Federal heath regulators have sent a warning letter to several licensed marijuana manufacturers, ordering them to stop making claims that their products can cure or treat cancer, which has never been proven.
Four companies that sell marijuana plant extracts received the FDA warning notice, over false claims that their products help diagnose, treat, or cure cancer. The unsupported statements may lead to cancer patients not seeking proper treatments, worsening their condition, the agency warns.
At issue are claims that products with the marijuana plant extract, cannabidiol (CBD), have cancer curing benefits. Cannabidiol is a component of the marijuana plant that is extracted and sold in many different forms such as oil drops, capsules, syrups, teas, and topical lotions and creams. Many consumers believe that the oil provides a wide variety of medical benefits, however, the FDA states that no scientific or medical evidence has supported these claims.
The FDA issued the warning letters after discovering the four companies were advertising that cannabidiol products could prevent, reverse, or cure cancer, or kill and inhibit cancer cells or tumors, along with various other anti-cancer claims.
The warning letters also claim that some of the products were advertised as an alternative or additional treatment for Alzheimer’s and other serious diseases.
The FDA sets advertising guidelines for companies to prevent consumers from receiving false or misleading information. The guidelines are meant to protect consumer health, so that patients with mild to severe diseases do not seek the wrong treatment and delay proper treatment, which could result in a worsened or fatal condition.
The FDA approval process is also meant to help determine proper dosage, risks the products could pose if used with additional medications, and whether any dangerous side effects need to be disclosed.
“When people are allowed to illegally market agents that deliver no established benefit they may steer patients away from products that have proven, anti-tumor effects that could extend lives, ” FDA Commissioner, Scott Gottlieb, stated in the press release.
Gottlieb said the agency is aware of marijuana extracts health claims, however there is an official process that must be followed before companies can make medical benefit claims.
The FDA sent the warning letters to Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprise LLC. Combined, the companies were accused of making more than 25 unsubstantiated claims of medical benefits related to the use of cannabidiol.
The companies must respond to the warning letter with how the violations will be corrected in a timely fashion. Failure to comply may result in legal action by the FDA, including seizure and injunction.
The latest action builds on at least 90 warning letters issued to companies by the FDA in the last ten years, including more than a dozen this year, who all have made deceptive or fraudulent marketing claims of benefits to cure of prevent cancer by way of website, social media or in store advertising.