Tag: FDA

FDA, Adams Have Opposing Views on Vaping and Covid

Credit: Kawee
In the last few weeks, numerous sources have suggested vaping could be a risk factor for either contracting or increasing the severity of COVID-19. These reports are almost entirely based on the speculation from anti-vaping advocates, who rarely receive significant pushback, writes Guy Bentley, director of Consumer Freedom for the Reason Foundation.
Appearing on NBC’s Today Show on March 23, U.S. Surgeon General Jerome Adams postulated, without evidence, that vaping could be the reason young people may be at higher risk from COVID-19 than previously thought. “There are theories that it could be because we know we have a higher proportion of people in the United States and also in Italy who vape,” said Adams.
But [on April 16] the U.S. Food and Drug Administration (FDA) told Bloomberg News, “E-cigarette use can expose the lungs to toxic chemicals, but whether those exposures increase the risk of COVID-19 is not known.”
While seemingly anodyne, the statement differs significantly from those of Nora Volkow, director of the National Institute on Drug Abuse (NIDA). Volkow, recently wrote in the Annals of Internal Medicine that vapers could be at high risk for coronavirus.
Similarly, last week, Massachusetts Attorney General Maura Healey went so far to issue an advisory warning that vaping could worsen the spread of COVID-19. And last month, New York City Mayor Bill de Blasio claimed, “If you are a smoker or a vaper that does make you more vulnerable.”
Following an apparently unclear email exchange with an FDA official, Bloomberg News published a story with the headline: “Vaping Could Compound Health Risks Tied to Virus, FDA Says,” that prompted Iowa Attorney General Tom Miller and 12 public health experts to write to the FDA to complain. The signatories warned the FDA that if its communications are “arbitrary and ill-conceived, spreading fear and confusion with little scientific basis and unpredictable consequences, then it would be better if the FDA and its media spokespeople did not comment further at this time.”
Thankfully, the FDA finally appears to be taking this advice seriously. There is currently no evidence from anywhere in the world showing vapers to be at higher risk for COVID-19, Bentley writes in his editorial.
The Science Media Research Center recently released statements from public health experts to help reporters understand what we do know about smoking, vaping, and COVID-19. “There is no evidence that vaping increases the risk of infection or progression to severe conditions of COVID-19,” said Dr. Caitlin Notley. She added that since switching from smoking to vaping improves cardiovascular and respiratory conditions, smokers who switch “might be expected to have a better prognosis if infected by COVID-19.”
Similar to last year’s outbreak of lung illnesses that were initially wrongly associated with conventional e-cigarettes, but later found to be the result of adulterated black market marijuana products, much of the communication around vaping and COVID-19 is targeted at young people in an effort to get them to stop vaping.
The Campaign for Tobacco Free-Kids (CTFK) and Parents Against Vaping Electronic Cigarettes (PAVE) has consistently promoted stories linking vaping and the coronavirus. On April 15, for example, they even promoted a campaign to tell the White House that vape shops are not essential businesses.
“There is growing concern among public health experts that e-cigarettes can put users at greater risk for serious complications from COVID-19, these products are addicting our kids, and they have not been proven to help smokers quit,” says CTFK.
The statement is disingenuous. E-cigarettes have been proven beyond any reasonable doubt to be far safer than combustible cigarettes and consistently shown to help smokers quit. Italy, Spain, France, and Switzerland are keeping their vape shops open because they recognize the public health benefit of ensuring access to safer alternatives to cigarettes.
It’s time for anti-vaping groups to stick to the facts and stop spreading fear and misinformation about a product that is saving millions of lives both in the U.S. and across the globe. Stopping kids from vaping is undoubtedly a noble goal, but it’s not an excuse for misleading the public in ways that could prevent smokers from switching to a dramatically safer product.
April 23, 2023
U.S. Representative Demands FDA Hand Over CBD Data
Credit: Anankkml
The chairman of a congressional committee is demanding that the U.S. Food and Drug Administration turn over documents relating to the agency’s decision not to regulate CBD products.
Rep. James Comer, chair of the House Oversight and Accountability Committee, sent a letter to FDA Commissioner Robert Califf on Monday, announcing an investigation into the agency’s decision and criticizing the “insufficient rationale for inaction” on CBD regulations.
The agency said in January that, after years of review since hemp and its derivatives like CBD were legalized under the 2018 Farm Bill, it determined that there is not a regulatory pathway in place to enact rules allowing the non-intoxicating cannabinoid to be marketed as a food item or dietary supplement.
It said that congressional action is required to develop CBD regulations, according to Marijuana Moment.
Prior to that announcement, Comer had pledged to confront FDA over the lack of regulations for cannabidiol in his capacity as Oversight Committee chairman.
“CBD is an increasingly popular product among adults and has seen an uptick in usage in recent years,” the letter to Califf says, adding that the World Health Organization (WHO) has found CBD to be generally safe and well-tolerated.
The chairman listed “documents and information” that he’s asking FDA to provide to the committee by May 1:
All documents, communications, and drafts related to the January 26 announcement titled “FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward.”
All documents and communications relating to the FDA’s assessment of the existing regulatory framework at issue regarding CBD.
All scientific data, reports, and research in the possession of the FDA relating to the safety of CBD products for consumption.
Congressional lawmakers in the U.S. have refiled a pair of bills meant to provide a pathway for the regulation of hemp derivatives like CBD as dietary supplements and food and beverage additives.
April 18, 2023
Public Hearing for Manufacturing Rules Tomorrow

