Tag: U.S. Food and Drug Administration

TPB’s Marketing Denial Order Rescinded

Photo: momius
The U.S. Food and Drug Administration has rescinded the marketing denial order (MDO) it issued for some Turning Point Brands (TPB) e-liquids. The products that had been denied are now back under review.
In a letter addressed to TPB’s senior vice president of external affairs, Brittani Cushman, the FDA said it had found relevant information that was not properly assessed.
“Specifically, your applications did contain randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use and perceptions in current smokers, current ENDS users, former tobacco users and never users, which require further review,” wrote Matthew Holman, the director of the Office of Science at the FDA’s Center for Tobacco Products.
The agency indicated that it would not initiate enforcement action against the TPB products under review.
The move comes after TPB challenged the MDOs in court. TPB has now withdrawn its appeal.
“We are encouraged by the FDA’s decision to reconsider our product applications and look forward to engaging the agency as our PMTAs are reviewed,” said TPB President and CEO Larry Wexler in a statement. “It is important that the PMTA process is transparent, purposeful and evidence-based. Our organization dedicated significant time and resources in filing our applications in accordance with agency guidance.
“We remain hopeful that the depth and range of our studies and data will persuade the FDA that the continued marketing of our vapor products is appropriate for the protection of the public health and that the agency will ultimately preserve a diverse vapor market for the more than 30 million American adult smokers who may wish to transition from combustible cigarettes to lower risk alternatives.”
Industry representatives suggest the clerical error is a result of the rush with which the FDA was forced to decide on premarket tobacco product applications. The Sept. 9 deadline was ordered by a court in response to litigation by anti-vaping groups, including the Campaign for Tobacco-Free Kids.
The MDO withdrawal has left some speculating as to whether the rejected applications of other companies would also receive a second look. Several companies, including Triton and Bidi Vapor, are currently awaiting court decisions on their MDO challenges.
October 9, 2021
MDO Recipients Warned for Continued Marketing

Photo: Ljupco Smokovski
The U.S. Food and Drug Administration has issued warning letters to 20 companies for continuing to unlawfully market electronic nicotine-delivery system (ENDS) products that are the subject of marketing denial orders (MDOs). These are the first warning letters issued for products subject to MDO determinations on their premarket tobacco product applications (PMTAs).
The FDA also issued warning letters today for the unlawful marketing of tobacco products to one company that received “refuse to file” (RTF) determinations on their PMTA, one company that received RTF and MDO determinations on their PMTA, and six companies that did not submit any premarket applications.
Collectively, these 28 companies have listed a combined total of more than 600,000 products with the FDA.
“Today’s action shows that we’re prioritizing enforcement against tobacco product manufacturers who received a negative action on their application, such as a marketing denial order or refuse to file notification and continue to illegally sell those unauthorized products as well as products for which manufacturers failed to submit a marketing application,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products, in a statement.
“It is our responsibility to make sure that tobacco product manufacturers comply with the law to protect public health, and we’ll continue to hold companies accountable for breaking the law.”
As of Sept. 23, the FDA has issued a total of 323 MDOs, accounting for more than 1,167,000 flavored ENDS products.
October 7, 2021
FDA Issues Two Final Rules for Applications

Photo: Araki Illustrations
The U.S. Food and Drug Administration has issued two final rules for the premarket review of new tobacco products. These foundational rules provide additional information on the requirements for the content, format and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports—two of the most commonly used pathways through which a manufacturer can seek marketing authorization for a new tobacco product from the FDA.
According to the agency, the finalization of these rules helps ensure that all future submissions contain the basic information needed to determine whether the new tobacco products meet the relevant premarket requirements to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act.
“These final rules are important components of the FDA’s comprehensive approach to tobacco product regulation, which includes premarket application review, science-based use of the product standard authority and prioritized compliance and enforcement actions,” said acting FDA Commissioner Janet Woodcock in a statement. “The FDA is committed to protecting Americans from tobacco-related disease and death by ensuring that new tobacco products undergo appropriate regulatory review to determine if they meet the public health standards set by law. If new tobacco products do not meet the standards for these pathways, they cannot be marketed or sold in the United States.”
“Conducting review of new tobacco products before they can be legally marketed is a critical responsibility of the FDA,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “These final rules will provide greater clarity and efficiency in review of new tobacco products by describing information that any company must provide if they seek to market a new tobacco product in this country.”
On Jan. 19, 2021, the PMTA and SE final rules were displayed in the Federal Register but did not publish. On Jan. 20, 2021, a memo from the White House Chief of Staff ordered the withdrawal of any rules that did not publish in the Federal Register by noon on that day. Therefore, these final rules were withdrawn at that time. The rules displaying today reflect clarifying changes made from the previous versions but no significant substantive changes. Both final rules will publish on Oct. 5 and are effective Nov. 4. Beginning on the effective date, applications submitted through these pathways must meet the requirements described in these final rules.
October 4, 2021
First Lawsuits Filed Over Marketing Denials

