The U.S. Food and Drug Administration has accepted all of Nicopure Labs’ Halo products’ premarket tobacco product applications (PMTA) for the substantive scientific review phase.
Just over six months after submission, Nicopure Labs’ PMTAs for Halo Turkish Tobacco E-liquid, Halo Triton II Starter Kit, Halo ZERO Starter Kit and all supporting consumable components have been accepted and advanced to the final phase, substantive scientific review, by the FDA. Halo FDA accepted premarket tobacco product applications include:
Halo Tribeca Tobacco e-liquid
Halo SubZero Menthol e-liquid
Halo Turkish Tobacco e-liquid
Halo Fusion Unflavored Tobacco e-liquid
Halo Triton II Starter Kit (and supporting consumable components)
Halo ZERO Starter Kit (and supporting consumable components)
“Halo’s more than 12 years of commitment to producing the highest quality vaping products available for adult consumers has been our organization’s mission for more than a decade,” said Jeffrey Stamler, co-founder of Nicopure Labs, in a statement. “We believe in science, and we believe in transparency; we are honored to continue to work with the FDA, and as always, in the best interest of the industry and the most important thing of them all, our loyal customers.”
Vapor Voice, in partnership with TMA, has created a tool to track PMTA submissions as they make their way through the review process.
By Timothy S. Donahue
The world is waiting. When premarket tobacco product applications (PMTA) were due to the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) on Sept. 9, 2020, the vapor industry wanted to know what companies had submitted the required data and could remain in the U.S. market legally. In response, the CTP stated it would release a list of products that may continue to be sold during the review process.
Nearly five months later, the CTP has yet to produce anything to help the retailers, wholesalers, manufacturers and suppliers. In late January 2021, CTP Director Mitch Zeller said that the FDA would release the information in the “coming weeks.” Zeller has also said that “thousands” of PMTAs were submitted. Meanwhile, the CTP has stated that before making such a list available, the agency needs to ensure that publishing any such information complies with federal disclosure laws.
The CTP did finalize PMTA and substantial equivalence rules (SE) meant to guide how a manufacturer can seek a marketing order for electronic nicotine-delivery systems (ENDS). The text of the final rule was published long after the provisional PMTA submissions were due. Then, nearly a week after its posting, the new Biden administration froze all new and pending rules introduced in the last part of the Trump administration, including the just-finalized PMTA rule. The rule was removed from the Federal Register prior to its effective date.
“While a memo from the White House chief of staff ordered the withdrawal of any rules that did not publish by noon on Jan. 20, 2021, and the PMTA and SE final rules were withdrawn, this does not impact the FDA’s review of PMTAs or SEs that the agency has received,” an FDA spokesperson told Vapor Voice. “The agency continues to process the large number of submissions received and has already begun reviewing many applications. In the coming weeks, the FDA intends to provide a more detailed update on the agency’s progress since the Sept. 9, 2020 deadline.”
The FDA spokesperson says the agency will work closely with the new administration to advance appropriate regulations and policies that were withdrawn and are in line with the agency’s public health mission.
To help stakeholders gain some visibility on this crucial issue, Vapor Voice partnered with data specialists TMA to locate and confirm who has submitted PMTAs and at what stage the application is in in the regulatory process. The PMTA list can be found here.
Because there is no central, publicly available database, the information had to be pieced together from multiple sources, according to TMA research assistant Karen Pace. Several organizations issued press releases as their PMTAs moved through the process. Many others did not. Pace says that Vapepmta.com, an online resource also attempting to collect PMTA information, has been a valuable resource in her research.
“Not all of the press releases are as specific as others,” says Pace. “I tried to research those that had minimal information. Sometimes that worked, sometimes I could not find anything more. Then I found Vapepmta.com. The site was extremely helpful and is where I gathered most of the information. It was still a challenge to gather information on the total number of submissions a company had and the actual products submitted.”
It was also difficult to know what brands and how many flavors or nicotine strengths (or even if a submitted product used a freebase or salt nicotine) a company submitted. Pace says the only way to know for sure about some submissions was to go to the source. “We checked corporate websites and also called or emailed the companies directly to verify submissions,” she says. “It is something we will continue to do moving forward as we update the listing.” In the end, Pace choose to list companies individually and list the brands submitted when possible. “We are going to need help from the industry in keeping the information accurate and up to date,” she says.
