In a recent letter to the National Association of Attorneys General (“NAAG”) and in the latest iteration of the Obama Administration’s Unified Regulatory Agenda, the FDA shed some light on the likely content of its “deeming” regulations that will subject additional tobaccco products to regulation under the Family Smoking Prevention and Tobacco Control Act. The deeming regulations have been drafted, but are not yet public, pending review by the White House Office of Management and Budget under Executive Order 12866.
The FDA’s November 14, 2013 letter to NAAG came in response to a recent request, signed by 42 state and territorial Attorneys General, urging the FDA to immediately regulate electronic cigarettes. The FDA’s response agrees that e-cigarettes should be regulated, citing evidence showing a purportedly “dramatic” rise in youth usage of the products. The letter indicates that the deeming regulations will apply all generally-applicable provisions of the Tobacco Control Act to the newly deemed tobacco products, which would include e-cigarettes that fall within the definition of “tobacco products” (products made or derived from tobacco). For example, e-cigarettes and other tobacco products would be subject to FDA premarket review of new products, which includes not only new brands but existing products whose formulations have changed. The letter notes that any regulations restricting flavors in e-cigarettes would need to be covered in a separate rulemaking, based on a determination that such regulations would be appropriate for the protection of public health.
The latest entry in the White House’s Unified Regulatory Agenda provides more information regarding the content of the proposed “deeming” regulations. The Unified Regulatory Agenda is a broad outline of federal agencies’ priorities and plans for future regulations. The compilation of agendas and regulatory plans covers everything from workplace safety, employee benefits, health care standards and yes, tobacco regulation.
The notice indicates that FDA is subjecting all tobacco products (which would necessarily include cigars, pipe tobacco, and e-cigarettes with nicotine derived from tobacco) to the generally-applicable requirements of the Tobacco Control Act. This also suggests that other, non-generally-applicable requirements will be applied on a case-by-case basis. Although FDA indicates that it has considered the costs and benefits of alternative approaches – including exempting certain products from all or certain requirements – FDA’s statement that it is deeming “all tobacco products to be subject to the FD&C Act” suggests that it rejected the idea of exempting certain types of tobacco products from all or part of the generally-applicable requirements.