The irony is not lost on U.S. trade groups representing manufacturers, marketers and retailers of dietary supplements.
FDA has repeatedly asserted CBD (cannabidiol) cannot be marketed in conventional food or dietary supplements. Yet, legions of supplement products containing the hemp-based compound are available online and through a growing number of health and wellness retailers.
Thereâs an estimated 750 brands in the hemp-derived CBD business, according to a market assessment by Colorado-based brand Functional Remedies. Amid the swift growth in an evolving âhemp extractsâ market, the federal government has offered minimal resistance.
âThey are doing very little in the way of enforcement other than warning letters because they say theyâve got priorities,â said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), who referenced, for example, the agencyâs work responding to food-safety outbreaks tied to produce and meat.
Since 2015, FDA has asserted CBD cannot be sold in dietary supplements. For several years, FDA has delivered warning letters to companies for selling CBD-containing products that purportedly made claims of treating diseases including cancer. But the agency has stopped short of the kind of headline-grapping enforcement actions that would require collaboration with the U.S. Department of Justice and potentially drawn-out fights in federal court.
âI think âŚ if theyâre going to stand at the podium and say, âThis is an illegal ingredient,â then they need to do something in the way of enforcement,â Mister said in an interview. Or, he continued, FDA needs to âstop saying thatâ because large playersâincluding public companiesâwonât enter the CBD market due to the potential exposure.
FDA has not retreated from its stance, even after President Trump signed the 2018 Farm Bill. The new law removed hemp from the Controlled Substances Act and, for practical purposes, authorized sales of hemp-based products in interstate commerce without fear of interference from the Drug Enforcement Administration.
It remains unlawful to market CBD or delta-9-tetrahydrocannabinol (THC) in dietary supplements or introduce food to which the cannabis-based compounds have been added into interstate commerce, even if the substances are derived from hemp, FDA Commissioner Scott Gottlieb, M.D., said in a Dec. 20 statement.
Interpreting a provision of law that industry attorneys sometimes call the âexclusionary clause,â FDA has asserted CBD canât be sold in dietary supplements because, in part, it was the subject of substantial clinical investigations by GW Pharmaceuticals plc. The company recently made available Epidiolex, a CBD medicine approved by FDA in June 2018 to treat patients with certain forms of epilepsy.
âFDAâs problem with CBD when it comes to food and dietary ingredients,â Mister explained, âis that there are parallel provisions in the Food Drug & Cosmetic Act (FD&C Act)âone in the definition of food and one in the definition of dietary supplementsâthat says if the article was previously studied in substantive clinical investigations before it was marketed as a supplement, the drug gets a monopoly on the article.â
GW, though, hardly wields a monopoly on CBD. Based on correspondence with a member company, Daniel Fabricant, Ph.D., of the Natural Products Association (NPA), said there are 1,400 SKUs (stock keeping units) marketed as CBD supplements or CBD oil supplements.
Fabricant, who previously led FDAâs Division of Dietary Supplement Programs, anticipates CBD products will continue to proliferate if his former employer is going to continue to rely on the exclusionary clause but fails to take enforcement action.
During the interview, Fabricant reflected on what he and an NPA colleague endured while both working at FDA: hesitance by government lawyers to bring a lawsuit for fear of losing a case.
âAnd itâs like well if youâre not using that part of the law, youâve already lost it,â he said. âIf you go by the letter of the law, they have the authority now to take action on these [CBD] products. These products are technically adulterated.â
Perhaps complicating matters further, Gottlieb disclosed in December that his agency is considering whether to pursue the issuance of a regulation that would authorize the use of CBD in foods and dietary supplements.
Still, a rulemaking could take years before it is finalized. In the interim, industry insiders are thirsting for additional clarity from an agency that has consistently held CBD canât be sold in dietary supplements but has not vigorously enforced its controversial and unpopular position.
âWe want to have a better understanding about what is the message going forwardâ from FDA, Fabricant said. âWeâre not going to tell our members to break the law. Thatâs not good business.â
Fabricant suggested one step FDA could take to provide additional clarity: describe, in a compliance policy manual, how it would exercise its enforcement discretion against the CBD industry.
In his recent statement, Gottlieb signaled his agency will continue to focus its enforcement resources on CBD products making claims of treating diseases.
âSelling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective,â he said. âThis deceptive marketing of unproven treatments raises significant public health concerns, as it may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.â
With large retailers and manufacturers remaining on the sidelines, Mister is among those in the industry eager to broker a deal with FDA that would allow CBD to be lawfully sold in dietary supplements and conventional food.
Doing so would create âan immediate regulatory framework around the products,â Mister said. âThey would be subject to GMPs (good manufacturing practices). They would be subject to adverse event reporting. They would be subject to review of their claims.â
Mister added, âAll of these things would immediately allow these products to be part of a regulatory framework rather than what you have now, which is FDA saying theyâre illegal, not doing a lot of enforcement, and itâs just a free for all.â
Fabricant suggested itâs not sufficient for the CBD industry to be âpassionateâ about its cause. It must follow requirements under the FD&C Act, such as those requiring evidence of the safety of its ingredients in conventional food and dietary supplements.
âYou canât be passionate alone,â he said. âWe got to be smarter than that because âŚ youâre not just protecting CBD. Youâre protecting the legacy of the whole industry, and people need to think in those terms. They need to be thoughtful.â
FDA, industry leaders said, also must be thoughtful. Michael McGuffin is president of the American Herbal Products Association (AHPA). He highlighted the importance of subjecting CBD products to a federal regulatory framework.
âIf FDA does nothing, then they would essentially be declaring this to be an unregulated class of goods,â he said during a recent webinar hosted by AHPA to discuss the significance of the 2018 Farm Bill and answer questions related to hemp and CBD. âThatâs inconsistent with the agencyâs strong commitment to protecting public health.â