Countdown to PMTA Deadline Begins

WASHINGTON — With the COVID-19 emergency causing a deadline delay for manufacturers to submit premarket tobacco applications (PMTAs) to the U.S. Food and Drug Administration (FDA), makers of e-cigarettes and alternative nicotine-delivery products have a brief, 120-day reprieve before putting their products through official government review.

On April 22, a U.S. district court granted approval of the FDA’s request to move the deadline from May 12 to Sept. 9, 2020. Then on April 29, the FDA announced it updated its guidance on PMTAs to reflect the new deadline.

Some manufacturers have kept to their original timetables. Greensboro, N.C.-based Fontem U.S., for instance, announced April 28 that it had submitted several PMTAs for its family of myblu e-cigarettes to the FDA.

“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 Fontem U.S. “Fontem U.S. looks forward to working with the FDA as the agency develops and enforces an evidence-based regulatory policy.”

Other manufacturers will probably take advantage of the extension. In its court request to delay the FDA deadline, officials with Richmond, Va.-based Altria Group said that while it was set to meet the original May deadline, many of its third-party contractors, such as analytical labs, were requesting more time due to stay-at-home orders and other government-imposed prevention measures.

What follows are important aspects of the PMTA process that convenience-store retailers should be familiar with, as well as an update from several tobacco and vape manufacturers about their application plans.

The FDA’s process, which covers both PMTAs and substantial equivalence (SE) applications, requires any product put on the market or modified after Feb. 15, 2007, go through agency review to stay on store shelves.

PMTAs are for new products and likely involve categories such as electronic cigarettes, e-vapor, hookah, nicotine gels or oral alternative nicotine tobacco products, according to tobacco retailing association NATO, Lakeville, Minn.

SEs cover products that are substantively similar versions of products that were on the market before Feb. 15, 2007, so they will most likely involve combustible or moist smokeless tobacco products.

If a manufacturer submits an SE or PMTA to the FDA, its product can stay on the market until the FDA decides whether it should stay on store shelves. Unfortunately, federal law prohibits the FDA, in general, from disclosing information about pending market authorization applications or even disclosing which product applications have been submitted, NATO officials said.

As a result, the FDA has said it will not publish a list of SE or PMTAs that have been accepted for review by the agency or status updates on a product’s review.

Retailers and wholesales need to rely on manufacturers to inform them about whether they have submitted timely applications or have received a negative decision at any point in the process.

Chris Howard, vice president, general counsel and chief compliance officer for E-Alternative Solutions, Jacksonville, Fla., says the PMTA deadline delay also grants retailers a reprieve. “C-store retailers would have more time to assess which manufacturers are planning to submit PMTAs for their products,” he said. “They should be seeking for manufacturers to provide evidence of submission prior to Sept. 9.”

In addition, Howard said retailers can request letters of filing or acceptance from the FDA, which manufacturers should expect to receive in later stages of the FDA review process.

The FDA has published a list of products—albeit a short one—that it has already authorized for sale in the United States:

Authorized in 2019:

Company: 22nd Century Group Inc., Williamsville, N.Y.

Category: Cigarettes, low nicotine

Product names: Moonlight and Moonlight Menthol

Company: Philip Morris Products SA, New York

Category: E-cigarettes, noncombustible

Product names: IQOS System Holder and Charger, Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks and Marlboro Fresh Menthol Heatsticks

Authorized in 2015:

Company: Swedish Match North America Inc., Richmond, Va.

Category: Smokeless tobacco

Product names: General Loose, General Dry Mint Portion Original Mini, General Portion Original Large, General Classic Blend Portion White Large (12-count), General Mint Portion White Large, General Nordic Mint Portion White Large (12-count), General Portion White Large and General Wintergreen Portion White Large

In a declaration filed with the federal courts earlier this year, Mitch Zeller, the FDA’s director of the Center for Tobacco Products (CTP), said his agency has 30 PMTA applications pending for electronic cigarettes, 28 SE applications for cigars and 17 SE applications for pipes or pipe tobacco. Zeller said a large number of additional applications were expected by what was then the May 12, 2020, filing deadline.

What follows are a handful of major tobacco and vape manufacturers to the c-store channel and what they have said publicly about the PMTA process or their applications. Information relating to specific products is reflective of high-selling SKUs reported from distributor and research data gathered in CSP’s 2020 Category Management Handbook. While not a comprehensive list of suppliers, it provides a glimpse into what exists in the public domain …

Headquarters: Richmond, Va.

Product notes:

• Electronic cigarettes—In late 2018, Altria purchased a 35% minority stake in Juul Labs, San Francisco. Altria also has an agreement with New York-based Philip Morris International to market the heat-not-burn device IQOS in the United States. IQOS has already received FDA authorization.
• Nicotine pouches—In June 2019, Altria purchased an 80% interest in a company that produces the On product line of nicotine pouches.
• Cigars—the company has subsidiaries that produce cigars, some of which may require SE or PMTA submissions.

