FDA announces plans for ongoing evaluation of cannabis products

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In light of the burgeoning interest among consumers for health and wellness products containing cannabis and its components, the FDA has outlined plans for clarifying its regulatory authority in this area.

Enthusiasm for these products skyrocketed late last year with the passing of the 2018 Farm Bill, which established hemp as a unique category of cannabis not included in the Controlled Substances Act (meaning hemp is no longer considered a controlled substance under federal law). Hemp is defined as cannabis and cannabis derivatives that have extremely low concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). Cannabidiol (CBD), extracted from marijuana or hemp plants, has no psychoactive effects.

Under the Farm Bill, the FDA maintains regulatory authority over all cannabis-containing or cannabis-derived compounds through the Federal Food, Drug, and Cosmetic Act, says FDA Commissioner Scott Gottlieb in a statement from the agency. Therefore, any claims made must be approved by the FDA before the products can be sold to consumers.

In a statement released earlier in April, FDA Commissioner Scott Gottlieb, MD, outlined the agency's immediate plans for establishing a framework for the regulatory pathways for these products, including a public hearing to be held next month.

The purpose of the hearing is to “obtain scientific data about the safety, manufacturing, quality, marketing, labeling and sale of cannabis products,” according to a notice in the Federal Register. (Electronic or written statements will be collected through July 2, 2019.) In addition to giving industry stakeholders the opportunity to share their experiences and challenges, this hearing will inform the creation of an internal FDA working group to explore potential pathways for lawful marketing of dietary supplements and conventional foods containing CBD.

Announcing the hearing on Twitter, Dr. Gottlieb said, “We remain committed to exploring an appropriate, efficient and predictable regulatory framework to allow product developers that meet the requirements under our authorities to lawfully market these types of products.”

In late March, the FDA and Federal Trade Commission issued joint warning letters to three companies that market CBD products, saying the companies made “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.”

The FDA also intends to maintain and update an online FAQ addressing how the agency's requirements apply to cannabis-derived products.