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Category: FDA

  • FDA Whistleblower Dishes on Agency’s Shortfalls

    FDA Whistleblower Dishes on Agency’s Shortfalls

    David Oliveira, who recently left the FDA after six years as a senior staffer, is speaking out about problems at the agency under the Biden administration, including tobacco control, diversity, equity and inclusion, and failures to combat China flooding the U.S. market with illicit vapes after the FDA’s top tobacco official was removed from his position. 

    “Many of us had been anticipating it for quite some time. We knew that change was drastically needed at FDA when it came to Tobacco Control,” Oliveira said in an interview with Fox News Digital. “Because Tobacco Control had really gotten out of control, there were many, many failures in core missions for the center that needed dramatic change and new leadership.

    “Many of us, whether it be from public health, consumers, small business owners, industry, and including even Senator Dick Durbin, who last year at a hearing said to Brian King, ‘It looks to me that you have fallen down on the job.’ So really, it runs the spectrum of people who are unhappy with what’s gone on recently with FDA in terms of tobacco regulation.

    “I frequently would attend shows and visit vape shops, and I was somewhat a canary in a coalmine, and would report back as to what I was seeing, and I would warn them that what I was seeing on the ground was out of control. We had a lot of people in the building who would go online and try to do some surveillance, but when you get out into the real world and you see the number of vape shops that are flooded with these illicit products, and I started to warn them about the amount of nicotine that was in these devices. We went from a Juul device, which had around 200 puffs, which was the equivalent of one pack of cigarettes, then I started seeing 5,000 puffs. I brought that warning back to the center, and then the following year would see 10,000 puffs. Now on the market, you can see 40,000 and 50,000 puffs. This is what the Chinese have done. They have not sought to get products authorized. They will introduce the latest and greatest technology. I saw a Santa one that was red and white. They’ll introduce flavors like Gummy Bear, Blow Pop, and Fruit Rollups, and these things that are absolutely youth-appealing because they do not care.” 

    View the 15-minute interview here.

  • Brian King, Dozens of Staffers Out at CTP

    Brian King, Dozens of Staffers Out at CTP

    The Associated Press is reporting that Brian King, the Food and Drug Administration’s chief tobacco regulator, was removed from his post this morning (April 1) amid sweeping cuts at the agency and across the federal health workforce. According to sources familiar with the situation, King sent an email to staff saying, “It is with a heavy heart and profound disappointment that I share I have been placed on administrative leave.”

    King was removed from his position and offered reassignment to the Indian Health Service, according to a person familiar with the matter who did not have permission to discuss the matter publicly and spoke on the condition of anonymity. Dozens of staffers in the FDA’s Center for Tobacco Products (CTP) also received notices of dismissal Tuesday morning, including the entire office responsible for enforcing tobacco regulations.

    In recent years, the CTP has been besieged by criticism from all sides, including politicians, anti-smoking advocates, and tobacco and vaping companies. Under King, the FDA rejected applications for millions of flavored e-cigarettes, citing insufficient data that the products would help adult smokers while not becoming popular with underage kids. Those rejections have resulted in multiple lawsuits against FDA from vape makers.

    “King, who joined the agency in 2022, has been vigorously criticized by vaping lobbyists for ordering thousands of companies to remove their fruit and candy-flavored e-cigarettes from the market,” the AP wrote. “During his time at FDA, teen vaping has fallen to a 10-year low.”

    The latest changes mean that nearly all of FDA’s top leaders overseeing drugs, food, vaccines, medical devices, and now tobacco products have resigned or retired in recent months. This comes after Robert F. Kennedy Jr.’s moves to fire 3,500 FDA staffers and push ahead with plans to scrutinize ultra-processed foods, childhood vaccines, antidepressants, and other long-established products.

  • Senate Confirms New FDA Commissioner

    Senate Confirms New FDA Commissioner

    Last week the U.S. Senate confirmed former Johns Hopkins surgeon and professor Dr. Marty Makary to lead the U.S. Food and Drug Administration by a 56-44 vote. During his confirmation hearing, Makary said his goals for the agency were “more cures and meaningful treatments for Americans,” and offered several insights as to how he would achieve those goals throughout the hearing.  

    In the past, Makary has been critical of the FDA, in 2021 calling for “fresh leadership at the FDA to change the culture at the agency and promote scientific advancement, not hinder it.” Reporting to Health and Human Services Secretary Robert F. Kennedy Jr., Makary’s leadership of the FDA also includes its Center for Tobacco Products (CTP). However, it’s not yet clear how he will approach CTP’s looming issues of reviewing premarket tobacco product applications (PMTAs), the illicit vape market, and other tobacco-related issues.