Turning Point Brands has challenged the Food and Drug Administration’s orders that denied some of the company’s products access to the U.S. market. The company first filed a petition for review with the U.S. Court of Appeals for the Sixth Circuit. TPB then filed an emergency motion to stay the FDA’s order to remove TPB’s products from the market.
TPB is asking the court to review the FDA order “on the grounds that it is arbitrary and capricious, an abuse of discretion, contrary to the Federal Food, Drug and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act of 2009, and otherwise not in accordance with law.” The company requests the court “vacate or modify” the FDA order and asks that TPB be allowed to “continue to market the products subject to the challenged order.”
TPB accuses the FDA of moving the goalposts for data needed to receive a marketing order based on what the agency “learned” from the “review [of] PMTAs for flavored ENDS so far,” according to the stay. TPB noted that the “North Star of administrative law” is that agencies cannot induce regulated parties to rely on “agency representations about regulatory requirements,” then penalize them using the previously unannounced criteria after the fact.
“But that is precisely what FDA did here,” the stay motion states. “[The] FDA reasoned that TPB failed to conduct ‘a randomized controlled trial and/or longitudinal cohort study’ or other studies performed ‘over time’ to show that TPB’s specific flavored products help adult users stop smoking more than tobacco-flavored products do. Yet FDA previously deemed these studies unnecessary.”
Bidi Vapor and at least one other company have reportedly filed similar suits.
October 4, 2021
FDA Urged to Deny All Flavored E-Cigarettes

Photo: Boki
Seven leading public health, medical and parent organizations are urging the U.S. Food and Drug Administration to expedite decisions on remaining marketing applications for e-cigarettes and promptly deny applications for all flavored e-cigarettes, including menthol-flavored products.
The organizations say they are concerned about these products’ appeal to youth and the adverse impact on public health.
In a letter to acting FDA Commissioner Janet Woodcock, the groups also urged the FDA to prioritize enforcement against unauthorized flavored e-cigarettes with the largest market shares and products with the highest prevalence of youth use.
The groups sending the letter are the American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, Parents Against Vaping E-Cigarettes and Truth Initiative.
Since Sept. 9, the FDA has denied marketing applications for more than 1,167,000 products, but it has yet to issue decisions on e-cigarette brands with the highest market shares, such as Juul, Vuse, NJOY and blu, which make up over 78 percent of the market, according to Nielsen data.
The health groups expressed particular concern that the FDA is still considering whether to authorize any menthol-flavored e-cigarettes and urged the FDA not to do so given the clear evidence that menthol is a flavor that appeals to and is widely used by kids.
“Contrary to the FDA’s Aug. 26 statement that menthol e-cigarette products raise ‘unique considerations’ for purposes of FDA review, we do not believe there is anything ‘unique’ about menthol flavoring that would justify issuance of a marketing order,” the groups wrote in their letter. “Indeed, there is no question that when FDA decided to prioritize enforcement against cartridge-based e-cigarettes in flavors other than menthol and tobacco, youth shifted to using menthol-flavored products.”
September 29, 2021
More Marketing Denial Orders From FDA

Photo: Jhvephotos | Dreamstime.com
The U.S. Food and Drug Administration has issued additional marketing denial orders (MDOs) for electronic nicotine-delivery system (ENDS) products.
As of Sept. 23, the agency has issued 323 MDOs accounting for more than 1,167,000 flavored ENDS.
The list of MDOs is available here.
The FDA issued the first MDOs in August.
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.
September 23, 2021
FDA Issues More Marketing Denial Orders