Credit: Xtock
The U.S. Food and Drug Administration will hold a public hearing tomorrow, April 12, concerning its proposed guidelines for vaping product manufacturers. When finalizing its rules, the agency weighs the public’s perspective and the perspective of stakeholders like the vapor manufacturing companies that produce the products.
The FDA will also bring together its Tobacco Products Scientific Advisory Committee on May 18 to get the opinions of those independent experts. The proposed rules would apply to all FDA-regulated bulk and finished tobacco products, including cigarettes, cigars, chewing tobacco and e-cigarettes.
The hearing is an opportunity for the public to verbally comment on the agency’s proposed rule “Requirements for Tobacco Product Manufacturing Practice.” The FDA is proposing new requirements for vaping and other tobacco product manufacturers regarding the manufacture, design, packing and storage of their products.
Registration also includes a “listen-only” option for those who want to attend the session but do not want to request to speak.
When announcing the hearing, the FDA said speaking spots were limited, and the agency could not guarantee that it would be able to accommodate all requests. The agency asked groups and organizations to select a single spokesperson to help the agency hear as many different perspectives as possible.
Registration to provide oral comments closed on March 31, 2023. The oral session will be recorded, and a transcript will be added to the docket of the proposed rule.
April 11, 2023
Former CTP Director Zeller Joins Qnovia Advisory Board

