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What a long strange trip this is becoming! In the gray areas of marijuana - illegal federally, street-legit in four states - the latest chapter in the non-psychoactive CBD world has the federal rules pointing to pharma supremacy.
The U.S. Food and Drug Administration may have stopped the burgeoning CBD supplements market dead in its tracks on Monday when it issued warning letters to eight companies, from California to Michigan. In the letters, the agency ruled the companies are selling 22 different cannabis-derived CBD products in violation of federal law.
The companies were guilty of two relatively minor infractions but one huge one. First, many were marketing “unapproved new drugs” because the companies were making drug claims instead of the structure/function claims that are allowed for supplements.
One company, Healthy Hemp Oil, based in Austin, Texas, made claims on its CBD oil that it could “alleviate anxiety,” help heart disease and diabetes, and has “anti-cancer properties.” Such claims are in violation of the 1994 Dietary Supplements Health and Education Act (DSHEA), which states that supplements cannot claims to "diagnose, treat, cure or prevent" any disease. Healthy Hemp Oil could not be reached for comment.
The FDA also took the unusual step of testing the products for cannabidiol content. Almost all of them failed—though Healthy Hemp Oil’s Herbal Renewals 25% CBD Hemp Oil Gold Label passed this part of the test.
But the potential death knell for CBD as supplements is the federal Food, Drug and Cosmetic Act rule that while natural ingredients can be supplements first and then later become drugs—as with the Lovaza brand pharmaceutical fish oil concentrate—once a drug has been recognized by the FDA, it can never become a supplement.
And it turns out that GW Pharmaceuticals, based in the U.K., gained Investigational New Drug (IND) status and conducted a clinical trial on a CBD product in 2007, which allows a fast track for compounds for rare diseases where patients do not respond to any other conventional medicines. One GW Pharma product, Sativex, is 2.7 mg THC (the cannabinoid that gets you high) and 2.5 mg CBD. Another product, Epidiolex, is all CBD.
“I understand that it was part of the compromise when DSHEA was enacted,” noted Alice Mead, vice president of U.S. professional relations for GW Pharmaceuticals. “It was between protecting the resources involved in pharmaceutical development and prescription meds and balancing that against legitimate dietary supplements, so if an IND underwent clinicals that were publicized, then dietary supplements couldn’t do an end run around it.”
In the warning letter to Healthy Hemp Oil, the FDA explained that all doors appear to be shut down. “There is an exception,” wrote the FDA, “if the substance was marketed as a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD.”
The FDA first issued an opinion on the subject of CBD supplements in May 2015 when it said it did not believe they counted as supplements. However, there was no enforcement action around its online opinion. This led to controversy at Natural Products Expo (disclosure: A New Hope Natural Media event, as is this website) because many CBD makers wanted to exhibit at the show, and didn’t think the FDA had officially meant CBD to be unavailable as supplements. No more.
“FDA has taken action addressing CBD products marketed as ‘supplements,’” said New Hope Standards Director Michelle Zerbib. “This now gives us the FDA enforcement that supports our Expo Standards on the CBD issue.”
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