FDA disclaimer + DSHEA, what copy is required and what gets you a warning letter?

The FDA hasn’t fully regulated CBD as a food / supplement / drug, which leaves merchants in a gray zone. Two rules to follow:

1. The FDA disclaimer. Required on every PDP and any health-related CMS page: “These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.” We auto-inject this via a global block so a content editor can’t accidentally omit it.

2. DSHEA-compliant copy. The Dietary Supplement Health and Education Act lets you make structure-function claims (“supports calm”, “promotes restful sleep”, “may help with everyday stress”) but not disease claims (“treats anxiety”, “cures insomnia”, “heals chronic pain”). The FDA actively sends warning letters for disease claims, ~80-150 letters per year to CBD brands, publicly listed on the FDA enforcement page.

The banned-phrase list we scan for at content-publish time: cures, treats, heals, prevents, FDA-approved, anti-inflammatory, anti-anxiety, anti-cancer, opioid-replacement, addiction-treatment. Admin gets a soft block (“this looks like a disease claim, review before publishing”) rather than a hard block, because edge cases exist.

Real brands have lost millions in revenue and traffic to FDA letters, CBDistillery, Charlotte’s Web, and Curaleaf have all received letters for specific product pages. The guardrails are cheap insurance.