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.
Deeming Regulations — Initial Impressions — Warnings
Posted in FDA, Legislation
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.”
Deeming Regulations — Initial Impressions — Premarket Review
Posted in Legislation
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.
Alert — FDA Deeming Regulations Issued
Posted in FDA
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…
House Appropriations Committee Seeks to Exempt Premium Cigars, Relax Regulatory Burdens on Vapor Products
Posted in FDA
The House Appropriations Committee recently approved funding language that would exempt traditional large and premium cigars from FDA regulation and substantially lessen the regulatory burden on vapor products.
Troutman Sanders Tobacco Practice Partner to Speak at 2016 FDLI Annual Conference
Posted in Conferences and Events
We are excited to be participating in the 2016 Food and Drug Law Institute (“FDLI”) Annual Conference. This two-day conference on May 5-6, 2016 will host experts from the federal government in addition to representatives from the private sector. Bryan Haynes will be speaking on Thursday, May 5th in a…
Texas Supreme Court Upholds Tax on Non-Settling Tobacco Companies
Posted in Significant Cases, State Regulatory
On April 1, 2016, the Texas Supreme Court ruled that the state could impose a special tax on cigarette manufacturers that were not part of a multibillion-dollar settlement agreement reached with the major tobacco companies in the late 1990s.
Troutman Sanders Tobacco Team Quoted in Article on FDA Deeming Regulations
Posted in Articles and Publications, FDA
The Troutman Sanders Tobacco Team was recently quoted in a Tampa Tribune article discussing the potential impact of the FDA’s deeming regulations on the premium cigar industry in general, and one Tampa-area business (J.C. Newman Cigar Company) in particular.
Troutman Sanders Tobacco Team to Attend NATO Show
Posted in Conferences and Events
We will be attending the National Association of Tobacco Outlets’ trade show in Las Vegas on April 19-21. The show will feature a presentation by FDA Center for Tobacco Products Director Mitch Zeller. Amid speculation that the FDA’s deeming regulations could be issued imminently, Director Zeller is expected to speak…
Hawaii Seeks to Impose Excise Tax on Electronic Smoking Devices & E-liquids
Posted in State Regulatory
The Hawaii Senate has passed a bill that would tax e-liquids and “electronic smoking devices.” The bill now awaits further action in the Hawaii House of Representatives.