Manufacturer PMTA Update: May 2020

[UPDATED: New companies and products were added May 13.]

CHICAGO — Here’s the latest from major tobacco and vape manufacturers on the status of their premarket tobacco applications (PMTAs) or substantial equivalence (SE) applications to the U.S. Food and Drug Administration (FDA) for the month of May 2020, accompanied by specific products that reflect high-selling brands as reported in CSP’s 2020 Category Management Handbook. While not a comprehensive list of suppliers or products, it provides a glimpse into what exists in the public domain.

In April, the FDA coordinated a delay in its submission deadline, moving the May 12 date back to Sept. 9, 2020, due to the coronavirus pandemic. The decision eased the burden for manufacturers and gave them a 120-day reprieve on the application deadline.

Product notes:

• Electronic cigarettes: In late 2018, Richmond, Va.-based 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.”

Product notes:

The e-cigarette company has pulled virtually all its Juul-branded flavored vape cartridges in the past year or so, leaving tobacco and menthol flavors.

Comments:

As the company prepared its PMTAs, a spokesperson for San Francisco-based 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."

Confirmed submissions:

• Vapor products: Vuse Ciro, Vuse Solo and Vuse Vibe

Product notes:

• Another popular line of products is the Velo nicotine pouches.

Comments:

A spokesperson for Winston-Salem, N.C.-based R.J. Reynolds provided the following details on the company’s response:

• Reynolds filed its first PMTA for Vuse Solo in October 2019, submitting more than 150,000 pages, to demonstrate that this 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 because the virus has affected the way people 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.
• Now that the deadline has changed, officials said, 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 affected 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.

“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 [earlier] May deadline for [electronic nicotine delivery systems or] ENDS products," said James Figlar, executive vice president and head of scientific and regulatory affairs for Reynolds, in April regarding Vuse Ciro and Vuse Vibe. "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.”

Officials said the PMTAs for Vuse Ciro and Vuse Vibe are the second and third complete grouped PMTA applications submitted by Reynolds to the FDA for review, following the initial PMTA applications for Vuse Solo submitted in October 2019.

Product notes:

• Little cigars: Cheyenne
• Moist smokeless: Kodiak

Comments:

Officials with Grover, N.C.-based Cheyenne called the PMTA delay “appropriate” and “necessary” during the COVID-19 pandemic. “The extension gives the FDA and companies submitting their PMTA and SE filings time to ensure that all involved parties are ready for the submissions,” they said. “Cheyenne International is fully prepared to meet the new deadline without any hesitation and, as always, ensuring that our customers can operate in a ‘business as usual’ manner is our top priority.”

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 Moorpark, Calif.-based 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.”

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, vice president, general counsel and chief compliance officer of Jacksonville, Fla.-based 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, retailers should ask 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.

This spring, Howard said EAS was on track to file PMTAs for its vapor products by the end of May.

Confirmed submissions:

• Vapor products: 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, officials with the Greensboro, N.C.-based company told CSP Daily News.

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 the FDA.

Confirmed submissions:

• Vapor products: Ace, Daily

Comments:

A source at NJOY who is knowledgeable about the company's internal processes confirmed for CSP Daily News that the e-cigarette maker filed PMTAs for its Ace and Daily families of products in March 2020.

Product notes:

• Nicotine toothpicks: Winter Ice, Cinnamon, Tobacco and unflavored Original

Comments:

The company says it is in the process of completing PMTAs for all four of its offerings: Winter Ice, Cinnamon, Tobacco and the unflavored Original. 

“As a modern oral nicotine alternative, we are confident in Pixotine’s ability to obtain market authorization,” Evan Grossman, president of Pixotine, told CSP Daily News. “This is why we have always offered our wholesale customers a 100% guarantee.”

Upon filing, Grossman said they will email customers stating that its PMTAs have been received by the FDA and are currently under review.

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.

Roerty did not comment on the company’s progress on its PMTAs.

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. Citing the FDA’s own expressed concerns about its ability to review applications while responding to the pandemic, she said, “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.”