Additional Tobacco Companies File PMTAs for Regulatory Review
NATIONAL REPORT — Time is up for tobacco companies to file premarket tobacco applications (PMTAs) for the majority of newly deemed tobacco products with the Food and Drug Administration (FDA).
Now that the Sept. 9 deadline has passed, convenience store retailers are finding out which companies have submitted PMTAs and can remain on the backbar pending final FDA review.
Under the 2009 Family Smoking Prevention and Tobacco Control Act, the FDA must approve PMTAs for newly deemed tobacco products — including electronic cigarettes and vapor products — to remain on the market.
In summer 2019, District Judge Paul Grimm of the U.S. District Court for the District of Maryland set a May 12, 2020 deadline for companies to submit their applications to the agency. However, this April, Grimm agreed to extend the deadline to Sept. 9, 2020 as tobacco companies and the FDA weather the challenges of the COVID-19 pandemic.
In early September, the FDA said it will publish a list of those products with submissions on file. Without a listing from the FDA, retailers would have to rely on their suppliers, wholesalers and distributors to inform them which products are no longer available — a concern that drew retailer groups, including NACS, to urge the agency to provide an account of the PMTAs.
In addition to several PMTAs previously detailed by Convenience Store News, the following companies have filed applications with the agency:
Bidi Vapor LLC
Bidi Vapor LLC filed a PMTA for its family of disposable e-cigarette products under the Bidi Stick brand name. The Melbourne, Fla.-based company's application detailed 11 flavored varieties with nicotine concentrations of 6 percent weight/volume as part of the company's proprietary e-liquid formulation. Included in its PMTA submission, Bidi Vapor also conducted one "combined" consumer and three independent surveys of people aged 21 and over.
Its application runs more than 285,000 pages, providing science-based evidence demonstrating that the Bidi Sticks are appropriate for the protection of public health. The application further supports the public need to provide options to adult smokers of combustible tobacco products, officials with the company said.
"Bidi Vapor fully supports proper regulation of the category so that all ENDS (electronic nicotine delivery systems) products meet the highest manufacturing, safety and marketing standards for adult smokers, with the ultimate goal of improving the public health," said Niraj Patel, owner of Bidi Vapor. "We look forward to working with the FDA as it constructs its regulatory policy based on science and facts."
Black Buffalo Inc.
Black Buffalo Inc. electronically filed PMTAs for its five long cut and three pouches smokeless tobacco alternative products on Sept. 9. In compiling the applications, the Chicago-based company worked with several partners, including consulting firm Chemular Inc. and legal counsel Kleinfeld Kaplan & Becker LLP.
"We are very pleased to have timely submitted our PMTAs to FDA's Center for Tobacco Products (CTP). Since the company's founding in 2015, our team has worked exceptionally hard — investing in thousands of hours of research and development — to provide adult smokeless tobacco users with a true alternative that contains no tobacco leaf or tobacco stem," said Mark Hanson, Black Buffalo's President and co-founder. "We are confident that our comprehensive PMTAs demonstrate to FDA and CTP that these eight Black Buffalo products are appropriate for the protection of public health, and we look forward to working with FDA and CTP during the review of our applications."
FLIQ Vapor filed applications in connection with its disposable device, FLIQ XL. The company prepared and submitted a compliant PMTA for FLIQ Vapor XL products preloaded with the PachaMama e-juices to the FDA.
Fresh Farms E-Liquid LLC
Fresh Farms E-Liquid LLC confirmed its submissions to the FDA on Sept. 6, which encompasses dozens of products from its portfolio.
"From day one, we have sought to be the best," said Tony Devincentis, CEO and co-founder. "From our branding, our messaging, our team and the quality of our products — our commitment to the PMTA process has been no exception. We have spent years and countless hours evaluating our products, preparing for this moment, and the preliminary results have been phenomenal. Ultimately, our goal is to receive a marketing granted order from the FDA and begin post-market reporting to them immediately. We plan on being a leader in our industry for years to come."
Nicopure Labs LLC
Nicopure Labs LLC recently filed PMTAs for Halo Tribeca E-liquid, Halo SubZero E-liquid, and Halo Fusion E-liquid, which have advanced from submission to the substantive scientific review phase.
"Our entire team has been working tirelessly for over four years to ensure we provided the safest, most consistent, quality product batch after batch and provide the FDA with the necessary testing and documentation to demonstrate the Product’s position within Public Health," said Jeffrey Stamler, CEO and co-founder of Tampa, Fla.-based Nicopure Labs LLC.
Pixotine Products Inc.
Pixotine Products Inc. submitted its PMTA for its Pixotine Nicotine Toothpicks on Sept. 9. As required by the FDA's CTP, the application includes information and evidence that solidify the view that Pixotine's Nicotine Toothpicks are appropriate for the protection of public health.
"Our team did an excellent job showing where our products fit in the risk spectrum in comparison to traditional tobacco products. I'm proud of everyone involved in the process," said Pixotine CEO and Founder Evan Grossman.
Among other items, Pixotine's PMTA submission includes medical epidemiology and toxicology reviews, manufacturing practices, environmental assessments and consumer surveys, the Jupiter, Fla.-based company said.
"We have followed the PMTA process and look forward to the next step as the FDA commences review of our application," added Steve Sandman, Pixotine chief operating officer.
Reynolds American Inc.
In addition to its previously submitted proposals for Vuse Solo, Vuse Vibe and Vuse Ciro vapor products, Reynolds American Inc.'s R.J. Reynolds Vapor Co. is seeking FDA marketing authorization to market Vuse Alto ENDS.
Winston-Salem, N.C.-based Reynolds also turned in applications for VELO lozenge and pouch products.
"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, the CEO of Reynolds American. "Today marks completion of a critical hurdle of submitting PMTAs for every newly deemed tobacco product offered by Reynolds for one of the broadest portfolios of products in the industry."
Thirteen Vuse Alto ENDS 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.