    Much of the confirmation hearing centered around past problems, including those with Covid-19 vaccines, the pharmaceutical industry, and various other issues that have often gained headlines of late, but he did not commit to specifics in that venue.

    “I have no preconceived plans on mifepristone policy except to take a hard look at the data and to meet with the professional career scientists at the FDA who have reviewed the data,” he said at his hearing. “We now have a generational opportunity in American healthcare. President Trump and Secretary Kennedy’s focus on healthy foods has galvanized a grassroots movement in America. Childhood obesity is not a willpower problem, and the rise of early-onset Alzheimer’s is not a genetic cause. We should be, and we will, be addressing food as it impacts our health.”

    When asked about the backlog of cases the FDA has across all departments, Makary did not rule out leveraging artificial intelligence and making other regulatory changes to streamline the drug review process. He suggested FDA reviewers could use AI “to help reviewers in the review process—not to replace human reviews, but to improve efficiency.”

    National Association of Tobacco Outlets (NATO) Executive Director David Spross told CSP on Friday that “NATO looks forward to working with Dr. Makary and the team at FDA on tobacco and nicotine product regulatory issues, including for the FDA is to support tobacco harm reduction policies by authorizing more PMTA vapor and nicotine pouch product applications that provide adult smokers with more choices.”

    Spross added that there is a “need for more transparency from the agency by providing retailers more information on illicit products, specifically in the vapor and nicotine pouch categories.”

    Makary is a surgical oncologist and health policy researcher who has spent more than 20 years at Johns Hopkins.

    “I am pleased to congratulate Dr. Makary on his new role as FDA commissioner,” said Johns Hopkins University President Ron Daniels. “We are fortunate to have one of our senior faculty members at the School of Medicine undertake this critical service to the nation.

    “An accomplished clinician and widely published health policy researcher, Dr. Makary has had a storied career at Johns Hopkins that reflects the research and clinical acumen and openness to different ideas and approaches undergirded by academic freedom that are the hallmark of our great institution,” said Daniels.

    Makary founded the Johns Hopkins Center for Surgical Trials and Outcomes Research and co-developed a surgical safety checklist used in operating rooms worldwide. He is a member of the National Academy of Medicine and has published more than 300 peer-reviewed articles and three New York Times bestselling books on healthcare.

    Senate also confirmed Jay Bhattacharya as the new director of the National Institutes on Health.

  • FDA Says it Prevented 444,000 Youth from Using E-Cigs Last Year

    FDA Says it Prevented 444,000 Youth from Using E-Cigs Last Year

    Today, a study co-authored by U.S. Food and Drug Administration scientists was released showing the agency’s youth e-cigarette prevention campaign, “The Real Cost,” successfully reduced e-cigarette use among youth. The campaign, which launched in 2018 under the leadership of President Trump, was found to have prevented an estimated 444,252 American youth (age 11 to 17 at study recruitment) from starting to use e-cigarettes between 2023 and 2024.

    Published in the peer-reviewed scientific journal American Journal of Preventive Medicine, the study found evidence that the campaign contributed to the nearly 70% decline in e-cigarette use among American youth that has occurred since 2019. According to the National Youth Tobacco Survey, the number of U.S. middle and high school students who currently use e-cigarettes has declined from 5.38 million in 2019 to 1.63 million in 2024, the lowest level in a decade.

    “As part of our work to Make America Healthy Again, we must ensure that children have a healthy start in life,” said Acting FDA Commissioner Sara Brenner, M.D., M.P.H. “This includes taking evidence-based actions to prevent youth tobacco product use.”

    Data from the evaluation, which followed a nationally representative sample of U.S. youth over time, showed that viewing ads from “The Real Cost” lowered chances that youth who had never used an e-cigarette would later initiate use. The survey collected information on how frequently youth were exposed to “The Real Cost” campaign and which youth went on to try e-cigarettes, among other variables.

    “Adolescence is a critical period for prevention efforts because most adults who use tobacco products begin using them in their teenage years,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “Youth tobacco prevention campaigns not only work, but they are also a cost-effective approach to protecting young people from a lifetime of nicotine addiction.”  

    “The Real Cost” Youth E-cigarette Prevention Campaign uses a variety of marketing tactics and creative advertising to reach youth. Advertising and prevention materials are delivered across communication channels relevant to teens, including digital and streaming platforms, social media and gaming platforms. The agency’s activities also include compliance and enforcement actions across the supply chain – in coordination with federal partners using their unique authorities – to ensure that those that make, distribute or sell illegal tobacco products are held accountable to the law.

