Watching and Waiting: FDA’s Deeming Regulation

  • January 17, 2014

By Kerry Roche

The 2009 Family Smoking Prevention and Tobacco Control Act gave FDA’s Center for Tobacco Products the authority to regulate certain tobacco products, including cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. But as Center director Mitch Zeller noted in a recent FDA webinar, the tobacco marketplace has been evolving rapidly and there has been an explosion of new products, including electronic cigarettes, dissolvable products, hookah, and even nicotine gel.

The Tobacco Control Act provides that other tobacco-related products can be subject to FDA regulation if the Agency deems them to be regulated products under a rulemaking process referred to as the “deeming regulation.” FDA submitted its proposed deeming rule to the Office of Management and Budget in October, where it is currently under review. It is widely anticipated that it will cover electronic cigarettes, which are not currently regulated by FDA.

But exactly how electronic cigarettes will be regulated is not known. If they are subject to the same provisions as currently regulated tobacco products, it is unclear what the “grandfather date” will be (products marketed after this date would be considered new and required to obtain FDA pre-market authorization) and what will constitute a baseline predicate product for documentation of substantial equivalence.

Many have argued that regulating products that do not contain any tobacco in the same way as products that actually contain tobacco is a mistake for many reasons. Zeller has acknowledged that, because of the known risks of smoking, consumers appear open to getting their nicotine in other forms. But he says the regulations come down to two basic questions: individual-level risk and population-level harm. Although individuals may have reduced their health risks by switching from cigarette smoking to an alternative product, the Agency must base regulations on net population effects.

Once the Notice of Proposed Rulemaking comes out, there will be a comment period (likely 60 to 180 days), followed by possible changes, and then a period of 6 months to one year to allow companies time to comply. E-cigarette companies and other interested parties should be prepared to comment on the NPRM as soon as it is published. The Weinberg Group has a long history of working on tobacco issues and is knowledgeable about the scientific literature on e-cigarettes. Clients with questions are encouraged to call us to assist.

Kerry Roche is a Senior Consultant at The Weinberg Group, the world’s leading food and drug consulting firm. If you have any questions or thoughts on this blog post or others, please contact us.