Category: U.S. FDA

U.S. Court Grants Stay of Reynolds Menthol MDOs

Credit: Sang Hyun Cho
The U.S. Court of Appeals for the Fifth Circuit has granted an administrative stay of a U.S. Food and Drug Administration marketing denial order (MDO) for two R.J. Reynolds Vapor Co. menthol flavored refill pods.
The order was granted as a temporary stay pending a motion to file a stay with the court by Feb. 1, 2023.
On Jan. 24, the FDA denied marketing applications for two menthol refills used in Vuse Vibe and Vuse Ciro vaporizers, which are sold in the U.S. by BAT subsidiary R.J. Reynolds. According to the agency, Reynolds’ applications presented insufficient evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.
British American Tobacco said on Jan. 25 that it intended to appeal the MDO for its Vuse Vibe Tank Menthol 3.0% and Vuse Ciro Cartridge Menthol 1.5%, the company announced in a statement.
January 26, 2023
Reynolds to Appeal FDA’s Denial of Menthol PMTAs

British American Tobacco will appeal the U.S. Food and Drug Administration’s marketing denial orders for its Vuse Vibe Tank Menthol 3.0% and Vuse Ciro Cartridge Menthol 1.5%, the company announced in a statement.
On Jan. 24, the FDA denied marketing applications for two menthol refills used in Vuse Vibe and Vuse Ciro vaporizers, which are sold in the U.S. by BAT subsidiary R.J. Reynolds. According to the agency, Reynolds’ applications presented insufficient evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.
“Reynolds intends to seek a stay of enforcement immediately and will pursue other appropriate avenues to allow Vuse to continue offering its innovative products to adult nicotine consumers age 21+ without interruption,” the company said.
“We believe that menthol vapor products are critical to helping adult smokers migrate away from combustible cigarettes. FDA’s decision, if allowed to go into effect, will harm, not benefit, public health.
“We remain confident in the quality of all of Reynolds’ applications, and we believe that there is ample evidence for FDA to determine that the marketing of these products is appropriate for the protection of public health.”
Anti-tobacco campaigners countered that menthol e-cigarettes appeal to underage consumers. “Existing evidence demonstrates that non-tobacco-flavored e-cigarettes, including menthol flavored e-cigarettes, have a known and substantial risk with regard to youth appeal, uptake and use; in contrast, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids in a statement.
Morgan Stanley said it expected the rejected products to remain on the U.S. market for the duration of BAT’s appeal, with minimal impact on the company’s operations. “Longer term, should today’s denial order reflect a broader effort by the FDA to ban menthol e-cigarettes, BAT’s U.S. cigarette business could benefit given its menthol mix as it might discourage some smokers from quitting or switching to reduced risk products,” the bank wrote in a note to investors. Reynolds’ Newport brand represents about 40 percent BAT’s U.S. cigarette dollar sales, according to Morgan Stanley.
The Jan. 24 rejection of the Vuse refills underscores the FDA’s ongoing reluctance to approve menthol e-cigarette flavors. To date, the agency has approved only tobacco-flavored e-cigarettes.
However, the FDA has granted both a premarket tobacco product application and modified risk tobacco product designation to IQOS’s menthol variant, which may eventually leave Philip Morris International’s heat-not-burn product as one of the few menthol reduced-risk alternatives on the market.
The FDA is targeting publishing a final rule to ban menthol cigarettes in August 2023, but considering expected industry litigation, final implementation could be five to six years away, according to Morgan Stanley.
January 25, 2023
FDA Denies Marketing of 2 Vuse Menthol Products

