EFSA Health Claims: What US Supplement Brands Get Wrong in EU Markets

US supplement brands expanding into European markets consistently trip over EFSA health claims regulations. What's acceptable marketing in America can trigger enforcement in the EU, affecting both your product sales and your advertising accounts.

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Critical Difference: In the US, you can make structure-function claims with substantiation and disclaimers. In the EU, you can ONLY make claims that EFSA has specifically evaluated and authorized. Your US marketing materials are probably non-compliant in the EU by default.

How EU Health Claims Work

The European Food Safety Authority maintains a register of authorized health claims. If a claim isn't on the list, you can't make it. This is fundamentally different from the US structure-function claim system.

The Authorized Claims Register

EFSA's register lists exactly which claims are permitted for which ingredients. For example, you can claim that calcium contributes to normal muscle function because EFSA authorized that specific claim for calcium.

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No Modifications Allowed: You cannot claim that your proprietary calcium blend provides "superior muscle support," even if you have studies showing it does. The claim must match the authorized wording exactly, and it must apply to the authorized ingredient.

This applies to all health claims in advertising, packaging, and product descriptions. There's no exception for "soft" claims or brand communications.

Common US Brand Mistakes

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The Four Mistakes:

Assuming US claims transfer — They don't. Your FDA-compliant structure-function claims may have no EFSA equivalent.
Modifying authorized claims — "Contributes to normal immune function" cannot become "boosts your immune system."
Claiming benefits for proprietary blends — EFSA authorizes claims for specific ingredients in specific amounts. Your branded complex doesn't have authorized claims.
Ignoring nutrient profiling — Some health claims can only be made if the product meets certain nutritional criteria.

Advertising Platform Enforcement

Google and Meta apply EFSA rules to EU-targeted advertising. Ad reviewers in EU markets are trained to recognize unauthorized health claims, and rejection rates for supplement advertising are higher in EU markets than in the US.

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Separate Creative Required: When your ads get rejected in EU markets, it's often because claims that passed US review violate EU rules. Having separate EU-compliant creative is essential. TikTok applies similar standards as it expands EU advertising operations.

Building EU-Compliant Marketing

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The Right Approach:

Start with the EFSA register—search for your key ingredients
Identify which claims are actually authorized
Work backward from authorized claims to marketing messages
Create separate product pages for EU markets with geo-targeting
Translate carefully—EFSA claims must maintain authorized wording

Instead of writing marketing copy and hoping it's compliant, start with what you're allowed to say and craft compelling messages within those constraints.

When to Seek EFSA Authorization

If you have proprietary ingredients with clinical evidence, you can apply for EFSA authorization of health claims. This process takes years and costs significant money, but it provides a competitive moat if successful.

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Reality Check: Most brands should work within existing authorized claims rather than seeking new authorizations. The investment only makes sense for flagship proprietary ingredients with strong clinical packages.

Working With EU Distributors

If you're using distributors in EU markets, make sure they understand EFSA compliance. Distributors who don't understand these rules may create non-compliant local marketing that creates liability for your brand.

Provide EU-compliant marketing materials and require approval for any local adaptations. The distributor relationship doesn't transfer compliance responsibility.

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