Comments:

On March 25, Altria Group sent a letter to the FDA’s CTP, expressing concerns about the effects of the coronavirus outbreak. The tobacco manufacturer said the company and many of the third-party contractors involved in creating its PMTAs have mandated remote-working requirements and social distancing. “We are on track for the original deadline, and we are committed to submitting our applications according to whatever timeline is imposed,” an Altria spokesperson said. “We asked that the FDA consider these extraordinary circumstances and how they impact employees, and the agency has heard similar requests from many manufacturers.”

Headquarters: San Francisco

Product notes: The company has pulled virtually all its flavored vape cartridges in the past year or so, leaving tobacco and menthol flavors.

Comments:

On the PMTA deadlines in general, a spokesperson for Juul said, “We are committing all necessary resources to submit a scientifically rigorous PMTA designed to provide FDA with the science and evidence needed to assess the role our products can play moving smokers away from cigarettes, while combating underage use. We respect the PMTA process and look forward to sharing our comprehensive scientific research program.”

Headquarters: Winston-Salem, N.C.

Product Notes:

• E-cigarettes—Vuse Solo
• Nicotine pouches—Velo

Comments:

A spokesperson for R.J. Reynolds provided the following statements …

• Reynolds filed its first PMTA for Vuse Solo in October 2019, submitting more than 150,000 pages, to demonstrate that its line of e-cigarette products is appropriate for the protection of public health, and as warranting the issuance of a marketing order to allow these products to remain in market.
• The company has worked to develop the same level of scientific evidence for its other deemed products with the intention of submitting applications by May 12, 2020.  
• Officials are sympathetic to the FDA’s larger current focus on coronavirus as the virus has affected the way everyone attempts to conduct business and research in this country. However, the company has been singularly focused on achieving the May filing date for the remainder of its deemed products.
• Officials said now that the deadline has changed, they hoped the agency would allow companies to supplement submitted applications with data from studies that were in-progress or scheduled to start prior to the May deadline, and which have been impacted by the coronavirus.
• The company urged the FDA to prioritize enforcement against illegally marketed tobacco products introduced after Aug. 8, 2016, as part of their revision to the January guidance.

Headquarters: Moorpark, Calif.

Product notes:

• Nicotine pouches—Dryft

Comments:

“We are very encouraged by the court’s [agreement] to extend the PMTA submission deadline to Sept. 9, 2020,” said Jason Carignan, president of Dryft. “This additional time will afford [companies] the ability to ensure complete applications in light of the burdens being placed on labs, clinical trials and the general travel bans posed by the COVID-19 pandemic.”

Headquarters: Jacksonville, Fla.

Product notes:

• E-Cigarettes—Leap Go

Comments:

For many makers of e-cigarettes and tobacco products, word of the delay was “promising,” said Chris Howard of EAS. Many companies had been working to meet the May 12 deadline but were experiencing delays because of COVID-19, he said.

During this time, he said retailers should be asking manufacturers to provide evidence of submission prior to Sept. 9. He said retailers can request letters of filing or acceptance from the FDA, which manufacturers should expect to receive in later stages of the FDA review process.

Headquarters: Greensboro, N.C.

Product notes: The company said April 28 that it had submitted PMTAs for a “wide range” of its myblu electronic vaping products.

Comments:

The PMTA 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.

Fontem officials said they believe the evidence provided shows that blu electronic vaping products could play a role in the protection of the public health, in line with the guidance issued by FDA. Fontem now awaits the FDA’s review of the applications and will provide additional information sought by the agency as part of the PMTA process.

Headquarters: Richmond, Va.

Product notes:

• Cigars—Game
• Nicotine pouches—Zyn

Comments:

In its communications with federal courts, the FDA questioned its own internal capabilities amid the crisis, said Gerry Roerty, vice president and general counsel for Richmond, Va.-based Swedish Match. He also said manufacturers were facing an almost impossible task. “COVID-19 has created human and technological challenges that make submission of quality [applications] not possible by May 12, 2020,” Roerty said.

Headquarters: Jacksonville, Fla.

Product notes:

• Cigars, cigarillos—Swisher Sweets

Comments:

“Although Swisher was in a good position to meet the original May 12 deadline, the company appreciates the action taken by the FDA,” said Jane Green, vice president of marketing operations for Swisher International, Jacksonville, Fla. “In addition to recognizing the potential impact of COVID-19 on necessary work related to the filings, such as lab testing, FDA expressed concerns about its own ability to review the applications under current circumstances. Swisher hopes that the 120-day delay will allow the agency to dedicate the personnel and resources necessary to the review of the many applications it will be receiving.”