  • Judge Pauses FDA Menthol Ban Case to August

    Judge Pauses FDA Menthol Ban Case to August

    In a two-page order, U.S. District Judge Haywood S. Gilliam granted a request filed last week jointly by both the government defendants and the public health advocates who filed the lawsuit, seeking a stay on the proceedings until mid-August. The lawsuit filed by anti-tobacco groups seeking to challenge the Food and Drug Administration’s delay to ban menthol cigarettes was paused by a federal judge in response to moves made by the Trump administration.

    Judge Haywood S. Gilliam Jr. for the US District Court for the Northern District of California issued a stay  in the case between the African American Tobacco Control Leadership Council and the FDA over whether the agency lawfully delayed a Biden-era final rule that would ban menthol cigarettes from store shelves.

    Both parties in a joint submission proposed the stay on Feb. 18.

    In late January, the FDA withdrew its proposed rules to prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars.

    “The recent withdrawal of both proposed federal flavor bans is compelling evidence that the Trump administration is taking a less aggressive rulemaking posture compared to the Biden administration,” Troutman Pepper Locke wrote on its Tobacco Law Blog. “The Office of Information and Regulatory Affairs withdrawal filings do not detail the reasoning behind the decision. However, several comments submitted during each proposed rule’s comment period detail ample justifications for withdrawing the proposals.

    “With respect to the menthol cigarette ban, industry argued that illicit markets would proliferate, fed by consumer demand for menthol cigarettes despite the proposed prohibition.”

  • Trump Administration’s Cuts Reach FDA Tobacco Product Employees

    Trump Administration’s Cuts Reach FDA Tobacco Product Employees

    The Trump administration’s attempts to reduce the size of the federal workforce have reportedly extended to the Food and Drug Administration (FDA) this weekend, as recently hired employees who review the safety of food ingredients, medical devices, and other products were fired.

    On Friday, the U.S. Department of Health and Human Services announced plans to fire 5,200 probationary employees across its agencies, which include the FDA, National Institutes of Health, and the Centers for Disease Control and Prevention. Probationary employees across the FDA received notices Saturday evening that their jobs were being eliminated, according to three FDA staffers who spoke to The Associated Press on condition of anonymity.

    The total number of positions eliminated is still not clear, but the firings appeared to focus on employees in the agency’s centers for food, medical devices, and tobacco products — which includes oversight of electronic cigarettes.

    The FDA employs nearly 20,000 people but has been strained since a wave of departures during the COVID-19 pandemic, with a reported 2,000 uninspected drug facilities that haven’t been visited since before the pandemic. It has also been criticized for not moving faster to catch recent problems involving infant formula, baby food, and eyedrops. A former FDA official said cutting recent hires could backfire by eliminating staffers who tend to be younger and have more up-to-date technical skills, whereas the FDA’s current workforce skews toward older workers who have spent one or two decades at the agency.

    “You want to bring in new blood,” said Peter Pitts, a former FDA associate commissioner under President George W. Bush. “You want people with new ideas, greater enthusiasm, and the latest thinking in terms of technology.”

  • FDA Tobacco Case Heads to Supreme Court

    FDA Tobacco Case Heads to Supreme Court

    The Supreme Court will hear oral arguments on Tuesday in a clash between RJR Vapor and the U.S. Food and Drug Administration (FDA) centered around the rules in which the FDA can be challenged in court. The FDA argues that the Tobacco Control Act allows cases to be argued in one of three areas: in the D.C. Circuit, in the place where the plaintiff resides, or in the place where it has its principal place of business. RJR Vapor, a subsidiary of British American Tobacco based in North Carolina, however, is trying to challenge the FDA in the conservative U.S. Court of Appeals 5th Circuit based in Louisiana.

    RJR Vapor filed a petition for review along with Avail Vapor, a Texas retailer, and by a trade association for Mississippi gas stations and convenience stores that sell RJR Vapor’s products— states that reside in the 5th Circuit. RJR’s North Carolina home resides in the 4th Circuit, which had previously turned their appeal against the FDA denial of applications aside. The 5th Circuit, however, previously ruled against the FDA denials, saying the government agency was sending companies on “a wild goose chase.”

    RJR Vapor and the retailers argue the law states “any person adversely affected” can challenge the FDA, to include retailers within the 5th Circuit trying to sell RJR Vapor’s popular menthol-flavored Vuse brand e-cigarettes who could potentially go out of business. In 2016, the FDA rejected RJR Vapor’s application, saying the product would not be “appropriate for the protection of the public health.”

