Venable partners Ralph Tyler and Todd Harrison were quoted in a Smoke Free Alternatives Trade Association (SFATA) press release on January 31, 2013, on regulatory and legal issues facing the electronic cigarette industry. Tyler was the keynote speaker at the recent 2013 E-Cig Summit hosted by SFATA on January 28, 2013, and spoke on whether the U.S. Food and Drug Administration (FDA) had the authority to classify electronic cigarettes as tobacco products and the implications and applicability of Sottera, Inc. v. Food & Drug Administration.
Addressing stakeholders in the e-cigarette industry who are concerned that e-cigarettes will be regulated under the Family Smoking Prevention and Tobacco Control Act (the “Act”), Tyler said that while rational legal minds may disagree, it remains clear that Congress never intended the Act to apply to electronic cigarettes.
Regarding the Sottera case, Tyler explained that while the Court in Sottera held that the FDA could not classify electronic cigarettes as “drugs,” “devices” or “combination products” absent therapeutic health claims, the FDA may [not shall], deem electronic cigarettes as tobacco products under the Act if, and only if, the FDA were to issue proper deeming regulations. Up until now, the FDA has not attempted to categorize electronic cigarettes as tobacco products and as such, electronic cigarettes are not deemed as tobacco products.
At the summit, both Tyler and Harrison emphasized the importance of industry stakeholders playing an active role in SFATA and in coming together to: (1) Implement universally accepted industry standards for Good Manufacturing Practices (GMPs) and scientific testing and (2) Communicate the standards to officials within Congress as well as to those at the White House’s Office of Management and Budget.