The U.S. Food and Drug Administration has now issued 168 companies marketing denial orders (MDOs) for an estimated 992,000 products. According to a press release, today the regulatory agency released a revised listing of MDOs that includes 125 company names but not any specific products that were denied.
Credit: FDA
The remaining 43 are expected to be for companies that did not currently have any electronic nicotine-delivery products on the market. “Several of the MDOs were issued to companies that are not confirmed to be currently marketing their products. To protect confidential commercial information (CCI), we cannot release additional information about those actions,” the agency stated.
Yesterday, the FDA announced it had issued MDOs to more than 130 companies requiring them to pull an estimated 946,000 products from the market. There were no updates provided on several high-profile submissions, such as those submitted by Juul Labs, BAT and Japan Tobacco International. The agency also offered no response to any submitted open-system hardware products or tobacco-flavored e-liquids.
“We continue to work expeditiously on the remaining applications that were submitted by the court’s Sept. 9, 2020, deadline, many of which are in the final stages of review,” the agency wrote in its announcement. “For premarket tobacco product applications, our responsibility is to assess whether applicants meet the applicable statutory standard for marketing their new products. As we have said before, the burden is on the applicant to provide evidence to demonstrate that permitting the marketing of their product meets the applicable statutory standard.”
The Campaign for Tobacco-Free Kids (CTFK) is urging U.S. states and cities to step up their efforts to eliminate all flavored nicotine products, including e-cigarettes, in the wake of the Food and Drug Administration’s failure to rule on the premarket tobacco product applications (PMTAs) of market leaders Juul, Vuse, NJOY, Blu, and Logic by yesterday’s deadline.
On Sept. 9, the FDA announced it had denied market access to nearly 1 million electronic nicotine delivery devices owned primarily by smaller vapor companies. At the same time, the agency indicated it would require more time to process the remaining PMTAs, including those submitted by Juul Labs, BAT, NJOY, Imperial Brands and Japan Tobacco International, which account for the lion’s share of U.S. e-cigarette sales. Juul alone has a U.S. market share of more than 40 percent.
“The FDA will leave our kids at risk unless it acts quickly on the remaining applications, including for products like Juul that have driven the youth e-cigarette epidemic, and eliminates all flavored e-cigarettes, including menthol-flavored products that are widely used by kids,” wrote CTFK President Matthew L. Myers in a statement. “Every day these products remain on the market, our kids remain in jeopardy.”
The FDA’s failure to act on the market leaders is remarkable given that the agency had previously indicated it would prioritize those brands while processing marketing applications. Decisions on the bestselling brands would likely have the greatest impact on public health, the agency explained in earlier communications. The failure also raises legal questions, considering that the Sept. 9 deadline was ordered by a court following litigation from public health groups, including the CTFK.
The CTFK indicated if the FDA does not decide on major application soon it would return to court to have the court enforce its order requiring the FDA to begin removing unauthorized products.
The U.S. Food and Drug Administration had the vapor industry on its heels today as the businesses that filed premarket tobacco product applications (PMTAS) awaited the fate of their products. However, when the FDA finally made its announcement, it seems only small business that submitted PMTAs for flavored products got any answers. The FDA issued marketing denial orders (MDOs) to more than 130 companies requiring them to pull an estimated 946,000 products from the market.
There were no updates provided on several high-profile submissions, such as those submitted by Juul Labs, BAT and Japan Tobacco International. The agency also offered no response to any submitted open-system hardware products or tobacco-flavored e-liquids.
“We continue to work expeditiously on the remaining applications that were submitted by the court’s Sept. 9, 2020, deadline, many of which are in the final stages of review,” the agency wrote in its announcement. “For premarket tobacco product applications, our responsibility is to assess whether applicants meet the applicable statutory standard for marketing their new products. As we have said before, the burden is on the applicant to provide evidence to demonstrate that permitting the marketing of their product meets the applicable statutory standard.”
Interestingly, the agency saw fit to issue marketing orders for more than 350 combustible tobacco products under the standard equivalency pathway, many of which, hookah tobacco for example, are flavored tobacco products. All of the issued MDOs were for flavored electronic nicotine-delivery systems (ENDS) products.
Harm reduction advocates were aghast by the FDA’s announcement. “So far, this looks like being a public health own-goal of historic proportions,” Jonathan Foulds, professor of public health sciences and psychiatry at Penn State University, College of Medicine, wrote on Twitter. “Will be interesting to see whether the stock value of cigarette manufacturers goes up.”
