Tag: PMTA

  • No Clarity for Top Brands at FDA Deadline

    No Clarity for Top Brands at FDA Deadline

    Photo: Araki Illustrations

    The much-anticipated deadline for the U.S. Food and Drug Administration to decide on millions of premarket tobacco product applications (PMTAs) passed without bringing the clarity about the future of tobacco harm reduction that many health advocates and industry representatives had hoped for.

    On Sept. 9, the agency issued marketing denial orders (MDOs) to more than 130 companies, requiring them to pull an estimated 946,000 products from the market. However, despite a court order to complete the PMTA review process by that date, the FDA failed to make decisions on some of the best-selling vapor products on the U.S. market. 

    There were no updates on 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,” acting FDA Commissioner Janet Woodcock and FDA Center for Tobacco Products Director Mitch Zeller wrote in a joint statement. “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 system products.

    The FDA’s announcement baffled health advocates and vapor industry representatives alike.

    “This looks like being a public health own-goal of historic proportions,” Jonathan Foulds, professor of public health sciences and psychiatry at the Penn State University College of Medicine, wrote on Twitter. “Will be interesting to see whether the stock value of cigarette manufacturers goes up.”

    “I want Juul’s five applications to be authorized. I want Reynolds’ two or three dozen applications to be authorized,” echoed 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.”

    Vuse owner BAT, for its part, was sanguine. “We remain confident in the quality of our applications, which are supported by scientific evidence that our Vuse and Velo products are appropriate for the protection of public health,” the company wrote in a statement. “In addition, we believe that these categories of important, innovative products may be potentially less harmful than traditional tobacco products.”

    Vapor industry representatives have long complained that the PMTA system favors big players. In 2019 court filings, the Vapor Technology Association noted the expenses greatly exceeded the $300,000 to $500,000 per product the FDA estimated in its regulatory impact analysis. Such a burden, say critics, can be borne only by the best-resourced players—i.e., the established tobacco companies. As a result, the products denied market access on Sept. 9 are unlikely to have been rejected because they present a greater health risk than any approved products. Rather, they failed because their manufacturers were unable to navigate the FDA’s complex and costly system.

    Meanwhile, the Campaign for Tobacco-Free Kids (CTFK), which helped set the Sept. 20, 2021, deadline through litigation, hinted it might resume legal action to have the court enforce its order requiring the FDA to begin to remove unauthorized products.

    “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 CTFK President Matthew Myers. “Every day those products remain on the market, our kids remain in jeopardy.”

  • Think Tank: Banning E-Cigs Will Boost Smoking

    Think Tank: Banning E-Cigs Will Boost Smoking

    Photo: jedsadabodin
    Guy Bentley

    Banning many e-cigarettes from the market could harm public health, warns Guy Bentley, director of consumer freedom research at the Reason Foundation, ahead of the deadline for the U.S. and Drug Administration to decide the fate of millions of premarket tobacco product applications (PMTAs).

    In a commentary published on the Reason Foundation’s website, Bentley says that the sooner that U.S. public health officials embrace vaping’s potential to improve public health by reducing smoking and smoking-related deaths, the better off we’ll all be.

    Today, the FDA is expected to announce which electronic nicotine-delivery systems (ENDS) will be allowed to remain on the U.S. market. The sheer volume of PMTAs—the agency has received more than 6.5 million applications—means that there may not be decision on every product, but the FDA’s announcement will likely cover the majority of the vape market.

    To remain on the market, every vapor product must prove to the FDA that it is “appropriate for the protection of public health.” Because the process is expensive and complex, larger companies enjoy a big advantage over their smaller competitors. Experts expect considerable consolidation in the vapor market after today’s announcement.

    Most of the vapor products that are likely to be banned are the nontobacco flavors that have proved popular among America’s 15 million vapers. Bentley pointed to a recent study on the effects of San Francisco’s ban on flavored tobacco products, which showed an increase in high school smoking following prohibition. He also cited research by the Centers for Disease Control and Prevention revealing that sweet or fruity flavors are not the primary reason youth vape. 

