Tag: U.S. Food and Drug Administration

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.
September 2, 2021
Uncharted Territory

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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.
September 1, 2021
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.
August 27, 2021
FDA Denies Marketing Orders for 55,000 ENDS

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The U.S. Food and Drug Administration has issued marketing denial orders (MDOs) for about 55,000 flavored electronic nicotine-delivery system (ENDS) products from JD Nova Group, Great American Vapes and Vapor Salon. In a news release published on its website, the agency 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.
The products subject to this action include flavors with names such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal.
“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.”

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.
Janet Woodcock, acting FDA Commissioner
The FDA has received applications from more than 500 companies covering more than 6.5 million tobacco products. 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.
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.
Recently, the agency refused to file more than 4.5 million applications from JD Nova Group on the basis that they did not meet the filing requirements for a new tobacco product seeking a marketing authorization.

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.
Mitch Zeller, director, Center for Tobacco Products
“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 FDA has until Sept. 9, 2021, to decide on the remaining estimated 2.5 million PMTAs.
August 26, 2021
FDA Chief Grilled About Action on Youth Vaping

Photo: Araki Illustrations
Juul Labs has played a significant role in creating a youth vaping epidemic in the United States, according to Acting Food and Drug Administration Commissioner Janet Woodcock, reports Bloomberg.
Asked during a June 23 hearing of the House Oversight Subcommittee on Economic and Consumer Policy if Juul was “the e-cigarette company most responsible for creating this epidemic,” Woodcock answered that it does “appear” to be the case.
Juul has been accused of marketing its products to youths, a charge the company denies.
Juul is one of hundreds of e-cigarette makers that is seeking the FDA’s permission to continue to sell its products. Those marketed since February 2007 have had to submit applications to the FDA in order to stay on the market.
Approval is based on the FDA finding a product is “appropriate for the protection of the public health,” which requires makers to demonstrate that their products won’t promote youth use but instead will help adults quit smoking.
Juul underage use fell in 2020 compared with other companies, according to a study in JAMA Pediatrics. That year also saw 1.73 million less youth tobacco users overall than in the year prior, according to a national youth tobacco survey conducted by the FDA and the U.S. Centers for Disease Control and Prevention.
Woodcock said Wednesday that the agency is prioritizing products from “about five” e-cigarette companies that account for large portions of the market but did not name the companies.
Subcommittee Chairman Raja Krishnamoorthi urged the FDA to deny approval for all vaping companies in the agency’s ongoing review of their products.
The agency must decide on marketing applications by Sept. 9.
June 27, 2021
FDA Asked to Extend PMTA Grace Period

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The U.S. Small Business Administration (SBA) has urged the FDA to allow nicotine products to remain on the market for another year while their premarket reviews are in progress, reports Vaping 360.
In a letter sent to the FDA on June 7, the SBA Office of Advocacy asked the agency to seek a court order extending for an additional year the current freeze on enforcement actions against small vape manufacturers who submitted premarket tobacco product applications (PMTAs) before last year’s Sept. 9 deadline.
In the current situation, manufacturers who submitted PMTAs on time may leave those products on the market until Sept. 9, 2021. The SBA advocacy office is asking the FDA to request that U.S. District Court Judge Paul Grimm allow the agency to extend the deadline until September 2022.
Considering the large volume of PMTAs submitted—the FDA says it received more than 6 million applications—It is unlikely that the agency will be able to process all submissions before manufacturers are required to pull their products off the market.
“Small ENDS manufacturers cannot afford to have their products pulled from store shelves while the FDA continues to review the timely submitted PMTAs for millions of ENDS products,” the SBA writes. “Most small ENDS manufacturers do not have the resources to absorb the losses from having their products pulled from the marketplace for several months or more. Once the FDA orders small ENDS manufacturers’ products removed from the market, those small businesses will close permanently.”
The letter also urges the FDA to end its current practice of processing PMTAs in order of manufacturer market share. By doing so, the FDA all but guarantees that small vaping companies will be unable to have their reviews completed in time to remain on the market, according to the SBA.
The SBA is a federal agency that represents the views of small businesses to the various branches of government.
June 10, 2021
FDA Issues Guidance on User Fees

