Tag: U.S. Food and Drug Administration

Comments in FDA Assessment Suggest Agency in Disarray

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The U.S. Food and Drug Administration is in disarray and influenced by outside forces rather than scientific research, according to several comments submitted to the Reagan-Udall assessment of the performance of the FDA’s Center for Tobacco Products (CTP).
In July, the FDA commissioned an independent review of the agency’s food and tobacco programs following months of criticism over its handling of a baby formula shortage and e-cigarette reviews. FDA Commissioner Robert Califf chose the nonprofit Reagan-Udall Foundation, a nongovernmental research group created by Congress to support the FDA’s work, to perform the review.
As part of its work, the Reagan-Udall Foundation has been soliciting feedback from stakeholders.
Many of the comments paint a picture of an agency struggling to fulfill its mandate.
One commenter said that reviewers of premarket tobacco product applications (PMTAs) in the CTP Office of Science 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),” this person wrote.
“In some divisions (e.g., Division of Nonclinical Science), 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.”
Another commenter claims that arbitrary and politically driven timelines set externally (by a judge for example) are driving reviews as opposed to allowing for a thorough scientific review. “When errors are found, the CTP reviewers are blamed when in fact the lack of adequate time to complete the reviews are at fault.
“Staff are burned out and constantly told to do more in less time and blamed for not meeting insane deadlines,” the commenter wrote. “In cases where reviews are finished and scientific decisions are made, they are also overruled by political agendas and pushed to change decisions.”
To read all comments, please visit the Reagan-Udall Foundation’s stakeholder portal.

October 31, 2022
$Logic Rejection Based on Fuzzy Math$

Logic Rejection Based on Fuzzy Math

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The FDA’s recent rejection of Logic products is based on questionable statistics, says the director of the Center for Substance Use Research.
By Neil McKeganey
Last week in Washington, D.C., at the FDLI Tobacco Conference, Brian King, director of U.S. Food and Drug Administration’s Center for Tobacco Products, explained that FDA would be using the recently released 2022 National Youth Tobacco Survey (NYTS) results to inform its judgment as to whether electronic nicotine-delivery system (ENDS) products being assessed under the premarket tobacco product application (PMTA) process would be deemed “appropriate for the protection of the public health.” For those unfamiliar with the National Youth Tobacco Survey, the just-published survey data showed that 9.4 percent of youth in the U.S. had used an e-cigarette in the last 30 days, that 84.9 percent of flavored e-cigarette-using youth had used a nontobacco flavor and that 26.6 percent of those had used menthol-flavored e-liquids.
If anyone in the audience thought that there might be a disconnect between King’s words and FDA actions, they were proved wrong barely a week later when marketing denial orders (MDO) arrived at the doorstep of Logic Technology Development for its Logic Power Menthol E-Liquid Package and its Logic Pro Menthol E-Liquid Package, with the FDA press release accompanying those denial orders expressly referring to the NYTS findings. In the light of King’s warning, you might think that the company receiving those denial orders could hardly have expected anything else. On the face of it, the NYTS figures are very scary, seemingly justifying immediate action on the part of the FDA. But as with all percentages, you have to look a little closer at what is actually being reported before you push the red button of alarm.
Within the CDC Mortality and Morbidity Weekly Report setting out the NYTS results, the prevalence of youth use of Logic products is shown to be 4.3 percent. However, that is not 4.3 percent of all U.S. youth but 4.3 percent of the 9.4 percent of youth who were currently vaping within the U.S. With that clarification, the numbers here begin to look very different to the headline announcements. Instead of alarming levels of Logic use among U.S. youth, the extent of that use reported by the CDC researchers is 4.3 percent of 9.4 percent, i.e., 0.4 percent. By their own calculations, the CDC authors estimate this to be 100,000 of all U.S. youth—hardly an epidemic of Logic use.
But it gets worse than this because the 0.4 percent figure of youth Logic use actually refers to the Logic brand not the two denied products. Unfortunately, the NYTS does not collect information on the specific Logic devices that youth in the U.S. are using. However, research currently underway by the Centre for Substance Use Research in Scotland does have these data. The Scottish researchers have been studying ENDS use among representative samples of U.S. youth and adults in 2021 and 2022, collecting data on over 20 leading ENDS brands and over 200 specific ENDS devices.
In this Scottish research, out of the 1,215 youth aged 13 to 17 surveyed in 2022, 0.2 percent had ever used a Logic Power and 0.5 percent had ever used a Logic Pro. When the Scottish researchers looked at youth e-cigarette use over the last 30 days, the levels of Logic use shrank even further with 0.1 percent of youth reporting having used the Logic Power in the last 30 days and the level of Logic Pro use so low that it was not even recorded.
In dispatching the MDOs for these two products, the FDA seems to have set aside a commitment to review the data around individual devices and liquids and to formulate a response in terms of the brand of products being used and justify the denial orders issued by reference to the NYTS data.
However, there is something even more troubling in the MDOs that have been dispatched this week. If the CDC researchers estimates of only 0.4 percent of U.S. youth having used a specific branded ENDS product is sufficient for the FDA to issue an MDO, one has to wonder at the relative value that is being placed here on the goal of helping adult smokers to quit and the goal of preventing youth vaping.
The good news in the NYTS research is that overall levels of e-cigarette use by youth in the U.S. is declining. The bad news is that it would appear from the Logic experience that for as long as the NYTS data reveal any level of youth ENDS use, no matter how small, the FDA may still regard that as sufficient to issue an MDO. The implicit suggestion here then is that the FDA are operating a zero-tolerance approach to youth ENDS use and are prepared to sacrifice the potential benefit of ENDS products for adult smokers on the altar of youth ENDS prevention.

