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 work through issues triggered by the final rule on deeming regulations.

 

On Thursday, May 4, 2017, Bryan M. Haynes, Partner, Troutman Sanders LLP, will moderate a session on the FDA Center for Tobacco Products’ Evaluation of Premarket and Modified Risk Tobacco Product Applications at the 2017 Food and Drug Law Institute Annual Conference, which will be held in Washington, DC. This session will include a discussion of the FDA’s standards for reviewing premarket tobacco applications, as well as modified risk tobacco applications.

 

On March 24, 2017, the Third Court of Appeals of Texas decided Hegar, et al. v. Texas Small Tobacco Coalition, et al., No. 03-13-00753-CV. The court held that a tax on nonparticipating or non-settling manufacturers (“NPMs”) did not violate either the Equal Protection or the Due Process Clause of the Fourteenth Amendment to the U.S. Constitution. The law at issue, Subchapter V to Chapter 161 of the Texas Health & Safety Code (“Subchapter V”), taxed NPMs remaining outside of the Master Settlement Agreement (“MSA”) at approximately $0.55 per cigarette pack and companies subsequently joining the MSA at approximately $0.15 per pack. The case was of particular interest because Texas is not a party to the MSA, yet the MSA’s distinctions were the bases for Subchapter V’s. Continue Reading NPM Tax Valid Under U.S. Constitution, Says Texas Appellate Court

On occasion, a  manufacturer of tobacco products may decide to use its permitted facility for another purpose, one that may exceed the permit or be altogether unrelated to the permitted use.  For example, a manufacturer of tobacco products may decide to manufacture cigarette papers and tubes, or to process tobacco for third parties, or even to make a product similar to a cigarette that has no tobacco in the product. Some manufacturers have assumed that a tobacco producer permit will automatically cover its activity to also make these products, but it does not.    Continue Reading Ramifications of Using the Permitted Area for Another Purpose

On September 2, 2016, California’s Office of Environmental Health Hazard Assessment (OEHHA) finalized its rule amending Article 6 of the regulations implementing Proposition 65 (i.e., California’s Safe Drinking Water and Toxic Environment Act of 1986).  As a result of the new regulation, tobacco and electronic cigarette manufacturers may be required to update their Proposition 65 warnings. Continue Reading California Finalizes New Prop. 65 Warning Label Rule

On April 21, 2016, Philip Morris, R.J. Reynolds and other tobacco companies filed a petition for writ of certiorari asking the Supreme Court to review a decision allowing Pennsylvania to receive a $125 million payment as part of a nationwide settlement over smoking-related health costs, saying a lower court exceeded its authority by altering an arbitration award. Continue Reading Tobacco Companies Appeal $125M Award to U.S. Supreme Court

Washington is the latest state to impose enhanced regulatory requirements upon retailers and distributors of vapor cigarettes, as well as upon the consumer use of these products.  New legislation concerning “vapor products” in Washington took effect on June 28, 2016. Continue Reading Expanded Washington Laws Regulating Vapor Products Take Effect

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. Continue Reading Tobacco Practice Partner Quoted in Vapor Voice Magazine