With all the recent litigation, legislative efforts, and controversy centered around the U.S. Food and Drug Administration’s Deeming Rule, perhaps there is now a more direct opportunity for stakeholders to influence the FDA on ways the agency can modernize its regulatory framework for tobacco products while reducing burden on industry. Recently, the FDA published Federal Register notices seeking to collect information and public feedback on how the agency can more efficiently and effectively regulate the various products under its regulatory jurisdiction, including food, drugs, devices and tobacco. These requests for stakeholder comment follow on the heels of President Trump’s executive orders from earlier this year directing federal agencies to establish Regulatory Reform Task Forces to review and identify existing regulations that may need to be modified, replaced or repealed. Continue Reading FDA Invites Feedback from Stakeholders on Agency Regulations

Decisions remain pending on the adequacy of the FDA’s defense in two cases challenging the Deeming Regulations. Those cases are Cigar Association of America v. FDA, No. 1:16-cv-01460 (D.D.C.), and Cyclops Vapor 2, LLC v. FDA, No. 2:16-cv-00556 (M.D. Ala.). The issue arose in Motions to Intervene filed by the American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Campaign for Tobacco-Free Kids, and the Truth Initiative on July 24, 2018. Continue Reading Deeming Regulations Litigation Update — Decisions Remain Pending on Health and Advocacy Groups’ Intervention to Defend Deeming Regulations

On August 29, 2017, Plaintiffs Nicopure Labs and the Right to Be Smoke-Free Coalition appealed the adverse judgment of the U.S. District Court for the District of Columbia in Nicopure Labs, LLC, et al. v. Food & Drug Administration, et al., No. 1:16-cv-0878 (D.D.C. July 21, 2017). The District Court held for the FDA on competing Cross Motions for Summary Judgment, denying all of the plaintiffs’ statutory and constitutional challenges to the Deeming Regulation. Continue Reading Vapor Plaintiffs File Notice of Appeal in Deeming Regulation Challenge

There has been much discussion around the U.S. Food and Drug Administration’s plans to regulate premium, hand-made cigars, particularly after FDA Commissioner Dr. Scott Gottlieb’s July 28, 2017 announcement declaring a comprehensive, risk-based regulatory approach for traditional and newly deemed tobacco products. In its announcement, the FDA extended the Deeming Regulation timelines under a new enforcement policy.  Under expected, revised timelines, premarket review applications (including substantial equivalence) for cigar products (including premium cigars) are now required to be submitted to the FDA by August 8, 2021.  As before, cigar manufacturers can continue to market products while the FDA reviews product applications. Continue Reading The Fate of Premium Cigar Regulation by the FDA

Several delays have come in a cigar industry challenge to the FDA’s Deeming Regulations. The case is Cigar Association of America, et al. v. U.S. Food & Drug Administration, et al., No. 1:16-cv-01460 (D.D.C.).

During the spring of 2017, there were several extensions of pending deadlines to “allow new leadership personnel at the Department of Health and Human Services to more fully consider the issues raised in this case and determine how best to proceed.” Another delay has come after the FDA’s most recent announcement of July 28, 2017, declaring a new comprehensive plan for focusing the FDA’s regulatory efforts regarding nicotine. Continue Reading Delays in Cigar Industry Challenge to Deeming Regulations After the FDA’s July 28 Announcement

Tobacco team members Bryan Haynes and Paige Fitzgerald attended this year’s Annual Conference hosted by the Food and Drug Law Institute (FDLI) in Washington, DC, on May 4-5, 2017.  Bryan and Paige covered each of the tobacco-related sessions, and wrote an article for the organization’s Update magazine, which covers current regulatory issues of importance to the industry.  Continue Reading Troutman Tobacco Team’s Article Featured in FDLI’s Update Magazine

The FDA’s July 28, 2017, announcement has spurred the parties and would-be intervenors to address the issue to the Court in Cyclops Vapor 2, LLC, et al. v. FDA, et al., No. 2:16-cv-556 (M.D. Ala.). A hearing will be held in the morning of August 10, 2017, in this case challenging the FDA’s Deeming Regulations.

On July 28, the FDA specially announced a new comprehensive plan for focusing its regulatory efforts regarding nicotine, including extending the deadline for premarket review of electronic nicotine delivery systems. Continue Reading FDA’s July 28 Announcement Among Subjects of August 10 Hearing in Deeming Regulations Challenge

Troutman Sanders partner Bryan Haynes was interviewed for a Law 360 article regarding the FDA’s July 27th announcement it is considering a rule regarding nicotine levels in cigarettes. While such a rule would likely be years away, people involved in the industry are already speculating on the consequences of such a policy. This may include the potential for illicit trade, which is one factor the FDA must consider when evaluating such a rule. Bryan was quoted as saying, “The potential for black markets [of higher nicotine cigarettes] is a very real issue.”

View the entire article here.

For questions and/or comments, please contact Bryan Haynes, Troutman Sanders tobacco practice partner, at 804.697.1420 or by email.

The FDA made a special announcement this morning regarding a new comprehensive plan to focus regulatory efforts on nicotine, specifically to lower nicotine levels in combustible cigarettes through product standards and to examine the role of non-combustible tobacco products to reduce addiction to nicotine.  Continue Reading FDA to Extend Premarket Review Application Deadlines for Newly Deemed Products and Announces Nicotine-Reduction Plan for Combustible Cigarettes

Pending a Pennsylvania state court’s determination of claims under state law, a federal court has put on hold a federal challenge to the Pennsylvania Department of Revenue’s expansive reading of Pennsylvania’s new tax on vapor products. The suit began in the Commonwealth Court of Pennsylvania and challenges the Department’s reading as a matter of statutory interpretation, the Pennsylvania Constitution and the U.S. Constitution. Continue Reading Pennsylvania State Court to Get First Say in Vapor Products Tax Case