Category: U.S. FDA

  • FDA Sends Nicotine Limits Proposal to White House

    FDA Sends Nicotine Limits Proposal to White House

    VV Archives

    The Biden administration has proposed a rule that would significantly lower the amount of nicotine in tobacco products. The U.S. Food and Drug Administration’s efforts to counter the dangers of the chemical in stretch back to 2018, when it first proposed the idea.

    Then, FDA Commissioner Robert Califf went even further in 2022 and announced that the agency was developing a rule requiring tobacco companies to reduce the amount of nicotine in cigarettes.

    The next step in that effort occurred Tuesday when the FDA finally submitted its refined proposal to the Office of Management and Budget. There won’t be any immediate changes to tobacco products. The approval process for the Office of Management and Budget can take months. There will also be a public comment period, and the nicotine industry often sues the government to stop new regulations.

    “A proposed product standard to establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain combusted tobacco products, when finalized, would be among the most impactful population-level actions in the history of U.S. tobacco product regulation,” the FDA said in a statement reported by CNN on Wednesday.

    When the FDA announced its initial plans to reduce nicotine in 2022, it estimated that reducing nicotine levels could keep more than 33 million people from becoming regular smokers, that about 5 million additional smokers would quit within a year, and that 134 million years of life would be gained.

    In the draft proposal from 2018, which the FDA has since refined, it cited a 2013 survey that found that reducing the total nicotine content of cigarettes to 0.5 milligrams per rod would minimize addictiveness. Still, it also said that questions remain with respect to the precise level of nicotine in cigarettes.

    The agency’s proposal was met with high praise Wednesday.

    “Once finalized, this rule could be a game-changer in our nation’s efforts to eliminate tobacco use,” said Harold Wimmer, president and CEO of the American Lung Association. “Making tobacco products non-addictive would dramatically reduce the number of young people who become hooked when they are experimenting. To fully address the toll of tobacco on our nation’s health and across all communities, it is critical to reduce nicotine levels to non-addictive levels in all commercial tobacco products, including e-cigarettes.”

    Not all smokers would quit if nicotine levels were limited, experts say, nor would all smoking-related diseases disappear since tobacco products contain other chemicals that can be harmful to health.

  • Robert Kennedy, Jr. Tapped to Lead Trump’s HHS

    Robert Kennedy, Jr. Tapped to Lead Trump’s HHS

    Robert Kennedy Jr. (Credit: Cage Skidmore)

    President-elect Donald Trump has nominated Robert F. Kennedy, Jr. to serve as the new secretary of the Department of Health and Human Services (HHS). The effects Kennedy will have on the nicotine market remain unclear. Kennedy must still be confirmed by Congress.

    “For too long, Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation, and disinformation when it comes to Public Health,” Trump posted. “The Safety and Health of all Americans is the most important role of any Administration, and HHS will play a big role in helping ensure that everybody will be protected from harmful chemicals, pollutants, pesticides, pharmaceutical products, and food additives that have contributed to the overwhelming Health Crisis in this Country.”

    As the leader of HHS, Kennedy will oversee the FDA, which regulates vaping, nicotine pouches, and all other nicotine and tobacco products through its Center for Tobacco Products.

    Kennedy’s position on vaping, nicotine, and tobacco harm reduction (THR) remains an unknown. During the presidential campaign, Trump promised that, if elected, he would “save vaping” after meeting with Tony Abboud of the Vapor Technology Association.

    “I saved Flavored Vaping in 2019, and it greatly helped people get off smoking,” Trump said on his Truth Social platform in September. “I raised the age to 21, keeping it away from the ‘kids.’ Kamala and Joe want everything banned, killing small businesses all over the country. I’ll save Vaping again!”

  • FDA Warns Companies For Selling ‘Smart’ Vapes

    FDA Warns Companies For Selling ‘Smart’ Vapes

    The U.S. Food and Drug Administration issued warning letters to nine online retailers and one manufacturer for selling or distributing unauthorized disposable e-cigarettes designed to resemble smart technology, including smartphones and gaming devices.

    The products mentioned in the warning letters are promoted as having various designs and functions that might attract young people, according to an agency press release. These include features like playing games, connecting to smartphones, receiving text or call notifications, playing music, and customizing products with personalized wallpaper.

