BIG TOBACCO & VAPE PRODUCT PMTA SUBMISSIONS
The clock is ticking for tobacco companies to file premarket tobacco product applications (PMTAs) with the Food and Drug Administration (FDA) for electronic nicotine delivery systems (ENDS) and other newly deemed tobacco products.
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.
Reynolds American Inc. submitted two PMTAs in mid-April, before the deadline was extended. The Winston-Salem, N.C.-based company is seeking FDA marketing orders for its Vuse Vibe and Vuse Ciro vapor products; this would allow them to remain on the market after the PMTA deadline. The filings include multiple flavor variants for each brand style.
The applications submitted to the agency include a range of scientific studies for Vuse Vibe and Vuse Ciro using well-known methodologies, including the comparative assessment of cigarettes and associated health risks, according to the company.
"I am incredibly proud of our diverse team of scientists, researchers and regulatory experts, who have worked tirelessly together to complete these applications well ahead of the FDA's May deadline for ENDS products," said James Figlar, Reynolds' executive vice president and head of scientific and regulatory affairs. "We are optimistic that we will receive a favorable marketing order for all of our applications, which would enable us to provide adult tobacco consumers with multiple acceptable alternatives to cigarettes, and we're hopeful that as PMTAs move forward, the agency prioritizes enforcement against illegally marketed tobacco products introduced after Aug. 8, 2016."
The PMTAs for Vuse Vibe and Vuse Ciro are actually the second and third complete grouped PMTA applications submitted by Reynolds to the FDA for review. The company filed PMTA applications for Vuse Solo in October 2019.
Fontem US LLC submitted PMTAs in late April seeking authorization to continue marketing a range of its myblu electronic vaping products. Its submissions include data from a comprehensive range of laboratory and clinical scientific studies, including product analyses, behavioral data, nonclinical health risk information, and information on the impact to both users and non-users of tobacco products.
"We agree that the electronic vaping industry should be held to the highest product and marketing standards, while providing adult smokers with alternative products that could serve the interest of the public health," said Antoine Blonde, president of the Greensboro, N.C.-based company. "Fontem US looks forward to working with the FDA as the agency develops and enforces an evidence-based regulatory policy."
Altria Group Inc. received word in early June that the FDA accepted and filed for substantive review (the second phase of the process) the company's PMTAs for 35 on! products manufactured by Helix Innovations LLC, an Altria joint venture responsible for the global on! nicotine pouch product portfolio.
To support these applications, Richmond, Va.-based Altria submitted more than 66,000 pages of documentation, including six primary studies.
"We believe the scientific evidence in these applications demonstrates that the marketing of on! is appropriate for the protection of public health," said Paige Magness, senior vice president, regulatory affairs for Altria Client Services. "On! nicotine pouches are a key part of our vision to responsibly lead the transition of adult smokers to a non-combustible future.”
The nicotine pouches, which are tobacco leaf-free, are available in seven flavors and five nicotine levels. They were distributed in more than 28,000 stores as of the end of the first quarter of 2020, including the top five convenience store chains by volume.
E-Alternative Solutions (EAS) also announced PMTA submissions for its Leap and Leap Go vapor products. The FDA accepted the filings in early July, moving the applications to the substantive review phase of the process.
"This milestone represents an important step forward for EAS as we support our mission of producing high-quality vapor products that serve as an alternative to combustible cigarettes with our Leap and Leap Go vapor products," said Jacopo D'Alessandris, president and CEO of the Darien, Conn.-based company.
"FDA Acceptance and Filing Letters are a testament to the strength and thoroughness of our applications, which we believe will meet FDA's requirements," he added. "We want to thank FDA for the prompt turnaround on these materials given the challenging circumstances, and we look forward to partnering with the agency as we move forward in the process."
Acceptance letters follow the agency's administrative review of filings to ensure that the submissions meet the baseline criteria for review. Filing letters are the result of a preliminary scientific review that ensures that applications include the necessary ingredients and health analyses.
"The substantive review is where our months of hard work assembling more than 100,000 pages of evidence will pay off in supporting our proposition that the Leap and Leap Go products are appropriate for the protection of public health," said Chris Howard, vice president, general counsel and chief compliance officer at EAS. "We are looking forward to continued collaboration with FDA in the weeks and months to come and remain optimistic that the PMTA process will result in marketing orders."
JUUL Labs, which counts Altria as a stakeholder, filed its JUUL System for the PMTA process. Its submission includes comprehensive scientific evidence for the JUUL device and JUUL pods in Virginia Tobacco and menthol flavors at nicotine concentrations of 5 percent and 3 percent, as well as information on its data-driven measures to address underage use of its products.
The application includes detailed scientific data from more than 110 studies, totaling more than 125,000 pages evaluating the product's impact on both current users of tobacco products and non-users, including those who are underage, according to the San Francisco-based company.
The research is supplemented with information on the controlled design and repeatable manufacturing processes associated with the JUUL system, as well as data-driven measures to limit unintended consequences to the overall population, including initiation among non-users.
"In order to earn a license to operate in society, we need to be a science- and evidence-based company, engage in open and transparent dialogue with our stakeholders, and take methodical and responsible actions to advance the potential for harm reduction for adult smokers, while combating underage use. Our PMTA submission is a key part of that approach," said Juul Labs CEO K.C. Crosthwaite.
511 Solutions LLC, owner of the PRISM e-liquid line and the master distributor, is also seeking FDA approval by filing what it says is the first of many PMTAs to come for its nicotine-based e-liquid products. The PRISM brand represents three e-liquid lines, with a total of 19 flavors going through the PMTA process.
The flavor profiles range from tobacco to menthol to fruits and bakery in a variety of nicotine strengths. All PRISM e-liquids are manufactured by Blackbriar Regulatory Services in an ISO class 6 cleanroom, tested in an ISO 17025 laboratory, and have published testing results available for every bottle, the company stated.