Many experts are concerned that banning e-cigarettes from the market could harm public health. In a commentary published on the Reason Foundation’s website, Guy Bentley, the organization’s director of consumer freedom research, warned that the result of shutting down a vast portion of the vape industry would be more smoking.
The majority of products denied market access by the FDA, he noted, were likely rejected not because they are inherently riskier than any approved products but because the applicants were unable to navigate the FDA’s complex regulatory system.
What’s more, several studies suggested that if vape products were restricted to tobacco flavors, many vapers would switch to smoking. One study, published in Nicotine & Tobacco Research, analyzed data from February to May 2020 and looked at 2,159 young adults in Atlanta, Boston, Minneapolis, Oklahoma City, San Diego and Seattle, examining support for e-cigarette sales restrictions and the perceived impact of flavor and vaping bans.
“While lower-risk users may be more positively impacted by such policies, other young adult user subgroups may not experience benefit,” the authors concluded. “Moreover, if vape product sales were restricted to tobacco flavors, 39.1 percent of users reported being likely to continue using e-cigarettes, but 33.2 percent were likely to switch to cigarettes.”
Two other recent studies showed similar results. A study in JAMA Pediatrics showed that following San Francisco’s flavor ban, teens were more likely to smoke than those in other school districts. A different study in Nicotine & Tobacco Research shows that teens who vape would be smoking cigarettes if vapes hadn’t become available.
The FDA’s failure to decide on the marketing applications for leading brands such as Vuse and Juul—the latter of which accounts for more than 40 percent of U.S. e-cigarettes sales—left many furious.
“I want Juul’s five applications to be authorized. I want Reynolds’ two or three dozen applications to be authorized,” tweeted Greg Conley, president of the American Vaping Association. “But to see them likely get more time from @FDATobacco after good small businesses spent the last month getting wrecked … Just wrong.”
“While FDA has said it has ruled on 93 percent of the applications, it hasn’t ruled on the products that have driven the youth e-cigarette epidemic,” said Matthew Myers, president of the Campaign for Tobacco Free Kids, which sued the FDA to create the Sept. 9 deadline. “Every day those products remain on the market, our kids remain in jeopardy,” he told Stat.
Myers added that if the FDA does not decide on the major applications soon, his group will “have no choice but to go back to the court to have the court enforce its order requiring FDA to begin to remove any product not authorized.”
The U.S. Food and Drug Administration is expected to ask for more time before deciding whether some “e-cigarettes from market leader Juul Labs Inc” and others can be sold in the United States, the Wall Street Journal reported today, citing people familiar with the matter. The FDA is expected today to announce the fate of more than 2 million vaping products that had submitted a premarket tobacco product application (PMTA).
Many businesses have already received marketing denial orders (MDO) from the FDA. Many companies have gone out of business, filed a lawsuit, or switched to synthetic nicotine after receiving MDOs.
Concerning the FDA asking more time for a Juul Labs PMTA review, Greg Conley, president of the American Vaping Association, tweeted, “I want Juul’s five applications to be authorized. I want Reynolds’ two or three dozen applications to be authorized. But to see them likely get more time from FDATobacco after good small businesses spent the last month getting wrecked … Just wrong. Good job, FDA.”
He also tweeted: “If I had the choice between 50,000 flavored vaping products being available or Juul surviving, I’d walk Juul over the plank myself. But that’s not the choice we have.”
After news of the FDA request was reported, Guy Bentley, director of consumer freedom research at the Reason Foundation, tweeted, “The FDA couldn’t get it together to make a decision on one of the biggest companies in this space. Complete shambles.”
No further information was provided. The FDA did not immediately respond to Reuters’ requests for comment.
The U.S. vaping industry is about to change fundamentally. Today, the U.S. Food and Drug Administration must decide whether millions of electronic nicotine delivery systems are “appropriate for the protection of public health.” Products that don’t meet its standard will have to come off the market or risk enforcement by the agency.
To date, vapor companies have operated without many of the restrictions on sales and marketing governing traditional cigarettes. But the FDA has come under increasing pressure from politicians and public health groups in recent years to limit the sale of vapes, largely over concerns about the products’ popularity with teenagers. E-cigarette companies argue that flavored vapes can help smokers switch to less-damaging nicotine products.
