Tag: FDA

  • Repeating the Past

    Repeating the Past

    Credit: CavDiyav

    Fentanyl misinformation could come with consequences much worse than those experienced with EVALI.

    By Timothy S. Donahue

    Earlier this year, media reports began to circulate that a dangerous trend was beginning to emerge in the vaping industry: the proliferation of fentanyl-laced vapes. “This lethal combination of the potent synthetic opioid fentanyl and electronic cigarettes has raised serious concerns among health experts, law enforcement agencies and the general public,” wrote PharmChek, a drug abuse data source.

    The first report of fentanyl-laced vaping products appeared in September 2019, when the U.S. Drug Enforcement Administration (DEA) San Diego division was contacted by local authorities regarding a suspected fentanyl overdose death. The roommate of the deceased, who admitted to vaping fentanyl regularly, told agents there was fentanyl and possibly other drugs located in their shared residence as well as fentanyl-laced “vape” tanks, according to the DEA. The San Diego County Medical Examiner reports that this was the first case in which they had found fentanyl in vape pens.

    The vaping devices were not sold in any store. They were not marketed as fentanyl vape pens. The products were adulterated products that were then sold on the black market, according to the DEA. Media reports at the time did not mention that vapes were altered illegally and instead blamed the nicotine vaping industry for the contaminated devices.

    During the Next Generation Nicotine Delivery 2023 conference held in Miami in June, Tony Abboud, executive director of the Vapor Technology Association (VTA), said that vaping industry veterans may remember something similar in vaping’s recent past that resembles the fentanyl crisis.

    In August 2019, an Illinois man succumbed in a hospital to a mysterious lung disease caused by a vaping product. Soon after, the U.S. Centers for Disease Control and Prevention (CDC) reported the initial instance of what it called e-cigarette or vaping product use-associated lung injury (EVALI). The number of cases hit its peak in September before dropping off through February 2020, at which point there were 2,807 reports and 68 deaths.

    Experts believe that one of the primary causes of the EVALI outbreak was vitamin E acetate, which had been added to some vaping products as a thinner. Additionally, many cases included tetrahydrocannabinol (THC)-containing products, not nicotine vaping products. Neither the CDC nor the U.S. Food and Drug Administration challenged the disinformation being disseminated by media outlets and anti-nicotine groups blaming nicotine e-cigarettes for the EVALI crisis. It nearly decimated the vaping industry.

    EVALI and the false reporting surrounding its cause boosted misinformation surrounding nicotine vaping products. A study led by researchers at the American Cancer Society at the time showed that perceptions of e-cigarettes as being “more harmful” than cigarettes by adults in the United States more than doubled between 2019 and 2020 and that perceptions of e-cigarettes as “less harmful” declined between 2018 and 2020 when the EVALI concern was at its peak.

    It wasn’t until late October 2019 that any government organization stated publicly that nicotine vaping products were not the cause of EVALI. Abboud warned conference attendees that if the e-cigarette industry doesn’t react differently to the misinformation surrounding nicotine vaping and illicit fentanyl-laced vaping products, the industry may not survive.

    “The misinformation that went along with the EVALI crisis had a traumatic impact not just on businesses but on consumers’ perceptions about vaping products in general. And it was driven largely by the media,” explained Abboud. “It was on the media every single day …. The most important thing, obviously, at this time, was for our regulatory bodies to figure out and speak clearly about what was causing the problem. That did not occur in the manner that it should have occurred.”

    The false link between nicotine vaping products and EVALI was also hijacked by anti-nicotine advocates, such as Matthew L. Myers, who was with the Campaign for Tobacco-Free Kids at the time, and Michael Bloomberg, the billionaire philanthropist and financial backer of anti-vaping organizations. The day after the CDC EVALI announcement, Myers and Bloomberg hit the airwaves talking about flavored vaping products and their commitment to spend $160 million to remove flavored vaping products from the market. Flavors attract kids, and EVALI would kill them, the group claimed.

    “What they said was frankly unconscionable because they leveraged the [then] current EVALI crisis that did not have anything to do with flavored nicotine products to their benefit. The impact of this kind of narrative led to the next day when President Trump announced [d] his ban on all flavors,” said Abboud. “At this point, we knew that the industry was facing somewhat of an existential crisis because they were talking about removing a huge segment of the market and a larger segment of the independent vaping industry. And that would have dramatic repercussions down the road.

    “We immediately started acting. We had to get on TV to explain what was really going on with vitamin E acetate to make clear that this was an illicit THC issue. We had to frame the issue in terms of public health. We also had to create the issue in terms of jobs. But we had to do more than that. We had to launch a public affairs campaign that made clear what was at stake with this policy decision that was made in this vacuum without frankly any sort of regulatory process behind it.”

