FDA Cracks Down on CBD Marketers for “Unfounded” Claims

Hemp-derived Cannabidiol or CBD has recently been thrust in the spotlight as a wellness product, but the Food and Drug Administration (FDA) is cautioning companies against making certain health claims on their products.

The agency sent warning letters to three companies that market the hemp-derived products, saying the companies are making “unfounded” claims, including the ability to treat serious diseases like Alzheimer’s and cancer.

These letters were issued jointly by FDA and the Federal Trade Commission (FTC), which has the authority to protect consumers from unfair trade practices, including false or misleading advertising claims

PotNetwork Holdings in Florida, Nutra Pure in Washington state and Advanced Spine and Pain in New Jersey are the companies that the agencies point to as having falsely advertised their products.

According to the release, the companies used advertising platforms to make “unfounded, egregious claims about their products’ ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious diseases, without sufficient evidence and the legally required FDA approval.”

The products are marketed under names such as “Hemp Oil,” “CBD Softgels,” “CBD for Dogs,” “Liquid Gold Gummies,” and “CBD Oil.”

Following the passing of the 2018 Farm Bill, FDA Commissioner Scott Gottlieb says the agency is in the process of creating guidelines for marketing CBD products. In the meantime, companies are advised to be wary of making any health claims.

The commissioner also said the FDA would take “enforcement action against those companies illegally marketing CBD in ways that violate current law and put consumers at risk.”

Within 15 days of receiving the warning letters, the companies have been instructed to notify the FTC with what actions they have taken to address their concerns.

“Selling unapproved products with unsubstantiated therapeutic claims can put patients and consumers at risk,” Gottlieb said. “These products have not been shown to be safe or effective, and deceptive marketing of unproven treatments may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”

CVS and Walgreens also both recently announced they will begin selling CBD-infused products, and in a Twitter thread Gottlieb said he was “concerned” and would be “contacting them to remind them of #FDA obligations and our commitment to protect consumers against products that can put them at risk.”

We’ll be contacting them to remind them of #FDA obligations and our commitment to protect consumers against products that can put them at risk.

— Scott Gottlieb, M.D. (@SGottliebFDA) April 2, 2019

The press release also sets a date for the previously promised public hearing on the future of CBD product regulation. The hearing, which is scheduled for May 31, 2019, will provide a platform for interested parties to “share their experiences and challenges” under the current regulatory environment.