The Vapepmta.com team built and operates its platform and has no affiliation with the FDA or any other company. Dan Daniel Racowsky has been in the industry for more than five years and says limited information and confusion around PMTAs led the group to take on the task of building a PMTA listing.
“It wasn’t very challenging to gather data upfront. After launching, we gained some publicity and were flooded with inquiries from brands asking to be included in our database,” Racowsky said. “Somewhat of a challenge has been keeping our data as accurate as possible. We’re in direct contact with the majority of brands listed on our platform, and most are pragmatically keeping us informed on their PMTA’s progress.”
The list is a solid source for interested parties, however, it is impossible for VV/TMA to guarantee its complete accuracy. While many companies have confirmed the accuracy of their listings, in some cases we have not been able to reach the applicant.
“We put in a lot of effort to validate these submissions, but there are still some companies that haven’t returned calls or emails to confirm their listing,” says Taco Tuinstra, editor-in-chief for Vapor Voice. “We note those instances in the list.”
If you note inaccuracies in your listing, please send an email to pmta@vaporvoice.net and we will be pleased to update the information.
Methodology explained
Thousands of manufacturers and importers submitted premarket tobacco product applications (PMTA) to the U.S. Food and Drug Administration (FDA) by the Sept. 9 deadline to keep their products on the U.S. market. But which products exactly are under review and how all those submissions have fared in the process is less clear. A comprehensive list promised by the FDA has yet to materialize.
In the absence of an official database, Vapor Voice decided to create its own tracker. As a news outlet, we already receive many press releases relating to PMTA submissions. In addition, we continuously monitor corporate websites, social media platforms and other industry sources. Individually, the pieces of information gathered during those endeavors make for interesting news announcements; taken together, they provide a coherent dataset to track PMTAs.
Of course, this approach has its limits. The data is self-reported, and at present, we cannot fully verify the veracity of all claims made in the announcements used to compile the list. The quality of the information that reaches us also varies greatly, from exact counts in all list categories to more general statements on a brand or brand family without further elaboration. As per our protocol, these issues are noted in the list. While we cannot present our dataset as a representative sample, we believe that, after capturing information on 180 companies, it paints as coherent a picture as possible.
Our tracker lists company, brand family, brand styles and PMTA stage. We view it as a “living document” that will be updated as new information becomes available. To that end, the tracker also includes a tool for user input. If the status of your application has changed or if you notice inaccuracies, we invite you to share that information with our editors, who will be pleased to make the required updates.
Keeping in mind the limitations of our tracker, we recommend using this tool to gain directional understanding of the volume of submissions for which the FDA’s Center for Tobacco Products is processing and as a starting point in a comprehensive due diligence search regarding products. We also strongly recommend that any retailer gain certification of products in their inventory from the manufacturer and rely upon advice of counsel as to appropriate due diligence and safe harbor.
On March 12, the U.S. FDA issued warning letters to 13 firms who manufacture and sell unauthorized e-liquids. The regulatory agency advised the companies that selling products lacking a premarket authorization is illegal, and therefore cannot be sold or distributed in the U.S.
Credit: Isaiah Rustad
The firms did not submit a premarket tobacco product application (PMTA) by the Sept. 9, 2020 deadline, according to a press release from the FDA. The firms receiving warning letters are VapinUSA-WI, LLC d/b/a VapinUSA, Vapor Springs, LLC, Vapor Cigs, LLC, Vegas Vapor Emporium, LLC, Vape 911, The Philosopher’s Stone, LLC, The Clean Vape, Tooters Vape Shop, Cloudchasor LLC, Boardwalk Elixir, LLC, Dieselbycg-Hometown Vape Lounge, Blue Lab Vapors LLC, and Revolution Vapor LLC.
“While each warning letter issued today cites specific products as examples, collectively these companies have listed a combined total of more than 75,000 products with the FDA,” the statement reads.
Following an initial set of such warning letters announced earlier this year, FDA has continued to issue additional warning letters for products that failed to submit a PMTA.
Per a court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-liquids—were required to be submitted to FDA by Sept. 9, 2020. For companies that submitted applications by that deadline, FDA generally intends to continue to defer enforcement for up to one year pending FDA review, unless there is a negative action taken by FDA on the application.