Neil McKeganey is the director of the Center for Substance Use Research in Glasgow, Scotland.

October 28, 2022
Juul Lab Publishes Details of MDO Appeal

Photo: Juul Labs

Juul Labs has published its administrative appeal of the marketing denial order (MDO) issued by the U.S. Food and Drug Administration, which explains the company’s position, based on science and evidence, that the MDO was substantively and procedurally flawed. This appeal, referred to as a 10.75 appeal, is currently under review by the FDA.
In its press release for the MDO, the FDA stated that Juul Labs’ premarket tobacco product applications (PMTAs) “lacked sufficient evidence regarding the toxicological profile of the products” and that some of the “study findings raised concerns due to insufficient and conflicting data.”
Juul Labs believes that each of the deficiencies in the MDO is based on an incorrect and incomplete assessment of the data, and when the data are appropriately evaluated within the PMTAs, the FDA can properly assess the toxicological profile of Juul products and relative to other tobacco products, including combustible cigarettes. The appeal also shows that all perceived limitations could have been resolved by clarifications through the usual, iterative process that the FDA has followed for prior applications.
Through its 10.75 appeal, Juul Labs requests that the MDO be rescinded and its PMTAs be placed back into substantive review so that the FDA can complete a full and fair review to determine whether the Juul system is appropriate for the protection of public health. “We believe that once the FDA does a complete review of all of the science and evidence presented in the applications, without political interference, as required by law, we should receive marketing authorization for our products,” Juul Labs wrote in a press note.
For context: In July 2020, Juul Labs submitted PMTAs to the FDA for its currently marketed products and a new device with age-verification technology. The PMTAs included over 125,000 pages of data, information and analysis from over 110 scientific studies across nonclinical (75-plus studies), clinical (14 studies) and behavioral (21 studies) research programs to support the marketing of Juul products. The company also assessed its products relative to combustible cigarettes, an FDA-authorized heated-tobacco product (IQOS) and other marketed vapor products.
Despite this science and evidence, on June 23, 2022, the FDA issued an MDO for Juul Labs’ PMTAs. On July 5, the FDA stayed the MDO, announcing, on its own, that it would review the decision after determining “there are scientific issues unique to this application that warrant additional review.”
A summary of the Juul Labs responses to what the company believes are the deficiencies of the MDO is available here.

October 24, 2022
FDA Completes 95 Percent of Synthetic Nicotine Applications

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As of Oct. 7, the U.S. Food and Drug Administration has issued refuse to accept (RTA) letters for more than 889,000 non-tobacco nicotine (NTN) products in premarket tobacco product applications (PMTAs) that do not meet the criteria for acceptance, the agency announced on its website.
The agency has accepted over 1,600 applications, with the vast majority being for e-cigarette or e-liquid products.
“While the application review is ongoing, FDA remains vigilant in overseeing the market and will continue to use our compliance and enforcement resources to curb the unlawful marketing of [non-tobacco nicotine] NTN products,” the FDA wrote. “To date, FDA has issued a total of over 60 warning letters to manufacturers, including brands popular among youth such as Puff Bar. The manufacturer warning letters include those for products for which an application had been submitted but where the agency has taken a negative action, such as a [RTA].”
The FDA has also issued over 300 warning letters to retailers for violations in relation to their sale of NTN products to underage purchasers, and imposed civil money penalties against two retailers for sales of NTN products to underage purchasers.
“To date, the FDA has not authorized any NTN products. Therefore, all NTN products on the market are marketed unlawfully and risk FDA enforcement action,” the FDA stated. “It is illegal for a retailer or distributor to sell or distribute e-cigarettes that the FDA has not authorized, and those who engage in such conduct are at risk of FDA enforcement, such as a seizure, injunction, or civil money penalty.”

