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. Continue Reading Deeming Regulations Litigation Update — Merits Panel to Take Up Intervention Question in D.C. Circuit Appeal, Further Briefing Expected

In the cigar industry’s challenge to the FDA’s Deeming Regulations, there has been a flurry of activity in anticipation of oral argument on the parties’ cross- motions. The case is Cigar Association of America, et al. v. FDA, et al., No. 1:16-cv-01460 (D.D.C.). Continue Reading Deeming Regulations Litigation Update — Recent Filings in Run-Up to December 14 Oral Argument on Cigar Industry’s Challenge

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. Continue Reading Deeming Regulations Litigation Update — State and Nonprofit Amici Support Cigar Challenge, Anti-Tobacco Intervention Disallowed

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. Continue Reading FDA Finalizes Guidance on the Prohibition of Free Tobacco Product Samples

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.). Continue Reading Deeming Regulations Litigation Update — Activity on Motions for Summary Judgment

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. Continue Reading What’s in a Label: FDA Offers Tobacco Industry a Streamlined Approach for Product Listing Labeling Submissions

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