Mitch Zeller, former director of the FDA’s Center for Tobacco Products
Mitch Zeller, the much-maligned former head of the U.S. Food and Drug Administration’s tobacco center has joined the advisory board of a company developing a first-of-its-kind smoking cessation inhalation product.
Zeller said Qnovia’s nicotine inhalation product, RespiRX, has the potential to be a “game changer” in lowering the use of combustible cigarettes.
The former director of the Center for Tobacco Products (CTP) from March 2013 until his retirement in April 2022, Zeller is now providing policy and regulatory strategy consulting to Qnovia, Inc.
The company is currently preparing an application to the FDA’s Center for Drug Evaluation and Research (CDER) for a cessation therapy which, if approved, will be the first inhaled prescription therapy to help tobacco smokers quit.
Zeller’s addition to the company’s advisory board comes as the FDA aims to finalize proposed bans on menthol cigarettes and flavored cigars by August. The FDA also plans to propose a rule limiting nicotine levels in cigarettes and some other tobacco products.
Zeller said access to Qnovia’s product can be one essential tool along with an administration-wide effort to provide support to those with nicotine addictions once those product standards take effect.
“Some people will be able to quit cold turkey, but a whole bunch won’t, and they will be seeking nicotine elsewhere,” Zeller said in an interview, told Bloomberg Law.
“The last thing that we want smokers to do if any of those policies go into effect is to simply switch to another tobacco product,” he added.
Qnovia’s goal is for RespiRx to be the first inhaled prescription smoking cessation therapy product, according to Qnovia CEO Brian Quigley. Instead of using heat to create vapor, the RespiRx device uses an orientation-agnostic vibrating mesh nebulizer. The aerosolizing engine is nothing like a traditional e-cigarette that heats a coil to atomize nicotine based in PG and/or VG.
RespiRx is activated when a user inhales on the device. To aerosolize the nicotine, it sends an electrical current that causes the perforated piezo mesh to vibrate more than 100,000 times a second. “It’s that vibrating action of the mesh that then forces the liquid to the holes, creating an aerosol that appears vapor-like, allowing it to be inhaled,” says Quigley. That, he says, is fundamentally different from a traditional e-cigarette product, where the heating process can create undesired thermal byproducts.
RespiRx uses proprietary software to deliver a precise dose of nicotine. Every time it’s activated, the device fires for three seconds and delivers a targeted dose of the drug. The base is reusable and serves as the housing for the battery and software. The RespiRx nebulizer sits within the pod that houses the nicotine drug product.
“The nebulizing unit (cartridge) gets replaced by the patient every one to two days. That interface means that the patient doesn’t have to clean the nebulizer,” explains Quigley. “The biggest challenge with other vibrating mesh products is that they require cleaning if used over an extended period. We’re mitigating that through the design of the interface. There is no cleaning required. We do believe that this will result in RespiRx having a very long use life.”
Late last year, Qnovia raised $17 million to continue the development of its RespiRx nicotine replacement product.
In June of 2020, the company appointed Quigley, a 16-year veteran of Altria Group, as its Chief Operating Officer. At Altria, Quigley served as CEO of its smokeless tobacco business from 2012 to 2018, a $2.3 billion business with over 800 employees,
March 31, 2023
Court: Reynolds Likely to Prevail in PMTA Lawsuit

