A memo from FDA published last week explicitly prohibited four prominent companies from claiming that CBD has cancer-treating properties, including in the form of customer testimonials. Additionally, the FDA highlighted that CBD cannot be sold as a food ingredient or as a food supplement, according to the Federal Food, Drug and Cosmetic Act (FD&C).
FDA’s Concern with CBD-Based Products
CBD has been steadily rising in demand in the last few years and companies have been striving to get their share of the pie. On the other hand, FDA wants to avoid the harm that can be done by false claims, sending warning letters to four companies that “market unapproved new drugs that allegedly contain CBD.”
The companies that were reprimanded by the FDA were Stanley Brothers Social Enterprises LLC, Green Roads of Florida LLC, Natural Alchemist (Alurent Inc.), and That’s Natural! Marketing & Consulting. According to FDA, these companies’ websites claim healing properties via user testimonials. The companies have not, as of yet, released official statements.
While it is obvious that the FDA wants to tighten its grip on the CBD industry, hemp attorney Garett Graff, an associate at Hoban Law Group suggests that this situation is controllable: “The industry should not be alarmed… Many of the positions and much of the rhetoric by the FDA is not new.”
In response to the treating benefit claims of CBD companies, Graff stated that “[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.”
According to the senior attorney of the Hoban Law Group, Patrick Goggin, FDA’s recent warning letters are important but “haven’t raised too much alarm.” A look at FDA’s page can prove that the agency has sent out similar warnings before. “FDA appears to be targeting companies that aren’t really following good legal advice,” added Goggin.
The aftershock of these warning letters was significant, even for companies that haven’t received similar warnings. Brandon Beatty, founder and CEO of Colorado-based Bluebird Botanicals, a hemp extract and CBD selling company, when asked about the warning letters, described their effect against the hemp industry as “disconcerting."
“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 commented.
The Policy Regarding Consumer Testimonials
The consumer right to state their opinion about a product is protected under the first amendment. However, things are not so relaxed about companies, said regulatory attorney Marc Ullman, a counselor to Rikvin Radler LLP. Testimonials are a great tool for marketing, but must be used within the confines of the law. “That’s black-letter law,” he added.
Colleen Keahey, executive director of the Hemp Industry Association commented that “Consumers want to share their testimony, and brands have given consumers a platform to openly share their experience with products (...) It’s not an unusual practice, but because CBD is not FDA approved as a cancer-treating drug or therapy, these claims are prohibited."
Keahey also added: “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."
The Epidiolex Clinical Trials and the Future of CBD
It should not come as a surprise that FDA’s warning letters were dated Oct. 31, just one day after GW Pharmaceuticals announced the completion of the rolling submission of a new drug application (NDA) to FDA for Epidiolex, a CBD-based pharmaceutical drug.
Epidiolex has been studied to treat rare and severe forms of epilepsy: Lennox-Gastaut syndrome (LGS) and Dravet syndrome.
FDA cited GW's clinical drug tests to support its claim that CBD products cannot be defined as dietary supplements under the FD&C. 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 healthcare professionals have reliable science-based evidence," stated Stephen Schultz, GW’s VP of investor relations. “We leave it to the FDA and other governmental entities to regulate how they deem appropriate,” he added.
According to some regulatory attorneys, the approval of Epidiolex could mean a lot of things for companies selling CBD in dietary supplements.
“The FDA's focus may of course change, especially if and when GW Pharmaceuticals receives approval for its CBD medicine," said Beatty of Bluebird Botanicals, “but for now, the actions against CBD sellers seem fairly reasonable and specifically focused on consumer protection.”