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 Alzheimer’s 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 don't let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we're 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 companies - Greenroads Health, Natural Alchemist, That's Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC - citing 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:
- "Combats tumor and cancer cells;"
- "CBD makes cancer cells commit 'suicide' without killing other cells;"
- "CBD ... [has] anti-proliferative properties that inhibit cell division and growth in certain types of cancer, not allowing the tumor to grow;" and
- "Non-psychoactive cannabinoids like CBD (cannabidiol) may be effective in treating tumors from cancer - including breast cancer."
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 they're on the market," Commissioner Gottlieb added. "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. 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."
This latest action builds on the more than 90 warning letters issued in the past 10 years, including more than a dozen this year, to companies marketing hundreds of fraudulent products making cancer claims on websites, social media and in stores. Additionally, the FDA recently took decisive action to prevent the use of a potentially dangerous and unproven treatment used in 'stem cell' centers targeting vulnerable cancer patients. The FDA encourages health care professionals and consumers to report adverse reactions associated with these or similar products to the agency's MedWatch program.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.