    The FDA argues that its rulings are “always or nearly always” regulating the manufacturer and that any effects on retailers are indirect and thus irrelevant, and that allowing this case in the 5th Circuit would allow “ready evasion” and create incentives for “forum-shopping.” The FDA contends the stakes are high in this case, as the 5th Circuit’s previous ruling would allow manufacturers to get around federal restrictions and cherry-pick the courts where its cases would be heard.

    The FDA approached the Supreme Court, and in October 2024, it agreed to hear the case. RJR Vapor argues the Supreme Court doesn’t have the authority to rule over “non-final” cases like this one to begin with, and wants the case dismissed without decision.

  • FDA Authorizes 20 ZYN Pouch Products

    FDA Authorizes 20 ZYN Pouch Products

    Today, the U.S. Food and Drug Administration (FDA) authorized the marketing of 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway following an extensive scientific review. This is the first time the agency has authorized products commonly referred to as nicotine pouches, which are small synthetic fiber pouches containing nicotine designed to be placed between a person’s gum and lip. 

    The FDA determined that the specific products receiving marketing authorization met the public health standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. This standard considers the risks and benefits of products to the population as a whole.

    “As a public health scientist and former Director of the Office of Science at FDA’s Center for Tobacco Products, I couldn’t be more excited for public health with FDA’s decision today,” Matt Holman, vice president of U.S. Scientific Engagement and Regulatory Strategy at PMI said on X. “Authorizing products that can help the nearly 30 million smokers in the United States switch to a better form of nicotine has the potential to save countless lives.”

    Among several key considerations, the agency’s evaluation showed that, due to substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products, such as moist snuff and snus, the authorized products pose a lower risk of cancer and other serious health conditions than such products. The applicant also provided evidence from a study showing that a substantial proportion of adults who use cigarette and/or smokeless tobacco products completely switched to the newly authorized nicotine pouch products.

    “To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks,” said Matthew Farrelly, Ph.D., director of the Office of Science in the FDA’s Center for Tobacco Products. “In this case, the data show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products.”

    Additionally, the FDA found that the applicant showed these nicotine pouch products have the potential to provide a benefit to adults who smoke cigarettes and/or use other smokeless tobacco products that is sufficient to outweigh the risks of the products, including to youth. As part of its evaluation, the FDA reviewed data regarding youth risk and found that youth use of nicotine pouches remains low despite growing sales in recent years. For example, the 2024 National Youth Tobacco Survey showed that 1.8% of U.S. middle and high school students reported currently using nicotine pouches.

    “It’s critical that the manufacturer market these products responsibly to prevent youth use,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “While current data show that youth use remains low, the FDA is closely monitoring the marketplace and is committed to taking action, as appropriate, to best protect public health.”

    While today’s actions permit these specific tobacco products to be legally marketed in the U.S. to adults 21 and older, it does not mean these tobacco products are safe, nor are they “FDA approved.” There is no safe tobacco product; youth should not use tobacco products and adults who do not use tobacco products should not start. 

    The FDA will closely monitor the marketing and use of these products. To reduce the potential for youth exposure to advertising of these products, the authorizations impose stringent marketing restrictions for digital, television, and radio, including measures to ensure ads are carefully targeted to adults ages 21 and older and the demographics of the audiences reached by the ads are tracked and measured by the manufacturer. The company also stated that they intend to implement additional measures to restrict youth access, reduce youth appeal, and limit youth exposure to their labeling and advertising, such as: not using mass-market advertising on radio and TV; employing actors/models for marketing that are no younger than 35 years old, or styled to appear under 35; and avoiding any content designed to target youth, including characters, images or themes. The agency may suspend or withdraw a marketing granted order issued under the PMTA pathway for a variety of reasons if the agency determines the continued marketing of a product no longer meets the necessary public health standard, such as if there is a notable increase in youth initiation.

    The products for which the FDA issued marketing granted orders are the following, each with two nicotine strengths (3 milligrams and 6 milligrams): ZYN Chill, ZYN Cinnamon, ZYN Citrus, ZYN Coffee, ZYN Cool Mint, ZYN Menthol, ZYN Peppermint, ZYN Smooth, ZYN Spearmint and ZYN Wintergreen. Importantly, today’s actions are specific to these products only; the authorizations do not apply to any other nicotine pouch or other ZYN products. Additionally, the authorization does not allow the company to make reduced-risk claims about the authorized products, which would require a modified-risk tobacco product application.

    Today’s actions are the latest of many the FDA has taken to ensure all new tobacco products marketed in the U.S. undergo science-based review and have received marketing authorizations by the agency. To date, the FDA has received applications for nearly 27 million products and has made determinations on more than 26 million of those applications. This includes authorization of other flavored oral tobacco products, including nicotine mints and chews in 2021 and mint smokeless tobacco in 2015. To find a list of tobacco products that may be legally marketed and sold in the U.S., visit the FDA’s Searchable Tobacco Products Database.

