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.
FDA’s July 28 Announcement Among Subjects of August 10 Hearing in Deeming Regulations Challenge
Posted in FDA, Significant Cases
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.
Troutman Sanders Tobacco Team Quoted in Law 360 Article Regarding FDA Announcement
Posted in FDA
Troutman Sanders partner Bryan Haynes was interviewed for a Law 360 article regarding the FDA’s July 27th announcement it is considering a rule regarding nicotine levels in cigarettes. While such a rule would likely be years away, people involved in the industry are already speculating on the consequences of…
FDA to Extend Premarket Review Application Deadlines for Newly Deemed Products and Announces Nicotine-Reduction Plan for Combustible Cigarettes
Posted in FDA
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.
Plaintiff Doubles Down, Sues FDA Over “Natural” Descriptor…
Posted in FDA, Significant Cases
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.).
Troutman Sanders Tobacco Team featured in June 2017 SMOKESHOP Magazine Re: Proper Planning to be Compliant with the FDA’s Deeming Regulations
Posted in Articles and Publications, FDA
Bryan Haynes, an attorney at Troutman Sanders, is featured in the June 2017 issue of SMOKESHOP discussing being compliant with the FDA’s deeming regulations requirements. Proper planning is the key.
Read the article here.
Troutman Sanders Tobacco Team featured in June ’16 SMOKESHOP Magazine Re: FDA Deeming Regulations
Posted in FDA
Troutman Sanders attorney Bryan Haynes was featured in a June 2016 SMOKESHOP article regarding the FDA regulations on deeming tobacco products. The article discusses the FDA’s stringent requirements for premarket tobacco submissions.
Read the full article here
U.S. Food and Drug Administration Extends Compliance Deadlines for Newly Deemed Tobacco Products
Posted in FDA
The FDA has extended their upcoming deeming regulations deadlines. This includes the May 10, 2017 deadline, or later, including deadlines for cigar warning label plans, registration and listing, ingredient submissions, health documents, and others. The extension gives the FDA and Department of Health and Human Services’ new leadership time to …
Lawsuits Being Filed Against the FDA Regarding Deeming Regulations
Posted in FDA, State Regulatory
In May through July several groups have filed lawsuits against the US Food and Drug Administration alleging that the deeming regulations that expand the regulation by FDA of additional tobacco products violate the law.
Currently there are eight lawsuits pending, of which 5 pertain to the vapor industry. Two of these five have been consolidated because they address similar claims.
Tobacco Practice Partner Quoted in Vapor Voice Magazine
Posted in Articles and Publications, FDA
Troutman Sanders tobacco team partner Bryan Haynes was interviewed for a June 21 Vapor Voice Magazine article titled “Dark Vapor.” The article deals with the huge propensity for black-market growth in the vapor industry as the FDA’s deeming regulations force many companies to cease their innovative efforts – or even shut their doors.