Tag: FDA

  • Regulatory Freeze Pending Review

    Regulatory Freeze Pending Review

    As the Trump Administration digs in, it has called for a regulatory freeze pending review across all agencies, citing five points:

    (1)  Do not propose or issue any rule in any manner, including by sending a rule to the Office of the Federal Register (the “OFR”), until a department or agency head appointed or designated by the President after noon on January 20, 2025, reviews and approves the rule.  

    (2)  Immediately withdraw any rules that have been sent to the OFR but not published in the Federal Register, so that they can be reviewed and approved as described in paragraph 1, subject to the exceptions described in paragraph 1. 

    (3)  Consider postponing for 60 days from the date of this memorandum the effective date for any rules that have been published in the Federal Register, or any rules that have been issued in any manner but have not taken effect, for the purpose of reviewing any questions of fact, law, and policy that the rules may raise.  

    (4)  Following the postponement described in paragraph 3, no further action needs to be taken for those rules that raise no substantial questions of fact, law, or policy.  For those rules that raise substantial questions of fact, law, or policy, agencies should notify and take further appropriate action in consultation with the OMB Director.

    (5)  Comply in all circumstances with any applicable Executive Orders concerning regulatory management.

    Should actions be identified that were undertaken before noon on January 20, 2025, that frustrate the purpose underlying this memorandum, the administration modify or extend this memorandum, to require that department and agency heads consider taking steps to address those actions.

  • Trump Admin Pauses Federal Health Communications

    Trump Admin Pauses Federal Health Communications

    According to CNN, the Trump administration has directed federal health agencies to pause external communications, such as regular scientific reports, updates to websites, and health advisories, according to sources within the agencies.

    Contributors Brenda Goodman and Meg Tirrell wrote that the initial orders were delivered Tuesday to staff at agencies inside the U.S. Department of Health and Human Services, including to officials at the U.S. Food and Drug Administration, the U.S. Centers for Disease Control and Prevention and National Institutes of Health, according to the Washington Post, which first reported the story.

    The direction came without warning and with little guidance as to what exactly it covered, according to sources inside the affected agencies who asked not to be named because they were not authorized to share the information.

    In a follow-up memo obtained by CNN on Wednesday, Acting Health Secretary Dr. Dorothy Fink provided additional details, including that the directive would be in effect through February 1.

    CNN reported that “The memo told health agency employees to have all documents and communications – including regulations, guidance, notices, social media, websites and press releases – reviewed and approved by a presidential appointee before issuing them. It also directed employees not to participate in any public speaking engagements without approval, and to coordinate with presidential appointees before issuing official correspondence to members of Congress or governors.”

    “As the new Administration considers its plan for managing the federal policy and public communications processes, it is important that the President’s appointees and designees have the opportunity to review and approve any regulations, guidance documents, and other public documents and communications (including social media),” Fink said in the memo.

    The directive also told employees to notify higher-ups of any documents or communications that should be exempt either because they’re required by law or because they’re critical for health, safety or other reasons. Already Wednesday morning, the FDA sent out a communication about a safety warning added to the multiple sclerosis drug glatiramer acetate, which goes by brand names including Copaxone, for a “rare but serious allergic reaction.”

    According to the Washington Post, “The pause on communications includes scientific reports issued by the CDC, known as the Morbidity and Mortality Weekly Report (MMWR); advisories sent out to clinicians on CDC’s health alert network about public health incidents; data updates to the CDC website; and public health data releases from the National Center for Health Statistics, which tracks myriad health trends, including drugoverdose deaths.

    Several health officials said they are wary of any messaging halt after the first Trump administration pushed to tightly control the agencies’ communications during the coronavirus response in 2020. Others, however, suggestedthe move is aimed at helping the newly installed Trump health officials understand the vast flow of information coming out of the agencies. The pause, according to one official who spoke on the condition of anonymity to describe internal agency conversations, “seemed more about letting them catch their breath and know what is going on with regard to” communications.

  • SCOTUS Tapdancing Around Vape-Venue Dispute

    SCOTUS Tapdancing Around Vape-Venue Dispute

    Tobacco and vape manufacturers have had little success battling the Food and Drug Administration (FDA) in the majority of appeals courts around the country. However, one place where they have enjoyed modest success is the Fifth Circuit which is located in Louisiana and also governs Mississippi and Texas, and is widely considered the most conservative court in the country. That so many such cases are ending up in the Fifth Circuit is “forum shopping” and shouldn’t be allowed according to the government, an argument that was presented to the Supreme Court January 21.