Unsurprisingly, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company.
In a release today, the regulatory agency said that the products include the Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5%. Reynolds is now banned from marketing or distributing these products in the U.S. or they risk FDA enforcement action.
The company may resubmit applications or submit new applications to address the deficiencies of the products that are subject to these MDOs. The company may also file a lawsuit against the agency’s denial.
“Consistent with the authorities granted by Congress, the FDA remains committed to evaluating new tobacco product applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole,” said Brian King, director of the FDA’s Center for Tobacco Products, wrote. “The applications for these products did not present sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.”
The FDA isn’t expected to approve any flavored vaping products in the near future.
Memos recently submitted to the U.S. Court of Appeals for the Third Circuit show that the U.S. Food and CTP King, reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists, according to Logic’s lawyers. The new documents were made available to Logic after it had filed its motion for a stay of its marketing denial order (MDO) for its menthol vaping products.
The Vuse products cannot be legally introduced into interstate commerce in the U.S. without risking FDA enforcement. In addition to ensuring that the manufacturer complies with this order, as with unauthorized products generally, the FDA intends to ensure compliance by distributors and retailers. Retailers should contact R.J. Reynolds Vapor Company with any questions about products in their inventory.
“Today’s decision pertains to the specific application submitted for review by FDA,” said King. “It is the responsibility of the applicant to provide sufficiently robust scientific evidence to demonstrate that the necessary public health standard has been met. In this case, the presented evidence did not meet that standard.”
January 24, 2023
Fifth Circuit Grants Triton Rehearing Before Full Court

Fifth Circuit Court of Appeals
The U.S. Court of Appeals for the Fifth Circuit granted Wages and White Lion Investments LLC, doing business as Triton Distribution, and Vapetasia LLC’s, request for the full court to re-hear Triton’s appeal of its marketing denial order (MDO), according to a court order handed down today.
Triton lost before a three-judge panel in July, but attorneys for Triton then filed a petition for a rehearing en banc by the entirety of the Fifth Circuit.
Most circuit court appeals are decided by a three-judge panel, however, the special circumstances surrounding the U.S. Food and Drug Administration’s denial of Triton’s premarket tobacco product applications (PMTAs) motivated the court to allow a majority of the active judges (an estimated 17 judges) to vote to rehear the case “en banc.”
The FDA rejected applications to market 55,000 flavored e-cigarettes in August 2021, including Triton’s, and said applicants would likely need to conduct long-term studies establishing their products’ benefits to win approval.
A Fifth Circuit panel in October then agreed with Triton’s claim that the new requirement for long-term studies differed from earlier FDA guidance and called the action a “surprise switcheroo” and the panel allowed Triton to keep selling its e-cigarettes until another panel could hear its appeal.
The court then denied Triton’s request for review of the agency’s MDOs in a 2-1 decision.
The Fifth Circuit will hear the en banc argument in Wages and White Lion Investments v. U.S. Food & Drug Administration in May.
January 19, 2023
U.S. FDA Says Misinformation ‘Leading Cause of Death’

The role of misinformation in the vaping industry was not mentioned when past and present commissioners of the U.S. Food and Drug Administration came together recently to discuss the role misinformation plays in public health.
The group say the agency needs partners in combatting public health misinformation, and industry, clinicians, patient advocates and academic leaders all have a role to play.

“Realistically, FDA needs help,” Mark McClellan, who served as FDA Commissioner from 2002-2004, said at the 2023 Innovations in Regulatory Science Summit sponsored by the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI).
On the FDA’s own website there are youth vaping prevention posters available to be used by various groups including doctors, schools, and state and local public health agencies. These claim, amongst other dangers, that “[n]icotine can rewire a teen’s brain to crave more nicotine and can create addiction,” despite there being no scientific basis for this claim.

While there is currently a lack of trust in officials from public health agencies, individuals still have trust in their own physicians, community leaders, and others who are “close to their experience,” McClellan said during a panel discussion among past and present FDA commissioners about how to counter the problem of misinformation and restore trust in the agency.
However, a 2021 study in the International Journal of Environmental Research and Public Health found that more than 75 percent of U.S. physicians believe that nicotine directly contributes to cancer and cardiovascular disease.
On the FDA’s website, the agency states, “while nicotine has a number of toxic effects on the body, it is not the primary cause of cancer and other chronic smoking-related diseases. More than 7,000 chemicals are present in cigarette smoke, including more than 70 that can cause cancer.”

