Petition ResponsehighMarch 20, 2025
FDA responded in March 2025 to a citizen petition filed by a coalition of public health organizations requesting an emergency rule establishing per-serving THC thresholds for hemp products and mandating intoxicant testing beyond delta-9 THC. FDA denied the petition's request for …
Public Meeting / RFIhighComment deadline: April 11, 2025February 10, 2025
In February 2025, FDA published a Request for Information (RFI) and opened a public docket (FDA-2025-N-0142) on hemp-derived vape products. The 90 Fed. Reg. 12847 publication invites comments from manufacturers, retailers, public health researchers, and consumers on safety, label…
Draft GuidancecriticalComment deadline: March 31, 2025January 28, 2025
In a significant development, FDA published draft guidance in January 2025 outlining conditions under which the agency intends to exercise "regulatory discretion" and refrain from enforcement action against dietary supplements containing CBD. The draft guidance (FDA-2025-D-0445) …
Enforcement ActioncriticalNovember 5, 2024
In November 2024, a federal district court granted FDA's request for a permanent injunction against a Colorado-based hemp CBD beverage manufacturer, halting the manufacture, distribution, and sale of CBD-infused sodas and sparkling waters. The injunction follows a multi-year enfo…
Guidance DocumentmediumSeptember 30, 2024
The FDA and National Institutes of Health (NIDA/NCI) jointly published a cannabinoid research framework in September 2024 identifying priority research areas and announcing coordinated funding through NIDA Notice NOT-DA-24-021. The framework prioritizes safety biomarkers, dose-re…
Guidance DocumenthighAugust 12, 2024
As part of the broader HHS review of cannabis scheduling initiated following President Biden's October 2022 directive, FDA submitted a formal input memorandum to HHS in August 2024 specifically addressing the scheduling status of cannabidiol (CBD). FDA's memorandum recommends tha…
GRAS NotificationmediumJuly 22, 2024
The FDA accepted GRAS Notice GN 000809 for hemp seed oil and hemp seed protein in July 2024. The GRAS affirmation applies specifically to hemp seed derivatives — not to CBD or other phytocannabinoids — at specified use levels in food.
Key scope limitations:
- GRAS status covers …
Consumer AlerthighMay 8, 2024
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 sust…
Rule ProposalcriticalComment deadline: July 1, 2024April 29, 2024
In conjunction with Farm Bill reauthorization negotiations, the USDA and FDA jointly opened a public comment period in April 2024 requesting input on the regulatory treatment of hemp-derived intoxicants — specifically delta-8 THC, delta-9 THC at or below 0.3% by dry weight in the…
Warning LettercriticalMarch 15, 2024
In March 2024, the FDA issued its third coordinated wave of warning letters targeting manufacturers and retailers of delta-8 THC products. The five cited companies sold products in forms specifically appealing to minors — including gummy bears, rice crispy treats, and vape cartri…