Due to the cost and the complexity of submitting a premarket tobacco product application, industry observers expect only a handful of applications, submitted by wealthiest companies, to survive the vetting process. Many vaping products are produced by smaller companies that lack the resources to thoroughly answer FDA’s scientific questions about safety, according to Ken Warner, a professor emeritus of public health and tobacco control at the University of Michigan. “Large companies such as Juul only sell a handful of types of e-cigarettes, but have the financial resources to stack their applications to make them more likely to be cleared by the agency,” he told Politico.
The FDA, which has said it will likely miss the Sept. 9 deadline for some applications, is prioritizing its review queue based on applicants’ market share. Juul Labs alone controls over 40 percent of the e-cigarette market.
The agency has already rejected a significant share of the estimated 6.5 million applications it received from more than 500 companies. On Aug. 9, the agency issued a “refuse to file” letter to JD Nova Group, notifying the company that the applications it submitted for approximately 4.5 million of its products do not meet the filing requirements for a new tobacco product seeking a marketing order.
In a statement, the FDA said the company’s applications for these products lacked an adequate environmental assessment. Under the FDA’s regulations implementing the National Environmental Policy Act, an environmental assessment must be prepared for each proposed authorization.
On Aug. 26, the agency issued marketing denial orders (MDOs) for about 55,000 flavored ENDS products from JD Nova Group, Great American Vapes and Vapor Salon. In a news release, the FDA explained that the applications from the three applicants lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the levels of youth use of such products.
According to Filter, the FDA on Aug. 31 denied an additional 800 flavored vaping products due to incomplete applications. The companies had reportedly planned to submit additional information after the Sept. 9, 2020, deadline. The FDA did not make a separate announcement of these denials on its website.
E-liquid manufacturer Riot Squad announced it’s premarket tobacco product applications (PMTA) have moved on to the substantive review phase of the regulatory process. The U.S. Food and Drug Administration has until Sept. 9 to make a decision on the more than 2 million remaining PMTAs from the nearly 7 million submitted.
Credit: Riot Labs
Ben Johnson, Riot Squad’s CEO, said the company has always been positioned as a disruptor in the sector. “We had a laser-like focus on creating the most premium e-liquids on the market and coupled it with a brand with attitude,” he said. “The goal has always been to help people quit smoking. Continuous innovation – like our most recent PMTA going into the substantive review phase – and adopting a leadership role within the sector, is what will allow us to achieve that goal.”
The UK-based company sells to 86 countries around the world, according to a press release. The substantive review phase the final stage before the FDA grants or denies a marketing order. In order to receive a marketing order, Riot Squad must provide sufficient data to ensure its products are appropriate for the protection of public health.
The FDA has so far issued an estimated 34 marketing denial orders (MDO) for an estimated 360,000 products. The agency refused to file more than 4.5 million applications from the JD Nova Group.
Riot Labs was established in 2016 by Johnson who has an extensive background in pharmaceuticals. He set out to build Riot Squad into an innovative brand, with the aim of “encouraging consumers to find the confidence to give up smoking and engage in a healthier alternative.”
Update: On Sept. 8, 2021 Riot Squad received a marketing denial order (MDO) from the FDA for its flavored (other than tobacco) e-liquid PMTAs.
In August, the U.S. Food and Drug Administration issued 29 warning letters to firms it says were manufacturing and selling unauthorized electronic nicotine delivery system (ENDS) products. The agency advised the companies that selling products which lack a marketing authorization is “illegal and therefore they cannot be sold or distributed in the U.S.” The companies did not submit a premarket tobacco product application (PMTA) by the Sept. 9, 2020 deadline.
Credit: Андрей Яланский
While each of these 29 warning letters cites specific products as examples of tobacco products that lack the required premarket authorization, collectively these firms have listed a combined total of more than 268,000 products, according to the FDA.
In a first for ENDS products, two of the warning letters went to companies for selling after their PMTAs were not accepted. “Both Vapor Boss, LLC, and Kaleidoscope Custom Vapor Lounge, LLC have continued to sell ENDS products after receiving “Refuse to Accept” (RTA) determinations from the agency following submission of their premarket tobacco applications,” the FDA stated. “These are the first warning letters issued for an application that was submitted by the Sept. 9, 2020 deadline that subsequently received a RTA determination.”