Many small vapor manufacturers are attempting to overcome the FDA’s rigorous PMTA requirements.
By Maria Verven
A process that was built for billion-dollar tobacco manufacturers has posed onerous challenges for small e-liquid manufacturers. With the enormous work of pulling together premarket tobacco product applications (PMTAs) for the U.S. Food and Drug Administration behind them, vapor manufacturers are now gearing up for the formal substantive review phase when the regulatory agency will conduct in-depth evaluations of the applications’ requisite scientific studies.
Many relied on help from the PMTA Sharing Group on Facebook to meet the challenge of submitting a separate application for every flavor in every nicotine level in every size bottle, sending literally millions of pages to the FDA. In addition, every PMTA had to contain a plethora of research into the product’s relative health risks for current users and nonusers as well as whether marketing the new product would be appropriate for the protection of public health (APPH).
A full assessment of how users consume their products over time as well as the potential for addictiveness, abuse and misuse was also required. And for those who missed the Sept. 9 deadline and/or failed to meet these requirements? In January 2021, the FDA issued warning letters to 10 e-liquid manufacturers that failed to submit PMTAs by the deadline, advising them that it is now illegal for them to sell their products in the U.S.
Vapor Voice took on the task of asking several vapor industry experts and business owners for their perspectives on the current situation.
A daunting process
Lindsey Stroud, policy analyst with the Taxpayers Protection Alliance, a Washington, D.C.-based nonprofit think tank dedicated to educating the public on the government’s effects on the economy, said many of her clients are still in the thick of the testing process.
Lindsey Stroud
“The process was daunting—among my clients and the folks I assisted, I probably worked on 100,000 to 200,000 individual products. Several of my clients made it past the first step, but there are many more to come,” she said. “AVM (the newly formed American Vapor Manufacturers) is really a genius idea when it comes to these small e-liquid companies. In getting more small businesses involved, the price of testing can slowly come down.
“In the aftermath of the vaping-related lung illnesses (EVALI) in late 2019, it’s imperative that regulatory agencies know what’s in the products and their effects on the U.S. population. The FDA is bound by law to apply the PMTA equally to all manufacturers, regardless of size. Still, the testing requirements for each and every liquid is unduly burdensome for small e-liquid manufacturers that offer hundreds of flavors, often with many flavor components found in numerous companies’ flavorings.
“Currently, if a manufacturer sells a strawberry e-liquid in 20 different nicotine strengths and three different bottle sizes, the FDA requires them to test all those products (20 products times three bottle sizes would mean 60 tests for just one flavor), which is inefficient, daunting and expensive. The FDA has shifted and made the PMTA requirements less burdensome; for example, [the] FDA now allows companies to submit a single PMTA instead of individual applications for each of their products
“Ideally, I would prefer the FDA to allow a flavor manufacturer to have only three tests per flavor—their zero nicotine option, their lowest nicotine option and their highest nicotine option.”
Phase 3: Substantive review
The team at North Carolina-based Bantam Vape worked with highly qualified labs to conduct the in-depth, product-specific and non-product-specific testing needed for their PMTAs, according to Bantam Vape spokesperson Anthony Dillon.
Anthony Dillon
Offering 21 “uniquely crafted flavors” created by chemists and flavorists in different nicotine levels and sizes, Bantam conducted storage and stability testing, toxicity testing and pharmacokinetic and topography studies as well as submitting an extensive review of available literature on its products. After hearing that the PMTAs for Bantam’s products were initially accepted and filed by the FDA last fall (indicating that the FDA had finished its preliminary review) the Bantam team is now waiting for the formal substantive review phase to commence.
“We invested significant resources into the foundation of our PMTA submissions, and we continue to invest resources in the PMTA process and post-market surveillance,” Dillon said. “We worked with reputable, like-minded industry players to share key costs to significantly improve efficiencies, which can help us continue selling our high-quality vape at an attractive price point.
“The PMTA process has certainly impacted the entire e-liquid industry—from manufacturers to retailers to consumers. We believe the PMTA process, though complex and resource-intensive, provides a benchmark for all e-liquid manufacturers, something that the industry, up until now, was lacking. E-liquid companies undergoing the PMTA process must evolve to remain on the market long term. Bantam is, and has always been, committed to developing and manufacturing high-quality, adult-use e-liquid products consistent with FDA guidance and applicable laws. That goal has not changed.
