The FDA Shows Its True Stance On CBD

The FDA Shows Its True Stance On CBD

The one obstacle to overcome with CBD and its perceived greatness is the U.S. Food and Drug Administration (FDA). And this past Monday, the regulatory agency displayed its true stance on CBD for the who country, and investment community, to view.

Back On July 22, the FDA issued a warning document to Curaleaf Holdings (CURLF) CEO Joseph Lusardi informing the CEO that his company’s CBD products, as well as its lotions, pain-relief patches, tinctures, and vape pens, were all “misbranded drugs” that were being distributed in violation of the Federal Food, Drug, and Cosmetic Act. The FDA also waved its Bido CBD products for pets as being unapproved and unstable.

More particularly, the FDA stated that Curaleaf is “illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain, and pet anxiety, among other conditions or diseases.”

As a result of this warning document, which will need Joseph Lusardi response to correct these deficiencies within 15 days, Curaleaf lost its topical partnership with pharmacy giant CVS Health (NYSE: CVS). As a reminder, CVS Health announced in March that it would carry Curaleaf’s topical products in roughly 800 of its stores in eight states, with CBD expected to be a means for low-margin pharmacy chains to drum up foot traffic to their stores. It’s unclear if CVS will look elsewhere for its CBD supplies, especially with Walgreens Boots Alliance and Rite Aid following suit with cannabis products in their own stores shortly after CVS.

With Curaleaf becoming the first multistate CBD provider to draw the ire of the FDA, it’s crystal clear that the agency, which is currently reviewing CBD and has recently promised to expedite a report detailing its progress by either late summer or early fall, has little understanding of its benefit-versus-risk profile.

Let’s not forget that even though the FDA gave green light to GW Pharmaceuticals’ CBD-based oral solution known as Epidiolex back in June 2018 for the treatment of two rare forms of childhood-onset epilepsy, these two signs are the only ailments the FDA considers to be benefiting from cannabis and its cannabinoids, period. Even with many positive university-level studies, the FDA does not see cannabis or CBD as being medically holding value.

And take note of what acting FDA chief information officer, Dr. Amy Abernethy, had to say in tweets just two weeks ago. While noting the need for the FDA to expedite its review process given the proliferation of CBD in various derivative products, she notes the “need to balance safety,” and points out that the agency will merely be highlighting its progress, not necessarily making any conclusive findings or laying out CBD regulations as they pertain to food, beverages, and dietary supplements.

Published at Mon, 29 Jul 2019 19:01:52 +0000

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