    “These products may resemble smart devices, but there’s nothing smart about them,” said Brian King, director of FDA’s Center for Tobacco Products. “They’re illegal to sell and a flagrant attempt to target kids.”

    The agency states that the designs of the unauthorized products cited in the warning letters are likely to appeal to youth because they help conceal the nature of the products as tobacco products from parents, teachers, or other adults. Example images of unauthorized products cited in the warning letters compared to electronic devices on the consumer market, such as smartphones and gaming devices.

    “The firms receiving these warning letters sold and/or distributed e-cigarettes in the United States that lack authorization from FDA to legally market a new product, which is in violation of the Federal Food, Drug, and Cosmetic Act,” the release states.

    In addition to the violations mentioned in the warning letters, the retailers and manufacturer were warned to address any violations that are the same as, or similar to, those stated in the warning letter and promptly take any necessary actions to comply with the law. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalty.

    “FDA is steadfast in our commitment to enforce the law,” said John Verbeten, director of CTP’s Office of Compliance and Enforcement. “We will continue to take appropriate measures, working hand in hand with our federal enforcement partners, to address unauthorized tobacco products, especially those most appealing to youth.”

  • CMSA Files Amicus Brief With SCOTUS in Triton Case

    CMSA Files Amicus Brief With SCOTUS in Triton Case

    This week, the Coalition of Manufacturers of Smoking Alternatives (CMSA), a trade coalition that represents a diverse array of members who manufacture and distribute smoking harm reduction products, filed an amicus curiae brief before the Supreme Court of the United States supporting White Lion Investments, dba as Triton Distribution, in its case against the U.S. Food and Drug Administration.

    In its brief, CMSA argues that FDA violated the Family Smoking Prevention and Tobacco Control Act (TCA) in its wholesale rejection of applications for flavored vaping products by applying a surprise and improperly adopted standard and foregoing the required notice-and-comment process. The brief emphasizes that the U.S. Congress specifically requires the FDA to undergo a transparent rulemaking process before imposing any restriction that amounts to a “tobacco product” standard.

    “Importantly, this process tasks FDA with considering the broader public health effects of any such standard, ‘such as creating demand for and increasing the use of unregulated black-market products,’ or other harmful consequences,” the CMSA states. “In its efforts to unilaterally reject flavored vapor product applications based on a new and heightened standard, FDA unlawfully sidestepped this critical regulatory check and operated outside the bounds of its authority.”

    The CMSA states that the FDA circumvented the very procedures Congress imposed to check the arbitrary or unreasonable exercise of such delegated power, and causes real harms as the FDA “misleads and whipsaws” manufacturers seeking to provide a robust set of options for consumers seeking to quit smoking,” the CMSA wrote in its brief. Further adding that “the long delays in FDA’s review of the many PMTAs (premarket tobacco product applications) it has received, coupled with the moving goal posts imposed via the review process, creates a level of uncertainty that severely deters investment and innovation in new products with harm-reduction potential.”

    Earlier this week, 13 members of Congress, including U.S. Senator Roger Marshall and U.S. Representative Andy Harris, filed an amicus brief supporting the position of Triton Distribution and CMSA. In their brief, the members of Congress write, “There is a clear lack of authority for such a ban. Congress has specifically prohibited the FDA from banning products. Despite this, the FDA imposed a categorical prohibition.”

    Also, the Global Action to End Smoking wrote in its amicus brief to SCOTUS that the FDA strayed from a “sensible, science-based harm-reduction approach, adopting an all-or-nothing stance that exalts outright cessation and all but ignores the harm-reduction strategy that Congress mandated…. [ignoring the] overwhelming scientific evidence that e-cigarettes containing flavor additives have an important role to play in moving adult smokers down the continuum of risk.”

    SCOTUS announced Dec. 2, 2024 as the date for the U.S. Food and Drug Administration v. Wages and White Lion Investments, LLC, d/b/a Triton Distribution hearing.

    Credit: Renas Child
  • Supreme Court to Hear Avail, Reynolds ‘Venue’ Case

    Supreme Court to Hear Avail, Reynolds ‘Venue’ Case

    The Supreme Court of the United States has agreed to consider another case involving federal approval of vapes at the request of the Biden administration on Friday.

