Laws and Regulations

FDA STEPS FURTHER INTO THE CBD WORLD

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Written by CBD Intel

A high-level internal working group will explore legal pathways to market for certain CBD products, according to the US Food and Drug Administration (FDA) – which also revealed it had sent warning letters to three companies it accused of making “unfounded claims” for their products.

The announcement came in an early April statement from outgoing FDA commissioner Scott Gottlieb in response to the increased interest in cannabis-derived products.

The working group will look into what statutory or regulatory changes might be needed for the legal sale of food and dietary supplements containing CBD, Gottlieb said. It will also examine the likely impact on public health.

The working group will be co-chaired by FDA principal deputy commissioner Amy Abernethy and principal associate commissioner for policy, Lowell Schiller.

Gottlieb said he wants to know if there are more “efficient and appropriate pathways” for the category than “might be available under current law”.

There will be a public hearing on 31st May to address CBD and cannabis use in consumer products with a view towards publicising findings as early as this summer, Gottlieb said. The FDA is asking for comments and information on issues such as the levels of cannabis-derived compounds that might trigger “safety concerns”; how the mode of delivery affects the compounds; and how they interact with other substances.

In particular, the agency says it is concerned about how the commercial availability of CBD products might cause consumers to forgo medical treatment or allow companies to forgo clinical testing.

“For example, in the case of Epidiolex, the adequate and well-controlled clinical studies that supported its approval, and the assurance of manufacturing quality standards, can provide prescribers confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. It’s important that we continue to assess whether there could be medical ramifications if patients choose to take CBD to treat certain diseases at levels higher or lower than studied in well-controlled clinical studies,” the statement said.

Gottlieb emphasised that the FDA treats cannabis-derived compounds the same as any other product – meaning that marketing claims of therapeutic benefit must be approved before interstate commerce begins. He repeated that it was unlawful to sell CBD-containing products as they are considered an unapproved drug because CBD is the active ingredient in an approved drug that has undergone substantial clinical investigations.

“In such situations, with certain exceptions that are not applicable here, the only path that the FD&C [Food, Drug and Cosmetic] Act allows for such substances to be added to foods or marketed as dietary supplements is if the FDA first issues a regulation, through notice-and-comment rulemaking, allowing such use,” the FDA added.

The agency insisted these rules were in place for consumer safety. For example, it mentioned risks discovered during the 2018 approval of CBD-containing Epidiolex for the treatment of certain forms of epilepsy. These included the potential for liver damage and showed the potential for danger if CBD were to be used in more general settings without medical supervision.

There were also still questions about the potential cumulative health impacts, not to mention the intended functionality of CBD in consumer products, the FDA added.

In the meantime the agency said it would issue warning letters to companies marketing CBD products with “egregious and unfounded” claims to “vulnerable populations.” Three companies were singled out as having received warning letters already from the FDA and the Federal Trade Commission (FTC).

Those companies are Advanced Spine and Pain (trading under the name Relievus), Nutra Pure and PotNetwork Holdings. All three have received letters for “making unsubstantiated claims related to more than a dozen different products and spanning multiple product webpages, online stores and social media websites,” the FDA said.

Among the claims alleged to have been made by those companies are 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”. Gottlieb said the claims were “over the line” and “deceptive”.

Examples provided by the FDA of the “unfounded and egregious claims” included:

“CBD successfully stopped cancer cells in multiple different cervical cancer varieties”
“CBD also decreased human glioma cell growth and invasion, thus suggesting a possible role of CBD as an antitumor agent”
“For Alzheimer’s patients, CBD is one treatment option that is slowing the progression of that disease”
“Fibromyalgia is conceived as a central sensitization state with secondary hyperalgesia. CBD has demonstrated the ability to block spinal, peripheral and gastrointestinal mechanisms responsible for the pain associated with migraines, fibromyalgia, IBS and other related disorders”
“Cannabidiol May be Effective for Treating Substance Use Disorders”
“CBD reduced the rewarding effects of morphine and reduced drug seeking of heroin”
“CBD may be used to avoid or reduce withdrawal symptoms”.
The FDA also said it would update its website with FAQs pertaining to cannabis-derived products.

The obvious conclusion to draw from all this is that the FDA is looking to bring cannabis, and cannabis-derived products, more fully within its control. The agency has been consistent in its belief that these products are subject to the usual FDA regulations and rules. The absence of clear federal guidelines, however, has led to a piecemeal, choose-your-own interpretation for marketing and enforcement. The entrance of the FDA, once the kinks are worked out, may offer more solid guidelines on questions such as interstate commerce.

CBD-Intel (www.CBD-Intel.com) provides impartial, independent and premium market and regulatory analysis, legal tracking, and quantitative data for the cannabidiol (CBD) sector, with a focus on non-US markets.

We provide our clients with the tools to navigate this fast-moving sector, tailor their business strategy, optimise resources and make informed decisions. In addition, we offer customised research and consultancy support.

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