Cancer Therapy Advisor Opinion: Understanding the FDA’s Take on Cannabidiol

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This just in from Cancer Therapy Advisor Opinion: Understanding the FDA’s Take on Cannabidiol

In December of last year, the Agriculture Improvement Act of 2018 (“the Farm Bill”) was signed into law. Among other things, this new law changed certain federal authorities relating to the production and marketing of hemp. These changes include removing hemp from the Controlled Substances Act, which means that it will no longer be an illegal substance under federal law. But just as important for the FDA is what the law didn’t change: Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds – such as CBD.

Specifically, it remains unlawful under FDA regulations to market CBD products as (or in) dietary supplements, regardless of whether the substances are hemp-derived. Per the FDA, this is because CBD is an active ingredient in an FDA-approved drug (Epidiolex), and is the subject of substantial clinical investigations. Under the Food, Drug, and Cosmetics Act, it’s illegal to introduce drug ingredients like these into dietary supplements. So, Farm Bill or no Farm Bill, the FDA has made it clear that cannabidiol is not a legal dietary supplement.

In February 2019, FDA Commissioner Scott Gottlieb announced a newly created Botanical Safety Consortium, a public-private partnership that will gather leading scientific minds from industry, academia, and government to promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements. This group will look at novel ways to use cutting-edge toxicology tools, including alternatives to animal testing, to promote the goals of safety and effectiveness we share with consumers and other stakeholders. No mention was made of cannabidiol, but that’s certainly viewed by many as the 800-pound gorilla sitting in the regulatory corner.

According to the FDA announcement, “Our first priority for dietary supplements is ensuring safety. Above all else, the FDA’s duty is to protect consumers from harmful products. Our second priority is maintaining product integrity: we want to ensure that dietary supplements contain the ingredients that they’re labeled to contain, and nothing else, and that those products are consistently manufactured according to quality standards. Our third priority is informed decision making. We want to foster an environment where consumers and health care professionals are able to make informed decisions before recommending, purchasing or using dietary supplements.

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