    The case arose after the FDA denied R.J. Reynolds Vapor Company’s request to introduce three flavored vapes on the market. The FDA said the company failed to meet federal requirements concerning tobacco products’ marketing, but the company contends the decision was arbitrary and capricious.

    Reynolds is based in North Carolina, and the federal appeals courts located there and in D.C. already had precedent on the books unfavorable to the manufacturer.

    Under federal law, companies can challenge the U.S. Food and Drug Administration denying of a marketing order for a new tobacco product in Washington, D.C., or where the company’s principal place of business is located, reports The Hill.

    The 5th U.S. Circuit Court of Appeals has been more sympathetic to the industry, making it an attractive place for companies to contest their products being denied.

    The 5th Circuit’s rule effectively enables it to host any tobacco company’s challenge, so long as its lawsuit is joined by a convenience store or other retail seller within the 5th Circuit’s borders — which spans Louisiana, Mississippi and Texas.

    The companies instead filed its challenge in the 5th Circuit alongside Avail Vapor Texas and the Mississippi Petroleum Marketers and Convenience Stores Association. The federal government attempted to move venues, but the 5th Circuit said the additional challengers meant the case was properly brought.

    No matter which way the justices rule, they are not expected to address the merits of the FDA’s denial. The Supreme Court only took up the question of whether the 5th Circuit was a proper venue.

    “There is no circuit conflict over the meaning of this venue provision. And other vehicle problems abound,” the company wrote in court filings urging the justices to turn away the appeal.

    The U.S. Supreme Court agreed in July to hear the U.S. Food and Drug Administration’s defense of the agency’s rejection of two companies’ premarket tobacco product applications (PMTAs) to sell flavored vape products that it has determined pose health risks for young consumers.

    The justices took up the FDA’s appeal filed after a lower court ruled that the agency had failed to follow proper legal procedures under federal law when it denied the applications to bring their nicotine-containing products to market.

  • FDA Clears RespiRx IND Inhaler Application

    FDA Clears RespiRx IND Inhaler Application

    Image: Qnovia

    The U.S. Food and Drug Administration has cleared an Investigational New Drug (IND) application for Qnovia’s RespiRx nicotine inhaler (QN-01).

    According to Qnovia, the RespiRx is the first truly inhalable nicotine replacement therapy (NRT) to assist smokers attempting to quit smoking.

    The company will initiate a Phase 1, randomized, crossover, open-label trial to determine the pharmacokinetics, safety and tolerability following self-administration of nicotine-containing products in up to 24 healthy adult subjects who currently smoke combustible cigarettes.

    “The FDA clearance of our IND application for QN-01 marks a significant achievement for Qnovia as we transition to a clinical-stage therapeutics company,” said Qnovia CEO Brian Quigley in a statement.

    “Our U.S. clinical development plan is derisked by the positive first-in-human data we generated last year in support of advancing QN-01 in the United Kingdom where we demonstrated pulmonary delivery and a superior pharmacokinetic profile for the RespiRx when compared to existing nicotine replacement therapies,”

    “The next step for our U.S. program is to initiate a randomized Phase 1 trial that evaluates QN-01 compared to the Nicotrol Inhaler and combustible cigarettes in a head-to-head comparison. We remain on track to dose our first patient in the fourth quarter of 2024 and in parallel will be advancing to a pivotal clinical trial in the U.K. to support an MAA submission [Marketing Authorization Application] to the MHRA [ Medicines and Healthcare products Regulatory Agency] in 2026.”

    Qnovia’s proprietary drug/device combination already demonstrated dose-dependent pharmacokinetics, pulmonary delivery and was well tolerated in a first-in-human study conducted to support advancing QN-01 in the U.K., according to the company.

    “There have been no treatment options for smoking cessation approved in the U.S. in over 20 years. As a result, attempting to quit ‘cold turkey’ remains the most popular method of quitting smoking,” said Mitch Zeller, Qnovia’s policy and regulatory strategy advisor.

    “There is an extraordinary public health need for truly innovative products to help health-concerned smokers stop using cigarettes. Any effort to reduce the death and disease caused by tobacco use must include new and better tools in the treatment toolkit,” Zeller added.

