Major consumer products makers that sell beverages, food, and even tobacco have been developing products containing cannabidiol (CBD) in the belief (or is it hope?) that the U.S. government will review and ultimately approve CBD-infused products for sale in all 50 states. The latest company to announce a plan to include CBD in a consumer product is Unilever plc, the owner of Ben & Jerry’s ice cream brand. Two scoops of Cherry Garcia, anyone? CBD consumption in whatever form may or may not turn out to be one of the major lifestyle trends of 2019.
In one of his last actions as U.S. Food and Drug Commission (FDA) chief, Dr. Scott Gottlieb announced a May 31 meeting of a “high-level” committee whose task it is to determine how the agency will review “dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health.”
CBD is a non-psychoactive ingredient of cannabis contained in both marijuana plants, prized for their psychoactive qualities, and hemp. In the 2018 Farm Bill, Congress legalized hemp production and hemp-derived products containing no more than 0.3% by weight of THC, the psychoactive ingredient in cannabis and hemp. However, Congress explicitly left intact the FDA’s authority to regulate products containing cannabis and products derived from the plant. Makers of products containing CBD, in Gottlieb’s view, are “subject to the same authorities and requirements as FDA-regulated products containing any other substance.”
The FDA has approved only three medicines containing CBD or similar substance: Epidiolex used to treat rare forms of epilepsy; two therapies, Marinol and Syndros, to treat anorexia associated with weight loss in AIDS patients; and Cesamet, used to treat symptoms in patients receiving cancer drug treatment. Epidiolex contains a highly purified form of CBD while Marinol and Syndros contain a synthetic form of THC and Ceramet contains another synthetic that is similar to THC in its chemical structure. The FDA has neither tested nor approved other drugs containing CBD.
The FDA has not approved any product containing CBD that claims to offer a therapeutic or medical benefit, although the agency has declared several hemp-derived products to be generally regarded as safe (aka, GRAS). The May 31 meeting is a first step in coming up with a procedure to review and approve over-the-counter consumer products from firms like Unilever and many much smaller firms, allowing them to sell CBD-laced ice cream and other goodies to consumers in all 50 states. Walgreens and CVS announced in March that stores in several states would begin selling CBD-infused products. None of the products offered by either chain has been reviewed by the FDA and none has been approved for sale in the United States.
Whether or not these products contain any CBD or if they offer any benefit to the consumer remains an open scientific question. Marketing claims for CBD products can get a little, shall we say, overheated. Check out, for example, the 42 most outrageous product claims of all time.
For example: “CBD successfully stopped cancer cells in multiple different cervical cancer varieties;” “For Alzheimer’s patients, CBD is one treatment option that is slowing the progression of that disease;” and “CBD reduced the rewarding effects of morphine and reduced drug seeking of heroin.” All of these claims may be true (no matter how unlikely that seems) but none has been subjected to FDA scrutiny or been approved for use. The agency has sent warning letters to several product makers
The FDA hearing on Friday is scheduled to include literally dozens of speakers and to last from 8 in the morning until 5:30 in the afternoon. The agency will accept comments on the hearing until July 2. The hearing is likely to include representatives of the nation’s ten largest legal marijuana companies