WASHINGTON — The Food and Drug Administration has become more active in regulating cannabidiol (C.B.D.) products. The agency sent warning letters dated March 28 to three companies marketing C.B.D. products with “egregious and unfounded claims that are aimed at vulnerable populations,” the agency said. The F.D.A. also has scheduled a May 31 public hearing to discuss how C.B.D. products may be marketed legally.
“As our actions today make clear, the F.D.A. stands ready to protect consumers from companies illegally selling C.B.D. products that claim to prevent, diagnose, treat or cure serious diseases, such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes,” said Scott Gottlieb, M.D., commissioner of the F.D.A “The agency has and will continue to monitor the marketplace and take enforcement action as needed to protect the public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and are being marketed and distributed in violation of the F.D.A.’s authorities.”
Under F.D.A. regulations, it is against the law to introduce food containing added C.B.D. into interstate commerce or to market C.B.D. as dietary supplements because C.B.D. is an ingredient in F.D.A.-approved drug products. Before C.B.D. is added to foods or marketed as dietary supplements, the F.D.A. first must issue a regulation, through notice-and-comment rule-making, allowing such use.
NaturePure L.L.C., Advanced Spine and Pain L.L.C. (doing business as Relievus), and PotNetwork Holdings, Inc. all received warning letters. The letter to NutraPure L.L.C., Vancouver, Wash., which markets hemp oil and C.B.D. soft gels, may be found here. The letter to PotNetwork Holdings, Fort Lauderdale, Fla, which markets Liquid Gold gummies and blue C.B.D. crystals isolate, may be found here. The letter to Advanced Spine and Pain, Mount Laurel, N.J., which markets C.B.D. salve, C.B.D. oil and C.B.D. for dogs, may be found here.
The unsubstantiated claims related to more than a dozen different products and spanned multiple product web site pages, online stores and social media web sites, according to the F.D.A. Examples of the claims included:
- “C.B.D. successfully stopped cancer cells in multiple different cervical cancer varieties.”
- “C.B.D. also decreased human glioma cell growth and invasion, thus suggesting a possible role of C.B.D. as an antitumor agent.”
- “For Alzheimer’s patients, C.B.D .is one treatment option that is slowing the progression of that disease.”
- “Fibromyalgia is conceived as a central sensitization state with secondary hyperalgesia. C.B.D. has demonstrated the ability to block spinal, peripheral and gastrointestinal mechanisms responsible for the pain associated with migraines, fibromyalgia, IBS and other related disorders.”
- “Cannabidiol may be effective for treating substance use disorders.”
- “C.B.D. reduced the rewarding effects of morphine and reduced drug seeking of heroin.”
- “C.B.D. may be used to avoid or reduce withdrawal symptoms.”
Dr. Gottlieb said, “I believe these are egregious, over-the-line claims, and we won’t tolerate this kind of deceptive marketing to vulnerable patients. The F.D.A. continues to be concerned about the proliferation of egregious medical claims being made about products asserting to contain C.B.D. that haven’t been approved by the F.D.A., such as the products and companies receiving warning letters today.”
The proliferation of C.B.D. products increased when hemp, the source of C.B.D., was removed from the Controlled Substances Act as part of the Agriculture Improvement Act of 2018, also known as the 2018 farm bill. President Donald Trump signed the Agriculture Improvement Act into law on Dec. 20, 2018. Hemp and marijuana are both Cannabis sativa L., but hemp now is defined as cannabis and cannabis derivatives that contain no more than 0.3% concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (T.H.C.).
The F.D.A. regulates products containing cannabis or cannabis-derived compounds under the Federal Food, Drug and Cosmetic Act.
The public hearing will take place May 31 in Silver Spring, Md. Details of the hearing appeared in the April 3 issue of the Federal Register, which may be found here.
“As part of the public hearing and related public comment period, the agency is interested in whether there are particular safety concerns that we should be aware of as we consider the F.D.A.’s regulatory oversight and monitoring of these products,” Dr. Gottlieb said. “For example, we’re seeking comments, data and information on a variety of topics, including: what levels of cannabis and cannabis-derived compounds cause safety concerns; how the mode of delivery (e.g., ingestion, absorption, inhalation) affects the safety of, and exposure to, these compounds; how cannabis and cannabis-derived compounds interact with other substances such as drug ingredients; and other questions outlined in the hearing announcement.”
Requests to make oral presentations at the public hearing will be accepted by the F.D.A. until May 10. The F.D.A. also will accept public or written comments on C.B.D. until July 2. Electronic comments may be submitted at www.regulations.gov. Written comments may be sent to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1001, Rockville MD 20852. The docker number is FDA-2019-N-1482.
Besides the public hearing, a working group within the F.D.A. will explore potential pathways for dietary supplements and/or conventional foods with C.B.D. to be marketed lawfully. Amy Abernethy, M.D., Ph.D., principal deputy commissioner of the F.D.A., and Lowell Schiller, principal associate commissioner for policy, will co-chair the group.