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

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

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.  Continue Reading Anti-Tobacco Messaging Could Hit Airwaves and Print Soon, Depending on Court’s Entry of Order

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

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

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