Since the start of 2014, the FDA Center for Tobacco Products (CTP) has issued four Not Substantially Equivalent (NSE) Orders, 13 Refusals to Accept Exemptions from Substantial Equivalence (SE), four Refusals to File (RTF) submissions for Premarket Tobacco Applications (PMTAs), and 43 Withdrawals of SE Reports.
The FDA’s Regulatory Quagmire – and What it Could Mean for E-Cigarettes and Cigars
Posted in FDA
Troutman Sanders tobacco practice partner Bryan Haynes was quoted in a February 27th Reason article titled “FDA Cigarette Regulations Protect Big Tobacco, Not Public Health.”
Pending FDA Regulation, Lobbyists Push for E-Cigarette Clarity in Washington
Troutman Sanders tobacco team partner Bryan Haynes was quoted in a February 26th NPR article titled “Lobbyists Amp Up Efforts To Sell Washington On E-Cigarettes.”
FDA’s First Order of Not-Substantially-Equivalent for Four Currently Marketed Tobacco Products.
Posted in FDA
On February 21, 2014, the FDA issued it’s first orders to stop the sale & distribution of tobacco products that are currently on the market, as they were found not substantially equivalent (NSE). FDA’s press release on the subject can be found here.
Troutman Sanders Tobacco Practice Comments on Applicability of FDA New Product Requirements to E-Cigarettes
Posted in Articles and Publications, FDA
Troutman Sanders tobacco team partner Bryan Haynes was quoted in a February 20th article titled “E-cig industry on tenterhooks ahead of U.S. regulation.”
The article discusses the heavy cloud of speculation hanging over the rapidly expanding e-cigarette industry as it awaits the release of deeming regulations by the FDA. In addition to concerns over potential advertising restrictions, flavoring bans, and the regulation of internet sales, the article also discusses how regulations could affect this relatively new segment of the tobacco industry when it comes to its rapidly changing product dynamic.
Graphic Warning Labels are Unconstitutional
Another shameless plug for a Troutman Sanders tobacco team publication — we recently published an article in the Food and Drug Law Journal entitled “Compelled Commercial Speech: the Food and Drug Administration’s Effort to Smoke Out the Tobacco Industry through Graphic Warning Labels.” The article discusses the court decisions addressing…
Understanding the Tobacco Control Act and FDA Investigative Process
Posted in Articles and Publications, FDA
Bryan Haynes of the Troutman Sanders tobacco team recently authored the chapter “Understanding the Tobacco Control Act and FDA Investigative Process,” which discusses the FDA’s enforcement of the Family Smoking Prevention and Tobacco Control Act, in the recent book, Inside the Minds –Recent Developments in Food and Drug Law.…
FDA Offers Clues Regarding Content of “Deeming” Regulations
Posted in FDA, Legislation
In a recent letter to the National Association of Attorneys General (“NAAG”) and in the latest iteration of the Obama Administration’s Unified Regulatory Agenda, the FDA shed some light on the likely content of its “deeming” regulations that will subject additional tobaccco products to regulation under the Family Smoking Prevention and Tobacco Control Act. The deeming regulations have been drafted, but are not yet public, pending review by the White House Office of Management and Budget under Executive Order 12866.
Troutman Sanders Tobacco Practice to Attend the Food and Drug Law Institute Conference on FDA Regulation of Tobacco Products
Posted in Conferences and Events, FDA
The Troutman Sanders Tobacco practice is proud to be participating in the Food and Drug Law Institute’s (“FDLI”) FDA Regulation of Tobacco Products Conference. This one-day conference will focus on latest developments in FDA tobacco product regulation, both in review for 2013 and in the future. The program will host government, industry and public interest experts in order to provide updates on various issues, such as changing product standards and current and future research efforts, in addition to a discussion of the regulation of modified-risk tobacco products, especially in reference to electronic cigarettes.
Tobacco Law Team Practice Quoted in Washington Post article
Posted in Articles and Publications, FDA
Troutman Sanders’ Tobacco team practice partner Bryan Haynes was quoted in a July 30 Washington Post article titled “FDA backs low-nicotine cigarette research as it weighs new regulatory power” about a new study regarding the effect of cigarettes with lower levels of nicotine, and how the FDA may choose to…