Tag: FDA

Preparing for a Radically Different Landscape

Photo: PixaBay
The U.S. market for nicotine products is set to change dramatically after the Sept. 9 deadline to submit premarket tobacco product applications (PMTAs) to the Food and Drug Administration (FDA).
If a company does not submit a PMTA by the deadline, it must remove its products from the market. If the product was “verifiably” on the market prior to Aug. 8, 2016 (the FDA’s cutoff for new products) and submitted a PMTA application before Sept. 9, the product can stay on the market for up to a year or until the FDA approves or denies the PMTA. For any PMTA submitted after today’s deadline, a product may not be marketed until the FDA grants a marketing order, according to the FDA.
Because the cost of complying with the regulations is staggeringly high, experts expect that many manufacturers will fail to clear the hurdle, and the e-cigarette market will be left largely to the tobacco giants.
Although the FDA estimates a single PMTA costs anywhere from $117,000 to $466,000, those figures are considered low by the industry. The Rocky Mountain Smoke-Free Association estimates a single PMTA costs between $8.6 million and $11.1 million per stock keeping units. It forecasts 14,000 small vape businesses employing 166,000 workers will be destroyed, representing $24 billion in economic activity.
Deep-pocketed Philip Morris International, by contrast, already has four separate PMTAs approved: one for its IQOS heated-tobacco device and three for flavors of its disposable HeatSticks.
Vapor advocates have cautioned that millions of vapers who had used e-cigarettes to quit smoking will revert to combustible cigarettes, which are generally believed to be riskier than vapor products.
The vapor industry is not dead, however, as several manufacturers have announced that their PMTA submissions have been accepted and filed by the FDA. Independent vapor business that have submitted PMTAs include Avail Vapor, Charlie’s Chalk Dust, Bidi Stick, E-Alternative Solutions, Innoken, Jarvis Vaping Supply, KangerTech, Nicopure Labs, Prism, Smok, Smoore/Vaporesso and Voom.
As of Aug. 31, the FDA had received applications for around 2,000 deemed products, of which around 40 percent have been resolved, according to Mitch Zeller, director of the agency’s Center for Tobacco Products.
Receiving a marketing authorization to sell vapor products isn’t the end of the process for manufacturers, as described by Broughton Nicotine Services’ Yvonne Wilding in Tobacco Reporter’s September issue. The FDA requires companies to conduct post-market surveillance and studies to determine the impact of the marketing orders on consumer perception, behavior and health, and to enable the FDA to review the accuracy of the determinations upon which the orders were based.
These post-market requirements include a rigorous toxicity study using computer models to help predict potential adverse effects in users. The orders also require the company to monitor youth awareness and use of the products to help ensure that the marketing of the product does not have unintended consequences for youth use.
September 9, 2020
Turning Point Submits PMTAs for 250 Products

Photo: Bacho | Dreamstime
Turning Point Brands (TPB) has submitted to the U.S. Food and Drug Administration (FDA) premarket tobacco product applications (PMTAs) for 250 products.
The PMTAs cover a broad assortment of products in the vapor category including multiple proprietary e-liquid offerings in varying nicotine strengths, technologies and sizes. They also include proprietary replacement parts and components of open system tank devices, along with a closed system e-cigarette.
According to TPB, the filings provide detailed scientific data to demonstrate that the products are “appropriate for the protection of public health,” as required by law.
The applications are supported by five pharmacokinetics studies, a likelihood-of-use study, and a patterns-of-use study, in addition to a toxicological review. Data throughout the applications underline that TPB products do not appeal to never users, youth or former users; that an extremely small percentage of users are never users, youth, or former users; that a significant majority of users have completely ceased use of combustible cigarettes; that a low percentage of users engage in dual or poly use; and that the products are substantially less harmful than combustible cigarettes and comparable to other products in the vapor category.
TPB has also provided a detailed marketing plan to illustrate how it will continue to prevent youth exposure to the products.
“We look forward to engaging with the FDA as it reviews our submissions,” said Larry Wexler, president and CEO of TPB.
The FDA deadline for submitting PMTAs is today.
September 9, 2020
Tobacco to Dominate Vapor Business Post-PMTA

Photo: Ethan Parsa from Pixabay
Tomorrow’s deadline for the submission of premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration (FDA) marks the start of a new era for the e-cigarette industry, according to an article published by The Motley Fool.

Companies who fail to apply for marketing authorization by the deadline will be required to remove their hardware and e-liquids from store shelves, and The Motley Fool expects many e-cigarette companies to exit the business.

Because the cost of complying with the regulations is staggeringly high, many manufacturers will not be able to make it over the hurdle, and the e-cigarette market will be left largely to the tobacco giants.