Janet Woodcock, the agency’s Principal Deputy Commissioner who served as Acting Commissioner from 2021-2022, said patient advocates are trusted and often aligned with FDA’s mission but that their reach is often limited to the disease areas where they are focused, leaving prevention and treatment of common diseases as areas where misinformation can proliferate, according to an article from Regulatory Focus.

“I actually believe that misinformation is the leading cause of death right now in the U.S. because whether we’re looking at COVID or chronic disease, people are making bad choices driven by the information that they get,” said current FDA Commissioner Robert Califf, who also served in the role from 2016-2017. “We were just not prepared for what broad access to the Internet would do to communication channels.”

Califf called out the academic community for not doing more on the misinformation front and said some of their criticism of FDA and other public health agencies is having unintended consequences.

“As a public agency, we need to be critiqued, but I think often the people that are doing the critiquing assume that the agency’s going to be there in the future in the way that they expect it to be there,” Califf said. “So, they’re critiquing it to make it better. But to a lot of unsuspecting people that hear it, it just completely erodes their belief in the institution.”
In an FDA-funded study last year, researchers found that the use of electronic cigarettes costs the United States $15 billion annually in healthcare expenditures—more than $2,000 per person a year. The study, published on May 23 in Tobacco Control, was the first to look at the healthcare costs of e-cigarette use among adults aged 18 and older, according to researchers at the University of California San Francisco School of Nursing.
The study was found to be rife with misinformation after it claimed that healthcare expenditures for a person who uses e-cigarettes are $2,024 more per year than for a person who doesn’t use any tobacco products. Chuck Dinerstein, director of medicine at the American Council on Science and Health (ACSH), who has over 25 years of experience as a vascular surgeon, said that in order to get their data, researchers developed a model using the National Health Interview Survey (NHIS), a household survey of the general population in the U.S. that includes detailed questions on health and use of tobacco products.
“The researchers point to a study using NHIS data that per smoker—meaning combustible—attributable healthcare expenditures are $5,602,” explained Dinerstein. “The finding of this study, for both those exclusively using e-cigarettes and the dual users, is roughly a third as much. E-cigarettes reduce healthcare utilization and costs.”
Scott Gottlieb, who served as FDA Commissioner from 2017 to 2019, said rapid response to online misinformation is critical and floated the idea of giving industry more leeway to counter false or misleading information about products. It is currently illegal for any vaping product manufacturer to make health claims concerning e-cigarettes, including saying they are safer than combustible cigarettes.
While commissioner, Gottlieb championed e-cigarettes as a way to help adults stop smoking.
“We’ve seen FDA weigh in, admirably, around some dangerous disinformation on specific products,” he said. “But that can’t be the business of the FDA.”
Margaret Hamburg, who served as FDA Commissioner from 2009-2015, said that while some of the larger issues around misinformation are difficult to solve, FDA can take concrete steps to restore public confidence in its role. That boils down to showing why FDA matters, how the agency does its work and opening up some of the processes that have historically not been transparent, she said.
“Despite so much that is going on that is hard for FDA to control, the work of the agency and its trustworthiness can be demonstrated,” Hamburg said.
That transparency is especially important in areas where there is the most controversy, McClellan said.
January 10, 2023
CTP Director Pens Op-Ed, Fails to Mention Recent Reviews