“With any new process, there are kinks to be ironed out. The PMTA is no different. Wherever possible, we are committed to working with the FDA to streamline and improve the process, and we will also work with our retailers and consumers to help them better understand this complex but necessary process. Currently, our biggest challenges are not due to the regulations but the need for transparency in the process and for enforcement against those that are not in compliance with FDA guidance and applicable laws.
“The PMTA process provides a benchmark for all e-liquid manufacturers—something that the industry was lacking. We are proud of and confident in the e-liquid products that are going through the PMTA process, and we look forward to Bantam’s products being enjoyed by adult consumers for years to come.”
Exceptions for artisan cigars
Established in February 2014, 906 Vapor is located in a small community in Michigan. While at one time, they had about $250,000 in annual revenues, sales plummeted to about $180,000 last year due to a state flavor ban and the EVALI scare. One of 906 Vapor’s first customers, Mark Slis bought the store in October 2015. They currently carry over 100 e-liquid flavors using freebase and salt nicotine, along with kits, tanks and mods, a line of disposables and miscellaneous batteries and accessories.
Mark Slis
Since 906 Vapor does not manufacture e-liquids, Slis didn’t have to submit any PMTAs; however, he helped the small Michigan juice manufacturers whose e-liquids he carries submit their PMTAs. Slis lobbied in Michigan, suing the state, health and human services and Governor Whitmer to stop last year’s flavor ban. He also organized a state trade organization and lobbied against flavor bans and other anti-vaping bills in the state’s house and senate, assisting various national organizations in their efforts.
“The required testing places a massive and completely unnecessary burden on all manufacturers,” Slis said. “The proper regulatory response is to set standards, since all e-liquids utilize the exact same four ingredients with variation only in the specific flavoring(s) used. The ingredients have already been thoroughly studied and tested and found to be safe for human consumption. Only product standards should now be required.
“Requiring duplicate testing for each of the 419 million flavors registered with the FDA and duplicate testing for each and every nicotine level for the same flavor is a transparent attempt by the FDA to eliminate the electronic cigarette industry—not regulate it. The FDA has already made it abundantly clear where they stand on independent, small vapor manufacturers. They refused to talk to vapor manufacturers and denied them any relief. Yet when artisan cigar manufacturers lobbied the FDA for a realistic approval pathway and assistance, the FDA not only granted them an indefinite exemption from the PMTA; they offered to spend taxpayers’ money to conduct the prohibitively expensive testing on their cigars.
“In effect, [the FDA] will bend over backward to ensure deadly combustible products remain on the market while regulating smoking cessation out of existence.”
Concerning job losses
A member and vice president of the American Vaping Manufacturers (AVM) Association, a member of the Smoke-Free Alternatives Trade Association (SFATA) and the U.S. Vaping Association (USVA), Char Owen owns a small line of wholesale e-liquids called Unchained as well as two brick-and-mortar stores in Texas called Cloud 9 Vapor Shop that opened in December 2013.
Char Owen
“Absolutely no consideration has been given to small business owners except a short PMTA extension during this pandemic,” Owen said, adding that although she contracted Covid-19 in December, she continued to help small businesses while combatting the illness. “There’s no process for notifying the FDA to request an extension when your family has been affected by Covid[-19]. A large company doesn’t need this, but most small companies are one-person shops or only have a few employees.”
With over 800 e-liquid recipes, Owen ended up submitting PMTAs for over 332,000 SKUs to the FDA. As of this writing, all her PMTAs had been received but had not yet been accepted. They held a listening session with the FDA to obtain feedback on a testing protocol that Owen said could significantly cut the cost of testing.
“The FDA said they will not be creating a simplified pathway for small business,” Owen said. “Testing requirements will put an unnecessary burden on them. These businesses have been selling the same product for many years. I’ve been selling the same product for eight years with zero complaints that our products have caused harm.
“Using standard testing methods and one of the handfuls of testing labs, the testing requirements would cost me over $9 billion dollars. The market, however, will narrow to only those owned by large tobacco, which sells closed pod systems extremely high in nicotine sold in grocery stores and convenience stores. They are the only ones that can afford the PMTA process.
