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. [Read more →]
May 24, 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. [Read more →]
May 12, 2016
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.”
May 11, 2016
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. [Read more →]
May 5, 2016
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.
May 5, 2016
House Appropriations Committee Seeks to Exempt Premium Cigars, Relax Regulatory Burdens on Vapor Products
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. [Read more →]
May 1, 2016
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 panel entitled “Tobacco Product Standards.” During this session, speakers will discuss the formation of specific product standards for tobacco products, including potential bans or regulations of menthol and/or other flavors.
May 1, 2016
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. [Read more →]
April 24, 2016
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. [Read more →]
April 17, 2016
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 on current FDA regulations and research on tobacco products that could form the basis for future regulations.
We look forward to seeing our clients and friends at the show.
April 17, 2016