Brian King / Credit: FDA
In a new op-ed published in the HPHR Journal, The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) Director Brian King writes about what the FDA is calling “health equity.” However, missing from the editorial is any response to either the recent Reagan-Udall Review or the findings of a recent investigation into the CTP by the U.S. Office of Special Counsel (OSC).
In the editorial, King writes that “there is no safe tobacco product; however, products do exist on a continuum of risk, with combustible products being responsible for the overwhelming burden of disease and death from tobacco use.”
He also states that “science is central to informing tobacco regulatory decision making,” noting that he is “a scientist by training” and is “particularly attuned to the vital importance of ensuring we gather and use the best scientific evidence available.”
In writing about his “vision” for the CTP, King does not address memos recently submitted to the U.S. Court of Appeals for the Third Circuit that show King reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists, according to Logic’s lawyers.
King also failed to address the conclusion a recent investigation conducted by the OSC that found the CTP had relaxed its standards of review for certain tobacco products and stifled attempts by its scientists to raise concerns. The OSC sent a letter to the U.S. President and Congress outlining the findings.
In the op-ed, King claims that the CTP “strive[s] to engage with a wide array of stakeholders, including those that work with and represent individuals and communities who are disproportionately impacted by tobacco use, to facilitate an open exchange of opinion from diverse groups.”
However, when the Reagan-Udall Foundation submitted its recommendations to Robert Califf , commissioner of the FDA, in December, the report concluded that vaping industry stakeholders observed a lack of “consistent implementation” of what the industry understood to be the policies of the CTP, particularly with respect to tobacco harm reduction and the requirements needed to navigate the premarket tobacco product application (PMTA) process.
King then goes on to state that in the 13 years since the landmark Tobacco Control Act (TCA) was signed into law, CTP has done “significant work to effectively research, regulate, and educate in a complex and rapidly changing tobacco product landscape.”
However, the Reagan-Udall report stated that the CTP needs to make “process improvements and identify and address the policy and scientific questions” that underpin its regulatory framework. The review concluded that CTP’s implementation of its PMTA program also has been affected by “changes in leadership and administrations.”
Since the implementation of the TCA, CTP has operated under seven different commissioners in three different administrations, and recently hired its third CTP director, King. In October, numerous comments from staffers of the CTP for the Reagan-Udall assessment of the performance of the FDA’s tobacco center claimed the regulatory agency is in a state of disarray and being influenced by outside forces, not scientific research.
One comment stated that reviewers of PMTAs in the CTP’s Office of Science (OS) lack the autonomy to exercise “best scientific practices” in their reviews of PMTAs.
“Scientific disagreement is frowned upon, if not entirely suppressed, and punished through various backhanded methods (e.g., lack of assignments, projects, and other opportunities that are needed for career development/promotion),” the comment states. “In some divisions (e.g., Division of Nonclinical Science [DNCS]), leadership pushes a ‘gotta get em’ mentality onto staff, which is unsupportive of a reviewer’s fundamental duty to provide an unbiased review using the best available science.”
January 5, 2023
FDA Accepts Bantam Vape Non-Tobacco PMTAs

Bantam Vape received acceptance of its premarket tobacco product application (PMTA) submission from the U.S. Food and Drug Administration for its non-tobacco nicotine e-liquids, according to a press release. Bantam’s application now moves to the next step in the PMTA process—a preliminary scientific review to confirm the application contains all required items to permit a substantive review by the FDA.
Bantam submitted its application for its non-tobacco nicotine e-liquids to the FDA on May 13, 2022, and is seeking marketing orders from the agency.
“The receipt of this acceptance letter reflects Bantam’s efforts to provide adult consumers with high-quality, science-based e-liquids while upholding our responsibility to restrict youth access and use of these products,” said Bantam spokesperson Anthony Dillon. “Bantam remains supportive of the need for science-based regulation in the e-liquids industry and is proud of the progress of our various PMTAs. We remain confident in the quality and consistency of our products and the science behind them.”
Prior to its non-tobacco nicotine-focused submission, Bantam submitted a PMTA to the FDA in September 2020 for its tobacco-derived e-liquids. The application entered scientific review in August 2021, and, to date, remains under FDA review.
Earlier this year, the -liquid manufacturer received an exemption from the United States Postal Service (USPS) that allows the company to ship its e-liquid products to select vape retailers and distributors throughout the United States.

