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At the same time that the Food and Drug Administration (FDA) is working to create a regulatory framework for hemp-derived cannabidiol (CBD), it's also cracking down on companies that are in its view irresponsibly marketing CBD products and making unsanctioned claims about their medical benefits.

FDA officials announced April 2, 2019, that they sent warning letters to three such companies in March 2019: PotNetwork Holdings in Florida, Nutra Pure in Washington, and Advanced Spine and Pain in New Jersey. The letters were sent “in response to their making unsubstantiated claims related to more than a dozen different products and spanning multiple product webpages, online stores, and social media websites,” outgoing FDA Commissioner Scott Gottlieb said in a press release.

In a Twitter thread, the commissioner added that he was “concerned to hear recently that several national pharmacy chains and other major retailers have begun to sell or will soon begin to sell” CBD products and that the agency will “be contacting them to remind them of #FDA obligations and our commitment to protect consumers against products that can put them at risk.”

CVS and Walgreens both recently announced they will begin selling CBD-infused products.

In the press release about the warning letters his agency has already sent to CBD companies, Gottlieb asserted that they used their websites to “make unfounded, egregious claims about their products' ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious diseases, without sufficient evidence and the legally required FDA approval.”

The FDA is hustling to provide manufacturers guidelines on marketing CBD following the federal legalization of hemp in late 2018, but the process is complicated by the fact that CBD is the active ingredient in an FDA-approved drug, Epidiolex, and remains the subject of intensive clinical testing. Gottlieb has indicated that it will take years to develop a regulatory plan for CBD without further congressional action.

In the meantime, companies that continue to choose to engage in CBD commerce should be wary about making health claims about their products. The commissioner said FDA has “limited resources” for enforcement operations, but it would take action against companies that make “over-the-line” statements.

In the press announcement, FDA listed some of the unauthorized claims that the three companies made. For example, the products were touted as being able to treat cervical cancer, Alzheimer's disease, and substance use disorder.

“I believe these are egregious, over-the-line claims and we won't tolerate this kind of deceptive marketing to vulnerable patients,” Gottlieb said. “The FDA continues to be concerned about the proliferation of egregious medical claims being made about products asserting to contain CBD that haven't been approved by the FDA, such as the products and companies receiving warning letters today.”

I believe these are egregious, over-the-line claims and we won't tolerate this kind of deceptive marketing to vulnerable patients. Click To Tweet

“Selling unapproved products with unsubstantiated therapeutic claims can put patients and consumers at risk,” he said. “These products have not been shown to be safe or effective, and deceptive marketing of unproven treatments may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”

Questions about what constitutes an unauthorized claim that would put a company at risk of enforcement action will likely come up at the agency's just-announced public hearing CBD issues on May 31, 2019. Stakeholders are invited to submit information about the public safety impacts of CBD and how to manufacture and market products that contain the cannabis compound.


This article was republished from Marijuana Moment under a content syndication agreement. Read the original article here.

Featured Image: Photo by @kellysikkema via Unsplash

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