Warning letters have been sent to four cannabidiol (CBD) product brands as the FDA makes good on their promises from a month ago.
The brands that received these warning letters are:
- Green Roads – Letter
- Natural Alchemist – Letter
- That’s Natural – Letter
- Charlotte’s Web – The Stanley Brothers – Letter
The letters take issue with a number of different violations and give each company 15 days to respond. Happy Halloween.
In each letter, the FDA spells out how they take issue with stating treatment for any type of illness or condition. Whether it is bipolar disorder, cancer, autism, or anything in between.
“Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.”
Additionally, the FDA took issue in many complains regarding the fact that there were no “adequate directions for use.”
“A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.”
Three of the four letters contain reference to GW Pharmaceuticals and their clinical trials for Sativex and Epidolex with the letter to the Stanley Brothers going into the most detail:
“The existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex Under FDA’s regulations [21 CFR § 312.2], unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the Act. FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Act, but you may present FDA with any evidence that has bearing on this issue. . FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect.”
The links to the GW Pharmaceuticals references are:
- Sativex® Commences US Phase II/III Clinical Trial in Cancer Pain
- GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex® in the Treatment of Dravet Syndrome
The letters came from three different parties with two from Steven E. Porter, Jr. Director, Division of Pharmaceutical Quality Operations IV, one from Maridalia Torres-Irizarry Director San Juan District Program Division Director OHAFO IV East, and one from Darla R. Bracy, District Director Office of Human and Animal Food Division 5 West.
These are some of the clearest indications of desire for control of labeling from the federal government as CBD products begin to hit shelves and get quickly pulled from them as well.
These letters also come just one day after GW Pharmaceuticals made a significant announcement. From GW Pharmaceuticals and Its U.S. Subsidiary Greenwich Biosciences Completes Rolling New Drug Application Submission to U.S. Food and Drug Administration for Epidiolex® (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome:
“The submission of the Epidiolex NDA is an important milestone for patients with LGS and Dravet syndrome in that a potential new treatment option is within sight for these very difficult to treat and devastating conditions,” stated Justin Gover, CEO of GW Pharmaceuticals. “On behalf of all those patients, clinicians and GW employees who have supported the Epidiolex program, we are pleased to submit this promising therapy for FDA review and we look forward to working with the FDA throughout the review process. This regulatory submission is a demonstration of GW’s commitment to developing innovative cannabinoid-based treatments that have the potential to address significant unmet medical needs.”