Credit: Sang Hyun Cho
When the U.S. Court of Appeals for the 5th Circuit granted a stay to RJ Reynolds Vapor Co. (RJRV) of the U.S. Food and Drug Administration’s denial of its 150,000-page premarket tobacco product application (PMTA) for its menthol Vuse products, the judges indicated that the court believes RJRV is likely to prevail on the merits when the full review is heard.
Tobacco harm reduction expert Clive Bates, of Counterfactual, said the substantive decision rests on three main arguments, as outlined by the judges granting the stay. The order states:
Specifically, RJRV demonstrates that the FDA failed to reasonably consider the company’s legitimate reliance interests concerning the need for longitudinal studies and marketing plans; failed to consider relevant evidence, inter alia, that youthful users do not like menthol-flavored e-cigarettes; and has created a de facto rule banning all non-tobacco-flavored e-cigarettes without following APA notice and comment requirements.
The three main points argued by the court are outlined below:
FDA changed the decision-making criteria after the application.
1. Legitimate reliance interests
“The FDA did not reasonably consider RJRV’s legitimate reliance interests before changing its position on the types of comparative studies and marketing plans critical to a compliant and complete PMTA.”
Failure to consider Reynolds’ arguments adequately
2. Failure to consider relevant factors
The FDA did not adequately address RJRV’s evidence that substantial health benefits would accrue to adult and youth cigarette smokers alike who switched to menthol Vuse, while popularity among youth would remain low overall. For example, RJRV’s application contained studies that “switching from smoking to use of menthol Vuse Vibe substantially reduces toxicant exposure in a manner similar to smoking abstinence.” RJRV also submitted evidence of low popularity among youth relative to other flavored ENDS.
Bates stated that at least one portion part of the court’s argument looks troubling for Brian King, the newly appointed director of FDA’s Center for Tobacco Products (CTP).
Then in July 2022, a new CTP director appeared on the scene and told OS that “the approach to menthol-flavored ENDS should be the same as for other flavored ENDS, i.e., the products could be found [appropriate for the protection of the public health] 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.” OS then changed its position.
FDA has been implementing a de facto tobacco product standard (a flavor ban) without using the rule-making process, public comment etc.
3. “Tobacco product standard”
RJRV has adduced evidence that the FDA has effectively banned all non-tobacco-flavored e-cigarettes, pursuant to its new and secret heightened evidentiary standard, without affording affected persons any notice or the opportunity for public comment. There is no dispute that the TCA requires the FDA to abide by notice-and-comment rulemaking procedures before establishing a “tobacco product standard.”8 21 U.S.C. § 387g(c)–(d). Similarly, it is clear that a ban on all but tobacco-flavored e-cigarettes would constitute a “tobacco product standard.”
Bates explains that the court justifies its assertion that FDA is imposing a de facto standard with reference to the so-called “fatal flaw memo.” This was an expedited decision-making regime that stipulated that applications for non-tobacco-flavored products must be supported with controlled trials or longitudinal studies showing a quitting or switching advantage over a tobacco flavor. Otherwise, they would be automatically denied.
We conclude that the Fatal Flaw memo’s heightened evidentiary standard “bears all the hallmarks” of a substantive rule. City of Arlington, 668 F.3d at 242. First, the memo is binding on its face by mandating that applications contain “the necessary type of studies.” Second, it has been applied in a way that indicates it is binding; indeed, the subsequent, myriad Denial Orders refer to the same deficiencies identified as “fatal” in the memo. Third, it took away the FDA reviewers’ former discretion to consider individual PMTAs solely on their merits and instead requires a cursory, boxchecking review.
Finally, it affected the rights of literally hundreds of thousands of applicants whose PMTAs were denied. This is not a close call.
Bates stated that the third point the court makes is potentially “very” serious for the FDA and “not a close call,” as the court suggests. “A tobacco product standard under the TCA s.907 means that the burden is on FDA to show that its de facto standard is appropriate for the protection of public health – e.g. considering the impact of closing down all vape shops, likely impact on adults or youth who smoke, unintended consequences, illicit trade etc,” explains Bates. “It shifts the analysis from the individual applicant (PMTA) to the system-wide impact (Product Standard) – and FDA will find this difficult or impossible to meet, in my view.”
Taking everything into account, the court weighs up its decision to grant the stay against four criteria, as Bates outlined:
Our judgment is “guided by sound legal principles” that “have been distilled into consideration of four factors: (1) whether the stay applicant has made a strong showing that he is likely to succeed on the merits; (2) whether the applicant will be irreparably injured absent a stay; (3) whether issuance of the stay will substantially injure the other parties interested in the proceeding; and (4) where the public interest lies.”
Bates stated that the first of these four criteria reflects the courts’ view on the merits discussed in the three above-stated substantive arguments. In the fourth: (4) where the public interest lies, the court gives significant weight to the “highest public importance that federal agencies follow the law” and states:
In sum, “there is generally no public interest in the perpetuation of unlawful agency action,” Texas v. Biden, 10 F.4th at 560. And there is no evidence that “Congress’s policy choice” included an exemption from mandatory federal administrative procedures.
No date has been set for the court to complete its full review.
March 24, 2023
U.S. FDA Publishes Webpage for Citizen Petitions

A new webpage was published by the U.S. Food and Drug Administration of all the tobacco products-related citizen petitions received by the agency’s Center for Tobacco Products (CTP).
A citizen petition is a way for the FDA to give individuals, regulated industry representatives, or consumer groups to petition the agency to issue, amend, revoke a regulation, or take other administrative action. The requirements for a citizen petition are set out in the Code of Federal Regulations.
As part of CTP’s stated commitment to increase transparency, the webpage was developed to provide the public with more easily accessible and user-friendly information about tobacco product-related citizen petitions submitted to FDA and the center’s responses.
This webpage was one of the immediate actions toward transparency outlined by CTP Director Brian King in CTP’s Response to the Reagan-Udall Foundation’s report.
March 23, 2023
Vuse Menthol Pods Granted Stay by Appeals Court

