Bryan Haynes, Troutman Sanders tobacco practice partner, will be attending the Vapor Expo International June 15-16 in Rosemont, Illinois. Bryan will be speaking the morning of June 15, giving an overview of the current e-cigarette regulatory environment in light of the recently-released deeming regulations. This session will also deal with state regulatory initiatives in addition to the new federal requirements.

The FDA’s proposed deeming regulations extend the FDA’s regulatory authority to additional tobacco products including e-cigarettes, e-liquids, cigars, hookah tobacco, pipe tobacco and dissolvables, referred to as “covered tobacco products.”  The FDA currently regulates cigarette tobacco, roll-your own, cigarettes, and smokeless tobacco.

Troutman Sanders tobacco team partner Bryan Haynes was quoted in a May 13 Convenience Store News article that recapped “tidbits” gleaned from this year’s TMA’s Annual Conference and Meeting, which was held in Williamsburg, Virginia.

Troutman Sanders tobacco team partner Bryan Haynes was interviewed for a May 22nd Tampa Bay Times article titled “U.S. fans of Cuban cigars still have long wait before they can be sold here.” The report describes trials and tribulations facing Cuban manufacturers of premium cigars in light of the new deeming regulations published by the FDA on May 10, 2016.

On May 11, 2016, Bryan Haynes participated in a panel regarding “The Tobacco Control Act Seven Years Later” during the TMA Annual Meeting and Conference at the Kingsmill Resort in Williamsburg, Virginia.  The panelists discussed the impact of the Tobacco Control Act on their law practices including the consequences of the finalized deeming regulations, best practices in advising clients trying to navigate the FDA regulatory process and tips for manufacturers in preparing for the future.

Nicotine: The deeming regulations promulgated by the Food and Drug Administration contain new warning requirements for certain tobacco products, including cigars, pipe tobacco, e-cigarettes, vapor products, hookah tobacco, dissolvables, and nicotine gel.  Effective August 8, 2018, a nicotine health warning is required on packaging and advertisements.  The language is:

“WARNING: This product contains nicotine. Nicotine is an addictive chemical.”

This will be the first part in our continuing series of posts discussing certain aspects of the FDA’s proposed deeming regulations, which were issued today.

This part focuses on the premarket review process that will be applicable to the newly deemed products — principally e-cigarettes, cigars, and pipe tobacco.  The FDA contemplates that the premarket review process applicable to currently regulated tobacco products (cigarettes, smokeless tobacco and cigarette tobacco) will be equally applicable to the newly deemed products.  Significantly, the statutory grandfather date of February 15, 2007 applies to the newly deemed products.  This means that any product that has been introduced or changed in any way since that date will be subject to the premarket review process.  This means that all or almost all e-cigarettes will be subject to premarket review.

The FDA issued this morning its long-awaited deeming regulations, which will subject all tobacco products (including e-cigarettes, cigars and pipe tobacco) to the FDA’s regulatory authority.  We are currently digesting the regulations and will be posting a series of blog entries regarding various aspects.

Our initial impression is that, notwithstanding…