Industry Reacts to Proposed FDA Regulations

WASHINGTON, D.C. – The wait may be over, but the process for final electronic cigarette regulation is still a long ways off.

Three years after announcing it would regulate e-cigarettes as tobacco products and six months after sending along deeming regulations to the Office of Management and Budget for review, the Food and Drug Administration (FDA) today finally released proposed rules for the increasingly popular products.

The FDA gained authority over tobacco products in the Family Smoking Prevention and Tobacco Control Act of 2009. Deeming regulations refer to any products not specifically written into that measure. The proposed regulations released today apply to e-cigarettes, cigars, pipe tobacco, nicotine gels, water pipe (or hookah) tobacco, and certain dissolvables not already under the FDA's authority.

The regulations are "at first glance, not as bad as feared," said Bonnie Herzog, managing director of beverage, tobacco and convenience store research at Wells Fargo Securities LLC.

"Our quick take on the proposed deeming regulations is that they are broadly as expected and not as restrictive as some had feared. In general, they increase the barriers to entry for existing manufacturers, which is positive," she said. "However, our main concern remains around e-cigarettes/e-vapor innovation which, if stifled, could dramatically slow down industry growth and conversion from combustible cigarettes, which would ultimately result in net negative public health impact. Clearly, this would be in direct opposition of the agency's goal."

Herzog's comments came Thursday morning before a review of the full FDA document. However, she said Wells Fargo Securities continues to believe the FDA will base its decisions on the science, pointing to the agency's 14 tobacco research centers and ongoing research on toxicity and addiction.

"We acknowledge the daunting nature of the task the FDA faces in trying to regulate e-vapor. We believe the FDA understands the continuum of risk, but does not yet have all the answers," she explained.

It's All About the Science

Eli Alelov, CEO and founder of LOGIC Technology Development Corp., told CSNews Online that he is happy the FDA took a science-based approach to regulating electronic cigarettes, noting that the agency took a very strong position in supporting the e-cigarette industry.

In a released statement, Lorillard Inc., owner of blu eCigs, also applauded the agency's initial efforts to establish a "reasonable" regulatory framework for the electronic cigarette category –- something it has supported since the beginning -– such as establishing minimum age-of-purchase requirements, setting product quality and safety standards, and listing of ingredients and other relevant consumer information. 

Lorillard's blu eCigs brand has already implemented measures to limit the access of individuals under age 18 to blu eCigs' advertising and promotional activities, and to prevent minors from purchasing its products, the Greensboro, N.C.-based company said.

"It appears that the FDA is taking a science-based approach and that the proposed rule itself defines a constructive process that recognizes that e-cigarettes are different than combustible cigarettes," said Murray S. Kessler, chairman, president and CEO of Lorillard. "Despite what I am sure will be a robust give-and-take process over the comings months, we remain committed to our belief that electronic cigarettes represent a major opportunity to align the interests of business and public health.  We look forward to working collaboratively with the FDA through the notice-and-comment rulemaking process to devise a reasonable, scientifically-based regulatory framework covering e-cigarettes."

Scottsdale, Ariz.-based NJOY has also been in favor of electronic cigarette regulations and welcomed today's announcement. 

"We have long supported FDA regulation of electronic cigarettes and believe that the issuance of today's proposed regulations is a critically important milestone," said Craig Weiss, NJOY's president and CEO. "By resisting calls to regulate ahead of -- and indeed in opposition to -- the science and data, the FDA has brought NJOY a giant step closer to achieving its corporate mission of obsoleting cigarettes. There are encouraging signs that 10 years from now, this date will be remembered as the beginning of the end of the tobacco epidemic." 

Richard Carmona, chairman of NJOY's scientific advisory board, agreed that well-written FDA regulations could help reduce the incidence of tobacco smoking in the United States and the health consequences related to it. Carmona previously served as surgeon general of the United States.

NJOY said it will further review the proposed regulations and looks forward to continued engagement in the regulatory process regarding the content of the final regulations.