Last week, the United States Department of Agriculture (USDA) issued its interim final rule on the establishment of a domestic hemp production program.  It is intended to be effective for two years and then be replaced with a final rule.  The rule outlines provisions for USDA to approve plans submitted by States and Native American tribes for the US domestic production of hemp.

On October 7, 2019, Illinois Congressman Raja Krishnamoorthi introduced the “Ending Nicotine Dependence from Electronic Nicotine Delivery Systems Act of 2019” (or “END ENDS Act”), which was referred to the House Committee on Energy and Commerce. According to the bill, the Act would “amend the Federal Food, Drug, and Cosmetic Act to establish a tobacco product standard prohibiting any e-liquid with a concentration of nicotine higher than 20 milligrams per milliliter” in an attempt to reduce adolescent use of ENDS.

On October 23, 2019, the Appeals Court of Massachusetts upheld the decision (which was the subject of a previous blogpost) of the Superior Court of Massachusetts requiring the lifting of the State’s vapor products ban on October 28th.  The State had filed a motion for stay pending…

On October 21, 2019, the Massachusetts Superior Court for Suffolk County preliminarily enjoined the State – from and after October 28, 2019 – from implementing and enforcing the ban as to “nicotine-vaping products” unless and until the executive branch promulgated the regulation in accordance with Massachusetts due process requirements.  The court allowed the ban to continue with respect to “products containing tetrahydrocannabinol (THC) and any other cannabinoid or to black market products.” 

The Troutman Sanders Tobacco Team will attend a meeting at the Food and Drug Administration Center for Tobacco Products on “Deemed Tobacco Product Applications” October 28-29, 2019.

The meeting is intended to provide information on the agency’s expectations for tobacco product applications, with a particular focus on deemed tobacco products, including electronic nicotine delivery systems, cigars, pipe and waterpipe. 

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.