FDA Warns Companies Marketing Unproven Products, Derived From Marijuana, that Claim to Treat or Cure Cancer

From Drugs.com - November 1, 2017

FDA Warns Companies Marketing Unproven Products, Derived From Marijuana, that Claim to Treat or Cure Cancer

November 1, 2017 -- As part of the U.S. Food and Drug Administrations ongoing efforts to protect consumers from health fraud, the agency today issued warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes. Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of the Federal Food, Drug and Cosmetic Act, but also can put patients at risk as these products have not been proven to be safe or effective. The deceptive marketing of unproven treatments may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases. The FDA has grown increasingly concerned at the proliferation of products claiming to treat or cure serious diseases like cancer. In this case, the illegally sold products allegedly contain cannabidiol (CBD), a component of the marijuana plant that is not FDA approved in any drug product for any indication. CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, teas, and topical lotions and creams. The companies receiving warning letters distributed the products with unsubstantiated claims regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims. Some of the products were also marketed as an alternative or additional treatment for Alzheimers and other serious diseases.

Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors. We dont let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and were not going to look the other way on enforcing these principles when it comes to marijuana-containing products, said FDA Commissioner Scott Gottlieb, M.D. 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.

The FDA issued warning letters to four companiesGreenroads Health, Natural Alchemist, Thats Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLCciting unsubstantiated claims related to more than 25 different products spanning multiple product webpages, online stores and social media websites. The companies used these online platforms to make unfounded claims about their products' ability to limit, treat or cure cancer and other serious diseases. Examples of claims made by these companies include:

Unlike drugs approved by the FDA, the manufacture of these products has not been subject to FDA review as part of the drug approval process and there has been no FDA evaluation of whether they work, what the proper dosage is, how they could interact with other drugs, or whether they have dangerous side effects or other safety concerns. The FDA has requested responses from the companies stating how the violations will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure and injunction.

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 the FDA once theyre on the market, Commissioner Gottlieb added. We recognize that theres interest in developing therapies from marijuana and its components, but the safest way for this to occur is through the drug approval processnot through unsubstantiated claims made on a website. We support sound, scientifically-based research using components derived from marijuana, and well continue to work with product developers who are interested in bringing safe, effective, and quality products to market.


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