On Tuesday, departing FDA Commissioner Scott Gottlieb released a statement detailing the agency’s future plans for the marketing and regulation of products that contain cannabidiol (CBD).
In it, the Commissioner provided a date for the much-anticipated public hearing on the matter; supplied more information on a working group tasked with exploring pathways for dietary supplements and foods containing CBD to be lawfully marketed; and spoke to actions taken against non-compliant companies.
The loosening federal grip on CBD has been years in the making. In 2013, Sanjay Gupta’s CNN documentary Weed focused on a young girl with epilepsy who was helped by a CBD oil extracted from cannabis that came to be known as Charlotte’s Web. The following year, the FDA fast-tracked a CBD-based cannabis plant extract called Epidiolex that was undergoing clinical trials. In 2015, the director of the National Institute on Drug Abuse, Nora Volkow, wrote a blog post called “Researching Marijuana for Therapeutic Purposes: The Potential Promise of Cannabidiol (CBD),” in which she noted that the placement of CBD in Schedule 1 subjects researchers to “strict regulations and administrative hurdles.” In tandem, the 2014 Farm Bill opened up pathways for state hemp (and hemp CBD) cultivation and research, and the 2018 Farm Bill fully legalized hemp.
So here we are, with CBD simultaneously a breakthrough pharmaceutical product and the wellness craze of the last half decade. And the FDA has some tough decisions to make.
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The public hearing on “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds” will take place on May 31, in Maryland. The FDA will also provide an opportunity to submit written public comment. In issuing its call for input, the agency asked stakeholders to share their experiences with products that contain CBD, as well as insights related to product safety.
When it comes to CBD in food, considering CBD is an ingredient in FDA-approved pharmaceuticals, the FDA emphasized that “allowing drug ingredients in foods can undermine the drug approval process and diminish commercial incentives for further clinical study of the relevant drug substance.”
Broadly, the issues under consideration by the FDA are: “health and safety risks,” “manufacturing and product quality,” and “marketing/labeling/sales.” And the product types include: food and drugs (either for humans or animals), dietary supplements, cosmetics, medical devices, and tobacco products, for example, vaping devices, or, “an e-liquid mixture that contains both a cannabis-derived ingredient and nicotine made or derived from tobacco, and that is intended for human consumption.”
More specifically, the FDA requested “data and information” on topics including: “what levels of cannabis and cannabis-derived compounds cause safety concerns; how the mode of delivery (e.g., ingestion, absorption, inhalation) affects the safety of, and exposure to, these compounds; [and] how cannabis and cannabis-derived compounds interact with other substances such as drug ingredients.” (For the full list, see pages 10 to 15 of the document here.)
Gottlieb, who announced his resignation last month, also put together an internal FDA Working Group, to be co-chaired by Principal Deputy Commissioner Amy Abernethy and Principal Associate Commissioner for Policy Lowell Schiller. According to the Commissioner, the group will “consider whether there are legislative options that might lead to more efficient and appropriate pathways than might be available under current law” and plans to share new information and findings with the public as early as Summer 2019.
The agency has also been cracking down on companies that use “online platforms to make unfounded, egregious claims about their products’ ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious diseases, without sufficient evidence and the legally required FDA approval.” In his statement, Gottlieb pointed to warning letters issued by the FDA, in collaboration with the Federal Trade Commission, to three companies making “unsubstantiated claims”— Advanced Spine and Pain LLC (d/b/a Relievus), Nutra Pure LLC, and PotNetwork Holdings Inc. The three companies did not immediately respond to Cannabis Wire’s requests for comment.
Jonathan Miller, a spokesperson for the trade association Hemp Roundtable, lauded the FDA’s efforts. “Over the last several weeks,” he said, “the Commissioner has taken small, positive steps forward to ensure the full legalization of hemp CBD.”
When asked about the agency’s cracking down on non-compliant companies, Miller added: “We applaud it. We believe our worst enemies are people out there who are making false claims, because they hurt our reputation.”
Gottlieb wrote in his statement, “We … don’t want patients to forgo appropriate medical treatment by substituting unapproved products for approved medicines.” Additionally, because products that contain CBD are not evaluated by the FDA, “there may be other ingredients that are not disclosed, which may be harmful.”
The FDA singled out the side effects of Epidiolex, the first FDA-approved cannabis extract-based medicine in the US, which is a CBD-based pharmaceutical prescribed for patients with epilepsy. They noted that liver injury can occur, and the difference between managing those side effects under medical supervision and not, writing, “Questions remain regarding the safety considerations raised by the widespread use of these products. These questions could impact the approaches we consider taking in regulating the development and marketing of products.”
It is unclear how the FDA’s course of action will affect companies like CVS and Walgreens, which recently announced that they carry, or will soon carry, CBD-containing products, like creams, salves, and sprays. Neither company immediately responded to Cannabis Wire’s requests for comment.
Update: CJ Montgomery of Nutra Pure LLC told Cannabis Wire: “we have already been in correspondence with the FDA to resolve the few pending concerns with several sentences on our internal pages, and made proactive changes to address their points. We are committed to meeting the highest standards of compliance when it comes to the marketing of CBD to end-consumers.”
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