  • Penalties for U.S. Retailers Selling Illegal Vapes

    Penalties for U.S. Retailers Selling Illegal Vapes

    The U.S. Food and Drug Administration is seeking fines against two brick-and-mortar retailers and nine online retailers. The FDA previously issued warning letters to these retailers for their sale of unauthorized tobacco products, however, follow-up inspections revealed that the retailers had failed to correct the violations. Accordingly, the agency is now seeking a civil money penalty of $20,678 from each retailer.

    To date, the FDA has filed civil money penalty complaints against 70 manufacturers and 160 retailers for distribution and/or sale of unauthorized tobacco products. These actions reflect the FDA’s continued dedication to bringing enforcement actions against entities along the supply chain who violate the law relating to tobacco products.

    The FDA has currently authorized 34 e-cigarette products and devices. The agency maintains a printable one-page flyer of all authorized e-cigarette products that retailers can easily consult to determine which products may be lawfully marketed and sold in the United States. Entities manufacturing, importing, selling or distributing e-cigarettes that lack the required premarket authorization risk enforcement actions.

     

  • FDA Warns 6 Companies for Trade Show Sales

    FDA Warns 6 Companies for Trade Show Sales

    Credit: Mr. Fog

    The U.S. Food and Drug Administration has issued six warning letters to manufacturers and retailers for selling or distributing unauthorized e-cigarette products promoted at an industry trade show.

    After observations made by Center for Tobacco Products (CTP) staff attending the trade show, the FDA conducted investigations and issued warning letters to six retailers and manufacturers for selling or distributing unauthorized e-cigarette products.

    Regulated entities must comply with all applicable requirements under the Federal Food, Drug, and Cosmetic Act. Under these requirements, the sale and distribution of unauthorized tobacco products is illegal, including at industry events such as trade shows or expos, according to the FDA.

    “Regulated industry should be aware that CTP obtains leads that inform investigations from many sources, including trade shows,” said John Verbeten, director of CTP’s Office of Compliance and Enforcement. “We remain committed to identifying and taking action against those breaking the law, including at these events.”

    FDA also announced the issuance of warning letters to five online retailers for selling unauthorized e-cigarette products popular with youth, including products marketed under the brand names Breeze, Mr. Fog, and Raz.

    “Results from the recently released 2024 National Youth Tobacco Survey found that Breeze and Mr. Fog were among the top five most commonly used brands among youth who use e-cigarettes,” an FDA release states. “Additionally, Raz was identified as a popular brand through routine surveillance, with youth-appealing flavors such as sour mango pineapple and razzle-dazzle.”

    The companies receiving these warning letters sold or distributed e-cigarette products without marketing authorization from the FDA. Warning letter recipients are given 15 working days to respond with the steps they will take to address the violations cited in the warning letter and to prevent future violations.

    Failure to promptly address the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.

    The trade show was not named in the FDA release.

  • Lawmakers Blast FDA for Rise of Illegal Vapes

    Lawmakers Blast FDA for Rise of Illegal Vapes

    The agency is struggling to justify the need for additional resources to combat illegal vape products.

    A bipartisan group of powerful House lawmakers are doubtful of the Food and Drug Administration’s proposal to begin collecting fees from e-cigarette companies, akin to how the agency charges fees to tobacco firms.

    FDA officials say that the fees would give regulators resources to tackle the thousands of illegal vapes lining store shelves.

    Lawmakers on the House Energy & Commerce Committee questioned whether the FDA’s Center for Tobacco Products (CTP), which has struggled for years to police the vaping industry, is capable of effectively using allocated funds.

    The agency is caught in a Catch-22 situation. Some lawmakers are demanding that the FDA crackdown on illegal e-cigarettes before receiving more funding, but the FDA argues that it needs additional funding to boost its enforcement efforts.

    Brian King

    CTP Director Brian King attempted to persuade lawmakers that the agency has taken significant action against vape companies selling illegal products. This includes imposing fines on retailers, seizing products at the border, and filing injunctions against manufacturers in federal courts. Lawmakers from both sides questioned if the agency was taking sufficient action.

