FDA decision causes legal limbo for U.S. CBD industry

August 16, 2021

Cannabidiol (CBD) is left stranded in legal limbo as the United States Federal Drug Administration rejects an application from a well-known CBD brand to get a product designated a health food supplement. On August 11th the FDA published the rejection letter, dated July 23, they sent to the CBD company, Charlotte's Web, on their official website. What does this now mean for America’s booming CBD industry?

Charlotte’s Web has been a prominent American CBD and hemp oil company since 2011. The family owned business is run by the Stanley Brothers who were originally in the medical marijuana business in Colorado where cannabis has been a legal medication since 2000.

When the brothers developed a cannabis-derived compound with a 30:1 ratio of CBD and THC that helped treat a young girl with Dravet’s syndrome (severe epilepsy), the CBD company Charlotte’s Web was born. Over the past decade, the long-time hemp, CBD and marijuana activists have been actively campaigning for policy change, researching the benefits of cannabis and building a multi-million dollar corporation.

What did the F.D.A. decide?

The F.D.A. decided to reject an application that a Charlotte’s Web product could be designated a health food supplement. Their reasoning behind this decision is based on the fact that a CBD-based pharmaceutical drug, Epidiolex, used to treat epileptic seizures already exists. Another reason cited by the F.D.A was that they did not feel the company provided them with enough information about CBD’s safety and effectiveness, specifically relating to concern over CBD’s effects on male reproductive health.

In response to the F.D.A. Charlotte's Web issued a press release explaining that its full-spectrum extract is different from pharmaceutical CBD, which is an isolate with no other cannabinoids. The statement also took issue with the F.D.A.’s second conclusion.

We absolutely disagree with the FDA's statement, in our view we offered extensive, meticulous and substantial scientific evidence that supported a very different understanding. The conclusion does not appear to be founded on the evidence presented.”

The company has requested that the FDA update its records to reflect the information it provided. Additionally, the brand urged Congress to act and recognise hemp-derived CBD as a nutritional supplement. A bill to that effect is currently pending in the Senate but has yet to be voted on.

According to Steve Mister, president and CEO of the Council for Responsible Nutrition, the FDA's failure to distinguish hemp extracts from Epidiolex clinical studies was “disturbing” (CRN). Both new dietary ingredient notifications (NDINs) were for full-spectrum hemp extracts, not CBD isolate, and the extracted doses are “vastly lower” than Epidiolex, he explained in an interview.

In a press release criticising FDA's rejection of the NDINs, Mister stated, “The agency has incorrectly misclassified these products as the same thing as a prescription drug and has ignored, dismissed, and downplayed abundant evidence that these full-spectrum hemp products can be marketed in a safe manner. Meanwhile, the agency has done little to protect consumers with its inability to act for two years contributing to the creation of an unregulated market.”

What does the F.D.A.’s decision mean for the U.S. CBD Industry?

In the short-term, the F.D.A.’s decision won’t affect the multi-billion dollar CBD industry. Companies like Charlotte’s Web can continue selling similar CBD products. However, this means that products like CBD oil and edibles will remain in a legal grey area without the F.D.A.’s regulatory oversight.

The recent judgment demonstrates the F.D.A’s continued reluctance to regulate the non-psychoactive component of the cannabis plant. As customers seek aid with anything from relaxation to focus to improved sleep, the market for CBD products has already risen to more than $6 billion. Even still, there are periodic crackdowns on CBD companies in an industry that has not been provided with a legal framework to operate within.





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