Category: Regulation

Anonymous Staff Comments say FDA Dysfunctional

Credit: Andrii Yalanskyi
Numerous comments from purported staffers of the U.S. Food and Drug Administration for the Reagan Udall assessment of the performance of the FDA’s Center for Tobacco Products (CTP) claim 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.
“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.”
In July, the FDA commissioned an independent review of the regulatory agency’s food and tobacco programs following months of criticism over its handling of the baby formula shortage and e-cigarette reviews. FDA Commissioner Robert Califf chose the non-profit Reagan-Udall Foundation, a non-governmental research group created by Congress to support the FDA’s work.
The comments are anonymous and open to the public. Many of the comments paint a picture of an agency that is inept and making decisions persuaded by political agendas and not based on the science surrounding next generation nicotine products. One reported FDA staffer claimed that there’s a toxic culture permeating the OS that begins with the FDA’s leadership teams.
“The so-called leaders do not solicit feedbacks from the actual reviewers, instead, listening to few of the loudest ducks, who are not the experts in any of the specific disciplines,” the commenter wrote. “Favoritism/nepotisms, unconscious bias, racism/sexism, permeating the whole office/Division, the minority and women consistently being ignored for their suggestions/feedbacks, although they are the ones who did most amount of work.”
Another comment 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 comment states. “In cases where reviews are finished and scientific decisions are made they are also overruled by political agendas and pushed to change decisions.”
Another comment states that the Tobacco Control Act (TCA) favors combustible tobacco products by allowing new combustible products to take easier pathways to market, such as being considered pre-existing tobacco products or through the standard equivalency (SE) pathway.
“CTP has explicitly stated that the science supports the notion of a continuum of risk, i.e. that combustible products are the deadliest and noncombustible products appear to be nominally safer. Nevertheless, CTP has elected to conduct a product by product premarket review of new tobacco products,” the comment states. “So any innovative product, such as an e-cigarette, would most likely have to undergo a more robust and burdensome pathway to market, e.g. PMTA.”
It not all doom and gloom, however, as some claim that agency staffers are just overworked. One commenter stated that CTP is constantly working under impossible deadlines with long review queues that none of the other centers overseen by the FDA are required to endure.
“The volume of applications it sees and products it regulates are astronomical in comparison, but we are not being given any protection, support, or leeway to handle this burden,” the comment states. “Instead, it seems as if CTP and OS are blamed for having large queues or not making deadlines, without anyone taking a look to see just how much work is being done to ensure that things are done as soon as humanly possible. Treating this Center as the rest of the Centers in terms of queues and timelines is unhelpful and encourages burnout.”
Another commenter wrote that the FDA doesn’t have the ability to give all PMTAs a “fair and equal” review, a claim that has been denied by the agency in court cases surrounding its issuing of marketing denial orders. “There are so many layers to make sure the science makes sense, its being communicated in a way that makes sense. But it doesn’t have the people or breathing room to apply that system to every single application equally,” the comment states. “We are definitely all being overworked and stretched too thin with unreasonable deadlines, lack of protection from those outside of CTP, and a staffing shortage.”
October 28, 2022
McKeganey: FDA Seems to Have set Aside Science

Credit: Lisa F. Young
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 results to inform its judgement as to whether 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 non-tobacco 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 order 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 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 amongst 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 amongst representative samples of U.S. youth and adult 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 1215 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 MDO’s 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 MDO’s 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 FDA to issue a 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 FDA are operating a zero-tolerance approach to youth ENDS use and 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
FDA Denies First Menthol-Flavor PMTAs After Review