“The problem is SKU inflation. In the FDA’s definition, my 800 products equal 332,000 products, or a 41,400 percent inflation of product SKUs. Something as simple as offering a different bottle size—common in our industry—is a major factor in testing costs, even though the original recipe is still the same. In vitro and in vivo studies could be withdrawn since these products have been on the market for almost 10 years. Just the high range of nicotine could be tested, and if those tests are acceptable, then obviously any lower nicotine levels would be acceptable.
“Vapor shops cater to an over-21 clientele and mainly offer open system e-liquids. They employ a more hands-on approach to helping adults off-ramp from combustibles. We support, educate and help smokers convert to noncombustibles. Because of this support, we see a much higher rate of success than is reported by the FDA, which includes consumers who purchase at convenience stores and big chains. Mainly, we are just trying to help people stay off combustible cigarettes in our local communities.
“It’s important to realize that this industry was founded by small business. The FDA’s requirements, together with a lack of a streamlined process, could cost over 100,000 people their jobs. We already have a huge job loss in the U.S. It’s the last thing we need.”
The original “Vaping Vamp,” Maria Verven owns Verve Communications, a P.R. and marketing firm specializing in the vapor industry.
In July 2020, Puff Bar announced that it would cease all online sales and distribution in the U.S. until further notice. However, the brand resumed sales on its website last month with a changed product. To get around the ban, Puff Bar is now using tobacco-free nicotine, according to The Wall Street Journal.
Credit: Puff Bar
The U.S. Food and Drug Administration (FDA) has started investigating Puff Bar’s redesigned fruit-flavored disposable vaporizers because of the changes, reports The Hill. The regulatory agency said it was aware of Puff Bar’s actions but would not say whether the agency’s ban was still applicable, citing the ongoing investigation.
In mid-2020, the FDA told Puff Bar to stop selling its fruity vaporizers as part of a broader crackdown on underage vaping. In a letter to Puff Bar, the FDA’s Center for Tobacco Products said Puff Bar products hadn’t been authorized for sale by the agency and that the company had made unauthorized claims on its website that its vaporizers were less harmful than traditional cigarettes.
In early 2020, the Trump administration banned fruity flavored e-cigarettes in reusable devices like Juul, the blockbuster brand that helped trigger the teen vaping craze in the U.S. Under that policy, only menthol and tobacco flavors were allowed for those devices. But the flavor ban did not apply to disposable vaping products like Puff Bar, which is offered in more than 20 flavors, including pina colada and pink lemonade.
Following the ban, Puff Bar quickly emerged as the vape of choice among young people. Puff Bar has fallen to No. 3 in the disposable category this year, after Bidi Stick and Blu, according to Nielsen data.
It’s unclear who owns Puff Bar. Previous owners include Cool Clouds Distribution in California and DS Technology Licensing in China.
Kaival Brands Innovations Group, the global distributor of all Bidi Vapor products, announced its premarket tobacco product application (PMTA) has moved the substantive review phase of the regulatory process. Bidi’s disposable e-cigarettes, Bidi Stick, comes in 11 flavor varieties, according to a press release.
Substantive Review is where the scientific review of the U.S. FDA’s regulatory process is undertaken. The company received its acceptance letter, the first step, on Feb. 9. The FDA will determine if Bidi products meet the criteria for “appropriate for the protection of the public health” established in the Tobacco Control Act. The agency issues marketing orders that authorize the continued marketing and sale of products meeting the criteria.
“Seeking an order for the continued marketing of Bidi Sticks in the United States is a long process. But it was always our goal to provide a premium vaping experience and an option to traditional, combustible tobacco that meets the needs of every adult smoker,” said Niraj Patel, the president and CEO of Kaival Brands. “This substantive review phase is where months of extensive information collection and hard work gathering together 285,000 pages of science-based evidence will pay off, as we continually put consumer health and the environment first.”
Bidi Vapor also announced they have discontinued their online direct-to-consumer (DTC) sales through its website as of February 22, 2021. The company will allow sales through gopuff.com. “With a long history of distribution of alcoholic beverages, goPuff has pioneered a very stringent and dynamic compliance program and age-gating process,” the release states.
“We are extremely excited to partner with one of the fastest growing and most secure online delivery services in the country,” stated Kaival Brands’ Chief Executive Officer, Niraj Patel. “More importantly, goPuff’s commitment to protecting minors and stringent procedural implementations will allow Kaival Brands to focus on our rapidly developing additional wholesaler distribution agreements.”
