FDA Renews and Expands CBD Consumer Alert: Gaps in Safety Data Persist

The FDA renewed and expanded its existing CBD consumer alert in May 2024, reaffirming its position that CBD cannot lawfully be added to food or marketed as a dietary supplement under the FDCA. The updated alert adds new safety data concerns, including hepatotoxicity risks at sustained doses and drug-drug interactions with commonly prescribed medications including blood thinners and seizure drugs. Updated FDA position: - CBD remains unapproved as a food additive and cannot achieve GRAS status through self-affirmation given the open IND/NDA history of Epidiolex - Dietary supplement status is precluded because CBD was approved as a drug (Epidiolex) before being marketed as a supplement - The agency received more than 7,200 adverse event reports associated with CBD products from 2021–2024 - FDA calls on Congress to create a new regulatory pathway for CBD products rather than relying on existing FDCA frameworks The renewed alert does not represent new enforcement action but signals that FDA's legal position has hardened and that congressional legislation remains the most viable path to a compliant CBD market.