FDA and FTC Basics Every EU Brand Needs Before Selling in the US

FDA FTC requirements EU brands face depend on what the product is and what you say about it. Food, supplements, and cosmetics fall under the FDA. Apparel labeling and advertising claims in every category fall under the FTC.

Meeting EU rules does not satisfy either agency. The US systems are separate, and several of their duties land on a US-side party, such as an importer or a named US agent. This is the first item on the Compliance & Labeling list in our EU to US Expansion Checklist: confirm your federal requirements before you ship.

What federal US requirements apply to EU products entering the US market?

It depends on the product category. The FDA regulates food, dietary supplements, cosmetics, and drugs. The FTC enforces textile labeling and truth in advertising across all categories.

The table maps the FDA FTC requirements EU brands should check first. Treat it as a first pass, since the details turn on your exact product and claims.

Our EU to US Expansion Guide lists this as a checklist item for a reason. A product can clear customs and still fail on its label or its claims later.

Why doesn't EU compliance satisfy US federal rules?

Each regime has its own registrations, labels, and responsible parties, and none of them recognizes EU conformity as a substitute. Your EU paperwork does not register your facility with the FDA, name a US agent, or file your claims.

The US rules also put weight on parties inside the US. A food importer carries verification duties. A foreign food facility needs a US agent. A cosmetic's responsible person is the company named on the label.

For FDA FTC requirements EU brands must meet, someone in the US has to hold these roles before inventory ships.

What are the FDA FTC requirements EU brands face in each category?

Work through your own category below. Each section covers the first things to check, and a regulatory specialist should confirm the rest.

Food and beverage

Three requirements usually come first. Owners and operators of foreign facilities that make, pack, or hold food for US consumption must register with the FDA (opens in new tab), unless an exemption applies. Registration must list a US agent, who has to live or keep a place of business in the US, and the FDA will not confirm a foreign facility's registration until that agent agrees to serve.

Second, the FDA requires Prior Notice (opens in new tab) before imported food arrives. Third, the US importer runs a foreign supplier verification program (opens in new tab). The importer is the US owner or consignee at entry, and the program covers a hazard analysis, supplier evaluation, and verification activities. A DUNS number identifies the importer when the entry is filed.

Dietary supplements

Supplement claims are where many EU brands run into trouble. A structure/function claim, such as "calcium builds strong bones," is not pre-approved. The manufacturer needs substantiation and must notify the FDA (opens in new tab) no later than 30 days after marketing the product.

The label must also say the FDA has not evaluated the claim and that the product is not intended to diagnose, treat, cure, or prevent any disease. Only a drug can make a disease claim, so wording that works on a European product page may need to change. Because supplements sit close to the food framework, ask a specialist whether the registration and import steps above apply to yours.

Cosmetics and personal care

The FDA classifies a product by intended use (opens in new tab), shown through label claims, advertising, and websites. Anti-dandruff shampoo, fluoride toothpaste, antiperspirant, and sun-protection moisturizers are cosmetic and drug products at once. A product that counts as both has to meet the requirements for both, and drugs generally need an approved application or must follow an OTC monograph.

Pure cosmetics have their own rules under MoCRA (opens in new tab). Manufacturers and processors register facilities and renew every two years, and the responsible person lists each product with its ingredients. The responsible person is the manufacturer, packer, or distributor named on the label.

The responsible person must also keep safety substantiation records and report serious adverse events within 15 business days. Certain small businesses are exempt from registration, listing, and GMP, with exceptions for products such as those that contact the eye. Check whether yours qualifies before relying on it.

Apparel and textiles

Apparel is an FTC matter. The Textile Act labeling rules (opens in new tab) require fiber content by generic name and percentage, the country where the product was made, and the name or Registered Identification Number (RN) of the responsible company. RNs are issued only to US businesses.

Labels must be in English. "Made in the European Union" is not enough for a product made entirely abroad, so name the specific country. Garments also need care instructions under a separate FTC rule, and importers are responsible for accurate labels. Customs can test products and impound mislabeled shipments.

Every category: FTC advertising rules

The FTC's advertising guidance (opens in new tab) says ads must be truthful, and advertisers need objective evidence before an ad runs. Health and safety claims generally call for competent and reliable scientific evidence. The same rules apply to your website and social ads.

Endorsements must reflect honest experience, and paid or employment connections have to be disclosed. The fake reviews rule (opens in new tab) bans buying or selling fake reviews and suppressing negative ones through threats.

How do you confirm the federal requirements for your category?

Work through five steps and keep a written record of each answer.

Step 1: Classify the product by what you claim

Write down the category and every claim on the label, the site, and the ads. The FDA judges intended use from those claims, so a sunscreen claim on a moisturizer changes the answer.

Step 2: Map each product to its agency and rules

Use the table above to find the FDA FTC requirements EU brands face for each product. Add the FTC advertising rules to every one.

Step 3: Name your US-side roles

Decide who acts as US agent, importer, and responsible person before inventory ships.

Step 4: Check labels and build your evidence file

Compare each label against the US rules, then collect the substantiation behind each claim. A file ready before launch saves you from rewriting labels after inventory lands.

Step 5: Get specialist sign-off before shipping

Have a regulatory specialist or customs broker confirm your category.

Frequently asked questions

What federal US requirements apply to EU products entering the US market?

It depends on the category. The FDA covers food, supplements, cosmetics, and drugs, with registration, import, labeling, and claim rules. The FTC covers textile labeling and advertising truthfulness in every category. These are the FDA FTC requirements EU brands should map first.

Does EU compliance satisfy FDA requirements?

No. The FDA runs its own registration, listing, and labeling systems, and EU conformity does not stand in for them. Product safety marks are a related but different question.

Do cosmetics need FDA approval before sale?

Cosmetics generally do not need premarket approval, and color additives are an exception. MoCRA still requires facility registration, product listing, and safety records, subject to certain small-business exemptions. A product with drug claims, such as sun protection, follows drug rules as well.

Does the FTC apply to a brand based in Europe?

The FTC's guidance covers advertising, and it does not address foreign sellers directly. If you advertise to US shoppers, plan to follow its rules, and ask counsel how they apply to your structure. Importers also carry their own responsibility for textile labels.

What should you do next?

Download the EU to US Expansion Checklist (opens in new tab) and work through the Compliance & Labeling list, including the federal check. Then read the compliance section of the EU to US Expansion Guide to apply the FDA FTC requirements EU brands face to your own range.