FDA Warns Companies Claiming Marijuana Products Cure Cancer

News
Article

FDA sent warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these statements.

On Nov. 1, 2017, FDA announced that it issued warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these statements. The warning letters sent to Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises cite unconfirmed claims related to more than 25 products spanning multiple product webpages, online stores, and social media websites. The companies used these online platforms to make unproven claims about their products' ability to limit, treat, or cure cancer and other conditions such as Alzheimer’s Disease.

The manufacturing of these products is not approved nor been reviewed by the agency, which leaves treatment information crucial to patients unsubstantiated, including effectiveness, correct dosage, side effects, and drug interactions. Claims made by the companies such as “CBD makes cancer cells commit ‘suicide’ without killing other cells” and “CBD … [has] anti-proliferative properties that inhibit cell division and growth in certain types of cancer, not allowing the tumor to grow” violate not only the Federal Food, Drug and Cosmetic Act, but exposes patients to a host of unregulated consequences and limits possible access to substantiated treatments.

“There are a growing number of effective therapies for many cancers. 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,” said FDA Commissioner Scott Gottlieb, MD, in an agency press release. “We have an obligation to provide caregivers and patients with the confidence that drugs making cancer treatment claims have been carefully evaluated for safety, efficacy, and quality, and are monitored by FDA once they’re on the market.”

The illegally-sold products are believed to contain cannabidiol (CBD), a component of the marijuana plant that is not agency approved in any drug product for any indication. CBD is found in a variety of products, including oil drops, capsules, syrups, teas, topical lotions, and creams. The companies receiving warning letters distributed the products with unsupported claims regarding preventing, reversing or curing cancer, killing or inhibiting cancer cells or tumors, or other similar anti-cancer claims. Additionally, some of the products were sold as an alternative or supplemental treatment for Alzheimer’s disease and other serious conditions.

“We recognize that there’s interest in developing therapies from marijuana and its components, but the safest way for this to occur is through the drug approval process-not through unsubstantiated claims made on a website,” added Gottlieb. “We support sound, scientifically-based research using components derived from marijuana, and we’ll continue to work with product developers who are interested in bringing safe, effective, and quality products to market.”

Source: FDA

Recent Videos
Roger Viney from ICE Pharma discusses the quality and compliance issues surrounding the use of animal-derived ingredients in the bio/pharma industry.
Tore Bergsteiner from MAIN5 discusses the most pertinent and impactful bio/pharma industry trends from 2024.
Simon Wright from Almac Pharma Services chats about shifting demand for commercial manufacturing services and how service providers are adapting to meet demand.
Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.
Miguel Forte from ISCT and Kiji Therapeutics talks about the potential impact of a changing European political landscape.
Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments
Miguel Forte from ISCT and Kiji Therapeutics chats about expectations for 2025 and the future technology agenda for industry.