FDA Warns Four CBD Producers About Making Medical Claims

On October 31, the U.S. Food and Drug Administration sent warning letters to four CBD producers over their claims that the cannabinoid can treat cancer and other serious ailments. While much of the mainstream media covered the news as a crackdown on medical marijuana, most of the offending products claim to contain CBD derived from hemp.

CBD (cannabidiol) has been gaining attention in recent years for its promise in treating a variety of medical conditions without much psychoactive effect. While patients and some cannabis researchers say its efficacy increases when used in conjunction with THC (and other cannabis compounds), CBD products have become especially popular in Midwestern states where access to marijuana is limited.

The FDA took special issue with claims that CBD can help treat cancer. In a letter to Joel Stanley, the CEO of CW Hemp in Colorado, the agency noted a page at the company’s website titled, «Cancer Dosing Guidelines.» The company gained nationwide attention after its Charlotte’s Web strain was featured on a CNN documentary about marijuana in 2013.

“The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist with your marketed products,” wrote Steven E. Porter, Jr., the FDA’s director of pharmaceutical quality operations. “You are responsible for investigating and determining the cause of the violations identified and for preventing their recurrence or occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal notice, including, without further limitation, seizure and injunction.”

A spokesperson for CW Hemp told the New York Times that the company takes «regulatory compliance very seriously,” and said the company would work to better monitor testimonials about its products that mention treating cancer with its products.

But the issue seems to go beyond websites publishing customer testimonials. The FDA did not approve of CW Hemp directing customers to the website for its affiliated nonprofit Realm of Caring, which, according to the agency, «establish[es] the intended use of [the CBD] products as drugs.”

The three other companies to receive similar warning letters were That’s Natural, also based in Colorado; Natural Alchemist, based in California; and Green Roads of Florida.

Both Green Roads and CW Hemp insist their CBD products are legal under a 2014 farm bill that allowed individual states to develop their own hemp programs. While many states have since set up industrial-hemp programs, the legislation does not let companies make medical claims about CBD. The FDA forbids companies from making medical claims about a product unless they’ve been demonstrated in agency-approved studies—although a 1994 law lets dietary-supplement marketers say the product “supports” better health, as long as they include a disclaimer that the FDA has not evaluated the claim and that the product is not intended to treat any disease. That disclaimer now appears in the fine print at the bottom of pages on the CW Hemp site.Hemp and Realm of Caring websites.

In September, Target pulled CBD products from their shelves. Last December, the Drug Enforcement Administration created a specific extracts code under the Controlled Substances Act for cannabidiol.

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