Agenda Packets - 2013/11/04 - Laserfiche WebLink

Home Browse Search

Regulating E -Cigarettes / 7 ' American Heart Assoc. or. al., Policy Guidance Document Regarding E -Cigarettes (April 9, 20 10) (this document was released prior to the final decision in Soterra Inc. v. Food & Drug Admin., but contains useful information about e -cigarettes from major public health organizations). ' The Food and Drug Administration took enforcement action against several e -cigarette manufacturers for violations of the Federal Food, Drug, and Cosmetic Act (FDCA), including unsubstantiated claims and poor manufacturing practices. For information about the litigation between the FDA and e -cigarette manufacturers, as well as legal documents related to the enforcement actions taken by the FDA regarding these products, visit the FDA's e -cigarette website at http•//www fda gov/NewsEvents/PublicHealthFocus/ucml72906.1rtm. Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776 (codified, in relevant part, at 15 U.S.C.A. §§ 1333-34 and 21 U.S.C.A. § 301 et seq. (20 10)) (preserving local and state authority to regulate the sale of tobacco products). s See Tobacco Control Legal Consortium, Restricting Tobacco Advertising—Tips and Tools (2011). 6 Proponents claim that e -cigarettes emit an odorless vapor made of water and harmless chemicals rather than the hazardous secondhand smoke of combustible cigarettes. ' Sottera, Inc. v. Food & Drug Admin., 627 F.3d 891 (D.C. Cir. 2010). s Generally, the nicotine in electronic cigarettes is "derived from natural tobacco plants." However, it is not entirely clear whether that is true of all electronic cigarettes currently on the market, or whether it will be true of future products. Furthermore, not all electronic cigarettes contain nicotine; some contain comparable chemicals such as lobelia. Letter from Michael M. Levy, Jr., Director, Division of New Drugs and Labeling Compliance, Food & Drug Administration, to William P. Bartkowski, President, Ruyan American, Inc. (Sept. 8, 2010), available at lo://www fda gov/ICECl/EiiforcementActions/WarningLetters/Ucm22518l.htm. 9 See Tobacco Control Legal Consortium publications on Commercial Speech and Commerce Clause issues in the regulation of tobacco products on its website section, Federal Regulation of Tobacco Products, at h—q1/publichealthlawcenter org/topics/special-collections/federal- regulation-tobacco-col lection. 10 Several other states are considering legislation to regulate the sale and use of e -cigarettes and a growing number of countries, such as Australia, Canada, Brazil, Israel, Mexico and Hong Kong, have imposed marketing restrictions on these products. Also, back in 2008, the World Health Organization announced that it does not consider e -cigarettes an effective nicotine -replacement therapy and that these products need to undergo toxicity analyses and "operate within the proper regulatory framework." Updated: May 2011 Tobacco Control Legal Ccnsortiun 875 Summit Avenue, Seint Paul, MN 55105-3076 vnvw.td00nline.org 651.290.7506