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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.”