And now we wait: FDA CBD Powwow One For the Books

Jun 10, 2019

The dust still has not settled from the May 31, full-day FDA hearing on CBD. It’s not obvious whether the meeting of the minds made things clearer or just further muddied the waters.

At the hearing, 120-plus interested professionals spoke in front of 12 FDA bureaucrats in Silver Spring, Md. The majority of witnesses believe the FDA has existing rulemaking tools and should expedite designating CBD as a "dietary supplement." Some want expedited FDA action, or temporary emergency rules, citing the consumer "explosion" of interest.

Everyone wants to see upgraded truth-in-labeling protocols, especially in terms of dosing information. Others would like a national testing regime for safety (and efficacy) helping to push out CBD "online fakers" and quick-buck "CBD private labelers."

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The extensive United Nations' WHO (World Health Organization) review of CBD that verified the cannabinoid as safe and non-addictive was cited by 20-plus of the 130 witnesses, including  Dr. Blair of Elixinol. Blair confirmed his own years of careful patient feedback and concluded little side effects were experienced.

Adverse effects cited in testimony included fatigue or sleepiness, headaches, constipation, diarrhea, adult liver toxicity.

Drug ingredient giant Noramco, a white label supplier of CBD to big pharma, claimed CBD is an ingredient, not a free-standing medicine on its' own. Several speakers stated that Epidiolex is not the same as CBD, and should not be placed in the same analysis category by the FDA.

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Speakers hoping to avoid potential two-to-five-year clinical trials called for expedited approval for New Drug Ingredient or GRAS status claiming that it would enable expeditious research into safety and efficacy. MJNA's Dr. Stuart Titus suggested that more than 2500 studies have been undertaken on medical cannabis or CBD, with more than 10,000 studies conducted on cannabis and terpenes in general.

Several attendees spoke to allowing over-the-counter CBD at a lower dose similar to products such as pain relievers with higher dosing available only through a prescription. However, FDA panelists fired back with concerns that this would not prevent overconsumption if a consumer were to use a variety of CBD-infused products in different forms such as oils, topical, edibles, and drinks on the same day.

With the passage of the 2018 Farm Bill, some are asking why is the FDA involved at all in CBD regulation. Hemp political expert and Washington veteran Ben Droz offered an answer in a comment written this week:

The FDA is in charge of keeping the public safe, not to restrict natural plant extracts. All CBD products should meet a baseline of requirements to be in the market, such as C-GMP manufacturing standards, and trackability of supply chain.  Anything more than that should only apply to pharmaceutical grade dosage {like GW's Epidiolex}, which could be in the hundreds and hundreds of milligrams per day. Importantly—and possibly to reflect the idea that the FDA knows that hemp derived CBD is, in fact, legal—the FDA is not actually holding the meetings and comment period on hemp CBD. Instead, it is “products containing cannabis or cannabis derived compounds.” By using the word “cannabis” rather than the 2019 definition of “hemp,” the FDA is taking comment on all cannabis products. This would show that any testimony or criticism against CBD, would be relating to any “cannabis-derived CBD,” not necessarily including legal, hemp-derived CBD.

A common FDA response to testimony was "please send us more data to back up what you just said." All submissions are due by July 2nd.

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While the FDA ponders the fate of CBD, many experts and politicians are now predicting that there is a strong chance that the federal government will end its four-score-decade-long prohibition of marijuana. Many stakeholders are hoping that the FDA grants CBD GRAS status before that happens.

Dr. Lloyd Covington contributed to this article.

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