Fifth Circuit Court of Appeals
Two menthol Vuse flavors that received a marketing denial order (MDO) can continue to be marketed by R.J. Reynolds Vapor Co. after the federal Fifth Circuit Court of Appeals issued a stay Monday.
On Friday, the U.S. Food and Drug Administration denied Reynolds Vapor’s premarket tobacco product applications (PMTAs) for the Vuse replacement cartridge Menthol 4.8% (nicotine level) G1 and the Vuse replacement cartridge Menthol 4.8% G2.
As a result, Reynolds would be prohibited from marketing or distributing the products domestically, or risk FDA enforcement action. However, the appeals court’s decision allows the products to stay in the marketplace.
In October last year, the FDA issued MDOs for several menthol-flavored vaping products marketed by Logic Technology Development. It was the first time the FDA has issued MDOs for menthol products after receiving a scientific review.
A few days after the order was issued, Logic obtained a court order from the U.S. Circuit Court of Appeals for the Third Circuit that temporarily stayed the order.
March 22, 2023
U.S. Senator Accuses Elf Bar of Advertising to Youth

Sen. Charles Schumer
A prominent U.S. senator is calling on the U.S. Food and Drug Administration to investigate an e-cigarette company because he believes it’s skirting American advertising laws.
Sen. Chuck Schumer says Elf Bar products are is wrapped in colorful packaging to attract youth and it hooks them with kid-friendly flavors like peach mango, cotton candy and vanilla ice cream, according to a Sunday statement.
“While the FDA has done much to snuff out the worst kinds of e-cigs that can hook kids, like Juul, there are clear workarounds and illegal methods being used by sneaky actors like Elf Bar,” Schumer said in the statement.
“Elf Bar is littering TikTok and Instagram, using influencers they pay directly, to push the e-cig to kids and teens,” he continued. “This kind of ploy might totally evade FDA advertising rules, and we have to get ahead of it.”
Schumer said Elf Bar may be even worse than Juul given its “shoddy manufacturing, the risk of counterfeit products and its risk for mislabeled nicotine levels.”
In the UK, Elf Bar was found to be selling e-cigarettes with volumes more than 50 percent over the UK’s legal limit after an investigation. The Chinese vaping giant admitted “inadvertently” breaking the law and ‘wholeheartedly apologized’ following lab tests of its 600 brand of disposable vape pens.
Recently, another Elfbar brand is being pulled from U.K. store shelves after finding the products surpass the legal limit for e-liquid volumes.
March 20, 2023
Lawmakers in U.S. Congress File Bills to Regulate CBD

Credit: Dogora Sun
Congressional lawmakers in the U.S. have refiled a pair of bills meant to provide a pathway for the regulation of hemp derivatives like CBD as dietary supplements and food and beverage additives.
The two measures that were filed on Friday—the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act and the CBD Product Safety and Standardization Act—are being sponsored by Reps. Morgan Griffith and Angie Craig, according to Marijuana Moment.
Earlier versions of the bills were filed last Congress and ultimately did not advance, but advocates and industry stakeholders feel that the U.S. Food and Drug Administration’s recent announcement that it wouldn’t be taking steps to regulate CBD will put pressure on lawmakers to act this time around.
The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act would mandate that hemp, hemp-derived CBD and other derivatives from the federally legal cannabis plant would be made lawful as dietary supplements under the Federal Food, Drug, and Cosmetic Act (FDCA).
The CBD Product Safety and Standardization Act, meanwhile, would require FDA to develop rules and hold a public comment period on the maximum amount of hemp-derived CBD that could be added to a food item or beverage per serving, labeling and packaging requirements and the “conditions of intended use,” the text of the legislation states.
March 20, 2023
U.S. FDA Issues Denial Orders for 2 Vuse Menthol Products
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 under the Vuse Solo brand.
Reynolds is expected to challenge the order.
The currently marketed products include the Vuse Replacement Cartridge Menthol 4.8% G1 and the Vuse Replacement Cartridge Menthol 4.8% G2, according to a statement. The company may resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs.
The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the risks and benefits of the product on the population as a whole.
“After reviewing the company’s 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, which is the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.
Specifically, the evidence submitted by the applicant did not demonstrate that its menthol-flavored e-cigarettes provide an added benefit for adult smokers relative to tobacco-flavored e-cigarettes.
In October last year, the FDA issued MDOs for several menthol-flavored vaping products marketed by Logic Technology Development. It was the first time the FDA has issued MDOs for menthol products after receiving a scientific review.
A few days after the order was issued, Logic obtained a court order from the U.S. Circuit Court of Appeals for the Third Circuit that temporarily stayed the order.
The case continues.
March 17, 2023