October 15, 2022
‘Current FDA Oversight to Have Minimal Impact’

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Current U.S. Food and Drug Administration oversight of the vaping industry in the U.S. is likely to have minimal impact, suggests an analysis of the regulator’s warning letters for marketing violations, published online in the journal Tobacco Control.
The regulator is failing to target the key players or the products most popular with young people, the analysis suggests, with over 90 percent of warnings sent to small online retailers rather than leading tobacco companies, and a focus on refillable devices.
While the prevalence of vaping among U.S. adults remains low, at just under 4 percent in 2020, it is four times higher among young people.
In 2016, the FDA announced plans to regulate the vaping industry, including a requirement for the manufacturers of e-cigarettes to obtain premarket approval (PMTA) to ensure that their products protect public health.
In 2017, the regulator began sending warning letters to manufacturers, retailers and distributors for potential violations, such as advertising to young people, selling to minors, packaging or labeling that contravened regulations, and failure to apply for a PMTA.
But little is known about who received these letters, the types of product they concerned, or details of the violations and their consequences.
To try and find out, researchers from Truth Initiative assessed the content and recipients of publicly available FDA warning letters issued in 2020 and 2021. In total, the FDA issued 303 warnings: 126 in 2020 and 177 up to Sept. 9, 2021.
The analysis revealed that in 2021, over 98 percent of all the targeted companies fulfilled all three roles (manufacturer, distributor and retailer).
But nearly all the letters (97 percent) were sent to small online retailers, none of which were large companies with measurable market share, as evidenced by sales data.
Companies were cited for between one and three infractions. Most involved failure to obtain a PMTA. In 2020 and 2021, respectively, 56 percent and 99 percent-plus of the infractions concerned a PMTA violation.
And more than 90 percent of the products cited—880 different ones in total—were flavored refillable e-cigarette liquids rather than the disposable vaping devices that the evidence indicates are most popular with young people.
Penalties ranged in severity from product detention to product seizure and fines. But loss of tobacco distributor license and criminal charges appeared less frequently in both years than these other consequences.
At the time of the review, most (72 percent) of the websites cited for 2020 infractions were still operating as were 29 percent of websites cited for 2021 infractions.
And as the authors note, it was impossible to find out how the targeted companies responded and whether the FDA followed through with the consequences cited in the warning letters because that information isn’t publicly available.
“While current research estimates that online sales comprise around one-third of the marketplace, data tell us that most young people get their products from friends (32.3 percent), buy them from another person (21.5 percent) or purchase from a vape shop (22.2 percent),” the authors noted in a statement.
“Prioritizing the products most accessed by youth, which are made available from a variety of sources, will be important to curb youth use,” they add.
“Strong, impactful and transparent consequences need to be in place to prevent the sale of products that violate regulations necessary in protecting the health of adult users of e-cigarettes and preventing youth use alike,” the authors added.
“The FDA should use its enforcement powers to target the manufacturing, distribution and sellers of the tobacco products that have the greatest impact on youth and products that provide no public health benefit.”

October 14, 2022
Confusion Persists About Magellan MDO

Photo: Damir Khabirov

The U.S. Food and Drug Administration has confirmed that Magellan Technology received marketing denial orders (MDOs) on Oct. 6 for 32 products.
In response to the FDA press statement announcing the order, Magellan Technology denied having received an MDO, saying the agency had refused to accept its premarket tobacco product application (PMTA) on a technicality without reviewing the PMTA on its merits.
Magellan Technology demanded that the FDA not only retract the press announcement but also issue a corrective statement, making clear that the FDA did not issue an MDO to Magellan and that it has not yet conducted a scientific review of Magellan’s products.
In response to an inquiry by Vaping360, the FDA reiterated that it had served Magellan Technology with an MDO.
“After reviewing premarket tobacco applications for 32 Hyde e-cigarettes, FDA issued marketing denial orders for these applications submitted by Magellan Technology Inc. on Oct. 6,” the agency told Vaping360. “In addition to the MDOs issued on Oct. 6, as acknowledged by Magellan Technology Inc. in their statement, FDA also issued a Refuse to Accept letter for other Hyde e-cigarette products.”

October 14, 2022
VTA Questions FDA’s Youth Vaping Analysis

Tony Abboud (Photo: Taco Tuinstra)

