Category — News & Updates
In May through July several groups have filed lawsuits against the US Food and Drug Administration alleging that the deeming regulations that expand the regulation by FDA of additional tobacco products violate the law.
Currently there are eight lawsuits pending, of which 5 pertain to the vapor industry. Two of these five have been consolidated because they address similar claims. [Read more →]
August 16, 2016 Comments Off on Lawsuits Being Filed Against the FDA Regarding Deeming Regulations
Washington is the latest state to impose enhanced regulatory requirements upon retailers and distributors of vapor cigarettes, as well as upon the consumer use of these products. New legislation concerning “vapor products” in Washington took effect on June 28, 2016. [Read more →]
June 29, 2016 Comments Off on Expanded Washington Laws Regulating Vapor Products Take Effect
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. [Read more →]
June 23, 2016 Comments Off on Tobacco Practice Partner Quoted in Vapor Voice Magazine
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. [Read more →]
June 13, 2016 Comments Off on Troutman Sanders Tobacco Practice Partner to Speak at Vapor Expo 2016
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 Comments Off on Tobacco Practice Partner Quoted in Cuban Cigars Article
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 Comments Off on Troutman Sanders Tobacco Team Participates in Panel at TMA Annual Meeting and Conference
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 Comments Off on Deeming Regulations — Initial Impressions — 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 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 Comments Off on Alert — FDA Deeming Regulations Issued
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 Comments Off on House Appropriations Committee Seeks to Exempt Premium Cigars, Relax Regulatory Burdens on Vapor Products
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 Comments Off on Troutman Sanders Tobacco Practice Partner to Speak at 2016 FDLI Annual Conference