    On the positive side, argues Bentley, if the FDA approves some e-cigarettes today, it will help put to rest the arguments about whether these products are beneficial to public health. Many studies suggest that vaping is considerably less harmful than smoking. It has also proven effective in helping people quit smoking traditional cigarettes. Public Health England has famously found e-cigarettes to be 95 percent safer than smoking, for example.

    An FDA seal of approval for some cigarettes would force policymakers and anti-smoking advocates to justify their crusades against products that the agency deems to play a role in improving public health.

    The majority of vapor products are likely to be banned today, however. In most cases, it won’t be because they are inherently riskier than approved products but because the applicants were unable to navigate the FDA’s complex regulatory system, according to Bentley.

    The result of shutting down a vast portion of the vape industry, he warns, will be more smoking.

  • ENDS Makers Prepare for U.S. Shakeout

    ENDS Makers Prepare for U.S. Shakeout

    Photo: Grispb

    The U.S. vaping industry is about to change fundamentally. By tomorrow, Sept. 9, 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 the wealthiest companies, to survive the vetting process. Many vaping products are produced by smaller companies that lack the resources to thoroughly answer the 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.

  • Warnings After ‘Refuse to Accept’ Notices

    Warnings After ‘Refuse to Accept’ Notices

    Photo: Marcus Krauss

    The U.S. Food and Drug Administration issued 29 warning letters to firms that manufacture and sell unauthorized electronic nicotine-delivery systems (ENDS) products in August. The recipients failed to submit a premarket tobacco product application (PMTA) by the Sept. 9, 2020, deadline. Collectively, the firms have listed more than 268,000 products with the FDA.

    In addition, the agency issues two warning letters to two companies for manufacturing and offering for sale or distribution ENDS products without a marketing authorization order. Vapor Boss and Kaleidoscope Custom Vapor Lounge have continued to sell ENDS products after receiving “Refuse to Accept” (RTA) determinations from the agency. These are the first warning letters issued for an application that was submitted by the Sept. 9, 2020, deadline that subsequently received RTA determination, according to the FDA.

    Companies that receive an RTA determination must remove any products currently on the market or risk enforcement by the FDA. Companies may submit a complete application for these products at any time but may not market the products unless they receive a marketing order.

    The FDA also issued the first warning letter to a company that submitted a PMTA for some but not all of its products. Maduro Distributors, which does business as The Loon, submitted an application covering 18 products, but it manufactures and sells additional products not covered by the PMTA.

    From January through August 2021, the FDA has issued 169 warning letters to firms selling more than 17 million unauthorized ENDS products by the Sept. 9, 2020, deadline.

  • Additional Products Denied Market Access

    Additional Products Denied Market Access

    Photo: chase4concept

    The U.S. Food and Drug Administration on Sept. 3 issued another round of marketing denial orders to 31 companies. “After issuing marketing denial orders (MDOs) to three companies for their flavored 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.

    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 its website, the FDA plans to release the names of the companies that received MDOs. Previously, the agency gave the names only of the first three manufacturers to receive MDOs for 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 wrote. “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 wrote 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 agency stated. “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. According to the FDA, JD Nova Group, Great American Vapes and Vapor Salon didn’t provide adequate information to show their rejected 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 alone. The agency has until Sept. 9, 2020, to decide on the remaining PMTAs.

  • Filter: FDA Denies Additional 800 Products

    Filter: FDA Denies Additional 800 Products

    Photo: Boki

    The Food and Drug Administration on Aug. 31 denied the premarket tobacco product applications for 800 vaping products from three e-liquid manufacturers, according to Filter. The marketing denial orders have not been published on the agency’s website.

    Earlier in August, the FDA announced its first outright denial of 55,000 flavored vaping products from three other companies. Prior to that, the FDA refused to file 4.5 million of the 6.5 million applications sent to the agency because the company that put them together did not include appropriate environmental assessments for each product.

