| Before California voters passed Proposition 215 nearly 25 years ago, sparking a state-by-state legalization trend for medical cannabis, there wasn’t a sense of urgency or regulatory necessity to test the plant and its end products for safety and efficacy.
During prohibition, law enforcement agencies were the ones responsible for testing, and their laboratories basically tested for the presence or absence of tetrahydrocannabinol (THC), primarily for prosecutorial purposes.
But as more and more states adopted medical and adult-use legalization measures, other government entities, like the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), have been tasked with regulatory enforcement to protect consumers from danger and deceit. Notably, those two agencies have shifted recent focus on monitoring companies that sell over-the-counter cannabidiol (CBD) products.
Earlier this month, settlements between the FTC and six CBD companies accused of making a broad range of unsubstantiated health claims became final, wrote Kristi Wolff, who chairs the cannabis law practice group as a partner at Kelley Dryer and Warren’s New York-based firm. The companies in question made claims that CBD can treat cancer, heart disease, hypertension, Alzheimer’s disease, bipolar disorder and chronic pain, among others.
The FTC’s announcement was coordinated to send an authoritative message to the CBD industry, broadly that the law requires companies to have robust evidence known as “competent and reliable scientific evidence” to support their health claims, a standard that applies to health claims for all consumer products, Wolff wrote.
Also cracking down, the FDA issued warning letters to two companies for illegally selling over-the-counter CBD products labeled for pain relief, which violates the Federal Food, Drug and Cosmetic Act, the administration revealed in a bulletin release on March 22. The FDA has consistently said in its guidance and in public statements that CBD is a permissible cosmetic ingredient, but companies cannot structure disease treatment claims, such as pain relief, about topical products, said Jonathan Havens, a partner who specializes in cannabis consumer health care products at Saul, Ewing, Arnstein and Lehr’s Philadelphia-based law firm.
Scientific evidence appears to be the theme in both cases, but the FTC’s enforcement is focused on whether product claims are deceptive under the law, while FDA’s enforcement is focused on whether the products can be legally sold as dietary supplements.
In an effort to provide science-based data so the FDA could explore viable and appropriate regulatory pathways for CBD products as dietary supplements, a group of 12 companies in the industry teamed up for clinical research that studied 839 adults who consumed oral CBD products. Their efforts revealed preliminary findings earlier this month that showed no evidence of liver disease nor indication of inflammation or damaged cells in the liver among those adult participants.
While safety and efficacy come first, CBD products have become somewhat ubiquitous. As a result, the FDA needs to approve CBD as a dietary supplement and regulate it so consumers know what they’re buying, and so well-founded CBD companies can meet consumer demands through additional sales channels.
-Tony Lange, Associate Editor | 