While Kaival Brands will continue its business-to-business (B2B) online sales to retailers, it believes its decision to halt online DTC sales specifically through www.bidivapor.com will set an example for the industry and help reduce the larger problem of underage access to vaping devices. “The decision also bolsters its commitment to brick-and-mortar retail, which Kaival Brands believes to be a stronger age-verification distribution model than online sales,” the release states.
On February 16, 2021, the Food and Drug Administration (FDA) published the long-awaited “public list” of “deemed” tobacco products that: (1) were on the US market on August 8, 2016, (2) are currently on the US market, and (3) were the subject of a request for marketing authorization submitted to FDA by September 9, 2020.
The stated intent of the “public list” is to advise stakeholders of “deemed” tobacco products that can be legally sold in the United States. However, FDA’s approach to the list leaves critical gaps that, in many cases, fails to apprise stakeholders of unlawfully marketed products and, in other cases, fails to identify products that are lawfully marketed.
The initial version of the list includes cigar, pipe tobacco and waterpipe tobacco products that were the subject of substantial equivalence (SE) or exemption from substantial equivalence (EXSE) applications filed by September 9, 2020. However, the list expressly does not include any submissions for electronic nicotine delivery systems (ENDS), apparently because FDA has not yet completed its intake review of the thousands of Premarket Tobacco Applications (PMTAs) submitted for ENDS products.
This omission is striking, given what appears to be the plethora of ENDS products that are currently on the market and for which no PMTA was submitted by the manufacturer or importer. Although FDA has issued a few warning letters to sellers of these unauthorized products, it appears that these warning letters have only scratched the surface of unauthorized products.
The “public list” is also underinclusive in that it does not contain “deemed” products that are grandfathered from the premarket review process. Under the Family Smoking Prevention and Tobacco Control Act, products sold in the US as of February 15, 2007 (and unchanged since then) are not subject to premarket review. There are thousands of grandfathered deemed products that are not subject to premarket review.
Although FDA has published a separate database of products that have received standalone grandfather determinations, industry stakeholders are rightly concerned that distributors and retailers may conclude a product is not legally marketed if it does not appear on the “public list.” Distributors and retailers would need to separately consult the grandfather database, which is itself underinclusive because there are many grandfathered products that have not received formal FDA determinations.
The “public list” is also underinclusive in that it does not contain “deemed” products that have actually received FDA marketing authorization. For that, stakeholders would need to consult separate databases of products that have received either SE, EXSE or PMTA marketing orders. However, those databases are not current. Indeed, to our knowledge, there are scores of deemed products that obtained FDA marketing authorization months ago, and those products have not been identified in any of FDA’s databases.
The “public list” was ostensibly designed to be a tool for stakeholders to understand products that can, and cannot, be legally marketed in the United States. In order to better advise the public as to which products can legally be sold, FDA will need to expedite the inclusion of ENDS products on the list, as well as consider better ways to advise the public of products that are exempt from premarket review or that have obtained marketing authorization.
The above opinion may not be the same as Vapor Voice or it’s staff. Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
The U.S. Food and Drug Administration (FDA) said it received thousands of premarket tobacco product application (PMTA) submissions covering millions of tobacco products, the majority of which came in very close to the Sept. 9, 2020 deadline. The submissions varied substantially in number of tobacco products contained in each submission, size, format and organization, including paper submissions and even hard drives and CDs, according to a press release.
Mitch Zeller speaking at a TMA annual meeting. Photo: Taco Tuinstra
FDA Center for Tobacco Products (CTP) director Mitch Zeller stated as of mid-January 2021, the agency has completed the Processing step of applications for more than 4.8 million products from over 230 companies. “We have accepted applications for about 84,000 products and refused to accept applications for about 3,100 products submitted through the PMTA pathway,” wrote Zeller. “As of mid-January 2021, of the applications submitted by Sept. 9, we have filed applications for about 29,000 products and refused to file applications for about 1,650 products submitted through the PMTA pathway.”
He also stated that several factors have slowed the agency’s progress in getting application’s into the system. Companies submitted PMTAs differently, for example some applicants provided information on one product per submission while other applicants provided information for all of the company’s products within one submission.
