3 Tobacco Companies That Recently Submitted PMTAs

CHICAGO — Tobacco companies had until Sept. 9 to submit tobacco products subject to the premarket tobacco application (PMTA) process.

The U.S. Food and Drug Administration (FDA) said it would put out a list of companies who had submitted their products, but that it would take some time.

Click through to see three companies that recently announced what products they submitted …

Reynolds American Inc., Winston-Salem, N.C., submitted its final group of PMTAs to the FDA to see orders authorizing the marketing of Vuse Alto electronic nicotine delivery systems (ENDS).

Reynolds first submitted a PMTA in October 2019 for Vuse Solo and submitted additional applications for its Vuse Ciro and Vuse Vibe vapor products in April. Applications for Velo lozenge and pouch products were submitted in August.

The FDA accepted the Velo product applications, Reynolds said, and its Vuse products are farther along in the process, in the substantive scientific review phase.

Thirteen Vuse Alto ENDS products were included in the Vuse Alto PMTAs, comprised of an ENDS component and 12 closed e-liquid cartridges, the company said. The cartridges are available in four flavors, each with three nicotine levels.

Vuse Alto offers flavor pods in Menthol, Rich Tobacco and Golden Tobacco. A PMTA was also also submitted for Mixed Berry flavor pods, the company said.

Bidi Vapor LLC, Melbourne, Fla., announced on Sept. 8 it had submitted its PMTA to the FDA. The submission included a family of disposable e-cigarette products under the Bidi Stick brand name.

The application included 11 flavors with nicotine concentrations of 6%.

The more than 285,000 pages submitted to the FDA show Bidi Sticks are appropriate for the protection of public health and supports the public need to provide options to adult smokers of combustible tobacco products, according to the company.

Pixotine, Jupiter, Fla., submitted on Sept. 9 PMTAs for its Pixotine Nicotine Toothpicks. The toothpicks are made of birch wood and infused with a proprietary blend of nicotine solution, according to the company’s website. Pixotine submitted applications for its four flavors of nicotine toothpicks: Cinnamon, Winter Ice, Tobacco and Original. 

The application includes medical epidemiology and toxicology reviews, manufacturing practices, environmental assessments and consumer surveys, among other items, the company said.