The U.S. Food and Drug Administration misrepresents the latest data on youth vaping, according to Vapor Technology Association (VTA) Executive Director Tony Abboud.
On Oct. 6, the FDA and the U.S. Centers for Disease Control and Prevention released new data from the 2022 National Youth Tobacco Survey (NYTS) on e-cigarette use among U.S. youth.
“The FDA represents the NYTS data to show that youth vaping ‘remains high,’ yet a deeper dive into the data show[s] only a small uptick in experimental or infrequent use while regular use remains flat or is slightly down,” said Abboud in a statement.
Abboud notes that since 2019, according to the CDC, the number of high school students who have tried vaping (one time in the last 30 days) has dropped by 50 percent, and the number of middle school students has plummeted by 70 percent. During that same time period, the number of high school students who “frequently” vape dropped by 37 percent, and the number of middle school students dropped by 65 percent.
“FDA’s near single-minded focus on youth who experiment with vaping versus those who are frequent users ignores what clearly is a consistent trend of youth away from vaping products. Rather than focusing on removing products from the market in an attempt to impact youth vaping, the FDA should instead support common sense regulatory reforms that would better restrict access to products instead,” said Abboud. “Simply removing products from the market is not the answer when those products are also proven to help adult smokers quit.”
According to Abboud, it is well documented that flavored vapor products help adult smokers switch to less harmful vaping and “study after study after study” has confirmed the data. Since 2010, when e-cigarettes became widely available in the U.S., smoking rates have declined by more than half, he noted.
“Tobacco use is down. Youth vaping is down. These are both good things and are not in dispute. Unfortunately, there are still 40 million Americans addicted to cigarettes,” Abboud said. “Every year, 500,000 die from smoking-related diseases and yet less than 3 percent of our kids are using vapes on a regular basis. The FDA’s failure to acknowledge this reality ignores the role vaping plays in harm reduction and smoking cessation and puts more lives at risk.”

October 9, 2022
Magellan Denies Receiving MDO

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Magellan Technology insists it did not receive a marketing denial order (MDO) for its Hyde Brand, despite a U.S. Food and Drug Administration announcement to the contrary.
In an email to Tobacco Reporter’s sister publication, Vapor Voice, Magellan CEO Jon Glauser said his company had received a “refuse to accept” (RTA) letter. An RTA is not a judgment on the product’s appropriateness for the protection of public health. It is merely a determination that the premarket tobacco product application doesn’t conform to the FDA’s standards, and it leaves the applicant the option to refile.
“A refuse to accept letter is a refusal based on nothing more than a technical review of the applications’ contents, which, in this case, was a missing document, i.e., a sworn certification related to the translation of certain components of the application,” wrote Gauser. “In other words, the refusal to accept was based on bureaucratic technicalities.”
In its letter to Magellan, the FDA wrote that the absence of the forms prevented the agency from accepting and processing the applications. “In other words, FDA could not have conducted any scientific review because it refused to accept the application,” wrote Glauser. “Our counsel has demanded that FDA not only retract the press statement it made but also issue a corrective statement making clear that FDA did not issue an MDO to Magellan and that it has not yet conducted a scientific review of Magellan’s products.”
Magellan is not the first company to take issue with the FDA’s handling of the PMTA process. The agency is currently facing more than 20 lawsuits and has had to backtrack on MDOs issued to companies such as Juul Labs, Turning Point Brands and Kavial Brands.

October 7, 2022
FDA Seeks TPSAC Nominations

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The U.S. Food and Drug Administration’s Center for Tobacco Products is requesting nominations for two individuals to serve as voting members on the Tobacco Products Scientific Advisory Committee (TPSAC). According the FDA website, individuals may self-nominate or be nominated by any interested person or organization.
Nominations received on or before Nov. 25, 2022, will be given first consideration. Nominations received after Nov. 25, 2022, will be considered as later vacancies occur.
TPSAC advises the CTP in its responsibilities related to the regulation of tobacco products. The committee reviews and evaluates safety, dependence and health issues concerning tobacco products and provides appropriate advice, information and recommendations to the FDA commissioner.
The notice has been published in the Federal Register.

September 26, 2022
Juul Sues FDA for Docs Justifying Product Ban

Juul Labs is suing the U.S. Food and Drug Administration to force the agency to disclose documents supporting its order banning the company’s products, reports Reuters.
On June 23, the FDA ordered Juul Labs to pull its e-cigarettes from U.S. store shelves, saying the e-cigarette manufacturer had submitted insufficient evidence that they were “appropriate for the protection of the public health.”
A federal appeals court then granted Juul Labs an emergency stay of the order to give the judges time to evaluate the merits of Juul’s appeal. The e-cigarette company separately asked the FDA to stay its own order pending the appeal.
In a complaint filed on Sept. 21 with a federal court in Washington, D.C., Juul accused the FDA of invoking the deliberative process privilege to improperly withhold scientific materials that are key to understanding the basis for the June 23 sales ban.
Juul said the materials would show whether the FDA conducted a legally required balancing of the public health benefits and risks of its products, including claims they help smokers quit cigarettes, and whether the agency’s reasoning was scientifically sound.
“The public deserves a complete picture of the scientific facts behind one of the agency’s most controversial and closely scrutinized decisions in recent years,” Juul said.
Juul accused the FDA of violating the federal Freedom of Information Act by withholding a majority of the “scientific disciplinary reviews” underlying the sales ban.

September 21, 2022