The U.S. Food and Drug Administration has issued marketing denial orders (MDOs) for several menthol-flavored vaping products marketed by Logic Technology Development. The products include the Logic Pro Menthol e-Liquid Package and Logic Power Menthol e-Liquid Package. It’s the first time the FDA has issued MDOs for menthol products after receiving a scientific review.
The move seems inline with the regulatory agency’s goal to ban menthol flavors from tobacco products. The FDA also isn’t expected to approve any flavored vaping product other than tobacco. In June, the National Institutes of Health and the FDA gave the University of Louisville a $3.6 million grant to study the effects of flavorings like mango and bubblegum used in vaping products. The study is still being conducted.
“Ensuring new tobacco products undergo premarket evaluation is a critical part of the FDA’s work to reduce tobacco-related disease and death,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP), in a release. “We remain committed to evaluating new tobacco products based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole.”
Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, told Vapor Voice the latest move by the FDA to ban menthol vaping flavors is reminiscent of the agency’s “fatal flaw” review of PMTAs that resulted in millions of denials. The term “fatal flaw” was used by the FDA for PMTA submissions that didn’t have specific studies. The term has been at the center of nearly all lawsuits filed against the FDA for its handling of the PMTA process.
“The dysfunction at the FDA knows no bounds. For the last year-plus, the FDA has sat back deferred decision making on menthol vaping products,” Conley said. “Lest anyone believe that FDA was hard at work coming up with ways to achieve balance, today they revealed that their big plan for menthol vaping products is to follow the exact same ‘fatal flaw’ review process that has led to dozens of lawsuits being filed against the agency.”
The agency stated that after reviewing the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications “lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health (APPH), the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.”
The FDA stated that the evidence provided within Logic’s denied PMTAs did not demonstrate that menthol-flavored e-cigarettes are more effective in promoting “complete switching or significant cigarette use reduction” relative to tobacco-flavored e-cigarettes.
The announcement is concerning, especially since CTP is undergoing an external review in which many industry stakeholders have called for a comprehensive plan for PMTA reviews, according to Tony Abboud, executive director of the Vapor Technology Association. He says that the FDA’s action raises at least four major concerns.
“First, the announced rationale makes no mention of the net public health benefit prong, begging the question of whether FDA addressed that required element of the APPH test? Second, how is the public health benefitted by FDA’s approval of 123 new menthol cigarette/cigar products, given its inability to authorize a single less-harmful menthol vaping product?” Abboud asks. “Third, how can the Agency continue to rely on general (i.e., non-Logic specific) menthol youth data to impose a heightened Logic-specific cessation standard, especially given the dramatically reduced [National Youth Tobacco Survey] NYTS youth use rates and no apparent tie to Logic products?
“Fourth, is the Agency undermining its proposed menthol cigarette rule, given that FDA’s science shows that half of the predicted quitters under the proposed standard must switch to menthol vapes, none of which have been authorized?”
Logic must now decide if it will resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs. However, the FDA states that for non-tobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, “existing evidence demonstrates a known and substantial risk” with regard to youth appeal, uptake and use.
“The FDA conducts a rigorous, scientific review of submitted premarket tobacco product applications, evaluating the data for each product to determine if it meets the public health standard,” said King. “In this case, the applicant did not provide sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks to youth.”
A recently accepted manuscript of an article set for publication in Nicotine & Tobacco Research found that flavored vaping and other tobacco sales restrictions in California did not affect youth e-cigarette use.
The MDO letter that Logic received today is not limited to the two products named above, according to the agency. In general, the FDA publicly names only products that the applicant is marketing to avoid potential disclosure of confidential commercial information.
Any products subject to an MDO may not be offered for sale or distributed in the United States, or the FDA may take enforcement action. These products cannot be legally introduced into interstate commerce in the U.S. without risking FDA enforcement. In March, the FDA authorized several tobacco-flavored e-cigarette products from the company under the Logic Vapeleaf, Logic Power and Logic Pro brands, including devices.
In addition to ensuring that Logic complies with this order, the FDA intends to ensure compliance by distributors and retailers. Specifically, the FDA notes that all new tobacco products on the market without the “statutorily required premarket authorization” are marketed unlawfully and their distribution or sale is subject to enforcement action.
Recently, the U.S. Department of Justice filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers on behalf of the FDA. The cases represent the first time the FDA has initiated injunction proceedings to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket review requirements for new tobacco products.
Retailers should contact Logic with any questions about products in their inventory.
October 26, 2022
Philippines Begins Consultation on New Vape Law

Photo: BillionPhotos.com
The Philippines Department of Trade and Industry (DTI) will begin consulting the public for the crafting of the implementing rules and regulations (IRR) of the country’s new vape law today, reports ABS-CBN News
“For private stakeholders who have an interest on the crafting of the IRR, they are included, and we will consider all inputs or all comments that were sent,” said DTI Undersecretary Ruth Castelo.
The Philippines’ Vaporized Nicotine Products Regulation Act governs the importation, manufacture, sale, distribution and use of vape products. Among other measures, it calls for lowering the vaping age to 18 from 21.
The DTI was tasked to craft the IRR, following the transfer of the regulation of vapes from Food and Drug Administration.
The proposal was submitted to the Presidential Palace on June 24, days before then-President Rodrigo Duterte stepped down from office. Because the executive branch did not act on it within 30 days, the proposed legislation lapsed into law in July.
October 24, 2022
Irish Minister: Disposable Vapes ‘Worsen the World’