  • FDA Proposes Limiting Nicotine Levels

    FDA Proposes Limiting Nicotine Levels

    The U.S. Food and Drug Administration (FDA) today issued a proposed rule that, if finalized, would make cigarettes and certain other combusted tobacco products minimally or nonaddictive by limiting the level of nicotine in those products. If finalized, the United States would be the first country globally to take such a stand. The FDA first announced its intent to propose such a rule in 2018, and now intends to seek input on the proposal, including through public comment and the FDA’s Tobacco Products Scientific Advisory Committee.

    Nicotine is the primary addictive chemical in tobacco products that keeps people using the products. In the case of combusted products, such as cigarettes, nicotine addiction leads to users being repeatedly exposed to a toxic mix of chemicals in the smoke that cause disease and death. Based on the scientific evidence outlined in the proposed rule, the proposed nicotine level for cigarettes and certain other combustible tobacco products would be low enough to no longer create or sustain addiction. Importantly, a large body of research also shows that reduced nicotine content cigarettes do not lead smokers to compensate for lower nicotine by smoking more.

    “Multiple administrations have acknowledged the immense opportunity that a proposal of this kind offers to address the burden of tobacco-related disease,” said FDA Commissioner Robert M. Califf, M.D. “Today’s proposal envisions a future where it would be less likely for young people to use cigarettes and more individuals who currently smoke could quit or switch to less harmful products. This action, if finalized, could save many lives and dramatically reduce the burden of severe illness and disability, while also saving huge amounts of money. I hope we can all agree that significantly reducing the leading cause of preventable death and disease in the U.S. is an admirable goal we should all work toward.”

    Based on the FDA’s population health model, by the year 2100, this nicotine product standard could prevent approximately 48 million U.S. youth and young adults from starting smoking. The model also projects that more than 12.9 million people who smoke cigarettes would stop doing so one year after the rule becomes effective, including those who would completely switch to noncombusted tobacco products; this estimate increases to 19.5 million people within five years of the rule being finalized. Additionally, the model estimates that by the year 2060, the product standard would result in 1.8 million tobacco-related deaths averted, rising to 4.3 million deaths averted by the end of the century.

    The proposed rule would not ban cigarettes or any other tobacco products. The FDA is proposing to cap the nicotine level at 0.7 milligrams per gram of tobacco in cigarettes and certain other combusted tobacco products, which is significantly lower than the average concentration in these products on the market today. The FDA’s proposal would apply to cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars (including little cigars, cigarillos, and most large cigars), and pipe tobacco. The proposed rule does not include e-cigarettes, nicotine pouches, noncombusted cigarettes (such as heated tobacco products that meet the definition of a cigarette), waterpipe tobacco (hookah), smokeless tobacco products, or premium cigars.

    “Today, we’re taking a critical step in the rulemaking process by providing the public with a proposal they can review and engage on,” said Brian King, Ph.D., director of the FDA’s Center for Tobacco Products. “This proposal allows for the start of an important conversation about how we meaningfully tackle one of the deadliest consumer products in history and profoundly change the landscape of tobacco product use in the United States.”

  • FDA Proposes Landmark Rule to Limit Nicotine Levels in Cigarettes

    FDA Proposes Landmark Rule to Limit Nicotine Levels in Cigarettes

    The FDA is preparing to propose a rule to cap nicotine levels in cigarettes and certain other tobacco products to make them minimally or non-addictive. This effort aligns with the Biden administration’s broader public health goals to significantly reduce smoking rates, particularly among youth, and to curb tobacco-related illnesses and deaths. Tobacco use remains the leading cause of preventable death in the U.S., accounting for approximately 480,000 deaths annually.

    The proposed rule, part of the FDA’s comprehensive tobacco control strategy, is expected to face strong opposition from the tobacco industry and some policymakers. Critics argue that the move could unintentionally boost the black market for cigarettes and may not address existing addiction among smokers. Proponents, however, emphasize the measure’s potential to save millions of lives and reduce healthcare costs in the long term.

    This regulation, if implemented, would mark a historic step in tobacco control, as no other country has yet enforced nicotine limits in cigarettes to this degree. The FDA has been exploring such measures since 2009 when Congress gave it authority to regulate tobacco products under the Family Smoking Prevention and Tobacco Control Act. While the proposal is still in its early stages, public health advocates view it as a critical milestone in reducing the public health burden of smoking.