December 22, 2022
Nothing to See: Reagan-Udall Submits CTP Review
Credit: Postmodern Studio
The Reagan-Udall Foundation today submitted its recommendations to Robert Califf , commissioner of the U.S. Food and Drug Administration. The findings are what many in the industry are calling “meaningless” and “less than compelling.”
The report concludes that vaping industry stakeholders observed a lack of “consistent implementation” of what the industry understood to be the policies of the Center for Tobacco Products (CTP), particularly with respect to tobacco harm reduction and the requirements needed to navigate the premarket tobacco product application (PMTA) process.
The “Operational Evaluation of FDA’s Tobacco Program” was facilitated at Califf’s request. The announcement came as Califf attempted to push past several controversies that dominated his second stint running the agency, including his issuing of a marketing denial order (MDO) to e-cigarette maker Juul Labs and later having to rescind that order.
The report did highlight several wide-ranging problems that the report states hinder its ability to regulate the industry and reduce tobacco-related disease and death. The report stated that the CTP should make “process improvements and identify and address the policy and scientific questions” that underpin its regulatory framework. The review concluded that CTP’s implementation of its program also has been affected by “changes in leadership and administrations.” In its first 13 years, CTP has operated under seven different commissioners in three different administrations, and recently hired a third CTP director, Brian King.
“From the stakeholders’ perspective, policy shifts with broad impact on the industry occurred without notice. The Center has faced significant challenges in clearing its policies through the career and political infrastructure. It took years to establish requirements and standards governing application reviews, frustrating industry and creating problems for the Center itself when it received deficient applications,” the report states. “Issues in application reviews resulted in litigation necessitating re-review of some applications. The current environment reflects an unintended shift from what was structured by law as a pre-market authorization framework to the reality of a post-market regulatory environment, which is much more difficult to deal with given that there are few incentives for industry to come into compliance and many incentives for industry to delay the process.”
The evaluation and resulting recommendations focused on four program areas: regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders, according to the review. The review and recommendations are meant to assist the agency in making changes to better carry out its regulatory responsibilities; to strengthen its relationships with stakeholders
The report identified several fundamental issues that the center needs to address and it states that the report offers “cross-cutting as well as program-specific recommendations to help CTP operate more effectively,” according to the authors of the review.
The key points from the report can be summarized as follows:

The panel observes that CTP has been forced to operate primarily in a reactive mode, moving
from one challenge to the next, mainly provoked by the outside forces. The Center should transition to becoming a more proactive and strategic program. With more substantial engagement with stakeholders and the public, CTP should take the time now to think strategically about where it is today and where it needs to go in the next several years.

Although CTP has a critical mission to protect the public health from tobacco-related disease and death and is regulating products that have no inherent benefit and huge societal costs, it is a government regulatory program with a duty to run efficiently, fairly, and transparently. This responsibility to function as an effective product regulator should be captured in the Center’s mission, vision, and goals and carried out to the best of the Center’s ability.

The panel recognizes that to improve the effectiveness of its application review, the Center should make process improvements and identify and address the policy and scientific questions that underpin its regulatory framework.

CTP needs to work with other entities on strategies to clear the market of illegal tobacco products more rapidly and provide more transparency to the public on its efforts to do so. This work is challenging but essential as CTP adopts a more strategic approach. While there is much the Center can do on its own, the panel notes that enforcement of the premarket requirements in the tobacco laws, particularly to help prevent youth use of tobacco products, requires the involvement and support of agencies other than FDA. The authors encourage the agency to elevate this issue and pursue a more comprehensive approach that leverages the resources of other agencies with a declared role in tobacco control.
“Overall, the panel is confident that many of the concerns raised in this report can be addressed by CTP’s
talented and dedicated staff, with the support of FDA leadership,” the report states.
Numerous comments from purported staffers of the FDA for the Reagan Udall assessment claimed the regulatory agency is in a state of disarray and being influenced by outside forces, not scientific research. One comment stated that reviewers of premarket tobacco product applications (PMTAs) in the CTP Office of Science (OS) lack the autonomy to exercise “best scientific practices” in their reviews of PMTAs. The report fails to address these issues.
The panel was comprised of former federal public health leaders, regulatory strategists, and process improvement specialists. Lauren Silvis, served as chair of the group, which included Jane Axelrad, Keith Flanagan, Charlene Frizzera, and Alberto Gutierrez.
“The panel provided recommendations to help the Agency’s tobacco program strengthen its operations as it works to reduce the harm associated with tobacco use,” said Lauren Silvis. “The Center for Tobacco Products has made significant progress in establishing a regulatory program for tobacco products and our recommendations are intended to help the Center develop additional tools for achieving its public health objectives.”
Through multiple listening sessions, interviews, and an online portal, the group received and carefully reviewed input from a range of stakeholders, including FDA staff and the public, according to the report. The author’s claim the report offers “cross-cutting and program-specific recommendations” for the FDA to consider, “focusing on regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders.”
The report did not address tobacco policy issues, which are outside the scope of the evaluation, according to a Reagan-Udall Foundation.
One industry stakeholder, who asked not to be named for fear of retribution from the FDA for its brands under PMTA review by the agency, said the report’s findings were “a joke” and “completely ignorant of the real problems at the CTP.”
Califf said Monday he will review the recommendations with the aim of outlining the agency’s next steps by February.
Earlier this month, Reagan-Udall delivered its food report that was commissioned at the same time as the tobacco report. The food response suggests the agency’s leadership be restructured to improve its response to emergencies, including the recent shortage of baby formula
Reagan-Udall was created by Congress to help further FDA’s mission. The non-profit receives funding from both the FDA and the industries it regulates, including drugmakers.
The report can be found at reaganudall.org.
December 19, 2022
CTP Director Ignored Science in Logic Menthol Decision

