Warning letters issued by the FDA to companies selling unproven cannabidiol products
As a part of its ongoing efforts to protect consumers, the US Food and Drug Administration (FDA) has issued warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat or cure cancer without support evidence.
The sale of unapproved products that have unsubstantiated therapeutic claims is a violation of the Federal Food, Drug and Cosmetic Act, and can potentially cause harm/risk to patients as the products have not been proven to be safe or effective.
The warning letters in these cases have been sent to companies selling products illegally that allegedly contain cannabidiol (CBD), a component of the marijuana plant that is not FDA approved in any drug product for any indication. The companies receiving warning letters distributed the products with unsubstantiated claims regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumours; 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 tumours. 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,” explained FDA commissioner Dr Scott Gottlieb. “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-tumour effects that could extend lives.”
The four companies are Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC. The warning letters cited that the companies had made unsubstantiated claims related to more than 25 different products spanning multiple product webpages, online stores and social media websites.
“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,” added Gottlieb. “We recognise 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.”
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.