What You Can (and Cannot) Say: Herbal Claims Rules in the US and EU

Two Markets, Two Philosophies

The US treats herbal products as foods (dietary supplements); the EU treats many of them as medicines with a simplified registration path. Mixing up the two frameworks is the fastest way for a new brand to earn a warning letter.

United States: DSHEA and Structure-Function Claims

Under DSHEA, you may make **structure-function claims** — "supports healthy stress response" — provided you:

1. Hold substantiation (competent, reliable scientific evidence) on file. 2. Include the FDA disclaimer verbatim on labels and marketing. 3. Notify the FDA within 30 days of first marketing the claim. 4. **Never** name a disease. "Reduces anxiety" is a drug claim; "supports a calm mood" is not. "Fights colds and flu" triggered many an elderberry warning letter in recent years.

cGMP compliance (21 CFR Part 111) applies to every supplement brand — including solo founders using contract manufacturers. You own the compliance even when you outsource the production.

European Union: THMPD and the Claims Freeze

In the EU, herbal products generally take one of two routes:

• **Traditional Herbal Medicinal Product registration (THMPD):** 30 years of traditional use (15 in the EU) earns registered medicine status with approved indications.
• **Food supplement route:** Permitted, but health claims must come from the authorized EFSA register — and nearly all botanical claims remain "on hold," creating a gray zone that member states police differently.

Practical Rules for New Brands

• Write claims from your evidence file, not your marketing dreams.
• Screen every claim against the disease-name test.
• Keep origin and identity records — both regulators increasingly audit supply chains, and batch-level traceability documentation is your best audit defense.

*This overview is educational and is not legal advice; consult a regulatory professional for your specific products.*