    The case revolves around R.J. Reynolds Vapor (RJR), a subsidiary of British American Tobacco, a company based in North Carolina, which has found little success battling the FDA in its home Fourth Circuit. Under the Family Smoking Prevention and Tobacco Control Act, manufacturers must get marketing authorization from the FDA before introducing new tobacco products into interstate commerce, and any appeals must be made in either the plaintiff’s home circuit or the D.C. Circuit. The agency previously denied Reynolds’ authorization for flavored e-cigarette products out of concerns for public health. As such, RJR joined several retailers it supplies in Texas and Mississippi and filed its lawsuit in the friendlier Fifth Circuit, a court that has deviated from seven other circuits including the Fourth Circuit and the D.C. Circuit which upheld the FDA’s bans on flavored e-cigarettes. The FDA argued the venue should be based on the location of manufacturers, not the countless retailers.

    “They have circumvented that ability of a court to identify the most convenient forum,” the government said. “By allowing them to use the tactic that they have used, they can unilaterally send the cases to whichever court they prefer.” 

    Justice Clarence Thomas, a George H.W. Bush appointee, suggesting the government had a bias against the Fifth Circuit, asked, “Does it have anything to do with your not winning in the Fifth Circuit?” 

    The government said more than a dozen e-cigarette companies filed appeals in the Fifth Circuit last year. “In 2024, by our count … about 75% of e-cigarette cases were filed all in the Fifth Circuit, all of them by out-of-circuit applicants trying to use the tactic that was approved in the decision below,” said Vivek Suri, assistant to the solicitor general at the Justice Department. “What’s happening now is all of these applicants, whether they’re in California, Michigan, Ohio, or even China, are going to the Fifth Circuit to sue.”

    “Congress was trying to ensure that these kinds of cases go in certain forums or they’re being litigated all over the country and not just in one place chosen by the defendants,” Justice Ketanji Brown Jackson, a Joe Biden appointee, said, suggesting companies were using loopholes to undermine Congress’ venue limitations.

    Kelsey Reichman, writing for the Courthouse News Service, said, “The high court was skeptical that local retailers should be completely barred from challenging marketing denials keeping flavored vapes off store shelves, but their bigger concern stemmed from the potential ripple effects of the case … concerned that a broad venue ruling in this case could touch hundreds of other statutes.”

    “Some of the amici claim that there are as many as 650 review provisions that are similar to the one here,” Justice Samuel Alito, a George W. Bush appointee, said. “Can you tell us how many of those would be subject to the limitation that you just set out?” 

    The government suggested a narrow ruling limited to the Tobacco Control Act. By the end of the argument session, this seemed to be the most likely resolution to the dispute, Reichman said. 

    However, some of the justices questioned whether this was solving the government’s actual complaint. Justice Neil Gorsuch, a Donald Trump appointee, said even if the court prohibited companies from piggybacking on retailer lawsuits, manufacturers could use other tactics to put cases before their preferred court.  

    “What would stop manufacturers from simply funding retailer suits?” Gorsuch asked. “We’d end up in exactly the same place. Third-party funded litigation is not unknown in this country.” 

  • 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.

  • Texas Judge Blocks FDA’s Warning Label Requirements

    Texas Judge Blocks FDA’s Warning Label Requirements

    A federal judge in Texas sided with R.J. Reynolds and other tobacco companies in finding the U.S. Food and Drug Administration (FDA) went beyond its authority by requiring packaging and advertising to contain 11 specific warnings.

    U.S. District Judge J. Campbell Barker, in Tyler, Texas, blocked the FDA from enforcing a looming requirement that cigarette packages and advertisements contain graphic warnings illustrating the health risks of smoking. He said those warnings go above and beyond the nine that Congress specified when in 2009 it passed the Tobacco Control Act, which gave the FDA the authority to regulate tobacco products and mandated adoption of the graphic warnings.

    Barker said not only did the FDA adopt two extra warnings beyond the nine the law required, but it only used the exact text Congress required for two of the remaining nine.

    The FDA argued it has the authority to adjust the format, type, and text of any required labels, but Barker said that power was limited, and even if the FDA was allowed to adjust the nine warnings, it could not add the extra two.

    “Courts are not free to second-guess policy decisions expressed in the plain text of the congressional enactments,” Barker wrote.

    The judge delayed the rule’s effective date pending further litigation, preventing the FDA from proceeding to enforce it starting in February 2026. It marked the second time Barker has blocked the FDA’s warning label rule. In 2022, the judge concluded the requirement violated the companies’ speech rights under the U.S. Constitution’s First Amendment.