    After several e-cigarette advocacy organizations sat down with President Trump to discuss flavors, the FDA only banned flavors in closed pod systems. Disposables were still going to avoid enforcement. Many in the industry say this FDA decision was the catalyst to the current issues of flavors and youth use. The FDA has not authorized a flavor other than tobacco. “But in that, the industry was largely preserved, and companies were able to stay in business,” said Abboud.

    Credit: Momius

    The next false flag

    On May 18, Tom Price, a former U.S. Secretary of Health and Human Services, published an op-ed on FoxNews.com where he started a narrative in the media about fentanyl-laced vaping products being imported from China in disposable vaping products. He offers no evidence of China’s involvement in the importation of fentanyl-laced vaping products other than China making most of the e-cigarette hardware.

    “Reports suggest these Chinese manufacturers are also boosting disposable vapes with illegal levels of nicotine to increase addiction levels among our children. But while added nicotine makes e-cigarettes more addictive for our kids, adding fentanyl to them can make them deadly,” Price wrote. “Given the extent that China funnels fentanyl into America, it shouldn’t come as much of a surprise that reports indicate officials have found some of these vapes laced with fentanyl.”

    There is no denying that fentanyl is a public health crisis. People are dying from overdosing on fentanyl because the U.S. has a huge problem in keeping illicit drugs out of the country, said Abboud. However, the “out-of-the-blue op-ed” tying fentanyl to Chinese-made disposable flavored vaping products is a new approach and new message.

    Abboud then revealed a series of op-eds that were published in June all making the same points. “It was quickly [brought up again] in June by the former GOP National Committee member from Nevada who makes almost identical statements, ‘flavored disposable vaping products are dangerous, but those coming from communist China are especially dangerous because they include fentanyl,’” said Abboud. Now, according to the op-ed, “kids are experimenting with vaping fentanyl. You see what’s happening here. That was June 10. Then media reports began talking about fentanyl vapes from Mexico. On June 11, a Georgia State senator penned an op-ed (that toed the same line).”

    The unsubstantiated claims that e-cigarettes contain fentanyl are increasing in frequency. Curiously, these cases have involved illicit THC vape pens or other devices—not disposables and not e-cigarettes purchased from reputable manufacturers, according to Abboud. Yet, a bill has now been introduced in the U.S. House filed by a member of Congress from the state of Florida that would remove flavored disposable vaping products from the market because of the fentanyl crisis. This call was amplified by a Florida-based retail association that made the same false claims about nicotine e-cigarettes.

    The unsubstantiated association between vaping and fentanyl is showing up in regulatory conversations as well, but interestingly, only disposables are implicated even though the organic media stories have involved all device types, according to Abboud. He said the first place that he found the association made in a regulatory context was when R.J. Reynolds filed a citizen petition on Feb. 6, 2023, asking for the FDA to use its enforcement powers to remove flavored disposable vaping products from the market because “illicit market-supplied vaping products are being laced with products such as fentanyl, which is lethal in doses as small as 2 milligrams.” A few days later, a bill was introduced in Congress to force the FDA to act on removing flavored disposables.

    In March, Robert Califf, commissioner of the FDA, testified before the House Appropriations Committee. “He is questioned by Representative Newhouse, and the question posed was ‘Can you tell us about your plan to get these potentially dangerous Chinese products off of the market and out of the hands of kids, and can you tell us what companies that you have (taken off the market) and that these products don’t contain harmful contents like fentanyl?’ There really hadn’t been much reporting on this issue before this, but (Califf) was asked this question,” said Abboud.

    Califf told Congress that “There’s recently been some publicity,” and “it’s no surprise but of great concern to me that fentanyl may be showing up now in vaping products, [that] it was just a matter of time” and that the United States needs an all-of-government approach to protect kids from this threat.

    The VTA reviewed all the stories that it could find that mentioned vaping and fentanyl. Abboud confirmed that the device in Reynolds’ petition was not disposable. The devices that were confiscated were vape pens, an open system and a pod device. The authorities, in that case, said that they found that the devices were altered when fentanyl or heroin was injected through the device into the e-liquid. All the other fentanyl reports involved cartridge-style vape pens or THC products. “Of all the cases that we looked at, only one of them even mentioned a disposable, a flavored disposable,” said Abboud. “Perhaps it’s time to ask the question ‘Why are we seeing this manufactured media narrative that is not supported by any publicly available data?’ Creating unfounded fears among consumers about fentanyl will harm the entire vaping industry and will make a mockery of the concept of tobacco harm reduction altogether.”

    The ultimate issue is that misinformation, as it relates to e-cigarettes, drives people back to smoking. The FDA has also talked about this publicly. CTP Director Brian King has expressed concerns over the misinformation surrounding vaping products, and he understands that there are misperceptions as it relates to nicotine and many products. However, the vaping industry is once again in a position where disinformation is driving a false narrative that will spin out of control, according to Abboud.

