The US CBD market (which is projected to hit $16 billion by 2025) currently operates without significant federal oversight. Indeed, some describe the industry as the “wild west”—a regulatory-free zone that puts consumer safety at risk. On Friday, the FDA grasped the regulatory reins: the agency held a nearly 10-hour public hearing on cannabis-derived products.

 

Stakeholders attended en masse—more than 400 individuals and groups applied for a chance to speak at Friday’s hearing, including consumer advocates, researchers, attorneys, dietary supplement lobbying groups, and CBD businesses. The FDA winnowed down the presenter-list to around 100, each providing a different perspective on CBD and the role it should play in American society. Although there was not a lot of agreement, everyone acknowledged that: (1) CBD products are flooding the marketplace; and (2) the FDA needs to act—fast.

 

A few key takeaways:

• The FDA still has a lot to learn about CBD: Norman “Ned” Sharpless, the FDA’s acting commissioner, opened the hearing by posing a series of questions: “How much CBD is safe to consume in a day? What if someone applies a topical CBD lotion, consumes a CBD beverage or candy, and also consumes some CBD oil? How much is too much? How will it interact with other drugs the person might be taking? What if she’s pregnant? What if children access CBD products like gummy edibles? What happens when someone chronically uses CBD for prolonged periods?” Sharpless noted that the FDA does not (yet) have answers to these questions. Dr. Sharpless’ remarks can be found here.
• CBD is an approved drug ingredient—which makes it tricky to add to the US food supply: Federal law prohibits adding drugs to human or animal food, which means that CBD cannot lawfully be added to food or marketed as a dietary supplement. Dr. Sharpless noted that the FDA could make an exception to that rule—but the agency had never done so before for any other compound. In the words of Dr. Sharpless, adding CBD to the food supply would be “new terrain” for the FDA.
• There are a lot of shoddy products in the marketplace: CBD labeling fraud abounds. One presenter tested more than two dozen CBD products and discovered mislabeling in nearly every product—in fact, one product contained 2,280% more CBD than advertised. Other presenters expressed concern about CBD products that tested positive for lead and other adulterants, including dangerous drugs.
• The FDA is concerned about misleading marketing: According to Sharpless, FDA’s “biggest concern” is the “marketing of products that put the health and safety of consumers at risk, such as those claiming to prevent, diagnose, mitigate, treat, or cure serious diseases, such as cancer, in the absence of requisite approvals.” The FDA has issued warning letters in cases where CBD products are marketed with “egregious and unfounded” claims.
• Americans believe that CBD is already regulated and safe: Consumer Reports presented the findings of a telephone survey conducted on the topic of CBD. Extrapolating from the survey results, Consumer Reports estimates that twenty-six percent of Americans have tried CBD. Many Americans claim that CBD helped them replace prescription or OTC drugs—including opioids. Half of CBD users are “very confident” that regulations exist to protect consumer safety.

 

In the wake of the public hearing, the FDA’s internal CBD working group will be exploring regulatory pathways to allow the legal marketing of ingestible CBD. According to former FDA commissioner Scott Gottlieb, the working group plans to share its findings as soon as this summer.

 

G2 is excited about helping our clients take advantage of the growing CBD market. To learn more, contact us at info@g2llc.com.