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The U.S. Food and Drug Administration has issued a draft guidance that helps answer frequently asked questions around tobacco product user fees.
The draft guidance provides information regarding the submission of information needed to assess user fees owed by each domestic manufacturer or importer of tobacco products and how FDA determines whether a company owes user fees in each quarterly assessment. Starting May 27, public comments related to this draft guidance may be submitted through July 26, 2021.
The Federal Food, Drug & Cosmetic (FD&C) Act requires FDA to “assess user fees on, and collect such fees from, each manufacturer and importer of tobacco products subject to” the tobacco product provisions of the FD&C Act. Under the calculations required by the FD&C Act, the tobacco products that are subject to user fee assessments are cigarettes, snuff, chewing tobacco, roll-your-own tobacco, cigars and pipe tobacco.
The FD&C Act provides for the total quarterly assessment to be allocated among specified classes of tobacco products. The class allocation is based on each tobacco product class’ volume of tobacco products removed into commerce. Within each class of tobacco products, an individual domestic manufacturer or importer is assessed a user fee based on its market share for that tobacco product class.
May 27, 2021
FDA Publishes List of Marketing Applications

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The U.S. Food and Drug Administration’s Center for Tobacco Products has introduced a new webpage on its site entitled “Deemed New Tobacco Product Application Lists.” The webpage lists and features 17 MS Excel files that include over 6 million deemed new tobacco products for which a premarket application was submitted to the FDA by Sept. 9, 2020.
A court order provided for a one-year period during which time such products might remain on the market pending FDA review. 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 risk FDA enforcement. If a positive order is issued by the FDA on a product in the below lists, the product will be listed on the positive marketing orders page and may continue to be marketed according to the terms specified in the order letter.
The FDA stressed it has not independently verified the information provided by applicants about the marketing status of their products. In addition, the list excludes entries of products from companies that did not provide information on current marketing status of their products to the FDA so that the agency could determine whether the existence of the application could be disclosed.
“It is important to note that the lists are not comprehensive lists intended to cover all currently marketed deemed tobacco products that a company generally might manufacture, distribute or sell without risking FDA enforcement,” the FDA wrote on its website.
Companies that submitted their application by the Sept. 9, 2020, deadline can keep their products on the market for one year pending FDA review.
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 risk FDA enforcement. If a positive order is issued by the FDA on a product in the lists, the product will be listed on the positive marketing orders page and may continue to be marketed according to the terms specified in the order letter.
The publication of the list likely signals the start of enforcement. The FDA has already issued 111 warning letters to vapor companies in 2021.
Stakeholders in the nicotine business have been anticipating the FDA list for months. In September 2020, the FDA stated that it would publish a list of vapor companies that had submitted PMTAs by the Sept. 9, 2020, deadline. The news came just one week after several retail groups submitted a letter to the agency asking for a published list of applicants.
May 20, 2021
FDA Warns Sellers of Unauthorized Liquids

Photo: Eugene Onischenko
The U.S. Food and Drug Administration on Feb. 12 sent warning letters to 11 firms for selling unauthorized e-liquids.
The firms receiving warning letters are Jojo’s Smokeless World (Mod Shield), Sugar Vapor Co., DC Vapor, Take Off Corp., The Vapor Spot, Premium Vapor Technologies, Vaping Xtreme, Vapes Gone Wild Juice, Vapeoholic, Vaporescence (Vape King USA) and Elemental Vapor Bar.
The firms did not submit a premarket tobacco product application by the Sept. 9, 2020, deadline.
Collectively, these companies have listed a combined total of more than 150,000 products with the FDA.
Following an initial set of such warning letters announced earlier this year, the 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,” the agency wrote in a statement.
“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. 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.”
February 15, 2021
FDA to Review Altria Nicotine Pouches

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The U.S. Food and Drug Administration (FDA) has accepted and filed for substantive review premarket tobacco product applications for 35 On! products manufactured by Helix Innovations, an Altria joint venture.
To support these applications, Altria submitted more than 66,000 pages of documentation, including six primary studies.
“We believe the scientific evidence in these applications demonstrates that the marketing of On! is appropriate for the protection of public health,” said Paige Magness, senior vice president of regulatory affairs for Altria Client Services. “On! nicotine pouches are a key part of our vision to responsibly lead the transition of adult smokers to a noncombustible future.”
On! nicotine pouches are tobacco-leaf-free and are available in seven flavors and five nicotine levels. In the fast-growing nicotine pouch category, On! currently offers the broadest portfolio of choices for adult tobacco consumers seeking alternatives to traditional tobacco products, according to Altria.
On! was distributed in more than 28,000 stores at the end of the first quarter, including the top five U.S. convenience store chains by volume. According to IRI, total oral tobacco derived nicotine category sales in 2019 grew approximately 275 percent compared to 2018.
June 10, 2020