Companies who receive an RTA determination must remove any products currently on the market or risk enforcement action by FDA, according to the agency. Companies may resubmit a complete application for these products at any time, however the products may not be marketed unless they receive a marketing granted order.
FDA also issued the first warning letter to a company that submitted premarket applications for some, but not all, of its products. The company (Maduro Distributors d/b/a The Loon) submitted a premarket application covering 18 products, but it manufactures and sells additional products not covered by the premarket application and thus lacking premarket authorization.
From January through August 2021, FDA has issued a total of 169 warning letters to firms selling or distributing more than 17 million unauthorized electronic nicotine delivery system (ENDS) products and that did not submit premarket applications by the Sept. 9 deadline, according to the agency.
On FDA’s Warning Letters page, you can find all of these warning letters by entering “Center for Tobacco Products” in the “Issuing Office” box in the “Filter by” section of the search tool.
The U.S. Food and Drug Administration stated on Friday, Sept. 3 that it had issued another round of marketing denial orders to 31 companies encompassing an estimated 300,000 products. “After issuing marketing denial orders (MDOs) to three companies for their flavored [electronic nicotine-delivery systems] ENDS products last week, @FDATobacco issued MDOs to an additional 31 companies for approximately 300,000 flavored ENDS products from Aug 27 through Sept. 2,” the agency tweeted.
Credit: Chase4Concept
Several of the MDOs were issued to companies that are not confirmed to be currently marketing their products. The regulatory agency did not release the names of the companies.
According to it’s website, the FDA does plan to release the names of the companies that received MDO. Previously, the agency only gave the names of the three manufacturers who it sent the first series of MDOs for a vapor products. “FDA understands that the public may be interested in the specific names of the currently marketed products subject to the negative decisions,” the FDA website states. “However, before releasing this information, FDA needs to ensure the Agency is not releasing the applicant’s commercial confidential information. Given the large number of products involved, sharing this information requires additional time and resources. Accordingly, FDA is actively exploring options related to this issue.”
In a release, the FDA stated that companies receiving these MDOs may have submitted premarket applications for other products “(such as ENDS devices, tobacco-flavored ENDS, or menthol-flavored ENDS),” and those products, if still pending, remain under review at FDA.
“FDA continues to make substantial progress reviewing the unprecedented number of applications received by the Sept. 9, 2020, court-ordered deadline for submission of premarket applications for deemed new tobacco products,” the release states. “The aggregate information on these actions will be provided within our regular updates on the Tobacco Product Applications: Metrics and Reporting page.”
As of Sept. 3, the FDA website lists 27 companies that have been issued MDOs:
Great American Vapes
JD Nova Group LLC
Vapor Salon
Big Time Vapes
J-Vapor LLC dba North Shore Vapor
SS Vape Brands Inc. Dba Monster Vape Labs
Custom Vapors
The Vaping Tiger
Gothic Vapor
TrendSetters E-liquid LLC
SWT Global Supply
Diamond Vapor
American Vapor Group
MV Enterprises
Planet of the Vapes
CITTG dba Orgnx E Liquids
Vapors of Ohio Inc. dba Nostalgic Vapes
Buckshot Vapors Inc.
Royalty Premium E Juice
Imperial Vapors
Midwest Vape Supply
Dominant Vapor
Mountain Vaporz
Sir Vapes -A-Lot
Loveli Design LLC dba
Alice in Vapeland
Nicquid
The first MDOs were announced on Aug. 26. The products from JD Nova Group, Great American Vapes and Vapor Salon didn’t provide adequate information to show their products offered enough benefit to adult smokers sufficient to overcome the public health threat posed by the “well-documented, alarming levels” of youth use of such products.
The FDA has received applications from over 500 companies covering more than 6.5 million tobacco products. The agency refused to file more than 4.5 million applications from the JD Nova Group. The FDA has until Sept. 9, 2020 to make a decision on the remaining estimated 2 million remaining PMTAs.
All of the premarket tobacco product applications (PMTAs) that have received marketing denial orders (MDOs) from the U.S. Food and Drug Administration have been for flavored products other than tobacco. On Aug. 31, the agency issued MDOs to three companies for only their other-than-tobacco flavored e-liquids, bringing the total number of companies known to have received MDOs to six. According to Filter, approximately 800 PMTAs were denied in the recent round of denials.
