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FDA Warns Four Companies Selling Cannabidiol Over Unproven Claims

Posted 01 November 2017 | By Michael Mezher 

FDA Warns Four Companies Selling Cannabidiol Over Unproven Claims

The US Food and Drug Administration (FDA) on Wednesday warned four companies selling cannabidiol (CBD) containing products for making claims that their products can treat or cure cancer and other diseases, including Alzheimer's, arthritis, heart disease and stroke.

"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," FDA writes.

Regulatory Status of CBD

The regulatory status of marijuana and its components such as cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC) in the US is complicated by conflicting state and federal laws.

Both marijuana and its cannabinoid components are considered Schedule I drugs under the Controlled Substances Act (CSA), meaning that in the federal government's view they have "no currently accepted medical use" and a "high potential for abuse."

However, 29 states and the District of Columbia have passed legislation allowing the use of medical marijuana and 18 states allow for the use of low-THC, high-CBD products, though the laws vary from state to state.

For its part, FDA has continued to support the classification of marijuana as a Schedule I drug, and in 2015 and 2016, the agency warned more than a dozen companies for selling CBD-containing products for making unapproved claims. Alongside those warning letters, FDA published the results of tests that showed that many of the products contained less CBD and more THC than the companies claimed.

Warning Letters

According to FDA, the four companies, Greenroads Health, Natural Alchemist, That's Natural! and Stanley Brothers Social Enterprises each made unfounded medical claims about various CBD products on their websites or social media accounts.

For instance, That's Natural! claimed that "CBD makes cancer cells commit 'suicide' without killing other cells," and Natural Alchemist claimed that CBD "combats tumor and cancer cells."

"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," FDA Commissioner Scott Gottlieb said.

In all four warning letters, FDA says that CBD-containing products are considered to be new drugs and are not generally recognized as safe and effective.

The agency also says that in each case, the products are misbranded as they do not have adequate directions for use.

"It is impossible to write adequate directions for a layperson to use your products safely for their intended purpose," FDA writes, as the diseases the products claim to treat "are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner."

Several of the companies marketed their CBD products as dietary supplements. However, FDA says that CBD-containing products do not qualify as supplements. The agency has authorized clinical trials under investigational new drug applications (INDs) for CBD-containing products such as GW Pharmaceuticals' Sativex and Epidiolex.

FDA, Warning Letters

Categories: Regulatory News

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