    All of the products rejected on Aug. 31 were flavored, and consumer advocates and manufacturers are worried that the FDA is moving toward an effective flavor ban.

    According to industry consultant Dimitris Agrafiotis, the applications he helped the three companies file were unfinished. The companies had intended to send more data piecemeal to the agency as substantial product stability testing wrapped up. Just last week, his clients drafted a letter to the FDA, stating that they would be sending further information.

    Agrafiotis said that each company he represents is now moving into the synthetic nicotine space, a legal gray area. The FDA defines a “tobacco product” as anything “made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product.”

    The FDA has until Sept. 9 to determine the legality of other vaping products, though the agency has signaled it will rule on the major players but not complete the process for everybody else by then.

  • Uncharted Territory

    Uncharted Territory

    Photo: JHVEPhoto

    The FDA’s review process of PMTA applications won’t be completed by the Sept. 9 deadline.

    By Stefanie Rossel

    Regulation of novel tobacco products can be a tedious and sometimes overwhelming process, as current developments in the United States show. Almost a year after the court-ordered deadline for manufacturers to hand in premarket tobacco product applications (PMTAs) for their products and only a few days before the grace period for unapproved products to stay on the market ends, the U.S. Food and Drug Administration sits on a mountain of more than 2 million applications for “deemed new tobacco products.”

    In 2019, a Maryland district court judge had ordered the FDA’s Center for Tobacco Products (CTP) to set a new and earlier PMTA deadline for electronic nicotine-delivery systems (ENDS), which was finally laid down for Sept. 9, 2020. The court order provided for a one-year period during which time such products might remain on the market pending FDA review. After Sept. 9, 2021, the FDA will be allowed to grant further extensions on a case-by-case basis for “good cause,” but no general extra time.

    If a negative action is taken by the FDA on the application prior to Sept. 9, 2021, the product must be removed from the market or will risk FDA enforcement. If the FDA issues a positive order on a product, it will be listed on the positive marketing orders page and can continue to be marketed, according to the terms specified in the order letter. At the time of writing, however, most applications, each consisting of hundreds or even thousands of pages of scientific data, still needed to be reviewed. In May 2021, the agency published a long-awaited list of vapor companies that had submitted PMTAs by the Sept. 9, 2020, deadline. The publication of the list is believed to signal the start of enforcement.

    Considering the large volumes of PMTAs submitted, though, it is improbable that the FDA will be able to process all submissions before manufacturers are required to withdraw their products from the market. In June, the U.S. Small Businesses Administration (SBA), a federal agency that represents small businesses to the various branches of government, urged the FDA to ask the Maryland district court judge to allow the agency to extend the deadline until September 2022. Most small ENDS manufacturers, the SBA argued, did not have the resources to absorb the losses from having their products pulled from the marketplace for several months or more. It said that once the FDA ordered small ENDS manufacturers’ products removed from the market, those small businesses would close permanently. The SBA also pressed the FDA to end its current practice of processing PMTAs in order of manufacturer market share.

    On August 4, Swisher International filed a motion for an emergency preliminary injunction against the CTP for threatening enforcement against products without PMTAs or substantial equivalence approval authorized. The cigar manufacturer, whose cigars are also in the FDA’s premarket-review process with authorization pending, called the FDA’s process “half baked” and accused the agency of creating chaos.

    Individual instead of standardized

    Jonathan Fell

    Consumer staples specialist Jon Fell, partner at Ash Park Capital, thinks it’s unlikely that the FDA will grant a blanket extra year extension. “The FDA has regularly stressed that it has discretion to defer enforcement action on a case-by-case basis, although it’s very hard to know what that will actually mean for the—presumably quite large number—of products which the FDA still hasn’t had time to review by September. I suspect that they will have to defer enforcement against products whose PMTAs have been accepted for review and aren’t obviously deficient, otherwise they’ll face more legal challenges.”