Although the FDA estimates a single PMTA costs anywhere from $117,000 to $466,000, those figures are considered low by the industry. The Rocky Mountain Smoke-Free Association estimates a single PMTA costs between $8.6 million and $11.1 million per stock keeping units. It forecasts 14,000 small vape businesses employing 166,000 workers will be destroyed, representing $24 billion in economic activity.

Deep-pocketed Philip Morris International, by contrast, already has four separate PMTAs approved: one for its IQOS heated-tobacco device and three for flavors of its disposable HeatSticks.

As of Aug. 31, the FDA had received applications for around 2,000 deemed products, of which around 40 percent have been resolved, according to Mitch Zeller, director of the agency’s Center for Tobacco Products.
September 8, 2020
RAI Concludes PMTA filings for 2020

PHoto: RAI
Reynolds American Inc. (RAI), has filed its final premarket tobacco product application (PMTA) submissions with the U.S. Food and Drug Administration (FDA) to allow its Vuse and Velo brands to remain on the market in the United States.
Submitted Sept. 4, the filing concludes an 11-month process for RAI. The company has filed six applications for its Vuse Solo, Vuse Ciro and Vuse Vibe vapor products, as well as for its Velo nicotine lozenge and modern oral pouch products. Across the six applications, more than 530,000 pages of scientific data and more than 8,600 scientific documents have been submitted as part of the filings.
RAI parent company BAT says it is committed to reducing the health impact of its business with a multicategory approach that offers consumers a wide range of enjoyable and lower-risk alternatives to cigarettes. With noncombustible nicotine products now available in more than 40 countries, the group’s ambition is to exceed 50 million noncombustible consumers by 2030.
Kingsley Wheaton
“The U.S. is the world’s largest vaping market and so the completion of our PMTA filings is a really important step for us as we transform our organization, drive a step change in our ‘new categories’ business, and increase our non-combustible consumer base and revenues,” said Kingsley Wheaton, chief marketing officer of BAT.
“Our transformation is progressing very well and in the first six months of 2020 we attracted an additional 2.7 million new noncombustible consumers compared to the same time last year. Globally, we now have nearly 12 million regular noncombustible consumers and the U.S. will play a large part of our ambition to grow this number to at least 50 million by 2030.
“We remain fully committed to building a better tomorrow and reducing the health impact of our business by offering consumers a range of enjoyable and lower risk products including vapor, tobacco heating and modern oral nicotine products.”
The FDA’s PMTA deadline is Sept. 9.
September 7, 2020
Vapor Firms Request Delay of PMTA Deadline

Photo: Nmedia | Dreamstime.com
Keller and Heckman has asked the U.S. Food and Drug Administration to postpone its Sept. 9 deadline for filing premarket tobacco applications (PMTAs) by six months because of the Covid-19 pandemic.
On behalf of a group of small vapor product manufacturers, retailers and trade associations, the law firm filed a citizen petition asking the FDA to postpone the PMTA due date until March 8, 2021.
Many of Keller and Heckman’s clients have experienced delays in preparing their applications because of the coronavirus. Without an extension, small vapor companies will either have to file incomplete PMTAs or forego submission altogether, according to Keller and Heckman. This would force them to layoff thousands of employees, close their doors permanently, and remove from the market less risky vapor products that addicted adult smokers rely on to move away from cigarettes, the law firm said.
The current PMTA deadline was set by a federal district court in Maryland as part of a lawsuit filed by anti-vaping groups challenging an earlier August 2022 deadline established by FDA through guidance issued in 2017.
The petition specifically asks FDA to request from the district court an extension on the court-imposed deadline that would apply only to small manufacturers that demonstrate to the agency that they have been working in good faith to complete PMTAs by the Sept. 9, 2020 cutoff and have otherwise taken steps to ensure that their products will not contribute to underage use.

September 3, 2020
RAI Submits Applications for Velo Pouches

Photo: RAI
Reynolds American Inc. (RAI) has submitted a group of premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration (FDA) seeking orders authorizing the marketing of Velo pouches. A grant of these marketing orders would allow these products to remain on the market after FDA review.
Velo is the group’s brand for modern oral products, designed to provide adult tobacco consumers with innovative alternatives to traditional combustible and smokeless tobacco products. A small, white pouch made with nicotine derived from tobacco but containing no tobacco leaf, Velo is placed between an adult tobacco consumer’s gum and lip. Unlike traditional dip, there is no need to spit the product and no lingering smell. The submitted group of applications includes varying nicotine strength levels and two flavors for Velo pouch products.
As with prior PMTA submissions, these commercially-proprietary applications provide the FDA with product analyses, information on human health risks, and assessments showing that these Velo pouches are appropriate for the protection of public health—including assessments on users and nonusers of tobacco products.
James Figlar (Photo: RAI)
“Velo represents an innovative space for us to identify what adult tobacco consumers want next—thus submitting the final group of Velo brand PMTAs was a great next step to help ensure adult tobacco consumers have consumer-acceptable products available that provide them with lifestyle choices and varying nicotine levels that make sense,” said James Figlar, RAI’s executive vice president and head of scientific and regulatory affairs, in a statement. “As the FDA begins evaluation of our industry’s collective PMTAs after the Sept. 9 deadline, it is critical that our chief regulatory agency continues to enforce against illegally marketed tobacco products introduced after Aug. 8, 2016.”
The PMTAs for Velo pouches are part of Reynolds’ ongoing submissions to the FDA seeking marketing orders following applications for Velo lozenges and Vuse Vibe, Ciro and Solo electronic nicotine delivery systems. The PMTA process allows the FDA to evaluate whether these products should remain on the market as part of the FDA’s public health mission. While these applications include relative risk information, the marketing orders sought make no claims of modified risk.
September 2, 2020
FDA to List PMTA Applicants

