by Josh Long – November 6, 2017
FDA last week reminded four companies that it won’t tolerate claims that CBD-containing foods and dietary supplements treat diseases such as cancer, highlighting the potential perils of sharing consumer testimonials. The warning letters also reinforced FDA’s view that CBD (cannabidiol) cannot be sold in dietary supplements, or added to food, under the Federal Food, Drug and Cosmetic Act (FD&C).
FDA’s positions above have been expressed in warning letters sent to several companies over the last three years, drawing the attention of a hemp industry striving to capitalize on rising demand for CBD while overcoming regulatory obstacles.
Commenting on the 2017 warning letters, hemp attorney Garrett Graff said, “The industry should not be alarmed…Many of the positions and much of the rhetoric by the FDA is not new.”
To the extent companies in the hemp industry have made claims of treating diseases, “[W]e need to look at ourselves and make sure that we’re complying with FDA regulations just like every other product line within the nutraceutical space,” said Graff, an associate attorney at Hoban Law Group, in a phone interview.
Brandon Beatty, founder and CEO of Colorado-based Bluebird Botanicals, which sells hemp extracts and CBD isolates, described the warning letters against the hemp industry as “disconcerting.” Beatty, whose company did not receive a warning letter, nonetheless said he understood the agency’s rationale for its enforcement actions.
“Based on the discretionary enforcement against CBD companies over the last three years, it seems the FDA is genuinely out to protect the consumer and to ensure cannabis companies employ fair marketing practices,” he said in an emailed statement.
Patrick Goggin, a senior attorney at Hoban Law Group, told INSIDER that FDA’s recent warning letters haven’t “raised too much alarm” and resemble previous statements made by the public health agency. He added FDA appears to be targeting companies “that aren’t really following good legal advice.”
FDA sent warning letters to Stanley Brothers Social Enterprises LLC, Green Roads of Florida LLC, Natural Alchemist (Alurent Inc.) and That’s Natural! Marketing & Consulting. According to FDA, the companies’ website claims and testimonials provided evidence that the CBD products were intended for use as drugs.
None of the companies responded to requests for comment.
“I was pleasantly surprised to find that CBD helped my arthritis,” one testimonial declared, according to FDA’s warning letter to Natural Alchemist of El Dorado Hills, California. “I have shared with my son, and he states he is a big believer in CBD for . . . TBI [traumatic brain injury] after being acquainted with military personnel who have tried it.”
Consumers have a First Amendment right to state their opinion; however, a company that links to or reposts a testimonial has adopted it as a claim for their product, noted regulatory attorney Marc Ullman, of counsel to Rivkin Radler LLP, in a phone interview.
“That’s black-letter law,” he added.
While testimonials remain a powerful marketing tool, companies promoting them must do so within the confines of federal law.
“Consumers want to share their testimony, and brands have given consumers a platform to openly share their experience with products,” observed Colleen Keahey, executive director of the Hemp Industries Association, in an emailed statement. “It’s not an unusual practice, but because CBD is not FDA approved as a cancer-treating drug or therapy, these claims are prohibited.”
Added Keahey: “I do not expect consumers to stop sharing testimonies about CBD from hemp-derived products, even if the brands are prohibited and cease offering a sounding board for consumers to do so.”
GW NDA Submission of Epidiolex
FDA’s warning letters were dated Oct. 31, just one day after GW Pharmaceuticals plc announced that it—along with its U.S. subsidiary—had completed the rolling submission of a new drug application (NDA) to FDA for Epidiolex®. The CBD drug has been studied to treat rare and severe forms of epilepsy: Lennox-Gastaut syndrome (LGS) and Dravet syndrome.
In reiterating its view that CBD products are excluded from the definition of a dietary supplement under the FD&C, FDA referenced GW’s clinical drug trials. Asked to comment on FDA’s warning letters, a representative for the biopharmaceutical company noted FDA took enforcement actions on its own.
“Where possible, we believe it’s appropriate that drugs—especially those to treat vulnerable patients—be studied and evaluated through the FDA process, so that patients and health care professionals have reliable science-based evidence,” said Stephen Schultz, GW’s vice president of investor relations, in a phone interview.
After going through FDA’s rigorous process, “the result is a modern medicine that has science-based evidence that patients and health care providers have confidence in,” he continued. “That’s why we selected that approach.”
Added Schultz: “We leave it to the FDA and other governmental entities to regulate how they deem appropriate.”
Some regulatory attorneys expect FDA to crack down harder against companies selling CBD in dietary supplements if and once Epidiolex is approved. GW also could target the nutraceutical industry, perhaps suing companies in private litigation or pressuring FDA to take enforcement actions against marketers of CBD based on alleged violations of the FD&C.
Schultz declined to comment on such speculation.
“The FDA’s focus may of course change, especially if and when GW Pharmaceuticals receives approval for its CBD medicine,” Beatty of Bluebird Botanicals acknowledged, “but for now, the actions against CBD sellers seem fairly reasonable and specifically focused on consumer protection.”
He, nonetheless, disagreed with FDA that CBD is not a lawful dietary ingredient. Still, some companies—including Bluebird Botanicals—have chosen to focus largely on the full spectrum of cannabinoids found in hemp extracts, rather than highlight the presence of CBD, the main constituent in Epidiolex.
The more brands focus on CBD, Goggin suggested, the more attention they will attract from FDA. Meanwhile, brands selling products containing CBD are on notice that FDA is carefully monitoring the market.
Said Beatty: “Bluebird Botanicals has for a long time taken an extremely conservative stance when it comes to the FDA, and these recent letters will undoubtedly serve as inspiration to continue that approach.”