“One firm submitted information on more than 4 million tobacco products within a single submission,” Zeller wrote. “The amount of content in each submission also greatly varied, with some applications including up to 2,000,000 files where each file contains multiple pages of content for FDA to review.” The letter is part of a pledge Zeller made that the agency would keep interested stakeholders updated on the agency’s progress.
FDA is prioritizing enforcement against any ENDS product that continues to be sold and for which the agency did not receive a product application. To date, the FDA has sent warning letters to 30 firms who manufacture and operate websites selling electronic nicotine delivery system (ENDS) products, specifically e-liquids, which lack premarket authorization, according to the letter.
The agency also stated that the likelihood of FDA reviewing all the applications by Sept. 9, 2021 is low. Because of the sheer number of applications, the agency has set aside the products with the greatest market share and will push those products through the process more quickly. “[We will] focus resources on products where scientific review will have the greatest public health impact, based on their market share, while also committing to providing an opportunity for review to all companies,” Zeller wrote. This could prove positive or negative as a quick denial would force the product off the market.
The agency can still not confirm when it would release a list of products that are approved to be on the market. Zeller wrote that the agency continues to work on processing submissions and verifying the dates of initial marketing and current marketing status of products that submitted a timely PMTA.
“We have already verified this information for around 86,000 products received through the PMTA pathway,” he wrote. “Due to the size and volume of the PMTA submissions and the variable quality, format and presentation of these submissions, processing these submissions and verifying this information will take more time.”
Update: The U.S. Food and Drug Administration (FDA) said it received thousands of premarket tobacco product application (PMTA) submissions covering millions of tobacco products, the majority of which came in very close to the Sept. 9, 2020 deadline. The submissions varied substantially in number of tobacco products contained in each submission, size, format and organization, according to a press release.
More than 15,000 premarket tobacco product applications (PMTA) were submitted to the U.S. Food and Drug Administration (FDA) during fiscal year 2020, according to data provided on the regulatory agency’s website.
In August 2020, the FDA received 10,184 applications and in September 2020 it received 4,567. Prior to August, the FDA had only received 686 applications. The FDA does not distinguish how many of those products are electronic nicotine-delivery system (ENDS) devices.
Of the 15,437 applications turned in during fiscal year 2020 (October 2019 to September 2020), 767 PMTAs were closed, according to FDA data. An application is considered closed after the FDA issues an order letter, a refuse-to-accept letter or the PMTA is withdrawn by the applicant.
Companies that submitted a PMTA by the Sept. 9, 2020 deadline and were previously on the market before Aug. 8, 2016, can remain on the market for up to one year while the FDA reviews the PMTA. The FDA said it will release a list of the deemed new tobacco products that were subject to the Sept. 9 PMTA deadline, however, no date has set for the list’s release.
The U.S. FDA issued warning letters today to 11 firms who manufacture and sell unauthorized e-liquids for premarket tobacco product application (PMTA) violations. The regulatory agency advised the manufacturers that selling products which lack PMTA authorization is illegal, and therefore cannot be sold or distributed in the U.S. The firms did not submit PMTA by the Sept. 9, 2020 deadline.
The firms receiving warning letters are Jojo’s Smokeless World Inc. d/b/a Mod Shield; Sugar Vapor Company; DC Vapor, Inc.; Take Off Corp; The Vapor Spot, LLC; Premium Vapor Technologies LLC; Vaping Xtreme, LLC; Vapes Gone Wild Juice, LLC; Vapeoholic LLC; Vaporescence LLC d/b/a Vape King USA; and Elemental Vapor Bar, LLC.
Credit: Premium Vapor Technologies
While each warning letter issued today cites specific products as examples, collectively these companies have listed a combined total of more than 150,000 products with the FDA, according to a to the FDA’s website.
Following an initial set of such warning letters announced earlier this year, FDA has continued to issue additional warning letters for these types of products. The FDA sent 10 warning letters in mid-January.
“Per a court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-liquids—were required to be submitted to FDA by Sept. 9, 2020. For companies that submitted applications by that deadline, FDA generally intends to continue to defer enforcement for up to one year pending FDA review, unless there is a negative action taken by FDA on the application,” the agency wrote. “In line with the agency’s stated enforcement priorities, after Sept. 9, 2020, FDA is prioritizing enforcement against any ENDS product that continues to be sold and for which the agency has not received a timely product application.”
