Tag: U.S. Food and Drug Administration

  • CTP: ‘Grandfathered’ Becomes ‘Pre-existing’

    CTP: ‘Grandfathered’ Becomes ‘Pre-existing’

    Photo: Olivier Le Moal

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has updated the term “grandfathered tobacco product” to “pre-existing tobacco product” to describe these products more appropriately.

    Additionally, the term “grandfathered,” when used to describe someone or something exempt from a new law or regulation has its roots in 19th century racist voting laws, according to the FDA.

    Like the grandfathered products before it, a pre-existing tobacco product is any tobacco product (including those products in test markets) that was commercially marketed in the United States as of Feb. 15, 2007.

    As was the case with submitting a grandfathered determination request, submitting a request to determine the pre-existing status of a tobacco product is voluntary and not required under the Federal Food, Drug and Cosmetic Act.

    According to the CTP, the terminology update requires no additional action by companies with pending grandfathered determination request.

  • FDA Warns VPR Over Nicotine Gummies

    FDA Warns VPR Over Nicotine Gummies

    Photo: Ljupco Smokovski

    The U.S. Food and Drug Administration on Aug. 18 issued a warning letter to VPR Brands (doing business as Krave Nic) for marketing illegal flavored nicotine gummies—the first warning letter for this type of product.

    According to the FDA, these types of gummies are of particular public concern because of their resemblance to kid-friendly food or candy products and the potential to cause severe nicotine toxicity or even death among young children.

    VPR Brands markets gummies that have 1 mg of nicotine each and are available in three flavors – Blueraz, Cherry Bomb and Pineapple. The packaging claims that the products contain tobacco-free nicotine. This firm has not submitted a premarket tobacco product application to the FDA, and does not have a marketing authorization order to manufacture, sell or distribute these products in the U.S.

    “Nicotine gummies are a public health crisis just waiting to happen among our nation’s youth, particularly as we head into a new school year,” said FDA Commissioner Robert M. Califf in a statement. “We want parents to be aware of these products and the potential for health consequences for children of all ages—including toxicity to young children and appeal of these addictive products to our youth. The FDA will not stand by as illegal products infiltrate the marketplace.”

  • ‘FDA Took Shortcuts in Reviewing PMTAs’

    ‘FDA Took Shortcuts in Reviewing PMTAs’

    Image: smolaw11

    In establishing whether a nicotine product is appropriate for the protection of public health, the U.S. Food and Drug Administration held its Center for Tobacco Products (CTP) reviewers to a lower standard than the companies submitting premarket tobacco product applications, according to Alex Norcia writing in Filter.

    Citing documents obtained through the Freedom of Information Act, Filter describes procedures such as batching and bracketing, which allowed the CTP to apply conclusions to categories of products rather than evaluating them separately. “Despite imposing extremely onerous bureaucratic requirements on applicants, the agency was happy to find ways to cut through its own paperwork,” writes Norcia.

    “It’s clear that FDA allows itself efficient shortcuts that it has denied to applicants,” Clive Bates, director of The Counterfactual, told Filter.

    “The problem has always been that FDA’s extraordinarily burdensome process was obviously tremendously wasteful for applicants, but of course it was always going to be unmanageable for the assessors in FDA. Without this sort of shortcut, the PMTA process would have become a human resources nightmare. So FDA has allowed itself the kind of efficiencies it should have offered to the applicants—batching and bracketing thousands of near-identical products.”

  • Delnevo to Chair TPSAC

    Delnevo to Chair TPSAC

    Photo: Rutgers

    Cristine Delnevo has been appointed chairperson of U.S. Food and Drug Administration’s Tobacco Products Scientific Advisory Committee (TPSAC).

    Delnevo is the director of the Rutgers Center for Tobacco Studies and a professor of health behavior, society and policy at the Rutgers School of Public Health. She was appointed to serve on the TPSAC in March 2021. Her appointment as chair will run through Jan. 31, 2025.