Credit: Veeranggull
“Dimitris Agrafiotis, the self-described ‘Vapin’ Greek’ who runs International Vapor Solutions, a consultancy firm, told Filter that three e-liquid companies companies he represents—two of them large and one medium-sized—were sent marketing denial orders (MDOs) by the agency,” Alex Norcia writes. “None of the PMTAs Agrafiotis helped file were totally finished, and the companies’ intention was to send more data piecemeal to the agency as substantial product stability testing wrapped up. Agrafiotis said he could not reveal the names of the companies because of nondisclosure agreements.”
Norcia was able to confirm that the FDA had issued additional MDOs, after it issued its first-ever MDOs for products from JD Nova Group, Great American Vapes and Vapor Salon for an estimated 55,000 products on Aug. 26. In its first MDO release, the agency stated that more marketing decisions would be forthcoming. The agency stated it would continue to review other premarket tobacco applications for non-tobacco flavored electronic nicotine-delivery systems (ENDS) to determine whether there is sufficient product-specific scientific evidence of a benefit to adult smokers to overcome the risk posed to youth.
“If the applications contain evidence of this type, the FDA will conduct further in‐depth scientific evaluation as to whether the evidence satisfies that statutory standard for authorization,” the FDA spokesperson explained to Norcia. “But in the absence of this evidence, the agency intends to issue an MDO. We know that flavored tobacco products are very appealing to young people, therefore assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed.”
Many in the vaping industry believe that the FDA will not approve a PMTA for a non-tobacco flavored product. A major e-liquid manufacturer recently told Vapor Voice that the agency may not immediately enforce the marketing of some flavored e-liquids for open systems that have submitted a PMTA, but the agency “will never give marketing approval for a flavor other than tobacco and menthol.”
The FDA’s review of new tobacco products before they can be legally marketed ensures that they meet the standard Congress set in the law to protect the public health, according to the agency. The agency noted that “the evidence of benefits to adult smokers for such products would likely be in the form of a randomized controlled trial or longitudinal cohort study.” The FDA stated that there is the possibility that other types of evidence may exists that could be adequate if sufficiently robust and reliable. However, because the evidence was absent in these applications, the FDA issued MDOs.
The FDA has received applications from over 500 companies covering more than 6.5 million tobacco products. The agency refused to file more than 4.5 million applications from the JD Nova Group. According to the FDA release, the products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. If the product is already on the market, the product must be removed from the market or risk enforcement.
In June, the Agrafiotis’s three clients got a letter from the FDA that their PMTAs had been received and would be moving onto the review stage, according to the Filter story. Last week, his clients drafted letters to the FDA, stating that they would be sending further information. “They have done substantial scientific work and testing,” Agrafiotis said. “They invested some real money in this.” One company, which filed 45 product applications, spent close to $1 million. “Some of the PMTAs were not complete, and some of them were more complete than others.” Of all his clients’ applications, only those for tobacco or menthol flavors now remain pending.
“It’s not clarified exactly why they were denied,” Agrafiotis said. “The FDA mentioned youth. The usual spiel. And I was honest with my clients that some of the product names might be considered appealing to youth by the FDA. I’m very honest with the industry.”
Agrafiotis added that now each company he represents is moving into the synthetic nicotine space. One of the large companies is totally transitioning to synthetic nicotine, a legal gray area, because it does not want to spend any more money on the PMTA process. The other was beginning to explore synthetic nicotine as a stopgap solution while pursuing legal action against the FDA. Numerous companies that have received either a warning letter or MDA from the FDA have chosen to start using synthetic nicotine in order to attempt to avoid FDA regulation.
The FDA has not stated whether or not it believes it has the authority to regulate synthetic nicotine.
The U.S. Food and Drug Administration issued the first marketing denial orders (MDOs) for electronic nicotine delivery system (ENDS) products today. In a press release, the regulatory agency determined that the premarket tobacco product applications (PMTAs) for about 55,000 flavored ENDS products from three applicants lacked sufficient evidence they appropriately protect public health.
The products from JD Nova Group, Great American Vapes and Vapor Salon subject to this action are non-tobacco-flavored ENDS and that include flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal. The FDA states the products didn’t provide enough benefit to adult smokers sufficient to overcome the public health threat posed by the “well-documented, alarming levels” of youth use of such products.