  • 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.

  • FDA Warns 9 More for Illegal Vape Sales

    FDA Warns 9 More for Illegal Vape Sales

    The U.S. Food and Drug Administration issued warning letters to eight online retailers and one manufacturer for selling and/or distributing unauthorized flavored, disposable e-cigarettes.

    Some of the unauthorized products cited in the warning letters are marketed under brand names for disposable products, including Geek Bar and Lost Mary, according to the FDA. Other unauthorized products cited feature the names and/or images of celebrities.

    The firms receiving these warning letters sold and/or distributed e-cigarettes in the United States that lack authorization from FDA to be legally marketed in the U.S., which is in violation of the Federal Food, Drug, and Cosmetic Act.

    In addition to the violations mentioned in the warning letters, the firms were warned to address any violations that are the same as, or similar to, those stated in the warning letter and to promptly take necessary actions to comply with the law.

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

  • Top Court to Hear Triton Vaping Case

    Top Court to Hear Triton Vaping Case

    The U.S. Supreme Court will next week 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 live audio of the hearing can be found here.

    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.

    The Supreme Court is due to hear the case in its next term, which begins in October, according to Reuters.

    Two e-cigarette liquid makers, Triton Distribution and Vapetasia, filed premarket tobacco product applications in 2020 for products with flavors such as sour grape, pink lemonade, and crème brulee and names such as “Jimmy The Juice Man Strawberry Astronaut” and “Suicide Bunny Bunny Season.”

    The FDA rejected the companies’ applications, along with more than 1 million other products.

    Triton and Vapetasia in 2021 asked the New Orleans-based 5th U.S. Circuit Court of Appeals to review the FDA’s denial of their applications.

    In January, the 5th Circuit ruled that the FDA had been arbitrary and capricious by denying the applications without considering plans by the companies to prevent underage access and use.

  • IKE Tech, Ispire to File PMTA for Age Gating Technology

    IKE Tech, Ispire to File PMTA for Age Gating Technology

    Ispire Technology and IKE Tech announced a successful pre-premarket tobacco product application (PMTA) meeting with the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) for their age verification technology for electronic nicotine delivery systems (ENDS).

    According to an e-mailed release, the technology aims to prevent youth access while expanding adult market access to flavored PMTA-authorized products. IKE Tech is a joint venture among three leading technology and research companies Ispire and Touch Point Worldwide d/b/a Berify and Chemular Inc.

    IKE Tech will submit a component PMTA, which would allow ENDS manufacturers to incorporate their blockchain-based age-gating solution if authorized. The FDA indicated potential priority review consideration and acceptance of a component PMTA. The company plans to complete the required studies in Q1 2025.

    This critical regulatory milestone marks an essential step in the journey to provide an innovative, secure universal solution aimed at preventing youth access to ENDS and expanding the market for adults who choose to use flavored PMTA-authorized products, according to the release.

    “The IKE Tech identity and age verification technology unlocks opportunities for adults who choose to use flavored vapor products while introducing a pioneering approach to reducing youth access and usage,” the release states.

    Due to its innovative design, reliance on blockchain technology, and partnership with leading identity and age verification providers, the IKE Tech system is an advanced component that could be used — in any ENDS device — to ensure only authorized adult users can access vaping products.

    FDA alignment on key points:

    • Component PMTA: IKE Tech will submit a PMTA for a component, as opposed to a finished tobacco product to be sold to consumers, and the FDA indicated it will accept such a component PMTA if all statutory requirements are met. Additionally, due to the fact this component employs novel point-of-use technology, the FDA indicated it will consider a request to grant the IKE Tech system priority review. If authorized, the component PMTA would allow ENDS manufacturers to use the IKE Tech system in their finished tobacco product PMTAs, as a plug-and-play age-gating solution, which may allow for the approval of a variety of flavored ENDS products.
    • Creation of Tobacco Product Master File (TPMF): IKE will create and file a TPMF for the IKE component. Once authorized, the component and TPMF can, subject to agreement, be available to ENDS device manufacturers for incorporation into products.

    IKE Tech anticipates completing the required studies for the component PMTA for the IKE Tech system, including the Identity and Age Verification component in Q1 2025.

    “Our commitment to harm reduction through innovation and our collaborative efforts with regulators are central to Ispire’s mission,” said Michael Wang, Co-CEO of Ispire. “We are proud to introduce technologies that are designed to responsibly support adult consumer choice while significantly reducing youth access. This technology represents our dedication to aligning with regulatory guidance and setting new standards for safer