FDA Regulations on the Horizon for Billion Dollar E-Cigarette Industry

In September, 40 state attorneys general wrote to the U.S. Food and Drug Administration (FDA) asking the agency to take all available measures to issue regulations on the advertising, ingredients, and sale to minors of electronic cigarettes, also known as e-cigarettes or e-cigs. The full text of the letter is available here. The FDA has set a deadline of October 31 to issue proposals to regulate e-cigarettes, but the agency has delayed action in the past.

E-cigarettes are battery-operated nicotine delivery devices that are meant to replicate the flavor and sensation of smoking a tobacco cigarette. The sales of these products are rapidly growing and have doubled every year since 2008. In 2013, the industry is projected to reach $1.7 billion in sales. Tobacco giants Altria, which owns Philip Morris, and R.J. Reynolds, both of which have not previously been involved in the e-cigarette industry, are now launching their own brands.

E-cigarettes have been available for several years, but there has been very little regulation of the industry since its inception. However, the calls for the FDA to explore regulation are becoming louder, and momentum is growing to have the FDA take action. Last month, Rep. Henry Waxman (D-Calif.) and three other House Democrats sent a letter to FDA Commissioner Dr. Margaret Hamburg urging the agency to take action on regulating e-cigarettes. Those same representatives also sent a letter to the Chairman of the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations, and the Subcommittee on Health urging the subcommittees to hold a hearing on the increased use and health impact of e-cigarettes.

In the past, the FDA has stated that it would not feel compelled to regulate e-cigarette companies unless they overtly advertised their products as smoking cessation devices. We have previously looked at Federal Trade Commission regulation of e-cigarette advertising claims. The FTC has jurisdiction to regulate advertisements for any product, but has yet to flex enforcement muscle with regard to e-cigarettes. There are currently no federal rules about advertising e-cigs to young people, but the attorney general letter asked the FDA to “ensure that companies do not continue to sell or advertise to our nation’s youth.”

There has been very little regulation of the industry since its inception– partially because the extent of the FDA’s authority to regulate e-cigarettes is not clearly defined. In 2010, the U.S. Court of Appeals for the D.C. Circuit issued an opinion in Sottera, Inc. v. Food & Drug Administration, affirming the district court’s decision that the FDA could not regulate e-cigarettes as a medical device under the Food, Drug & Cosmetic Act and finding that the FDA’s authority is limited to traditional tobacco products. The FDA also has authority to regulate e-cigarettes under the Tobacco Control Act of 2008, but that authority is limited. Specifically, the Tobacco Control Act authorizes the FDA to regulate “tobacco products,” giving the agency authority to impose restrictions on their sale, advertising and promotions, and establish other standards for their distribution and production.

It remains to be seen what actions will be taken by the FDA in response, but it does seem as if some type of regulation may be on the horizon. The industry will need to adapt to these changes and be active in the rule making and comment process to make sure that the regulations proposed are fair. We will continue to monitor developments on e-cigarette regulations here.