FDA Warning Letter Defense: Hemp-Derived CBD Ingestible Product Line

Matter Overview

A hemp-derived cannabinoid manufacturer received an FDA warning letter alleging that three of its CBD-infused ingestible products were marketed in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) — specifically that the products were unapproved new drugs and/or adulterated dietary supplements under Sections 301 and 502. The letter cited specific product label claims and social media posts. The company faced potential product seizure, injunction, and civil monetary penalties.

Work Performed

Hoban convened a response team within 48 hours of the client receiving the warning letter. We conducted a full label audit across all SKUs — not just those named in the warning letter — to identify additional exposure before FDA could expand its enforcement scope. The audit identified six additional products with claims language requiring immediate revision.

We drafted the formal FDA response, which took the position that the named claims were structure/function claims permissible under 21 CFR Part 101.93 and were not drug claims under FDA's established two-part test. We supported the argument with published FDA guidance, public statements from FDA leadership, and industry rulemaking comments to which the client had contributed. We did not concede that CBD was subject to drug exclusion under Section 301(ll) — a contested legal question FDA has itself acknowledged.

Parallel to the formal response, Hoban engaged FDA's Office of Dietary Supplement Programs through a pre-response communication to clarify the factual record on two of the challenged claims. This is an underused channel in warning letter response practice; it allowed us to correct a factual mischaracterization in the warning letter before the formal response was filed.

Outcome

FDA withdrew the warning letter 94 days after issuance. The client reformulated label language on the six additionally identified products as a proactive compliance measure.

Lessons Learned

FDA warning letters are not final agency action, but companies treat them as such and capitulate unnecessarily. The withdrawal rate for contested warning letters through formal response — rather than acquiescence — is meaningfully higher than industry assumes. Pre-response communication with program offices is underutilized and can correct factual errors that, if left in the record, would survive even a successful formal response.

Engage Hoban Law Group

If your hemp or CBD company has received an FDA warning letter or enforcement communication, time is critical. Hoban Law Group offers an immediate triage consultation. [Schedule a consultation](/consultation?source=matter&matter_slug=hemp-cannabinoid-fda-warning-letter-defense-2024&matter_type=hemp-thc-compliance).