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FDA Sends Warning Letters To Cannabis Companies Over False Claims
    #807546 - 03/09/16 10:26 AM (11 months, 14 days ago)

On February 9, the FDA sent out a number of warning letters to companies that make and sell products containing cannabidiol (CBD), a type of cannabinoid found in marijuana. Some of the products that the FDA tested contained no CBD in them at all.

Even more troubling, many of the products claim to be treatments for serious diseases and suggest that patients go into remission once they take the CBD product. The FDA is concerned that patients may believe these claims and delay seeing a doctor and taking approved drugs with a proven track record.

“The FDA is in the business of regulating claims. The more claims you make the more scrutiny you’ll face,” said Seth Yakatan, Chief Executive Officer of Kalytera, a company that is creating a synthetic form of CBD.

“Many of these products are claiming in their marketing and promotional materials that they are intended for the use in the diagnosis, cure, mitigation, treatment or prevention of diseases, including, for example: cancer, various infections, psychiatric disorders, multiple sclerosis, arthritis and diabetes,” said Michael Felberbaum, a spokesman at the U.S. Food and Drug Administration.

The companies claim that they are dietary supplements. However, claiming a product should be used to treat cancer means it is a drug and not a diet supplement and therefore, must go through the standard drug trials and testing phases. For example, GW Pharmaceuticals has two substantial clinical investigations regarding the use of CBD. The products are Sativex and Epidiolex and GW Pharmaceuticals has spent millions of dollars testing their drugs on patients.

“The companies receiving these warning letters were selected, in part, based on the egregiousness of the claims made about their products and the determination that inaction posed a potential risk to public health,” said Felberbaum.

The FDA has an exception to this rule: If the products were marketed as a diet supplement prior to being tested as a drug they can continue to be sold as a supplement. Robert Hoban, a lawyer with Hoban & Feola, believes that CBD products fit within the FDA exception. Hoban said that the CBD industry has provided substantial evidence indicating CBD was marketed and sold as a dietary supplement for many years.


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