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.
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.
As of Sept. 17, the U.S. Food and Drug Administration has issued 295 marketing denial orders (MDOs) for more than 1,089,000 flavored e-liquid products. The move has sent shockwaves through the industry and crippled many vapor industry businesses ranging from prominent players to small business owners. All of the MDOs were for flavored e-liquids that were not either tobacco or menthol.
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Many of the most surprising denials were from company’s that many believed had the funds and experience to submit extensive and detailed premarket tobacco product applications (PMTAs). Turning Point Brands (TPB) International, Humble Juice Co., Beard Vape Co. and Avail Vapor were a few of the long-standing vapor industry companies whose flavored other-than-tobacco products were denied marketing approval.
The letters are straightforward, according to James Xu, founder of Avail Vapor. “It just says you failed to demonstrate in your application for a flavored [electronic nicotine delivery system] ENDS product [that the benefits] outweigh the known risks of youth appeal,” Xu said, speaking only with Vapor Voice. “Then it goes on to say that it can be corrected with some form of a randomized controlled trial or longitudinal cohort studies that the FDA had previously stated weren’t required.”
Many industry experts believe the FDA will only approve some tobacco and menthol flavors, most expected to be in closed-system formats. The FDA has yet to make a decision on any major tobacco company’s PMTA submissions for brands such as Juul, Logic, Vuse and Blu. The agency has not denied any synthetic product, although it’s difficult to know for sure since only brand names have been released and not actual flavor profiles.
Many companies are moving towards using synthetic nicotine in their products in hopes to avoid current FDA regulations. The agency has stated that a synthetic product “may” be outside the agency’s jurisdiction.
Eric Lindblom, a senior scholar at Georgetown’s O’Neill Institute for National and Global Health Law and a former director of the FDA’s Center for Tobacco Products Office of Policy, said that, in response to such moves by vapor companies, the FDA could either assert jurisdiction over synthetic nicotine as tobacco product or push for synthetic nicotine to be regulated like any other drug.
The lawsuits are coming. At least two companies have already filed lawsuits against the FDA, although Vapor Voice could not confirm what companies had filed suit. The FDAs public list of companies released on Sept. 17 only includes 241 brands, the remaining 54 MDOs are believed to for brands that had not yet been on the market.
“If smoking rates go up in 2022 and beyond, do not blame the tobacco industry. This predictable result will entirely be the fault of elected officials and regulators who have utterly failed to protect public health,” said Gregory Conley, president of the American Vaping Association. “The FDA’s opaque review process was intentionally designed to eliminate all but the largest players from the market. We look forward to lending our support to future court challenges.”
No company is safe. The U.S. Food and Drug Administration has now issued marketing denial orders (MDO) to some of the largest manufacturers in the vaping industry. Turning Point Brands announced today that on Sept. 14 it had received an MDO in response to TPB’s premarket tobacco product applications (PMTAs) covering many of the company’s vapor products. All MDOs were for flavored products other than tobacco.
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“While we believe the FDA’s current conclusion is misguided, we will continue our dialogue with the agency in search of a path forward,” said Larry Wexler, president and CEO, Turning Point Brands. “As we explore options for appealing this decision, we are hopeful that the agency reaffirms its commitment to science-based decision making and to its announced Comprehensive Plan, which includes fully transitioning adult consumers down the continuum of risk in order to reduce the morbidity and mortality associated with combustible cigarette use by preserving the diverse vapor market.”
Numerous other major e-liquid manufacturers, including Avail Vapor, have confirmed to Vapor Voice that they have also received MDOs from the regulatory agency for e-liquid flavors other than tobacco. Other major manufacturers say they are expecting an MDO any day now.
TPB stated that its PMTA included an in-depth toxicological review, a clinical study, and studies on patterns and likelihood of use. The data demonstrated that TPB products “do not appeal to never users, youth, or former users and that a significant majority of users of TPB products had completely ceased use of combustible cigarettes. The scientific literature on lower-risk nicotine delivery systems shows that these products can significantly improve public health by providing alternatives that are much less harmful than combustible cigarettes.”
TPB’s press release stated that the company believed it had established that the products’ it had continued marketing would be “appropriate for the protection of public health,” the standard established by the Family Smoking Prevention and Tobacco Control Act of 2009. “These products are crucial to improving public health by helping adult smokers migrate to less harmful products,” the statement reads. “TPB will continue to engage with the FDA and other stakeholders as we consider options moving forward, including a formal appeal of the decision and potential legal relief.”
