CBD May Be the Wild West, but the Sheriff Is in Town
In late 2019, Forbes printed an article titled FDA Warning Letters Highlight CBD Industry's Wild West Attitude. The article focused primarily on FDA’s concern with companies selling products with unverified medical claims or that are unsafe for human consumption. With the number of warning letters issued to CBD companies for making health claims over the last few months, it seems that that “wild west attitude” is still prevalent, and even heightened by the COVID-19 pandemic.
But this time, it is not just FDA issuing the warning letters, rather they are being jointly released with FTC, “for selling fraudulent COVID-19 products” that are making health claims. Since March, and as recently as May 26, FDA and FTC have issued warning letters to nine companies for fraudulently selling CBD products that claim to cure, treat or prevent COVID-19.
As of April 14, 2020, 33 states had legalized medical marijuana while the other 17 legalized the use of CBD extract, usually in oil form, with minimal THC and often for the treatment of epilepsy or seizures in seriously ill children. Additionally, the 2018 Farm Bill removed hemp, defined as cannabis (Cannabis sativa L.) and derivatives of cannabis with no more than 0.3 percent THC from the definition of marijuana in the Controlled Substances Act (CSA). However, the Farm Bill explicitly preserved FDA’s authority over hemp/CBD in foods, dietary supplements, human and veterinary drugs, and cosmetics.
Because no CBD products (except Epidiolex) have been subject to FDA evaluation for treating a particular disease or having other effects that may be claimed for people or animals, the agency has been distributing warning letters for CBD health claims, particularly those claimed to prevent, diagnose, treat, mitigate, or cure serious diseases such as cancer and COVID-19.
As stated in one release naming seven companies issued warning letters, “FDA is particularly concerned that products that claim to cure, treat or prevent serious diseases like COVID-19 may cause consumers to delay or stop appropriate medical treatment, leading to serious and life-threatening harm.”
The May 26 warning letter focused on the company’s website claims which included ““Find the best CBD Oil to help fight Coronavirus.” “Use CBD Oil to fight coronavirus, COVID-19!” and “Let the power of CBD help you combat your illness, covid-19, coronavirus…” The warning advised the company to “take immediate action to correct the violations cited in this letter” and send an email to FDA within 48 hours describing the specific steps taken to correct them.
And FDA is not stopping with letters. In fact, the joint FDA/FTC release stated that there is an “aggressive surveillance program” in place that routinely monitors social media, online marketplaces and incoming complaints for health fraud products, and that they will “aggressively pursue” those that place the public health at risk and hold bad actors accountable. And, perhaps most significantly, that “These warning letters are just the first step. We’re prepared to take enforcement actions against companies that continue to market this type of scam.”
The willingness of FDA and FTC to take additional enforcement actions have been demonstrated already. On April 22, 2020, FTC filed an administrative complaint against Marc Ching and Whole Leaf Organics, and followed it up with a court petition to enter a temporary restraining order and grant a preliminary injunction to stop them from disseminating false or unsubstantiated advertisement claims in regard to their products. Although FDA had already sent a warning letter to Whole Leaf Organics, these actions show that the regulatory authorities are willing to take it to the next level of regulatory enforcement.
And it’s not just FDA and FTC. Rather, a cross-agency task force has been established, major retailers have been recruited, and healthcare professionals and consumers encourage to report issues and claims.
Some CBD companies may still have a “wild west attitude,” but the actions of FDA and FTC are demonstrating that the sheriff is in town and is not holding back.
For assistance with your programs and compliance, give the HashTAG experts a call today. We work with cannabis and hemp producers and retailers to produce and sell safe, quality products, assess programs and policies, conduct risk evaluations, and identify areas of opportunity for improvement.