More than a week after a Congressional deadline, FDA finally released its long-awaited report to Congress on the potential regulatory pathways for the sale of hemp-derived CBD products. Click here for the full report. Click Here for FDA’s Public Statement.
There’s not much cause for celebration — FDA continues to kick the can down the road, claiming that more study is needed before it takes action. The agency’s delay results in the worst of both worlds — U.S. hemp farmers are denied profitable markets for their crops, while unregulated products continue to proliferate, with no safeguards for public health and safety.
The report, however, does provide valuable insight into the Agency’s thinking and next steps including the following:
- FDA is actively evaluating a potential rulemaking to allow CBD in dietary supplements. In the meantime, the agency is considering the issuance of a risk-based enforcement discretion policy to provide more transparency regarding its enforcement priorities.
- With regard to adding CBD to food and beverages, FDA maintains that the data currently available raises safety concerns and encourages parties to share relevant information with FDA.
- FDA argues that those marketing cosmetics should ensure the safety of their products, noting that there is limited data on topical use of CBD, and that topical products – including those with CBD – should not make structure/function or therapeutic (drug) claims.
- FDA is re-opening the docket to obtain information on “full spectrum” and “broad spectrum” hemp extracts, and how they compare to CBD isolate products. The agency is also actively working to develop a sampling study of the CBD marketplace to determine the extent to which products are adulterated or misbranded.
FDA’s baby steps, combined with Commissioner Hahn’s recent statements that it would be a “fools game” to shut down the CBD business, offer some hope about the inevitably of FDA action on CBD regulation. But in order to protect hemp farmers — and provide U.S. consumers access to safe and legal products that they demand — FDA’s go-slow approach is not tenable.
We call on Congress to force FDA’s hand, declare CBD and other hemp constituents as lawful ingredients, and require the agency to implement a regulatory plan to protect consumers and unleash U.S. hemp farming.
Hemp’s friends in Congress are developing plans to spur FDA action. In the meantime, Hemp Supporters are encouraged to contact their U.S. Congresspersons, and urge them to co-sponsor H.R. 5587 which would allow FDA-regulated, hemp-derived CBD to be marketed in dietary supplements and as food and beverage additives. Please use our online portal to email your Representative to have your voice heard today.
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