Troutman Pepper Locke Tobacco Practice

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Expect about a year’s worth of new anti-tobacco messaging on television and in the newspaper as the result of a recent Consent Motion in United States v. Philip Morris USA Inc., et al., No. 1:99-cv-02496 (D.D.C.).

Over eighteen years ago, on September 22, 1999, the federal government filed this case under the Racketeer Influenced and Corrupt Organizations (“RICO”) Act. The trial court eventually found for the federal government in 2006, ordering (among other remedies) that Defendants issue “Corrective Statements” regarding previous representations as to their products. 

Shortly before the September 30, 2017 establishment registration and product listing deadline for domestic establishments manufacturing newly-regulated tobacco products as of August 8, 2016, FDA revised its Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments guidance to, among other things, provide a new compliance policy for product listing labeling submissions. Under this compliance policy, if certain conditions are met, FDA will not require separate labeling copies for all variations of a particular tobacco product. Using e-liquids as an example, FDA says it recognizes that product listing for particular tobacco products may result in copious labeling submissions, given the commonly seen variations in package size, nicotine strength, propylene glycol (PG)/ vegetable glycerin (VG) ratio and flavors for such products.

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Regulatory Reform Task Forces to review and identify existing regulations that may need to be modified, replaced or repealed.

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.

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.

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.

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.

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. 

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.