    Established in 2009, TPSAC reviews and evaluates safety, dependence and health issues related to tobacco products and provides advice, information and recommendations to the FDA’s commissioner. The FDA commissioner selects the committee members from among people with expertise in medicine, medical ethics, science or technology involving the manufacture, evaluation or use of tobacco products.

    “I have valued the importance of this FDA advisory committee since the signing of the Family Smoking Prevention and Tobacco Control Act in 2009,” said Delnevo in a press note published by Rutgers. “This advisory committee plays an important role in several ways, perhaps most notably on the review of modified risk tobacco product applications, as required under the Tobacco Control Act.

    “I value the service of Dr. Jonathan Samet and Dr. Robin Mermelstein who served admirably before me as chair, and I look forward to working with an esteemed group of colleagues to help the FDA make regulatory decisions to protect public health and reduce tobacco-related morbidity and mortality.”

    Delnevo’s expertise spans population-level tobacco behavior trends—particularly non-cigarette tobacco products like cigars and e-cigarettes—tobacco control policy and regulation, and survey methods research.

    In 2022, she received the John Slade Award from the international Society for Research on Nicotine and Tobacco for outstanding contributions to public health and tobacco control through science-based public policy and public advocacy. Her work has been extensively cited in two FDA proposed rules that would ban menthol in cigarettes and characterizing flavors in cigars and she recently served as an external peer reviewer on the FDA’s Scientific Assessment of Impact of Menthol in Cigarettes.

    In addition, she served as a committee member on the National Academies of Sciences, Engineering and Medicine report on the Health Effects and Patterns of Use of Premium Cigars.

    Delnevo co-leads one of nine Tobacco Centers of Regulatory Science and has published extensively on tobacco-use behavior patterns. She has authored more than 250 scientific articles, reports and book chapters and serves on the Editorial Advisory Board for the journal Tobacco Control.

    “We are excited that an RBHS faculty member was selected to be a member, and indeed the leader, of an important committee like TPSAC,” said Brian Strom, chancellor of Rutgers Biomedical and Health Sciences. “I am confident that Dr. Delnevo will bring to this role her passion, commitment, and leadership skills, which she has already exhibited at the Rutgers Center for Tobacco Studies, and will help FDA make decisions for the country that will help save lives.”

  • Association Calls For Investigation Of MDO’s

    Association Calls For Investigation Of MDO’s

    Photo: Andrey Popov

    The American Vapor Manufacturers Association (AVMA) has asked the U.S. Department of Health and Human Services’ (HHS) Inspector General to investigate whether the Food and Drug Administration’s marketing denial orders for vaping products are driven by political pressure.

    The AVMA says it wants the inspector general to help the public learn about FDA Commissioner Robert Califf’s coordination with elected officials, allied activists and reporters as his agency continues its review of premarket tobacco product applications (PMTA).

    Amanda Wheeler

    In a letter sent to HHS Inspector General Christi A. Grimm, AVMA President Amanda Wheeler contends that interference has corrupted FDA’s statutory obligation to properly implement its PMTA review process based solely on scientific, empirically based judgment.

    “Manufacturers are routinely meeting the PMTA requirements to scientifically demonstrate how their products are appropriate for the protection of public health,” Wheeler wrote. “Despite compliance, the agency isn’t approving the vape products sought by adults who want to quit smoking. The Office of Inspector General should open the door and hold the FDA accountable to its standards.”

  • FDA Ignored Evidence in ‘Deeming’ Premium Cigars

    FDA Ignored Evidence in ‘Deeming’ Premium Cigars

    Photo: Viacheslav Yakobchuk

    The U.S. Food and Drug Administration ignored evidence about health risks in considering premium cigars to be subject to same law as cigarettes, a federal judge ruled on July 5, reports Reuters.  

    The litigation focuses on the 2016 Deeming Rule, in which the agency identified a wide range of tobacco products, including premium cigars, to be subject to its regulatory authority along with cigarettes under the Family Smoking Prevention and Tobacco Control Act.