Credit: Schankz
Single use vapes have been described as “worsening the world” amid plans for their ban by Minister for State Ossian Smyth.
The Minister stated that single use disposable vapes could be banned under the Circular Economy Act or the single use plastic directive.
However, Smyth said that a ban would not come into effect before consultations with the general public and sellers took place. He told listeners on RTE’s Morning Ireland that vapes had now become the default option for smokers, as they are typically half the cost of cigarettes.
“If you were at the Electric Picnic festival earlier this summer, you would’ve seen these brightly coloured tubes all over the ground,” he said. “They’re everywhere and they are an innovation that has made the world a worse place.”
The Green Party politician also admitted that a complete ban would be unlikely as people would still attempt to purchase single use vapes online. However, he reassured listeners that it would “massively reduce” their purchase and ultimate benefit public health.
October 21, 2022
Third Time a Charm for Vape Ban in Nashville Bars

Credit: Adriano CZ
It still has another step. However, Nashville, Tennessee’s, Metro Council passed a law to prohibit smoking and vaping products in Nashville bars and venues on its third reading Tuesday night.
The rule overwhelming passed with 30 votes in approval and four against. One council member abstained from the vote, according to media reports. There will be one more vote to approve passage of the ordinance, however, the large amount of support for the ordinance almost guarantees it will become law.
The law, BL2022-1383, was deferred at Metro Council’s meeting on Sept. 20 due to a late-filed amendment that would protect vapor bars that generate direct revenue from the on-site sale of vapor products and accessories related to this use.
The law was then amended and passed on second reading as amended at Metro Council’s meeting on Oct. 4. Tennessee law previously allowed smoking in 21 and up bars at the owner’s discretion. If the rule passes, it wouldn’t go into effect until March of 2023 to give businesses time to adjust.
The council said they are not permitted to prohibit smoking or vaping at establishments that are specifically cigar bars, tobacco retail stores and vape retail stores due to state law. A law passed by the Tennessee General Assembly last year gives local governments the authority to prohibit the use of tobacco products on public property by ordinance.
October 19, 2022
DOJ Files Injunctions Against 6 Vapor Manufacturers
The U.S. Department of Justice (DOJ) today filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers on behalf of the U.S. Food and Drug Administration. The cases represent the first time the FDA has initiated injunction proceedings to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket review requirements for new tobacco products.
The FDA states that each of the defendants failed to submit premarket tobacco product applications (PMTAs) for their e-cigarettes and have continued to illegally manufacture, sell, and distribute their products, despite previous warning from the FDA that they were in violation of the law.
The injunctions would require the companies and named individuals to stop manufacturing, selling, and distributing their e-cigarettes. “Today’s enforcement actions represent a significant step for the FDA in preventing tobacco product manufacturers from violating the law,” said Brian King, director of the FDA’s Center for Tobacco Products. “We will not stand by as manufacturers repeatedly break the law, especially after being afforded multiple opportunities to comply.”
DOJ institutes judicial enforcement actions under the FD&C Act in court, according to a press release. Therefore, the injunctions were filed by DOJ on behalf of the FDA against the following defendants in their respective U.S. District Courts:

Morin Enterprises Inc. doing business as E-Cig Crib in the District of Minnesota

Soul Vapor LLC in the Southern District of West Virginia

Super Vape’z LLC in the Western District of Washington

Vapor Craft LLC in the Middle District of Georgia

Lucky’s Convenience & Tobacco LLC d/b/a Lucky’s Vape & Smoke Shop in the District of Kansas

Seditious Vapours LLC d/b/a Butt Out in the District of Arizona
The FDA states that the defendants continued to manufacture, sell, and distribute unauthorized e-cigarettes to consumers after receiving warning letters from the agency. The FDA’s prior warnings noted that further violations could lead to enforcement action, including injunction.
“These cases are an important step in stopping the illegal sale of unauthorized electronic nicotine delivery system products,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work closely with FDA to stop the distribution of illegal, unauthorized tobacco products.”
When companies are manufacturing and distributing unauthorized tobacco products, the FDA will typically first issue a warning letter in an attempt to achieve voluntary compliance with the law. If continuing violations are documented by the FDA, the agency may request that DOJ pursue a judicial enforcement action, such as an injunction or seizure.
The FDA also has administrative civil money penalty authority for violations of the FD&C Act relating to tobacco products.
October 18, 2022
AVM Asks for Ethics Investigation Into Dick Durbin

Dick Durbin and Center for Tobacco Products Director Brian King (Photo: The office of Senator Dick Durbin)
The American Vapor Manufacturers Association (AVM) has requested that the Senate Ethics Committee investigate Illinois Senator Dick Durbin for allegedly violating Senate rules by attempting to improperly influence U.S. Food and Drug Administration scientific decisions about vaping products, according to Vaping360.
On Oct. 14, the AVM delivered a letter to the chair and vice chair of the Senate Select Committee on Ethics that alleged Durbin pressured the FDA to ban all vaping products despite the agency’s premarket tobacco product application (PMTA) review process.
Citing Durbin’s track record (urging the FDA to ban vapor products via letters, Senate floor speeches, press releases and private meetings) the AVM says it believes Durbin attempted “to interfere with and influence the outcome of an ongoing executive branch agency review process in violation of Senate Ethics rules.”

