label.

Article 6(3) lists what the label must show, in addition to the general food labeling rules:

• the names of the categories of nutrients or substances that characterise the product
• the recommended daily portion
• a warning not to exceed the stated daily dose
• a statement that supplements should not be used as a substitute for a varied diet
• a statement that the product should be stored out of the reach of young children

EU: nutrition and health claims.

Regulation (EC) No 1924/2006 governs claims on labeling, presentation and advertising. The Commission says claims must be clear, accurate and based on scientific evidence, and that food bearing claims that could mislead consumers may not be sold on the EU market. The public EU Register of Nutrition and Health Claims lists all permitted nutrition claims and all authorised and non-authorised health claims. Check each claim in the Register before you print.

Mismatches to look for.

1. The label amount differs from the formula. The Supplement Facts amount does not match the specification, or it states the weight of the source compound instead of the ingredient.
2. The ingredient source differs from the specification. A supplier or grade changed and the label did not.
3. A disease claim sits in a structure and function statement, or on the label, website and carton in different words.
4. The disclaimer is missing, too small, or on a panel without the statement.
5. A US structure and function claim was never notified to FDA within 30 days of first marketing.
6. An EU vitamin or mineral source is not in Annex II.
7. An EU claim is not in the Register, or is used outside its conditions.
8. An Article 6(3) statement is missing, or a national notification was not made where a Member State requires one.
9. One carton, several markets. The same artwork carries claims that one market allows and another does not.

Checks to run before you ship.

1. Compare every amount, unit and source on the label with the current specification.
2. Read every claim on the pack, the carton and your online listing against the destination's rules.
3. For the US, confirm that the disclaimer is present and correctly placed, and that the FDA notification was filed.
4. For the EU, check each claim in the Register, each vitamin and mineral source in Annex II, and the Article 6(3) statements.
5. Check each destination for a national notification requirement.
6. Keep a dated record of each check, and repeat it whenever a formula, supplier, claim or label changes.

Common questions.

Does FDA approve supplement labels or claims before sale?

The rules in 21 CFR 101.93 require a notification to FDA within 30 days after first marketing a product with a structure and function statement, together with the disclaimer on the label. They do not describe a pre-approval step.

What disclaimer must go with a structure and function claim?

"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." A plural version may be used for several statements.

Where do I check an EU health claim?

In the public EU Register of Nutrition and Health Claims, which lists all permitted nutrition claims and all authorised and non-authorised health claims.

Sources.

• eCFR, 21 CFR 101.36, nutrition labeling of dietary supplements
• eCFR, 21 CFR 101.93, certain types of statements for dietary supplements
• European Union, Directive 2002/46/EC on food supplements
• legislation.gov.uk, Directive 2002/46/EC, Article 6 (text as hosted there)
• European Commission, Food supplements
• European Commission, Nutrition and health claims

This guide is information, not legal advice. Rules differ by ingredient, product and destination, and national EU rules add requirements. Confirm each point with the authority or a regulatory specialist.