FDA Hunted CBD for a Decade and Never Built a Pathway
FDA Regulation of CBD: A Decade Without a Clear Pathway
The U.S. Food and Drug Administration (FDA) has enforced against CBD health claims for over a decade without establishing a regulatory pathway for the category. In January 2023, the FDA formally determined that existing food and dietary supplement frameworks are unsuitable for CBD, rejecting three petitions and stating that Congress must intervene. Congress has not yet acted, leaving CBD federally legal to sell but undefined regarding marketing regulations.
How CBD Became Legal and Unmarketable
The 2018 Farm Bill federally legalized hemp-derived CBD, requiring the source hemp to contain less than 0.3% Delta-9 THC by dry weight. In the same year, the FDA approved Epidiolex, a purified CBD drug manufactured by Jazz Pharmaceuticals, for two rare pediatric seizure disorders. This approval created a structural issue for subsequent CBD brands. Under existing food and drug law, an active ingredient approved as a drug generally cannot also be marketed as a food additive or dietary supplement without a specific FDA rule. The FDA has never issued such a rule, leaving the CBD category in a regulatory gap.
FDA Warning Letters: 2019 to Present
The FDA began issuing warning letters to companies selling CBD products in 2019, establishing an enforcement pattern that continues today. On November 25, 2019, the FDA sent warning letters to 15 companies for illegally selling CBD products. These letters were accompanied by a consumer update that reiterated the agency's safety concerns, including unknowns about long-term use, potential drug interactions, and effects on the liver and male reproductive system.
This initial wave set a precedent: brands making treatment, prevention, or cure claims (e.g., for anxiety, pain, inflammation, cancer, COVID-19, sleep disorders) typically receive warning letters. Conversely, brands using structure-function language and lifestyle positioning generally do not.
Warning letters have continued beyond 2019. In July 2024, the FDA and FTC jointly issued five warning letters to companies selling delta-8 THC products in packaging that resembled popular children's snacks and candy. In 2025, the FDA issued seven warning letters to companies for unapproved human and animal drug claims and unsafe product forms. These unsafe forms included CBD eye drops, intravenous CBD, and CBD-coated tampons. The FDA's enforcement record is an ongoing operational reality for the CBD industry.
January 2023: FDA Punts to Congress
On January 26, 2023, the FDA announced its conclusion following a multi-year internal review: existing regulatory frameworks for foods and dietary supplements are inappropriate for CBD, and a new pathway is necessary. In this announcement, the agency denied three long-pending citizen petitions that requested permission to market CBD as a dietary supplement.
Janet Woodcock, the FDA's working-group chair, cited safety concerns such as potential liver harm, drug interactions, risks to children and pregnant people, and issues with long-term use. Woodcock stated that the agency's existing tools, including labeling, dosage limits, and purchase-age minimums, were insufficient on their own. The FDA effectively declined to use its existing authority and requested that Congress build a new regulatory framework. No such legislation has passed, leaving CBD brands in a permanent middle ground: legal to sell, unapproved for health claims, and subject to ongoing enforcement while awaiting congressional action.
Within the regulatory gap, a compliance pattern for CBD communications has remained consistent since 2019 and continues in 2026. Permitted language includes structure-function claims, typically allowed for dietary supplements, even without formal supplement classification for CBD. Customer testimonials are acceptable when accompanied by clear disclaimers. Brands can also provide educational content about cannabinoids generally, rather than making product-specific efficacy claims. Lifestyle positioning that avoids naming specific health conditions is also generally accepted.
Phrases that reliably draw enforcement attention from the FDA include "cures anxiety," "treats inflammation," and "pain relief." Claims like "clinically proven" without supporting studies, references to any named medical condition, and specific dosage claims tied to an outcome also trigger warning letters.
AI Visibility and Legal Risk for CBD Brands
The FDA's enforcement pattern now influences AI visibility in addition to legal exposure for CBD brands. AI engines assess consistency: they check if a brand's language is uniform across its website, press coverage, and retail listings, or if it contradicts itself across channels. A brand making aggressive claims on its own site while using hedged language in press may be perceived as unreliable and dropped from AI answers. Brands that view the FDA's decade of enforcement as a communications discipline, rather than solely a legal review, are more consistently cited by AI engines. For further insights on how this discipline extends to partnership and creator programs, see Partnership Opportunities for CBD Brands.
More Information on CBD and Cannabis Communications
Partnership Opportunities for CBD Brands: The 2026 Growth Playbook
This article is for informational purposes only and is not legal advice. CBD and cannabis marketing rules vary by state, product type, platform, and audience age. Brands should consult qualified counsel before launching any campaign.
Frequently Asked Questions
Has the FDA ever approved CBD as a dietary supplement?
No, the FDA has not approved CBD as a food additive or dietary supplement. The FDA has approved only one CBD product, Epidiolex, as a prescription drug for two rare pediatric seizure disorders.
What did FDA decide about CBD regulation in January 2023?
In January 2023, the FDA concluded that existing regulatory frameworks for foods and dietary supplements are not appropriate for CBD. The agency denied three citizen petitions requesting a supplement pathway and stated that a new regulatory pathway requires action from Congress.
Has Congress created a new pathway for CBD since then?
As of late 2026, no federal legislation establishing a CBD-specific regulatory pathway has passed. The category continues to operate under the same enforcement-only framework the FDA described in its 2023 announcement.
What claims trigger FDA warning letters most often?
Claims of treatment, prevention, or cure tied to named conditions, such as anxiety, pain, inflammation, cancer, COVID-19, and sleep disorders, most often trigger FDA warning letters. Unapproved drug claims and unsafe product forms like CBD eye drops or intravenous products have also resulted in joint FDA and FTC action.
Why can't CBD brands just call it a dietary supplement?
CBD brands cannot simply call their products dietary supplements because the FDA approved Epidiolex, a CBD-based product, as a prescription drug before any company sought supplement status for CBD. Under existing law, an ingredient approved as a drug generally cannot also be marketed as a supplement without a specific FDA rule permitting it. The FDA has not issued such a rule.
Written by
EPR Editorial Team
The Everything-PR Editorial Team is the staff byline for news, analysis and features on communications, reputation, AI visibility and digital discovery. Everything-PR has published since 2009. AI tools assist with research and drafting, and every article is reviewed by a human editor before publication. Coverage follows the Editorial Policy, and substantive corrections are noted on the article under the Corrections Policy.
