The Council for Responsible Nutrition (CRN; Washington, DC) yesterday strongly objected to this week’s FDA Consumer Update on cannabidiol (CBD). On November 25, FDA published a Consumer Update on the agency’s website titled, “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-Derived Compounds, Including CBD,” outlining what the agency considers risks about CBD products, including potential liver injury, drug interactions, male reproductive toxicity, and side effects, as well as potential subpar manufacturing standards and labeling practices among some CBD companies.
Said FDA in its update: “The FDA is concerned that people may mistakenly believe that trying CBD ‘can’t hurt.’ The agency wants to be clear that we have seen only limited data about CBD’s safety, and these data point to real risks that need to be considered.”
FDA currently does not permit the use of CBD in dietary supplements or food products, reiterating in its Consumer Update that the agency is “actively working to learn more about the safety of CBD and CBD products.” Dietary supplement industry groups, meanwhile, have called on FDA to create a legal pathway to market for CBD as the CBD consumer market mushrooms.
One CBD brand, CV Sciences (San Diego, CA), called FDA’s Consumer Update warnings over CBD “inappropriately alarmist.” Yesterday, the company sent an e-mail to customers and associates from Stuart Tomc, the company’s PlusCBD Oil division vice president, regulatory science and education, titled: “CBD: Is this Sh*t Even Safe?”
In the letter, CV Sciences points out the safety and toxicological studies and generally recognized as safe (GRAS) work the company has done on its own PlusCBD hemp extract. The company also invited e-mail recipients to call the company regarding any questions they have about CBD or the company’s products.
Dietary supplement association CRN yesterday took a strong stance against FDA’s statements in its Consumer Update. “Yesterday evening, FDA unnecessarily alarmed consumers with a headline-grabbing announcement on the potential health risks of CBD-containing products consumed by over 20 million Americans, without any plan to address it,” said CRN’s president and CEO Steve Mister in a press release. “Meanwhile, it abdicates its regulatory oversight for the subset of these products that do pose risks to consumers because they are poorly made, improperly labeled, or illegally deliver THC. FDA’s inaction for the past year has facilitated an unregulated marketplace—which is bad for consumers and bad for business. It’s time for FDA to announce a legal pathway to market for these CBD-containing supplements and to commence meaningful enforcement against products that flout category-wide requirements for dietary supplements.”
Both CRN and CV Sciences pointed out that in FDA's Consumer Update, the agency's CBD risk warnings were conveyed as a blanket statement rather than specifying that some risks might be associated with specific types of CBD products, such as those with high CBD dosages. CRN pointed out that FDA did not distinguish between the high CBD levels in an FDA-approved CBD drug like Epidiolex—for which the agency said there could be potential side effects—and the supplement products currently on the market that CRN said contain far lower CBD doses, with suggested daily doses of 50 mg/day or less.
CV Sciences aired the same concern, noting that while “we agree with the FDA in that there are currently products that raise safety concerns due to their high levels of CBD or that are being marketed to children,” the agency’s Consumer Update warnings “did not differentiate the vast range of products, servings, and ingredient forms.”
Mister said that FDA continues to call on the CBD industry to produce research to validate the safety of CBD; however, while the agency has received “meaningful safety data” in the form of new dietary ingredient (NDI) notifications and GRAS submissions from "responsible companies,” the agency has so far “dismissed” these. Mister said FDA has not established an appropriate framework to encourage more of the research it claims to seek: “[T]he agency declines the opportunity to create incentives for that research or to give this data assurances of confidentiality that drug submissions are accorded.”
In the CV Sciences letter, Tomc offered CV Sciences’ own research: “The FDA stated that it cannot conclude that CBD is generally recognized as safe (GRAS) and this is because a GRAS affirmation is directly linked to a specific ingredient and conditions of use (serving size, age restrictions, etc.). To this point, we can share our research that supports the safety of our specific ingredients for our intended consumer. We believe that the FDA’s statements that CBD is not GRAS are directed toward companies that have piggybacked on our research, without addressing the significant differences in ingredients, products, levels of CBD, and serving size recommendations.”
Mister also said that FDA has the power to pull products found not to meet good manufacturing practices or supplement labeling regulations but said that instead of doing so, the agency has chosen to "issue tepid warning letters about CBD while the market of poorly made products continues to explode.”
This week’s Consumer Update is possibly FDA’s strongest and most specific public warning against CBD to date. At CRN’s recent annual conference, FDA guest speaker Lowell Schiller, principal associate commissioner for policy, said the agency does not “approach CBD or other cannabis-derived substances with any sort of animus or imposing new burdens.” Faced, however, with the growing CBD market and a lack of regulatory structure to rein that market in, FDA is relying on warning letters and now its Consumer Update to communicate its position on CBD.
While dietary supplement and hemp industry groups continue seeking a legal pathway to market for CBD, and to converse with FDA and Congress about potential options, strong responses to FDA, like those issued by CRN yesterday, could become more common if the industry believes the agency is delivering “alarmist” misinformation about CBD to the broad public.
Said Mister: "It is not too late for FDA to do the right thing: it should explicitly open the dietary supplement lane to CBD and be the ‘cop on the beat’ enforcing the whole range of dietary supplement laws and regulations against those products. The FDA’s continued failure to take this action, while raising consumer alarm over the entire market, requires that Congress get involved to direct the regulator to open the supplement lane to CBD and to police these products with the ample enforcement tools at its disposal. Responsible companies marketing CBD in dietary supplements already comply with the law— which means that they hold data justifying their own evaluations that their products are safe, that they follow good manufacturing practices, that they register their facilities, and that they have a serious adverse event reporting system in place. These responsible companies have been unfairly maligned by FDA’s overbroad warnings on safety, and ironically, are actually deterred from sharing the safety data they have with the agency."