    The FDA rule requires cigar makers to register their products annually, provide ingredient lists for each product and submit products for laboratory testing—procedures the premium cigar industry considers impractical for its handmade, “artisan” products.

    The Premium Cigar Association and Cigar Rights of America challenged the Deeming Rule, arguing that, unlike cigarettes and e-cigarettes, premium cigars do not appeal to young people and are not associated with addiction. They cited studies showing that young people are unlikely to use premium cigars, that users of premium cigars are unlikely to smoke them frequently and that infrequent cigar use is not associated with increased mortality.

    U.S. District Judge Amit Mehta in Washington DC agreed that the FDA had not adequately considered the studies cited by the plaintiffs, instead asserting that there was “no evidence” that premium cigars were less harmful.

    “Where, as here, an agency speaks in absolute terms that there is no evidence, it acts arbitrarily and capriciously when there is in fact pertinent record evidence and the agency ignores or overlooks it,” the judge wrote.

    Judge Mehta asked the FDA and the industry groups to submit briefs on whether he should vacate the FDA’s decision or simply remand the matter back to the agency.

  • It’s Official: FDA Denies Juul Market Access

    It’s Official: FDA Denies Juul Market Access

    Photo: steheap

    Today, the U.S. Food and Drug Administration confirmed what many had already been anticipating: Juul Labs must remove all currently marketed Juul products from the U.S. market.

    “Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” said FDA Commissioner Robert M. Califf. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”

    These marketing denial orders (MDO) pertain only to the commercial distribution, importation and retail sales of these products, and do not restrict individual consumer possession or use—the FDA cannot and will not enforce against individual consumer possession or use of Juul products or any other tobacco products.

    After reviewing the company’s premarket tobacco product applications, the FDA determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health. In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data—including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods—that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.

    The FDA says that, to date, it has not received clinical information to suggest an immediate hazard associated with the use of the Juul device or Juul pods. However, the MDOs issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the Juul products.

    “There is also no way to know the potential harms from using other authorized or unauthorized third-party e-liquid pods with the Juul device or using Juul pods with a non-Juul device,” the agency wrote in a statement.

    “The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products. “As with all manufacturers, Juul had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”

  • Zeller: CTP Tenure ‘Incredibly Rewarding’

    Zeller: CTP Tenure ‘Incredibly Rewarding’

    Photo: Tobaccco Reporter archive

    Mitch Zeller, the outgoing director of the U.S. Food and Drug Administration Center for Tobacco Products (CTP), described his tenure at the center as “incredible rewarding.” “I’ve had the opportunity to work with the best, hardest working people in the world and we’ve gotten a lot done, so my time here has been a joy,” he said in an interview published on the FDA website ahead of his retirement from public service in April.

    Zeller joined the CTP as director in March 2013. During his tenure, the center grew from 426 people to more than 1,110. The CTP, said Zeller, also published multiple foundational rules and took action on just over 99 percent of marketing applications for 6.7 million products.

    Asked about the remaining challenges for the CTP, Zeller cited the importance of taking action on the remaining marketing applications, but noted that the center and the agency are “more than up to the task.” He also stressed the importance of evidence-based policies.

    “We must be faithful to our responsibility that whatever decision we make on any of them is firmly grounded in the science, whether we’re issuing a marketing authorization or a marketing denial order,” said Zeller.

    Asked what advice he would give to the next CTP director, Zeller said he would encourage him or her to ask questions. “You’ll be working with extraordinarily talented people in the Commissioner’s Office and throughout the agency as well as the Department of Health and Human Services,” he said. “A lot of new insights and good thinking can come from people hearing a question that hadn’t occurred to them. 

    On the future of tobacco regulation, the outgoing CTP director said the opportunity over the next three to five years is for the center to continue the process of building the institution. “CTP remains the “baby” center in terms of how long it’s been around compared to the other FDA centers,” he said.

