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FDA Commissioner Gottlieb Resigns, Leaving Big Questions for CBD Policy

Mar 14, 2019

FDA Commissioner Gottlieb Resigns, Leaving Big Questions for CBD Policy

Alexander Beadle
Science Writer
@alexbeadlesci

The US Food and Drug Administration (FDA) commissioner Dr Scott Gottlieb has announced his resignation from his role as commissioner, saying he wishes to spend more time with his wife and three young children. 

In a letter issued to his staff on Tuesday, March 5, Gottlieb explained that he would formally leave the position “in the next month”. The Director of the National Cancer Institute, Norman “Ned” Sharpless will serve as the acting FDA commissioner after Gottlieb leaves the role in April. It is not known when the Trump administration intends to nominate a new permanent commissioner, but Politico reports that Sharpless, along with FDA principal deputy administrator Amy Abernethy and Health and Human Services’ assistant secretary for health Brett Giroir, are the early contenders for the job. 

Gottlieb’s resignation announcement comes at a pivotal time for the cannabis industry, as those in the cannabidiol (CBD) business were hoping to begin constructive talks with the FDA over the place of the cannabinoid as a food ingredient and/or dietary supplement. 


The FDA’s recent history with cannabidiol

Back in December 2018, Congress passed the Agricultural Improvement Act of 2018, also known as the farm bill. Among other boons to the agricultural industry, the farm bill included a clause that would remove hemp — a variety of the cannabis hemp with contains less than 0.3 percent of the intoxicating compound tetrahydrocannabinol — from the Controlled Substances Act. This would then legalize the production and sale of hemp and hemp-derived products. Since CBD can be easily isolated from hemp, by extension, this appeared to federally legalize hemp-derived CBD.

On the same day that President Trump signed the farm bill into law, the FDA released their own statement explaining what changes the bill would have on their ordinary operating procedure. The statement, authored by commissioner Gottlieb, acknowledged that while hemp and hemp-derived products like CBD may have been legalized, the FDA is still duty-bound to protect the public from products that may pose a public health risk or that may knowingly make untrue claims about their effects. 

As a result, the FDA would not be permitting hemp-derived CBD to be used as an ingredient in foods or beverages, or as a health supplement. 

“We’re aware of the growing public interest in cannabis and cannabis-derived products, including cannabidiol (CBD). This increasing public interest in these products makes it even more important with the passage of this law for the FDA to clarify its regulatory authority over these products,” wrote Gottlieb in the statement

“It’s unlawful under the [Federal Food, Drug and Cosmetic Act] to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs … under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements.”

This statement came as a blow to many in the CBD industry. CBD-infused edibles, drinks, and even CBD honeys and olive oils, have been gaining popularity in states that allow recreational cannabis use. Oftentimes people who want to use CBD for its reported health benefits might be uncomfortable about smoking as a consumption method, and so CBD-infused edibles or oral tinctures are an attractive alternative consumption method. By taking such a hardline stance against CBD-infused foods and beverages, trepidation began to spread throughout the CBD industry.


Planned CBD hearing could be left to languish

But an announcement from commissioner Gottlieb in February showed signs that the hardline approach might be softening; speaking to the House Appropriations Committee, Gottlieb revealed that the FDA was planning to hold a public meeting in April for the purpose of revisiting its stance on CBD policy. 

Via the public hearing, the FDA would be able to hear comments and suggestions for ways in which the agency could support the CBD industry while still protecting public health. For example, Gottlieb suggested a theoretical system in which concentration limits could be put on CBD-infused products, so that only high-potency CBD products would have to seek FDA approval.

“We want to preserve the incentive to study CBD as a pharmaceutical product,” he said at the time. “We’re also interested in hearing from stakeholders and talking to Congress on possible alternative approaches, to make sure that we have an appropriately efficient and predictable regulatory framework for regulating CBD products.” 

But following the announcement of commissioner Gottlieb’s resignation, there are now concerns that this public hearing could be left by the wayside. No fixed date has been set for the meeting and if one is not held before Gottlieb leaves office then it will be his successor who determines whether to review the current CBD rules at all. A successor could come into the role and decide to prioritize the issue, or in a worst-case scenario for the industry, they could decide to ignore CBD policy altogether. 

“In times of transition, issues like this that are not of highest priority could get delayed,” said Jonathan Havens, co-chair of the cannabis law practice at Saul Ewing Arnstein & Lehr, to CNBC

Havens expanded on this in an interview with Cannabis Business Times, saying that the FDA “acknowledged that there’s a lot of attention in the space, and that the agency would possibly consider pursuing regulation to allow CBD as a dietary ingredient. That’s really all they said. They didn’t give any sort of timeline. They didn’t say how seriously the agency was thinking about it.”

“I know that Gottlieb is surrounded by very competent advisors and folks at the relevant centers across the FDA, but his comments to me suggested that he was very well-versed in the issue, that he had talked to people about it [and] that he had really been working with senior staff. My fear is that the momentum that seemingly was occurring in the FDA around CBD … could slow down [or] could be stopped altogether. My fear is that [Gottlieb’s] departure might stall that progress.” 

Danny Davis, founder and chairman of Convectium, an automation equipment provider, also shares these concerns. Speaking to Cannabis Business Times, Davis explained, “It is still unclear if all that effort will continue to gain momentum by another changing of the guard or if some of these conversations and ideas will be left in the dust. There is clearly public support for this to continue, but we are keeping our fingers crossed, as we never know how the tides may turn with the current chaotic environment we are in.”

In the meantime, CBD companies are being advised to protect themselves from any FDA reprimands by making sure to not make any claims about the effects of their product that cannot be backed up by study and research. Misleading claims or marketing have resulted in several companies already receiving warning notices from the FDA. The FDA also has the power to issue fines, remove products from shelves, and even close down the businesses of repeat offenders. 

 

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