Mitch Zeller
The U.S. Food and Drug Administration (FDA) plans to publicly list all e-cigarette manufacturers that want permission to sell their products in the U.S., reports Bloomberg, citing a blog post published on Monday by Mitch Zeller, director of the FDA’s Center for Tobacco Products.
The move could help consumers and retailers spot illegal products.
Vapor product manufacturers who want to keep their products on the U.S. market will have to file requests for marketing authorization with the FDA by Sept. 9.
The FDA has received applications for about 2,000 e-cigarettes and other newly regulated tobacco products already. There are more than 400 million eligible items that would need to apply to stay on the market, according to Zeller.
Products whose applications were filed on time will have a one-year grace period to stay on the market while the FDA reviews them, unless the agency rejects the request. Large manufacturers, retailers who could be liable for selling illegal products and public-health groups had pushed the FDA to make the process more transparent.
In a letter to the FDA, several retail associations had asked the agency to release a list of manufacturers that have PMTAs on file so retailers can know what electronic nicotine delivery system (ENDS) brands can remain on store shelves.

September 1, 2020
FDA Accepts Vaporesso’s PMTA

Photo: Bacho | Dreamstime
Vaporesso received an acceptance letter for its first round of premarket tobacco product applications (PMTAs) from the U.S. Food and Drug Administration (FDA) on Aug. 20, 2020.
The acceptance letter came three days after the company submitted its PMTAs. The application received positive comments from the FDA on its preparation, according to the company’s U.S. scientific CRO agent.
“A successful acceptance has boosted the confidence of Smoore to keep investing in bringing more vaping products into PMTA in the future,” the company wrote in its press release. “Our commitment to vapers in the USA remains the same: We will make vaping as easy as possible, and we will consistently provide high-quality vaping experiences for vapers all over the world. So the first round of application accomplished by Smoore is merely the start with more products to come.”
August 25, 2020
Premium Cigar Makers Get Reprieve from FDA

Photo: 13 Motortion – Dreamstime.com
The District of Columbia on Aug. 19 ruled that the U.S. Food and Drug Administration (FDA) cannot enforce premarket review requirements for premium cigars until it considers a “streamlined” process for cigar makers to equate their products to older ones.
The ruling means that premium cigar companies will not have to file for product approval on the Sept. 9, 2020, deadline. This ruling applies to almost all cigars found in humidors across the country except for flavored and infused cigars, which are not considered premium by the FDA.
Companies will not need to file paperwork with the FDA to prove that their products are premium; rather, any company selling a cigar that does not meet the definition of “premium cigar” will be subject to the Sept. 9 premarket approval deadline and will need to file for substantial equivalence or another approval pathway.
The ruling does not require the FDA to enact a “streamlined” process for premium cigars but says it must study the issue and cannot require premium cigars to go through substantial equivalence or another process until after that study is complete.
The ruling came from a lawsuit against the FDA by three cigar trade groups: Cigar Association of America, Cigar Rights of America and the Premium Cigar Association (PCA). “This is another monumental victory for the premium cigar industry,” said PCA’s Scott Pearce. “This comes on the heels of legal victories striking down warning labels for premium cigars.”
August 21, 2020
FDA Accepts Juul Applications

Photo: Juul Labs
Juul and Juul pods will now move into the substantive review phase of the premarket tobacco product application (PMTA) process. Juul Labs has received acceptance and filing letters from the U.S. Food and Drug Administration (FDA) for its battery and nicotine cartridges, the company announced Tuesday.
Joe Murillo
Juul Labs filed the applications last month and all PMTA applications are due to the FDA by Sept. 9. The company’s submission includes “comprehensive scientific evidence for the Juul Device and Juul pods in Virginia Tobacco and Menthol flavors at nicotine concentrations of 5 percent, 3 percent and information on data-driven measures to address underage use of its products.
“We will continue to follow the PMTA process and look forward to this next step as the FDA commences substantive review of the application,” said Juul Labs Chief Regulatory Officer Joe Murillo in a statement.
August 19, 2020