    “In light of that, one of the things that I think I can safely predict is that more and more of those critically important foundational regulations will be proposed and finalized. With each one that comes, CTP will become that much more mature and stood up as a center like its sister centers that have been around for many, many decades.”

  • FDA to Provide PMTA Updates Every Three Months

    FDA to Provide PMTA Updates Every Three Months

    Photo: Niroworld

    The U.S. Food and Drug Administration will be required to give premarket tobacco product application (PMTA) status reports every 90 days. The first reports are due on April 29, according to a revised order from District Judge Paul Grimm for the United States District Court for the District of Maryland.

    The revised order, signed on April 15, granted a motion filed by American Academy of Pediatrics (AAP) and other plaintiffs that requires the FDA to “forecast the percentages of such products for which it expects to have taken ‘action’ by June 2022 and quarterly thereafter.” Subsequent reports will also be required to state any revisions to prior estimates.

    The order states that “covered applications” means all applications for newly deemed tobacco products “sold under the brand names Juul, Vuse, NJoy, Logic, Blu, Smok, Suorin or Puff Bar.” Additionally, any product with a reach of 2 percent of more (vaping product brands deemed to have the greatest public health impact) in “Retail & Sales” in Nielsen’s “Total E-cig Market & Players” or “Disposable E-Cig Market & Players.”

    The FDA has approved some products from Vuse and Logic, while denying applications for Blu’s Myblu products.

    The decision was expected by the vaping industry. Speaking during Keller and Heckman (K&H) annual E-Vapor and Tobacco Law Symposium Feb. 2–3, K&H Partner Azim Chowdhury said the FDA had appeared to concede to the requested requirement to submit status reports on many of the remaining submissions under review, adding that the updated requirements requested by the anti-vaping groups appeared to be even broader than the original.

    It’s been more than eight months since the 12-month continued compliance policy for products subject to timely submitted PMTAs ended, but the agency is still sitting on some 88,000 reviews, including some of the vaping products with the highest market shares as measured by Nielsen.

    Requiring the FDA to provide the status reports comes with some controversy. Chowdhury says that it wouldn’t be appropriate for the protection of public health (APPH) or positive for the vaping industry if a requirement for status updates forced the regulatory agency to make PMTA decisions only to appease the anti-vaping groups or politicians.

    “These status reports could be used as a tool to pressure FDA to act—i.e., deny— applications quickly,” Chowdhury told Tobacco Reporter’s sister publication Vapor Voice. “Rather, we want FDA to review the science carefully and take the time it needs to determine whether a particular product is APPH.”

    In November 2021, the anti-vaping organizations whose lawsuit brought forward the deadline for filing PMTAs asked U.S. District Judge Paul Grimm to reopen the case. The plaintiffs asked him to require the U.S. Food and Drug Administration to regularly report on the status of the applications for the 10 bestselling vapor brands according to Nielsen rankings.

  • FDA Denies Market Access to Myblu

    FDA Denies Market Access to Myblu

    Photo: Alex Kalmbach

    The U.S. Food and Drug Administration issued marketing denial orders (MDOs) to Fontem US for several Myblu electronic nicotine delivery system (ENDS) products after determining their applications lacked sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health.

    According to a notice published on the FDA’s website, the currently marketed products receiving MDOs include Myblu Device Kit, Myblu Intense Tobacco Chill 2.5% and Myblu Intense Tobacco Chill 4.0%.

    In reviewing premarket applications for tobacco products, the FDA evaluates the risks and benefits of those products to the population as a whole, including users and nonusers of the tobacco product, and considers, among other things, the likelihood that those who do not currently use tobacco products will start using those tobacco products.

    Based on the information submitted by Fontem US for these Myblu products and the available evidence, the applications lacked sufficient evidence regarding design features, manufacturing, and stability, according to the FDA. Additionally, the applications did not demonstrate that the potential benefit to smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth, the agency said.

    Tobacco products subject to an MDO may not be offered for sale, distributed or marketed in the U.S.