We’ve seen sweeping regulatory changes before, but the FDA’s anticipated regulation of cannabis and CBD-infused products – a market expected to reach more than $20B globally by 2024 – promises to pose significant and unprecedented challenges to food and cosmetics manufacturers already using cannabidiol as an ingredient.
Acting FDA Commissioner Norman Sharpless issued strong warning signals recently during the agency’s first hearing on CBD products. “There are important reasons to generally prohibit putting drugs in the food supply,” Sharpless told a packed hearing room at the FDA’s Rockville, MD headquarters. “Cannabis extracts like CBD are no exception.”
FDA regulators have many questions about CBD, which is already sold in pills, skin lotions, soda pop, and pet foods. Among other things, they want to know how CBD interacts with other drugs, how it may affect children or pregnant women, and what its long-term effects on teens and adults might be.
Regulations could dictate what products go on the market, how they can be marketed, who can purchase them, and how they can be used. There is only one thing we can count on in this scenario. FDA will undoubtedly regulate these products after they have been on the market and in fairly widespread use.
That raises several issues companies need to be aware of even before the FDA imposes regulation.
FDA will accept written and electronic comments and submissions to the public docket (FDA-2019-N-1482) through July 2, 2019. Those comments will be considered when the agency starts to share its findings from a designated internal working group as early as August.
In the meantime, we encourage anyone involved in the cannabis and CBD product category – from producer to retailer – to examine your quality standards and safety protocols, review your marketing communications, and think through how your business would pivot should the FDA take aggressive action. Worst case, are you ready to manage a recall of products already on the market?
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