“Senator Durbin’s arrogant bullying has now become a grave threat to public health.”
Amanda Wheeler, president, AVM
“Senator Durbin’s arrogant bullying has now become a grave threat to public health,” AVM President Amanda Wheeler said in a press release. “At a time when trust in public health authorities is already shaky, Durbin’s shameful campaign to hijack federal policy on this crucial health issue should come to an immediate end.”
The letter to the Senate committee marks the second time this year that the AVM has asked a government body to investigate corruption of the FDA PMTA review process.
According to Vaping360, the ethics committee is unlikely to seriously investigate Durbin or cite him for misconduct; Durbin is Senate Majority Whip, making him the second-highest ranking Democrat in the Democratic-led body.
October 17, 2022
FDA Denies Nearly 95% of Synthetic Nicotine PMTAs

The U.S. Food and Drug Administartion today announced that, as of Oct. 7, the agency has issued refuse to accept (RTA) letters for more than 889,000 products in premarket tobacco product applications (PMTAs) that do not meet the criteria for acceptance.
The agency also announced it FDA 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. To date, FDA has issued a total of over 60 warning letters to manufacturers, including brands popular among youth such as Puff Bar,” the FDA stated in a release. “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.”
All authorized e-cigarettes are posted on FDA’s Tobacco Product Marketing Orders page.
October 14, 2022
FDA Fails to First Inform Hyde of MDOs Before Public

The U.S. Food and Drug Administration confirmed that Magellan Technology received marketing denial orders (MDOs) on Oct. 6 for 32 products. However, Magellan CEO Jon Glauser said the FDA acknowledged in writing that it had “erred in failing to inform the company” about the MDOs and only after the Oct. 6 announcement did Magellan receive the letters from the FDA.
“Because the affected PMTAs had been pending with the agency for over two years, we can only surmise that what the FDA deemed an “inadvertent error” in failing to inform the company was caused by an apparent rush to include the MDO action with the Agency’s press release on the National Youth Tobacco Survey data, which shows youth vaping down 50% since 2019,” Glauser states in an email. “The MDOs covered only certain Hyde products containing tobacco-derived nicotine. No Hyde products containing non-tobacco nicotine are subject to an MDO.”
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 (MDOs) 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 (RTA) Letter for other Hyde e-cigarette products.”
Glauser states that the FDA did issue a Refuse to Accept (RTA) letter for certain of Magellan’s Hyde
products containing non-tobacco nicotine, identifying two administrative requirements the regulatory agency claims the company’s premarket tobacco product applications (PMTAs) were lacking.
“First, with respect to two of our bundled applications, the FDA stated that a signed statement as to the accuracy of certain translated documents was missing. However, the agency misunderstood the fact that the documents themselves are dual language documents that are maintained by our Chinese manufacturer in both English and Chinese. Because the relevant FDA regulation only requires a
certification for documents that have been translated from another language into English, we believe that the cited regulation is inapplicable,” Glauser explains. “This is the only issue cited against one of our bundled applications and on October 12, 2022, we filed a petition for stay with FDA requesting that the agency immediately stay the RTA determination on this basis.”
The second Item, Glauser wrote, relates to nine other applications that the FDA claims a certification statement verifying the PMTA submissions were “true and correct” was missing from those submissions. The FDA had preciously told Magellan that the company already had submitted amendments to its applications with the certification, but the agency could not determine to which applications the amendments needed to be applied.
“To that end, the FDA noted that ‘although your submission(s) may include the required content for a PMTA,’ the absence of the form made it impossible for the FDA to review the applications. While it is unfortunate that these technical issues cropped up with respect to these applications which had to be filed under enormously short time constraints, it is not a reflection of the high quality of scientific work that Magellan has assembled and continues to generate as part of its commitment to the PMTA process, work which the FDA has not yet reviewed,” wrote Glauser. “Magellan’s counsel and consultants already are engaging with the FDA regarding these issues and are asking the Agency to reconsider its initial determination so that Magellan’s application review can progress forward. In the event that FDA refuses, Magellan intends to move promptly to seek judicial relief regarding the RTA letter.”
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 FDA not only retract the press announcement 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.
October 14, 2022