The Troutman Sanders Tobacco Team will attend the Food and Drug Law Institute Tobacco and Nicotine Products Regulation and Policy Conference in Washington, D.C. October 24-25, 2019.

A diverse group of stakeholders, including manufacturers, governmental agencies, researchers and public health advocates, will meet to discuss effective regulation of the broad spectrum of tobacco and nicotine products.  FDA’s Center for Tobacco Products Director Mitch Zeller will provide an update on regulations, guidance documents and other initiatives. 

Flavored vapor product bans in two States were temporarily stayed this week.  On Tuesday, October 15, 2019, a Michigan state judge temporarily blocked the State’s emergency ban on flavored vapor products, which went into effect earlier this month.  The plaintiffs were two vapor product retailers and an individual owner.  In addition to presenting evidence that the ban had significantly hurt their businesses (resulting in the complete shutdown of one of the companies’ business), the plaintiffs also presented several witnesses whose testimony showed that the ban presented a harm to the public, challenged the efficacy of certain surveys presented by the State and challenged the supposed correlation between youth consumption of burning tobacco and e-cigarettes. 

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.

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.

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. 

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.

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.”

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.

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. 

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.”