    The agency has repeatedly issued warning letters to manufacturers and retailers to remove unauthorized products from the market, most recently in late July. “The FDA will continue to prioritize enforcement against companies that market ENDS without the required authorization and that haven’t submitted a premarket application to the agency—especially those products with a likelihood of youth use or initiation,” the agency said on its website.

    In contrast to the EU, which with the Tobacco Products Directive (TPD) created a regulatory framework that sets the legislative standards for nicotine strengths, ingredients, labeling, health warnings and other issues for ENDS, the U.S. opted for an individual approach at product regulation. In its recent application report of the TPD, the European Commission stated that the directive’s restrictions on additives in e-liquids, such as vitamins, likely was the reason why the EU was spared the EVALI (e-cigarette or vaping associated lung injury) that raged through the U.S. in 2019.

    “There are very few pros to the way FDA is regulating e-cigarettes in the U.S.,” says Fell. “About the only one I can think of is that having a product explicitly authorized to be marketed in the U.S. might help build consumer confidence in these products after various health scare stories, including the EVALI crisis. But that is at the cost of an enormously complicated and expensive regulatory process that really adds very little value and is a substantial barrier to innovation. I think it would have been far more effective to define a set of standards that e-cigarettes have to meet and then take enforcement action against any products on the market which don’t meet those standards.”

    IQOS on hold

    But it’s not always the FDA’s long-winded processes that prevent manufacturers from marketing their novel tobacco products. Altria subsidiary Philip Morris USA suspended sales of its IQOS heated-tobacco product (HTP) after the U.S. International Trade Commission (ITC) in late July 2021 had found that PM USA had infringed on two patents owned by British American Tobacco subsidiary Reynolds American Inc. (RAI). RAI, which sued PMI USA last year before the ITC and in federal court in Virginia, claims that IQOS violates its patents over the device’s heating blade and alleges PMI was using a former version of the current technology of its own HTP Glo.

    RAI was seeking to have an import ban into the U.S. imposed on IQOS devices and consumables unless PMI licensed the technology from it. The ITC judge’s findings are subject to review by the full commission, with the investigation scheduled to be completed by Sept. 15. In the Virginia case, Altria responded with its own patent-infringement claims and a separate suit in May. The company also filed petitions with the U.S. Patent and Trademark Office, challenging the legality of several RAI patents, inclusive of three investigated in the ITC court case.

    IQOS had been introduced in U.S. test markets, including Atlanta, Georgia, Richmond, Virginia, and metropolitan areas in North Carolina after the FDA had granted the product PMTA authorization in April 2019. IQOS was the first next-generation inhalable product to be authorized as a modified-risk product in July 2020. Its U.S. expansion is now on hold.

    “I hope that the two-way patent battles between PMI and BAT will be settled in a grown-up way before long,” says Fell. “It’s not a good look for an industry trying to make the case for harm reduction to be squabbling in this way, particularly if it results in consumer choice being restricted, by products being taken off the market or not rolled out as fast as they otherwise might. Robust competition ought to be a potent mechanism for encouraging more innovation and shifts in consumer behavior.”

    Another development with uncertain impact on the cause of tobacco harm reduction is Juul Lab’s recent funding of a scientific publication. According to The New York Times, the vaping company spent almost $60,000 to fund the entire May/June issue of The American Journal of Health Behavior to help establish Juul as a smoking cessation tool. Juul Labs has submitted a PMTA to the FDA for its Juul products.

    In the past, scientific articles on reduced-risk products sponsored by tobacco or ENDS manufacturers repeatedly had difficulties being accepted by renowned scientific journals. “Perhaps optimistically, I think if the tobacco harm reduction concept continues to take a broader hold, then over the medium to longer term, excluding research sponsored by tobacco or nicotine companies from academic journals will not be tenable,” says Fell.

    “It will come to be seen as what it is: an anti-scientific and unjustifiable attempt at censorship, rooted in a view of the industry which is at least a couple of decades out of date. Perhaps this is the other silver lining of FDA regulation: the FDA has to engage with industry science and recognize its integrity, and over time the influence of that might spread. Ultimately, the FDA’s decision on Juul’s PMTA will have to come down to rigorous science and hard data, whatever attempts are made to sway the agency’s hand via the emotive arguments of campaigning organizations.”