    New Jersey Rep. Frank Pallone said that while he hopes e-cigarette user fees would “make a difference,” he was skeptical of whether the FDA would be able to rein in the illegal vape market. “I hate to say it but you just make it seem hopeless to me,” he said.

    Tony Abboud, executive director of the Vapor Technology Association (VTA), said the FDA’s Center for Tobacco Products (CTP) created a flawed and broken premarket tobacco product application (PMTA) process. He explained that the House committee hearing revealed that, under King’s leadership, CTP continues to approve combustible cigarettes while also denying millions of e-cigarette PMTAs at a 91:1 ratio.

    “Director King’s statement that there is ‘no safe harbor’ for companies with pending applications clearly demonstrates that CTP continues to move the scientific goalpost and is not truly committed to harm reduction for Americans who smoke,” said Abboud. “Cigarette smoking continues to be the leading cause of preventable death and disease in the U.S., yet Director King calls for more money to remove less harmful products from the market.

    “The CTP must acknowledge the undisputed smoking cessation benefits of e-cigarettes, authorize a diverse marketplace of flavored nicotine alternatives to cigarettes, and stop approving new cigarettes.”

    House Energy and Commerce Committee Chair Cathy McMorris Rodgers said that out of more than 26 million applications for electronic nicotine delivery systems (ENDS) products and has authorized fewer than 50 products.

    “However, according to recent market data, those products only account for about 10 percent of sales, showing how behind the FDA is with keeping up with the demand,” she said. “The lack of clear enforcement policy and authorized products leaves tobacco users, distributors, and convenience stores in the dark on what products they can use and sell to those that are looking for alternatives to traditional cigarettes.

    “Companies need clear guidelines on what is required to meet the standard for authorization and what changes to products require new applications.”

    The CTP currently collects user fees from cigarette and cigar companies. However, it requires Congressional approval to begin collecting user fees from vaping product manufacturers. The agency has been advocating for this change for some time. This change is estimated to increase CTP’s budget by approximately $114 million from its current budget of over $700 million.

    Half of this additional funding would be allocated to increasing enforcement efforts, according to STAT News.

    The hearing, titled “Evaluating FDA Human Foods and Tobacco Programs,” was House lawmakers’ first chance to question both King and Jim Jones, the FDA’s deputy commissioner for Human Foods. King joined the agency in July 2022. Jones joined last September.

  • Mixed Feelings for Four-Year Anniversary of PMTAs

    Mixed Feelings for Four-Year Anniversary of PMTAs

    Credit: Asier Romero

    Representatives of the U.S. vapor industry expressed mixed feelings at the four-year anniversary of the filing of the first premarket tobacco product applications (PMTAs).

    Since the Sept. 9, 2020, deadline, the Food and Drug Administration’s Center for Tobacco Products (CTP) has received applications for 26 million novel tobacco products, mostly electronic cigarettes or e-cigarettes.

    However, despite its acknowledgement that e-cigarettes overall are less harmful and less toxic than combustible cigarettes, the agency has rejected more than 99 percent of PMTAs for these products.

    At the same time, the FDA has authorized 6,670 new combustible tobacco products to be sold in the U.S., including 3,232 new cigars, 1,291 new pipe tobacco products,1,073 new hookah tobacco products and 973 new cigarettes.

    According to the Vapor Technology Association (VTA), current CTP Director Brian King has authorized only four vaping devices as alternatives to cigarettes, compared with 1,270 combustible products.

    Director King has justified his refusal to authorize flavored e-cigarettes that are widely used by American adults with the need to protect youth. Yet the most recent National Youth Tobacco Survey revealed that the youth vaping rate—the share of users who say they’ve used an e-cigarettes at least once in the past 30 days—has declined to 5.9 percent, the lowest level in more than a decade.

    “Since Sep. 9, 2020, 1.93 million Americans have died from smoking cigarettes (480,000 each year), and approximately 64 million Americans suffered from smoking-related disease (16 million each year), according to the CDC, at a cost of hundreds of billions of dollars to the U.S. health care system and gross domestic product,” the VTA wrote in a statement.

    “In this time, the FDA has only allowed the purveyors of these deadly combustible products to strengthen their grip on the market. Meanwhile, more and more Americans die from smoking, making this anything but a happy anniversary.”