The FDA has extended their upcoming deeming regulations deadlines. This includes the May 10, 2017 deadline, or later, including deadlines for cigar warning label plans, registration and listing, ingredient submissions, health documents, and others. The extension gives the FDA and Department of Health and Human Services’ new leadership time to work through issues triggered by the final rule on deeming regulations.


Troutman Sanders tobacco team partner Bryan Haynes was interviewed for a June 21 Vapor Voice Magazine article titled “Dark Vapor.” The article deals with the huge propensity for black-market growth in the vapor industry as the FDA’s deeming regulations force many companies to cease their innovative efforts – or even shut their doors. Continue Reading Tobacco Practice Partner Quoted in Vapor Voice Magazine

The U.S. Food and Drug Administration (“FDA”) draws its authority from the Food Drug & Cosmetic Act (“FD&C Act”), whereas the Alcohol Tobacco Tax and Trade Bureau (“TTB”) is authorized under the Internal Revenue Code (“IRC”).  Each of these laws has different definitions of “tobacco products” for different purposes.  FDA’s Deeming Rule has no effect on TTB’s jurisdiction over tobacco products, and vice versa.  While the FDA has deemed certain products to be “tobacco products” under the FD&C Act, some deemed products do not meet the definition of “tobacco products” under the IRC.  Continue Reading Deeming Regulations: Effects of Different Definitions of Tobacco Products

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. Continue Reading Deeming Regulations: Important Deadlines in 2016

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. Continue Reading Tobacco Practice Partner Quoted at Tobacco Merchants Association’s Annual Conference and Meeting

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.”

Continue Reading Deeming Regulations — Initial Impressions — Warnings

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 the flood of comments regarding the proposed regulations, the final regulations are not markedly different.  Significantly, the FDA rejected the so-called “Option 2” that would have exempted a defined category of premium cigars from regulation.  Under the final rule, all cigars will be regulated.

The FDA also rejected calls to shift the so-called “grandfather” date for purposes of premarket review to the effective date of the regulations.  Although shifting the grandfather date would have been reasonable and defensible, the decision is not surprising given that the FDA has repeatedly (and incorrectly) stated that shifting the grandfather date would “emasculate” its authority over the newly-deemed products, including e-cigarettes.

We will continue to report on other impressions.

For questions and/or comments, please contact Bryan Haynes, at 804.697.1420 or by email.