Reynolds Completes 2020 PMTA Submissions

FDA to determine if various e-cigarette products can remain on the market.

September 08, 2020

WINSTON-SALEM—Reynolds has completed the submission of a group of Premarket Tobacco Product Applications (PMTAs) to the U.S. Food and Drug Administration through R.J. Reynolds Vapor Company, the tobacco company announced Friday.

As NACS Daily reported last month, the FDA will soon start reviewing applications from tobacco product manufacturers to evaluate whether these products should remain on the market as part of the agency’s public health mission.

Reynolds is seeking orders authorizing the marketing of Vuse Alto electronic nicotine delivery systems. These applications conclude a multi-year application process launched in advance of the FDA’s Sept. 9, 2020 deadline for PMTAs. Reynolds first submitted a PMTA application in October 2019 for Vuse Solo and submitted additional applications for its Vuse Ciro and Vuse Vibe vapor products in April 2020.  Applications for VELO lozenge and pouch products were submitted last month.

“Completing our 2020 PMTA submissions is a key milestone for us as we continue creating innovative products responsibly—so adult tobacco consumers have a choice available when they are ready for an alternative to combustible tobacco products,” said Guy Meldrum, CEO, Reynolds American. The company has submitted PMTAs for every newly deemed tobacco product offered by Reynolds for one of the broadest portfolios of products in the industry.

Thirteen Vuse Alto products are included in the Vuse Alto PMTAs, comprised of an ENDS component (the Vuse Alto Power Unit) and 12 closed e-liquid cartridges. Vuse Alto Cartridges are available in four flavors, each in three nicotine levels. The Vuse Alto Power Unit works in combination with all 12 closed e-liquid cartridges.

Vuse Alto currently offers flavor pods in Menthol, Rich Tobacco and Golden Tobacco, and a PMTA was also submitted for Mixed Berry flavor pods. If the Vuse Alto PMTAs receive a marketing order from the FDA, adult consumers would be able to choose from four flavor options in a variety of nicotine levels.

The Vuse brand offers vapor products for adult tobacco consumers’ evolving preferences—reflecting a longstanding commitment to develop innovative, consumer-acceptable and responsibly marketed products, the company said.

“We are heartened by the FDA’s recent enforcement actions against illegally marketed tobacco products, as well as their recent decision to make public a list of legally sold tobacco products for which PMTAs were submitted by the deadline, which will make it easier for retailers to identify illegal products that should be pulled from shelves after September 9,” said Dr. James Figlar, executive vice president and head of scientific and regulatory affairs, Reynolds. “This sort of regulatory enforcement ensures consumers have up-to-date, reliable information available on these highly-regulated products.”

Last week, the FDA said it would publish a list of ENDS products under review and available to retailers for marketing to help retailers avoid selling illegal products, as reported by NACS Daily.