Photo: pololia
The U.S. Food and Drug Administration has updated its list of marketing denial orders (MDO). The latest round of denials includes products from prominent players such as Turning Points Brands, Humble Juice Co., Beard Vape Co. and Avail Vapor.
As of Sept. 17, 2021, the agency has issued a total of 295 MDOs for more than 1,089,000 flavored electronic nicotine-delivery system (ENDS) 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 flavors.
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 told Tobacco Reporter’s sister publication, 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.”
Industry experts believe the FDA will approve only tobacco and menthol flavors, most expected to be in closed system formats. The FDA has yet to decide on the marketing applications of market leaders such as Juul, Logic, Vuse and Blu.
Many companies are moving toward using synthetic nicotine in their products in hopes to avoid current FDA regulations. Synthetic nicotine is 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.”
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 a tobacco product or push for synthetic nicotine to be regulated like any other drug.
September 20, 2021
In the Lurch

Photo: ltummy
By Paul Hardman
Electronic nicotine-delivery system (ENDS) companies in the U.S. have found themselves in limbo following the FDA’s recent statement on the regulation of e-cigarette products.
The long-awaited deadline for the review of manufacturers’ premarket tobacco product applications (PMTAs) was somewhat of an anticlimax, leaving many none the wiser as to whether they could continue to sell their products.
The result left company executives frustrated—and in a predicament when it comes to their responsibilities to public health versus their legal obligations.
The lead-up to Sept. 9, 2021, saw companies that had submitted PMTAs given a year’s grace to continue to sell their products until a decision on their future could be taken.
For many, that decision is yet to materialize, with the FDA announcing it had not managed to get through the sheer volume of applications received by the court-imposed deadline.
So, what has the FDA done? Its statement said that as of Sept. 8, the organization had completed acceptance review for all of the applications and completed filing review for about 90 percent of applications submitted by the Sept. 9, 2020, deadline.
Many of these applications were ultimately knocked back at the first hurdle, receiving a refuse to file (RTF) letter at the filing stage due to missing some of the required information, with 4.5 million products receiving refusal to file from just one company’s application. The FDA said this included the lack of ingredient listings, labels for each product and adequate environmental assessments.
As of Sept. 8, the FDA said it had issued substantial equivalence (SE) marketing orders covering more than 120 (non-ENDS) products and exemption from substantial equivalence requests marketing orders covering more than 230 products. Some companies had bad news in the form of the first marketing denial orders (MDOs), which were issued on Aug. 26 for about 55,000 flavored products. The FDA’s responsibility is with public health, weighing the potential benefits for adult smokers of using ENDS products to wean themselves off cigarettes against the potential appeal to teenagers or new users who may go straight to ENDS, potentially attracted by flavored varieties.
These companies will now have to remove their products from shelves or risk enforcement action. With limited resources, the FDA has suggested it will prioritize the enforcement of those that have received MDOs as well as products with no pending application while processing the backlog of applications and any new PMTAs.
That leaves a quandary for those who submitted their applications by the Sept. 9, 2020, deadline but who haven’t yet received an MDO. They can effectively continue to sell their products as no ruling has been made on them; however, the FDA has made it clear that any company that does continue to sell these products will be doing so unlawfully, although it is clear that they are not likely to face any enforcement action.
And there lies the difficult part. Many of these companies cleaned up their acts in recent years, putting in place codes of conduct setting out their ultimate aims of improving public health through promoting the replacement of combustible tobacco. If those that have submitted PMTAs have demonstrated and believe that their products are doing good in the world, then to follow the letter of the law by removing their products from shelves could potentially harm users by pointing them back in the direction of cigarettes—going against their codes.
That brings them to a decision between their obligations to the law and their responsibilities to the overall safety of users. The naysayers may suggest these manufacturers are putting profits first, but, as an extreme example, if all the companies out there decided to take their products off the market, there would ultimately be limited choices for users, which may make a return to tobacco an attractive prospect for them. There is also a risk that some may choose to fly under the radar by turning to the black market to sell their products.
Companies must decide whether they take a chance and wait for the FDA to take enforcement action against them.
One positive for ENDS companies from the statement is that the reason given for some of the MDOs was not that they were necessarily worse for health than cigarettes, but that the application lacked sufficient evidence provided within the submission. We know that the FDA is very much open to ENDS products having the potential to protect public health. I am sure that, with adequate evidence resubmitted, many of these products will receive marketing orders in time.