Brian King / Credit: FDA
Memos recently submitted to the U.S. Court of Appeals for the Third Circuit show that the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) allowed its director, Brian King, to reverse a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists, according to Logic’s lawyers. The new documents were made available to Logic after it had filed its motion for a stay of its marketing denial order (MDO) for its menthol vaping products.
Attorneys for Logic, which is represented by Troutman Pepper, stated that the new documents, that Vapor Voice is reviewing, reveal the “extraordinary fact that CTP’s Office of Science (OS) reversed its science-based recommendation to issue marketing granted orders for Logic’s premarket tobacco product applications (PMTAs) for its menthol-flavored electronic nicotine delivery systems (ENDS) after receiving pressure from the new CTP director and his office, the Office of Center Director (OCD).”
Logic attorneys claim the company is entitled to a stay of the agency’s MDO for the Logic menthol products because the OCD overruled OS’s initial recommendations to approve Logic’s products based upon its “science-based evaluation” of Logic’s submission. However, because the OCD said in the memos that menthol as a category would be “treated disfavorably,” Logic is asking the court to recognize that the agency’s actions of “basing product-specific decisions” on “unpromulgated, across-the-board policies” that were never subject to notice-and-comment rulemaking is “arbitrary and capricious.”
In the first memorandum (dated Oct. 25), the OS explains that it evaluated Logic’s PMTAs, including its product-specific evidence, and concluded that authorization of the marketing of Logic’s menthol-flavored ENDS was appropriate for the protection of public health (APPH). However, the memo shows that the OS changed course only after the new CTP director and OCD, to whom OS reports, concluded that menthol-flavored ENDS should be treated as a “disfavored” product category, despite the evidence to the contrary.
“From a policy perspective, OS believed at the time that as long as menthol-flavored cigarettes remain on the market, menthol-flavored ENDS could be a direct substitute for them, providing a less harmful alternative for menthol-flavored cigarette smokers who are less likely to successfully quit smoking than smokers of non-menthol-flavored cigarettes,” the OS memo reads. “OS considered that this suggested potential benefit in the form of increased opportunity for use and transition coupled with product-specific evidence of some benefits to smokers even if not greater than that of tobacco-flavored ENDS products amounted to a likelihood of greater cessation or significant reduction in smoking that would outweigh the known risks to youth from the marketing of the products sufficient to meet the legal standards for authorization.”
OCD then raised questions about OS’s recommendation including questions about “the role and sufficiency of the general scientific literature on adult menthol smokers’ differential preference for menthol ends in demonstrating likely behavioral change” and underscored its concerns about the substantial appeal of menthol to youth. A decision was still pending for the Logic PMTA in July 2022, when CTP transitioned to a new center director, Brian King.
“OS shared its views with the new center director and engaged in an open discussion on topics including the general body of literature, Logic’s clinical studies, risk to use, and potential postmarketing requirements,” the memo states. “After that meeting, the OCD senior science advisor shared OCD’s views with OS, articulating that in light of the substantial risk to youth and the lack of robust evidence of actual differential use to quit or significantly reduce cigarettes per day, the approach to menthol flavored ends should be the same as for other flavored ends, i.e., the products could be found to be APPH only if the evidence showed that the benefits of the menthol flavored ends were greater than tobacco flavored ends, which pose lower risk to youth.” The OS subsequently changed course and its opinion about Logic’s marketing approval.