Many companies say they are readying lawsuits. TPB’s states that it continues to monitor regulatory developments and intends to take appropriate measures to manage and mitigate any risk exposure that may result from these and any future MDOs. “The FDA’s scorched earth policy towards the vaping industry will move on to the courts,” a source told Vapor Voice this morning. “This has become a political process instead of a scientific one and the FDA is only trying to save face.”
Some companies, such as Bidi Vapor, stated they will continue to sell products even after receiving an MDO. Many other companies state that they will be switching to synthetic nicotine, an area where the FDA’s authority may be limited or even not exist.
Bidi believes its particular decision to be a mistake on the FDA’s part, and is currently exploring next steps to address the situation, according to Filter.
“It looks like FDA is making a mistake in many, many cases,” said Azim Chowdhury, a partner at the law firm Keller and Heckman, where he advises Bidi and other clients on nicotine regulations. “I have a number of companies that have received MDOs, but those MDOs are also identifying their menthol products. It seems like FDA, in their rush to get all these out, they’re not doing a very thorough job.”
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.
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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.”
According to sources, numerous companies received marketing denial orders (MDO) from the U.S. Food and Drug Administration overnight. A major white label manufacture confirmed that several of their clients received MDOs. The FDA is expected today to announce the fate of the vaping industry when it makes final decisions on premarket tobacco product applications submitted by Sept. 9. 2020.
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The manufacturer can not be named because he had yet to speak with his clients about the denial order. The exact number of products that have received MDOs could not be confirmed, but some are suggesting its “hundreds of thousands” of products.
Several companies have announced on Twitter having received them on Sept. 8, many late in the evening. Amanda Wheeler, president of the American Vapor Manufacturers Association (AVM) tweeted “Today was a tough day. Lots of very good people who I respect deeply and who helped thousands of smokers quit, got told by our government that their products were illegal. To all of you, I am so very sorry. To your customers, I am even more sorry. Our government is wrong on this.”
The FDA has yet to update its list of companies that received MDOs. Recently, the agency announced it had sent in total 34 MDOs from Aug. 27 to Sept. 1, covering more than 300,000 products. At least one company has already filed a lawsuit against the FDA, according to Vape Radio.
Many manufacturers have also said they would turn to synthetic nicotine because the FDA lacks the authority to regulate it. Vapor Salon will be switching to synthetic nicotine, the company wrote in a public Facebook post dated Aug. 26.
The post was published on the same day that the U.S. Food and Drug Administration denied some 55,000 marketing applications by Vapor Salon and two other companies on the ground that they “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by well-documented, alarming levels of youth use of such products,” according to an FDA press release.
“VaporSalon is switching to TOBACCO FREE NICOTINE on Friday, 8/27/2021,” the Facebook post reads. “The main purpose of this is to be outside of the FDA’s regulations with their hefty PMTA requirement which takes full effect on Sept 9th 2021 with needing an approved PMTA, or your product can no longer be sold. There has been 0 approved PMTA’s for anything ENDS related to-date.”
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.
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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.
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“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 Campaign for Tobacco-Free Kids (CTFK) reiterated its call for banning all flavored vapor products following the U.S. Food and Drug Administration’s denial of marketing applications for about 55,000 flavored e-cigarette products.
While welcoming the FDA decision, the CTFK noted the denial involved only a small percentage of the flavor products under review by the FDA. “
“The FDA’s action covers just a fraction of the more than 6.5 million tobacco products for which the FDA has received marketing applications, and it does not include any e-cigarette brands with a significant market share or that are most popular with kids, such as Juul, the number one youth brand,” CTFK President Matthew L. Myers wrote in a statement.
“Today’s action will be effective in reversing the youth e-cigarette epidemic only if FDA also denies the applications for all flavored e-cigarettes (those with flavors other than tobacco), as well as high-nicotine products like Juul that put kids at risk of addiction.”
According to the 2020 National Youth Tobacco Survey, 3.6 million kids use e-cigarettes, including nearly one in five high school students. The CTFK blames flavored e-cigarettes for this situation. Eighty-three percent of youth e-cigarette users report using flavored products, and 70 percent of youth users say they use e-cigarettes because of the flavors, according to the organization.
“To protect our kids and end the youth e-cigarette epidemic, the FDA should not authorize the sale of any flavored or high-nicotine e-cigarettes,” wrote Myers.
The FDA must decide whether to grant marketing applications for e-cigarettes by Sept. 9.
