TMA and Vapor Voice recently held their “Finding Direction: Navigating PMTAs” seminar and virtual workshop, which was hosted by Troutman Sanders at its Richmond, Virginia office on August 22, 2019. The seminar was moderated by Jim Solyst, the Vice President of Federal Government Affairs at Swedish Match North America. Speakers included Troutman Sanders Partner Bryan Haynes, Kevin Burd, CEO North America Nicotine, Josh Church, Chief Regulatory & Compliance officer at JWEI Group, Mike Ogden, Sr. Vice President of Scientific & Regulatory Affairs at Reynolds American Inc., Dr. Samina Qureshi, Vice President at PSI International Inc., Dr. Lorraine Rusch, President at High Point Clinical Trials, and Steve Sibley, Vice President at Synchrogenix. The seminar was provided to give companies insight on navigating the FDA’s Guidance regarding Premarket Tobacco Product Applications (PMTAs) for Electronic Nicotine Delivery Systems (ENDS), published in June 2019, which dictates the standards for PMTA submission process as companies prepare their submissions for the May 2020 deadline. Continue Reading Troutman Sanders Hosts TMA and Vapor Voice Conference on the PMTA Process
In a Vapor Voice article entitled “All Hands On Deck”, Timothy Donahue sifts through the information regarding the premarket tobacco review process as it pertains to the vapor industry. Donahue’s article condenses the key factors of what could be an overwhelming process for many vapor companies. As Donahue notes, “the clock just started ticking a lot faster” for vapor companies who plan to submit PMTAs, due to a court-ruling by a U.S. District Court in Maryland that bumped the original PMTA deadline from August 2022 to May 2020. Continue Reading Troutman Sanders Attorneys Discuss FDA Premarket Review Process in Vapor Voice Article
The City of New York filed on October 9, 2019, a lawsuit in federal district court against 22 national online e-cigarette retailers for allegedly selling their products to underage New Yorkers. The complaint alleges the online retailers do not have age verification systems in place and engage in marketing directed toward minors in violation of city law. Continue Reading Online Retailers Sued by City of New York
In the wake of recent reports tying health issues to vaping, a number of States have moved to ban non-tobacco flavored vapes, with one banning all vaping products. These actions may prove to be precipitous, with evidence emerging that THC products with specific ingredients are causing the problems. Continue Reading States Take Unprecedented Measures to Ban Electronic Nicotine Delivery Systems
On September 24, 2019, Massachusetts Governor Charlie Baker declared a public health emergency, and Public Health Commissioner Monica Bharel ordered the sale or display of vaping products in retail establishments, online, or through other means, to be prohibited in the Commonwealth. The moratorium “takes effect immediately and shall remain in effect, unless extended with the approval of the Governor and the Public Health Council, through January 25, 2020, or until the declared public health emergency is terminated, or the Order is otherwise rescinded by [the Commissioner], whichever happens first.” Continue Reading Massachusetts Orders Four-Month Moratorium on Vaping Products
On September 20, 2019, the Food and Drug Administration announced that it will issue a proposed rule governing the process for premarket tobacco applications, including for electronic nicotine delivery systems. The rule (when finalized) would establish binding procedures for PMTAs, as opposed to the current non-binding procedures reflected in FDA guidance. Continue Reading FDA Announces Proposed Rule for PMTAs Amid Threat to Advance Enforcement Against Flavored ENDS
California recently issued a Special Notice, which changes how the California Department of Tax and Fee Administration (CDTFA) will apply the OTP excise tax to the wholesaler’s cost basis when an out-of-state California licensed tobacco products distributor sells tobacco products to wholesalers, retailers, or consumers located in California. Continue Reading California Issues New Rule Raising Cost Base of Other Tobacco Products for Shipments by Out-of-State Distributors
Today, the Trump Administration announced that it is instructing the Food and Drug Administration to “finalize a compliance policy in the coming weeks that would prioritize the agency’s enforcement of the premarket authorization requirements for non-tobacco-flavored e-cigarettes, including mint and menthol, clearing the market of unauthorized, non-tobacco-flavored e-cigarette products.” Continue Reading Trump Administration Instructs FDA to “Clear Market” of Flavored ENDS Products (including Menthol and Mint)
In a press release dated September 3, 2019, Michigan Governor Gretchen Whitmer announced her administration would be introducing emergency rules to ban the sale of “flavored vaping products” in retail stores and online, and ban “misleading” marketing of vaping products, including the use of terms like “clean,” “safe,” and “healthy.” Continue Reading Michigan Moves to Crack Down on the Sale and Advertising of Vapor Products
On August 22, 2019, Troutman Sanders will host the Tobacco Merchants Association “(TMA”) / Vapor Voice conference entitled “Finding Direction – Navigating PMTAs.” The conference will address the FDA premarket tobacco application process for electronic nicotine delivery systems (ENDS). The conference will be held in our Richmond office and Bryan Haynes will be one of the panelists.
We look forward to seeing clients and friends at the conference. For more information, please see below.