This is where specialized companies, such as Broughton Nicotine Services, can assist, working with businesses to provide the evidence needed to complete this process. The FDA’s delay in processing applications provides an opportunity, too, to those companies whose PMTAs have not yet reached the substantive review stage. There is still time to bolster an application that has yet to reach this stage if you believe additional evidence would be beneficial—but time is of the essence.
The PMTA process, as is evident, is complex, perhaps favoring the larger companies with the resources to navigate the system and submit detailed information. Juul Labs, for example, was able to take action by reducing its products to only tobacco and menthol flavors, removing fruit options from the market, yet we are still to hear the outcome of their application.
The next step will be to discover how frequently the FDA plans to announce the results of PMTAs. My preference would be monthly to ensure ENDS companies and the industry feel a little less in the lurch.
FDA Postpones Decisions on High-Profile Marketing Applications
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 bestselling vapor products on the U.S. market.
There were no updates on high-profile submissions, such as those submitted by Juul Labs, Reynolds American Inc. 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.
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.
“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.”
Amanda Wheeler, president of the American Vapor Manufacturers Association, noted that the FDA ruling criminalizes thousands of longstanding businesses across the United States. “Those entrepreneurs have to junk their inventories, fire their employees and stiff their investors,” she said during the recent GTNF conference in London.
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.
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 that 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.
Meanwhile, MDO recipients have started looking for ways to continue serving their customers, with some of them turning to synthetic nicotine. The FDA currently 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.”
Whether the FDA will allow products with synthetic nicotine to remain on the market remains to be seen. 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, suggested that as more vapor companies move in this direction, the FDA could either assert jurisdiction over synthetic nicotine as a tobacco product or push for synthetic nicotine to be regulated like any other drug.
How the ENDS market will evolve from here is anyone’s guess. Since the Sept. 9 deadline, the FDA has continued issuing MDOs, including to products submitted by prominent companies such as Turning Point Brands, Avail Vapor and Bidi Vapor. At press time, the number of MDOs exceeded 1.16 million products from 323 companies.
A big question is whether the agency will grant marketing orders to the applications submitted by the market leaders. Previously, the FDA had indicated it would prioritize those products because doing so would have the greatest impact on the market. Even in the wake of substantial share losses, Juul alone still accounts for 40 percent of the U.S. vaping market.
Whatever happens, the FDA is certain to catch flak from industry critics and vapor companies alike. At GTNF, Wheeler announced a public campaign. “We will be at FDA’s doorstep demanding answers or forcing them through freedom-of-information laws and in the courts,” she said. “We are not going to sit still while the FDA endangers our health, crushes our livelihoods and treats the American people like gullible idiots.”
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.”
Paul Hardman is head of scientific affairs at Broughton Nicotine Services.

September 17, 2021
New Tobacco Retailer Webinars Available
The U.S. Food and Drug Administration Center for Tobacco Products has published two new tobacco compliance webinars—one on the Office of Small Business Assistance (OSBA) and one providing an overview of warning letters for online retailers.
The first webinar provides tobacco retailers, manufacturers and stakeholders with information about the OSBA, including the office’s free online resources and how to submit tobacco-related questions to the OSBA.
The “Overview of Warning Letters for Online Retailers” webinar outlines the FDA’s internet and publication surveillance. It provides information such as why online retailers might receive warning letters and how online retailers should respond to the FDA’s warning letters.
September 17, 2021
Marketing Denial Order for Turning Point Brands

Turning Point Brands (TPB) received a marketing denial order (MDO) from the U.S. Food and Drug Administration in response to a premarket tobacco product application (PMTA) covering certain of the company’s vapor products.
In a press note, the company said it stands behind the high quality of its PMTA, which it believes established that the products’ 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 company wrote. “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.”
The PMTA denied by this MDO included an in-depth toxicological review, a clinical study and studies on patterns and likelihood of use. According to TPB, 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,” the company stated.
“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 of 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.”
The company says 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.
September 17, 2021