Up in Smoke (or Vapor, as the Case May Be)September 22, 2013
By David B. Clissold –
Last week, House Democrats and a consortium of public health organizations turned up the heat on FDA to issue “deeming” regulations that would bring electronic cigarettes and other types of tobacco products under the Agency’s jurisdiction. The Family Smoking Prevention and Tobacco Control Act (“Tobacco Control Act”), Pub. L. No. 111-31, 123 Stat. 1776 (2009), broadly defined the term “tobacco product” to include “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.” However, the Tobacco Control Act only provided FDA the immediate authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. All other “tobacco products” could only be regulated if FDA first issued regulations “deeming” such other tobacco products to be subject to the Federal Food, Drug, and Cosmetic Act (“FDC Act”).
In a letter dated September 16, 2013, Representatives Waxman (D, CA), DeGette (D, CO), Pallone (D, NJ), and Dingell (D, MI) urged Dr. Margaret Hamburg, Commissioner of FDA, to issue deeming regulations that would assert jurisdiction over electronic cigarettes. On the same day, these representatives sent a letter to the Chairmen of the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations, and Subcommittee on Health urging a Congressional hearing on e-cigarettes and other tobacco products. Among other topics, the authors recommended that the hearing examine trends in the use of e-cigarettes, cigars, and pipe tobacco and statutory changes needed to bolster FDA’s ability to regulate these products.
Finally, the Tobacco Control Legal Consortium filed a Citizen Petition urging FDA to assert jurisdiction over additional tobacco products, including waterpipes (“hookahs”) and electronic cigarettes.
As noted in the letter to Dr. Hamburg, FDA has been “working on these ‘deeming’ regulations for years.” It remains to be seen whether these additional efforts will encourage the Agency to propose deeming regulations, or whether the Agency believes that additional statutory authority or clarity may be needed first.