Drugs

Regulate Cannabis Under Existing Law: CFCR

The industry-based Council for Federal Cannabis Regulation (CFCR) says FDA can and should regulate cannabidiol (CBD) and cannabinoid products through its enforcement discretion powers and enforcement policy. In a response to a request for input on cannabis regulation from the Senate HELP Committee and the House Committee on Energy and Commerce, CFCR says it does not take a position on FDA’s perceived need to create a new regulatory regime, but believes that FDA could act now while working with Congress to determine the best regulatory strategy for the products.

“FDA has the sole authority to enforce the Federal Food, Drug, and Cosmetic Act (FFDCA),” CFCR says, “and there is no private right of action for FFDCA violations. Thus, through FDA’s decision not to enforce certain provisions, it can create regulatory policy.”

The response cites other occasions when the agency has used its enforcement discretion and enforcement policy to allow certain products to remain on the market while moving toward a more established legal framework.

“CFCR believes that it would be beneficial for FDA, during this interim period where Congress and FDA work to establish a specific regulatory framework for CBD and cannabinoid products, to exercise enforcement discretion and develop specific enforcement guidance that appropriately balances the need for consumer access and consumer safety with respect to these products,” the response says. “Such an enforcement policy would help ensure, in the interim, that (1) manufacturers protect the public by producing products with adequate labeling, specific warnings, and maximum daily amounts for ingredients; (2) retailers do not stock products that fall outside FDA’s enforcement guidelines; and (3) consumers can still access cannabinoid products that they demand while having some regulatory protections prior to new legislation. CFCR believes that creating a clear enforcement policy establishing FDA priorities for enforcement, or lack thereof, against certain CBD and cannabinoid products that meet certain requirements is the best policy to help bridge the time until a more comprehensive cannabis policy can be enacted.”

The remainder of the CFCR submission answers specific questions raised by the committees on a possible legislated regulatory strategy.

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