The U.S. Food and Drug Administration is again taking aim at companies peddling cannabidiol (CBD) products that contain far-reaching health claims on their labels.
The 2018 Farm Bill legalized cannabis plants containing .3% THC or less, also known as hemp. Since then, the FDA has worked on developing the first rules for products derived from cannabis, so long as they contain .3% THC or less. The Administration has given very little information related to progress on the rules, or a timeline for release, but the FDA has reiterated multiple times the need for better data as it pertains to CBD.
Last October, the FDA released the “Cannabis-Derived Products Data Acceleration Plan,” because the cannabis product market in the United States “continues to outpace the growth in the science and our understanding of the public health implications of these products.”
Meanwhile, the FDA, and other federal entities, like the Federal Trade Commission, have started to try to curb the unregulated CBD market through enforcement by issuing warning letters to companies making false claims. The FDA has focused on baseless medical claims, while the FTC is focused on false advertising. For example, in December 2020, the FTC announced Operation CBDeceit, the Commission’s most widespread crackdown on CBD to date.
An FDA spokesperson told Cannabis Wire that the Administration previously sent warning letters to companies that made claims that their “unapproved CBD products” would “prevent, diagnose, treat, or cure serious diseases,” which is in violation of the Federal Food, Drug, and Cosmetic Act.
“Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food,” the FDA spokesperson said.
The most recent FDA warning letters, which largely focused on false claims related to Covid-19, went out to the following companies:
• Bea Lydecker’s Naturals, Inc. was issued a warning letter in February. The FDA “observed that you promote your CBD Oil Procana Spectrum as a product containing cannabidiol (CBD) for humans and animals.”
• Greenway Herbal Products LLC was issued a warning letter on March 28. “The FDA has observed that your website offers cannabidiol (CBD) products for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people,” the FDA noted in the company’s warning letter.
The warning letter also listed research that the company highlighted that appeared to favor cannabis and cannabinoids for infections like Covid-19.
• CBD Social was issued a warning letter on March 28.
“Some examples of the claims on your websites that establish the intended use of your products and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19 include,” the FDA highlighted. “As researchers the world over race to develop curative vaccines, and doctors across the country struggle to find effective treatments for symptoms, others are studying a more natural source to combat the effects of the coronavirus: cannabidiol (CBD) from the hemp plant. Scientists in the United States and Canada are unearthing growing evidence that cannabidiol — already a popular alternative for many facing maladies such as anxiety or chronic pain — may have a role to play in the treatment of COVID-19, the disease caused by SARS-CoV-2, ‘the coronavirus.’”
• Nature’s Highway was issued a warning letter on March 28, which highlighted similar research presented to emphasize the possibility of CBD to treat Covid-19.
“There’s hope that CBD (likely in partnership with other naturally occurring compounds in hemp), could deny the coronavirus the entryway it uses to connect to cells, fight lung inflammation, or even prevent the potentially deadly ‘cytokine storm’ in which a patient’s immune system goes haywire,” the FDA noted in their warning letter, quoting the company’s website.
• UPSY LLC was issued a warning letter on March 28. The FDA highlighted research-related claims on UPSY’s website, including “Can CBD Help with the Fight Against COVID? Some of the worst effects of COVID are caused by inflammation, and CBD is a potent anti-inflammatory.”
• Functional Remedies, LLC D/B/A Synchronicity Hemp Oil was issued a warning letter on March 28, with the FDA highlighting claims like, “Cannabinoids may decrease the number of receptors available to the virus giving your body more of a chance to fight it.”
• Cureganics was issued a warning letter on March 28, with the FDA highlighting claims like “The researchers found that two cannabinoid acids commonly found in hemp varietals of cannabis, CBD, can bind to the spike protein of SARS-CoV-2, the virus that causes Covid-19. By binding to the spike protein, the compounds can prevent the virus from entering cells and causing infection, potentially offering new avenues to prevent and treat the disease.”