    FDA Refuses to File Substantial Share of PMTA Applications

    On Aug. 9, the U.S. Food and Drug Administration issued a “refuse to file” (RTF) letter to JD Nova Group. The letter notified the company that the premarket tobacco product applications (PMTAs) 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.

    As a result of this RTF action, JD Nova Group must remove approximately 4.5 million products from the market or risk enforcement action by FDA. The company 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.

    The FDA’s action affects a significant share of PMTAs under review. The agency has received applications for more 6.5 million products from over 500 companies.

    According to the FDA, JD Nova was issued the RTF letter because the company’s applications for these products lacked an adequate environmental assessment. Under FDA’s regulations implementing the National Environmental Policy Act, an environmental assessment must be prepared for each proposed authorization.

    This RTF does not apply to all product applications submitted by JD Nova. The remaining product applications the company submitted by the Sept. 9, 2020, deadline are still moving through the review process, according to the FDA.

    The list of affected products is available at https://bit.ly/3fP6cZj.

  • FDA Urged to Deny All Flavored Vapes

    FDA Urged to Deny All Flavored Vapes

    Photo: Brian Jackson

    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.

  • FDA Refuses to File JD Nova PMTAs

    FDA Refuses to File JD Nova PMTAs

    Photo: BillionPhotos.com

    The U.S. Food and Drug Administration has issued a “refuse to file” (RTF) letter to JD Nova Group. The letter notifies the company that the premarket tobacco product applications (PMTAs) 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.

    As a result of this RTF action, JD Nova Group must remove approximately 4.5 million products from the market or risk enforcement action by the FDA. The company 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.

    The FDA’s action affects a significant share of PMTAs under review. The agency has received applications for more than 6.5 million products from over 500 companies.

    According to the FDA, JD Nova was issued the RTF letter because 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.

    This RTF does not apply to all product applications submitted by JD Nova. The remaining product applications the company submitted by the Sept. 9, 2020, deadline are still moving through the review process, according to the FDA.

    The list of affected products is available here.

  • FDA Urged to Extend Enforcement Deadline

    FDA Urged to Extend Enforcement Deadline

    Photo: Oleksandr Moroz

    A coalition of 23 organizations has asked the U.S. Food and Drug Administration to follow the recommendations of the Small Business Administration (SBA). Earlier this year, the SBA urged the FDA to allow nicotine products to remain on the market for another year after the current Sept. 9, 2021, deadline while their premarket reviews are in progress.

    Due to the large volume of PMTAs submitted—the FDA says it received more than 6 million applications—the FDA will unlikely be able to process all submissions before manufacturers are required to pull their products off the market, according to the SBA.

    In a letter to the FDA prepared by the Americans for Tax Reform (ATR), the 23 organizations say that the FDA’s promise to exercise discretion in its enforcement provides insufficient certainty for businesses who have complied with all relevant regulations and have not received authorization due to processing delays by the FDA.

    If an extension is not granted, the letter cautions, there could be devastating consequences for businesses, particularly small businesses. Furthermore, any potential reduction in the supply of safe alternatives to tobacco could have a negative impact on public health across the United States and lead to an increase in tobacco-related mortality, according to the authors.

    The letter also argues that “millions of consumers who depend on ENDS products for their health and thousands of businesses who depend on these products for their livelihood are threatened by this needless bureaucratic uncertainty.” The only way to avert such an adverse outcome for businesses and consumers is for the FDA to obtain a court order allowing it to extend the existing moratorium on enforcement by another year, according to the letter writers.

    “The vaping industry, unlike many others, was created by small businesses, and these same small businesses continue to drive innovation in the market,” the coalition letter states. “Without these entrepreneurs, the vape industry will be consolidated into a few large corporations, causing prices to rise and consumer choice to decrease.”