The second memorandum reiterates the same policy shift and suggests that meetings were held to address the concerns of OS staff regarding the appropriateness of the decision-making process behind the denial of Logic’s menthol PMTAs. The OS also had concerns that the new OCD approach would eliminate all non-tobacco-flavored ENDS products.
“During deliberations, it became clear that there was not agreement with CTP on the approach for evaluating menthol-flavored ends. OCD took steps to consider and address staff use and to ensure that the process for decisions on PMTAs was driven by the science. In July 2022, shortly after becoming CTP center director, Brian King, a doctoral-level scientist, conferred with OS and members of OCD about menthol-flavored ends and the Logic menthol-flavored ends PMTA,” the second memo states. “After that meeting, the OCD senior science advisor conveyed that Dr. King’s position was the same as the previously held OCD position. Articulating in particular that in light of the risk to youth and the lack of robust evidence of actual differential use of menthol-flavored ends to quit or significantly reduced cigarettes per day, the approach to menthol-flavored ends should be the same as with other flavored ends with respect to the evidence of adult benefit. Subsequently, and upon its own initiative, OS reassessed OCD’s approach … .”
In October, numerous comments from staffers of the CTP for the Reagan Udall assessment of the performance of the FDA’s tobacco center claimed the regulatory agency is in a state of disarray and being influenced by outside forces, not scientific research. One comment stated that reviewers of PMTAs in the OS lack the autonomy to exercise “best scientific practices” in their reviews of PMTAs.
“Scientific disagreement is frowned upon, if not entirely suppressed, and punished through various backhanded methods (e.g., lack of assignments, projects, and other opportunities that are needed for career development/promotion),” the comment states. “In some divisions (e.g., Division of Nonclinical Science [DNCS]), leadership pushes a ‘gotta get em’ mentality onto staff, which is unsupportive of a reviewer’s fundamental duty to provide an unbiased review using the best available science.”
Earlier this week, a unanimous panel of the United States Court of Appeals for the Fourth Circuit denied Avail Vapor’s petition to have its MDO invalidated. Avail also argued that the FDAs review process for PMTAs, although not specifically menthol, were arbitrary and capricious.
The U.S. Court of Appeals for the Eleventh Circuit stayed an MDO issued by the FDA to Bidi Vapor earlier this year, which also argued the agency’s rulemaking was arbitrary and capricious.
These two rulings were all made before the release of the Logic documents. Several industry experts have told Vapor Voice that this revelation of FDA memos could be “game changing” for industry lawsuits. Avail is rumored to be taking its case to the Supreme Court of the United States. The FDA does not comment on pending litigation.
December 14, 2022
FDA Accepts Several Streamline Synthetic PMTAs
Streamline, parent to Juice Herad and several other e-liquid brands, announced that the U.S. Food and Drug Administration had accepted the company’s premarket tobacco product applications (PMTAs) for several of its synthetic products under the Juice Head brand.
In an email, Streamline co-founder and CEO Patrick Mulcahy said that his staff and Accorto Regulatory Solutions were instrumental in preparing the PMTAs for submission.
“With ample investment and focus on ensuring the quality and compliance of all Juice Head products, we are thrilled to be making progress and look forward to a positive response from the FDA.
“Currently, our PMTAs for Juice Head 5Ks, Juice Head Bars, and Juice Head Pouches are still under review; however, we are confident that we will receive a positive response from the FDA soon,” Mulcahy said. “As always, we will maintain our commitment to transparency and communication throughout the process ahead.”
December 12, 2022