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.”2
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What’s the relevance for the nascent but swiftly growing CBD industry? First, their marketing plans need to be put on pause now that the FDA has stepped up to the plate. The agency carries a big stick and knows how to use it. Next, as with all FDA-regulated products, manufacturing quality and labeling integrity are joined at the hip, inseparable condiciones sine quibus non. Complying with FDA regulations isn’t easy or inexpensive and is certainly not a mom-and-pop proposition.
Many cancer patients have experienced the benefits of CBD. But long-term, broad-based, and validated patient outcomes studies don’t exist — at least not yet. And the FDA isn’t practicing salutary neglect. Many in the cannabidiol community think this is regulatory creep on the part of the FDA, and maybe it is. But that doesn’t change the law or the facts on the ground. Waving away the important public health role of the FDA as “Big Brotherism” doesn’t make the agency’s position or authority any less real or relevant.
It’s time for the denizens of CBD (including many highly vocal patients, physicians, pharmacists, manufacturers and distributors) to become part of the solution — and participate in the FDA’s new Botanical Safety Consortium. Remember what they say in Washington, “If you’re not at the table, you’re on the menu.”
Peter J. Pitts, a former Associate Commissioner of the FDA, is President of the Center for Medicine in the Public Interest, Director of Regulatory Affairs at Adherent Health Strategies LLC, and a member of the CannabisBPO advisory board.
References
- US Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, MD, on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds [press release]. Published December 20, 2018. Accessed February 11, 2019.
- US Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, MD, on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight [press release]. Published February 11, 2019. Accessed February 11, 2019.
