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On November 8, 2017, Congresswoman Diana DeGette (D-Colo.) introduced H.R. 4273. The next day, Senator Brian Schatz (D-Hawaii) introduced S. 2100. If passed, either bill would enact the “Tobacco to 21 Act.” The bills have been referred, respectively, to the House Committee on Energy and Commerce and the Senate Committee on Commerce, Science, and Transportation.

Troutman Sanders Partner Bryan Haynes will attend the Food and Drug Law Institute Conference on Enforcement, Litigation, and Compliance held December 6-7, 2017 in Washington, DC. Bryan will moderate a session on the FDA’s enforcement of age verification and other requirements for tobacco products.

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Further briefing and deliberation are expected on a Motion to Intervene filed by several anti-tobacco advocacy and health groups in Nicopure Labs, LLC, v. FDA, No. 17-5196 (D.C. Cir.). The would-be intervenors include 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.

Recent filings in the cigar industry’s challenge to the FDA’s Deeming Regulations involve outside support and opposition. The case is Cigar Association of America v. FDA, No. 1:16-cv-01460 (D.D.C.).

After Plaintiffs in the cigar-industry challenge to the Deeming Regulations filed a Motion for Preliminary Injunction and a Motion for Partial Summary Judgment on October 3, 2017, filings of amici curiae have come on their side. Meanwhile, the Court has denied a Motion to Intervene filed by several anti-tobacco advocacy and public-health groups.

The U.S. Food and Drug Administration recently finalized is industry guidance on the prohibition of distributing free tobacco product samples. This guidance is intended to assist tobacco product retailers, manufacturers, and distributors in interpreting the requirements related to the distribution of tobacco products through non-monetary exchanges, membership and rewards programs, contests and games of chance, and business-to-business exchanges, among others.

Activity on Motions for Summary Judgment seems to suggest different paths ahead for remaining trial litigation in Deeming Regulations challenges. This activity comes after delays owing to the need for new leadership in the Department of Health and Human Services to review the cases and, more recently, for the existing plaintiffs and defendants to reconsider the claims in light of the FDA’s July 28, 2017, announcement of a new comprehensive plan for focusing its regulatory efforts regarding nicotine. The 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.).

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.