Credit: Stan Cuic
“Congress gave the FDA the authority to regulate tobacco products to protect the public from the harmful effects of tobacco use through science-based regulation,” said acting FDA Commissioner Janet Woodcock. “Ensuring new tobacco products undergo an evaluation by the FDA is a critical part of our aim to reduce tobacco-related disease and death. We know that flavored tobacco products are very appealing to young people, therefore assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed.”
According to the TMA/Vapor Voice PMTA Tracker, Vapor Salon submitted 327 flavors in four sizes and 12 nicotine strengths covering approximately 47,108 submissions. Great American Vapes was also captured by the TMA/Vapor Voice PMTA Tracker with 150 flavors, including the Dr. Cola flavor mentioned in the CTP’s MDO release.
The FDA’s review of new tobacco products before they can be legally marketed ensures that they meet the standard Congress set in the law to protect the public health, according to the agency. The agency noted that “the evidence of benefits to adult smokers for such products would likely be in the form of a randomized controlled trial or longitudinal cohort study.” The FDA stated that there is the possibility that other types of evidence may exists that could be adequate if sufficiently robust and reliable. However, because the evidence was absent in these applications, the FDA issued MDOs.
The agency will continue to review other PMTAs for non-tobacco flavored ENDS to determine whether there is sufficient product-specific scientific evidence of a benefit to adult smokers to overcome the risk posed to youth. If the applications contain evidence of this type, the FDA will conduct further in‐depth scientific evaluation as to whether the evidence satisfies that statutory standard for authorization. But in the absence of this evidence, the agency intends to issue an MDO.
The FDA has received applications from over 500 companies covering more than 6.5 million tobacco products. The agency refused to file more than 4.5 million applications from the JD Nova Group. Although the agency has issued other negative actions for some applications, this is the first set of MDOs the FDA has issued for applications that have reached the substantive scientific review portion of premarket review.
According to the release, the products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. If the product is already on the market, the product must be removed from the market or risk enforcement. The MDOs announced today do not include all ENDS products for which the companies submitted applications. Applications for the rest of the products remain under consideration.
Credit: FDA
“Flavored ENDS products are extremely popular among youth, with over 80 percent of e-cigarette users between ages 12 through 17 using one of these products. Companies who want to continue to market their flavored ENDS products must have robust and reliable evidence showing that their products’ potential benefit for adult smokers outweighs the significant known risk to youth,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “The burden is on the applicant to provide evidence to demonstrate that the marketing of their product meets the statutory standard of ‘appropriate for the protection of the public health.’ If this evidence is lacking or not sufficient, the FDA intends to issue a marketing denial order, which requires the product to be taken off or not introduced to market.”
The agency also stated that the scientific review of menthol ENDS, as compared to other non-tobacco-flavored ENDS products, raises “unique considerations.” While menthol-flavored ENDS are not included in the these current FDA decisions, the regulatory agency stated that its reviews will “similarly examine whether the evidence in the application demonstrates a benefit to existing adult users that outweighs the known youth use” of ENDS products.
The American Lung Association commented via Twitter that it stands “firmly with the science that no flavored tobacco products are appropriate for the protection of public health, and all should be removed.”
Greg Conley, president of the advocacy group American Vaping Association, said the three companies targeted by FDA had minimal market share and chastised the agency for going after “low-hanging fruit.” Conley also stated via Twitter that its not a foregone conclusion that all or most pending flavored e-liquid applications will be rejected before the agency’s Sept. 9th deadline. He stated that how the FDA will handle products from manufacturers that submitted requests for extensions and have attempted to supplement their PMTAs are still unknown.
“The FDA never intended to fairly regulate open-system vape products. From the 2014 draft release of the agency’s Deeming Rule until today, the Center for Tobacco Products has looked forward to the moment it would eliminate the ‘wild west’ of the independent industry,” stated Conley.
Scott Gottlieb, who served as FDA commissioner during the Trump administration, blamed e-cigarette manufacturers for their predicament, saying “many companies had ample time, and the benefit of guidances that we issued, to provide a path toward compliance, so they could demonstrate their value as tools that could help current smokers quit combustible tobacco. Many of them chose to fight the laws Congress enacted, and the FDA, and they didn’t invest in demonstrating the public health benefits that they asserted.”
The FDA has until Sept. 9, 2020 to make a decision on the remaining estimated 2.5 million PMTAs.
The U.S. Food and Drug Administration had the vapor industry on its heels today as the businesses that filed premarket tobacco product applications (PMTAS) awaited the fate of their products. However, when the FDA finally made its 
