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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.

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. 

For agreeing not to challenge Natural American Spirit’s use of the word “Natural” in its product packaging and labeling, the U.S. Food and Drug Administration (“the FDA”) has been sued in the U.S. District Court for the Southern District of Florida. The case is Sproule v. U.S. Food & Drug Administration, et al., No. 9:17‑cv‑80709 (S.D. Fla.).