In the statement issued yesterday, Dr. Gottlieb noted that the US Food and Drug Administration has approved the first CBD drug, which was developed by English company GW Pharmaceuticals. The drug was approved to treat two rare forms of seizure disorder in children ages two years and older.
Drug approval process reaffirmed
Dr. Gottlieb noted that, “This is an important medical advance. But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition.”
Dr. Gottlieb noted that GW (which was not mentioned by name in the statement) went through the full-on drug approval process, to prove the claims it was making on its purified form of CBD. He noted this is an avenue that other product developers ought pursue if they want to make drug-like claims on their products which are derived from Cannabis sativa.
“That pathway includes a robust clinical development program, along with careful review through the FDA’s drug approval process. This is the most appropriate way to bring these treatments to patients,” Dr. Gottlieb said.
Unapproved drug claims cited
Dr. Gottlieb did not sidestep the issue of the presence of many products containing CBD on the market. Farther down in the communication Gottlieb noted the CBD products that are of most concern at the agency are those making drug treatment claims.
“[W]e remain concerned about the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims,” Dr. Gottlieb’s statement said.
“The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases . . . . We’ll continue to take action when we see the illegal marketing of CBD-containing products with unproven medical claims,” the statement went on to say.
IND issue, supplements not mentioned in statement
It’s what Dr. Gottlieb’s statement doesn’t say specifically that left some industry stakeholders scratching their heads. It does not mention the Investigational New Drug exclusionary clause, which is what FDA has used to rule that CBD is not a legal dietary ingredient for use in dietary supplements. This clause states that because GW started its drug development program before there was any evidence that CBD was on the market as a dietary ingredient, it can now only be a drug, not a supplement. Nor does it use the term “dietary supplement,” except in boilerplate language at the bottom pertaining to what product categories FDA regulates.
So, does this signal some enforcement discretion for those CBD products on the market not making disease claims? When contacted for further clarification, FDA spokesperson Lyndsay Meyer said the agency has already addressed this question. She referred to us to the section on a marijuana Q&A on FDA’s website where it responds to the question of whether CBD can be considered a legal dietary ingredient with a flat “No.”
Daniel Fabricant, PhD, president and CEO of the Natural Products Association, said he believes Gottlieb’s statement shrinks the maneuver room for the guerrilla marketers of CBD.
“I think this is consistent with his prior messages on CBD. I think he strongly upheld the drug approval process,” Fabricant told NutraIngredients-USA.
Interstate commerce issue
Fabricant said GW’s product will have to be rescheduled off of the Drug Enforcement Administration’s schedule one list of products that have no proven medical uses and a high risk for addiction. But it won’t remove Cannabis sativa from the list per se.
“So I think this could actually give enforcement a little more punch. Only GW’s drug will be rescheduled so that it can go into interstate commerce. The question then is where does that leave products marketed in those states that have legalization laws? I think that will depend on the character of the companies involved. Are they making rogue drug claims, or selling their products across state lines?” Fabricant said.
Attorney Marc Ullman, of counsel with the firm Rivkin Radler, said in his opinion Dr. Gottlieb’s statement leaves open more questions than it answers.
“I’m paraphrasing here, but they said they are going to continue to watch for CBD products that make crazy drug claims. The statement suggests FDA will only take action if you both have CBD in your product and you make an unapproved drug claim,” he said.
“And that’s baffling. If that is indeed FDA’s approach then the agency needs to say so. If anything, this muddies the water. There has got to be a clearer way to say ‘we are exercising enforcement discretion,’” Ullman said.
Better regulation
In a statement, the American Herbal Products Association said it continues to advocate for consumer access to Cannabis products. It praised the approval of GW's drug, but said more could be done.
"However, AHPA believes FDA can do more to ensure consumer access to the health benefits of safe Cannabis products. Specifically, FDA should expressly confirm that the Federal Food, Drug, and Cosmetic Act permits the sale of dietary supplement products containing cannabidiol (CBD), if necessary by exercising its current rulemaking authority. This would allow FDA to more effectively regulate safety, quality, and marketing claims," the statement said.