    “My perspective is that this is an intentional false flag. If, as asserted, millions and millions of illegally imported disposable vapes are coming into the country laced with fentanyl, where’s the outbreak? This is not something that would just ‘not’ be reported on. And as I’ve said, we looked at the reports, and there is just slim evidence that there is any connection between the fentanyl epidemic and nicotine vaping,” explains Abboud. “The problem, of course, is that we have illicit THC vapes [in] the United States that are the real issue. And given how unforgiving the Chinese government is toward illicit drugs, does anybody really believe [Chinese manufacturers] are going to make THC vapes adulterated with fentanyl and take the risk of being imprisoned or worse in their own country?”

    It seems like deja vu all over again. Abboud said that if the vaping industry allows a manufactured crisis that associates fentanyl with nicotine vaping devices to take hold, the entire industry will never recover in the eyes of the consumer. “As soon as you say vaping and fentanyl, consumers will not distinguish between disposables and open systems. They will reduce their risk, and for many, that will, unfortunately, mean a return to smoking,” said Abboud. “As with EVALI, we have hyped and overgeneralized headlines in the media talking about vaping. We have had direct calls for eliminating flavored nicotine in vaping and specifically flavored disposable products.

    “And we have regulators who contribute to this misleading narrative, specifically the statement made by the FDA commissioner in front of Congress. The bottom line is that I don’t think this industry gets three strikes. EVALI, strike one. I think this [fentanyl in vape devices] narrative, if it takes hold, the way it appears to be being pushed to take hold is strike two. The vaping industry won’t get a third at-bat.”

    Credit: Vitalii Vodolazskyi
  • U.S. FDA Cracking Down on Kid Friendly Products

    U.S. FDA Cracking Down on Kid Friendly Products

    Credit: FDA

    Regulators in the United States are cracking down on online retailers selling vaping products that are attractive to youth. The Food and Drug Administration today issued warning letters to 16 (the agency reported 15, but lists 16) online retailers for selling and/or distributing unauthorized e-cigarette products packaged to look like cartoon characters, school supplies, toys, and drinks.

    “The design of these products is a shamelessly egregious attempt to target kids,” said Brian King, director of FDA’s Center for Tobacco Products (CTP). “It’s a tough sell that adults using e-cigarettes to transition away from cigarettes need them to look like SpongeBob in order to do so successfully.”

    The unauthorized products described in the warning letters include e-cigarettes that feature youth-appealing characters from TV shows, movies, and video games, including “SpongeBob,” “Lots-o’-Huggin’ Bear,” and “Mario.” The also imitate drinks from companies such as Starbucks and Dunkin coffee cups, soda and water bottles, according to press release.

    “The retailers receiving these warning letters sell and/or distribute e-cigarettes in the United States that lack authorization from FDA, which is a requirement under the Federal Food, Drug, and Cosmetic (FD&C) Act to legally market a new tobacco product,” the FDA states. “In addition to the specified products mentioned in the warning letters, the retailers 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 bring the tobacco products that they offer for sale in the United States into compliance with the FD&C Act.”

    The retailers were given 15 working days to respond with the steps they’ll take to correct the violation and to prevent future violations. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.

    “CTP will continue to closely monitor all those in the supply chain, including retailers, for compliance with federal law,” said attorney Ann Simoneau, director of the Office of Compliance and Enforcement within the CTP. “As always, we will hold anyone accountable that sells unauthorized tobacco products labeled, advertised, and/or designed to encourage use by our nation’s youth.”

    The companies receiving warning letters include:

    • VR Products I LLC d/b/a eJuiceDB
    • Titan Star Resources d/b/a Vape Vandal Ltd
    • Vapesstores.com
    • Disposable Vapes Wholesale
    • Vapestore.to
    • Venture Concept Groups d/b/a High Light Vape Co.
    • Best Vapes Store
    • Apex Vape
    • The Juice Machine
    • StrikesUSA
    • Finest Ounce Vape Stor d/b/a Finest Ounce Vape Malaysia
    • Spongbob Vape
    • Mini Cup Vape
    • Vape123
    • Viper Vapor d/b/a Viper Vapor Kelso
    • Mochivap

    These new warning letters mark another step in the FDA’s continued efforts to remove illegal e-cigarettes from the market, particularly those that appeal to youth, the agency states. As of August 2023, the FDA has issued approximately 600 warning letters to firms for manufacturing and/or distributing illegal tobacco products, including e-cigarettes, filed civil money penalty complaints against 26 e-cigarette manufacturers, and worked with the Department of Justice to seek injunctions against 6 e-cigarette manufacturers.

  • Tomorrow: FDA Tobacco Center Strategic Plan Event

    Tomorrow: FDA Tobacco Center Strategic Plan Event

    Vapor Voice Archive

    Tomorrow, Aug. 22, 2023 is the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) online forum centered on developing a 5-year strategic plan to advance its mission.

    As part of an iterative, center-wide process, CTP has developed five proposed goal areas. These goal areas are intended to be interconnected with four proposed cross-cutting themes: health equity, science, transparency, and stakeholder engagement.

    The center intends to publish the strategic plan by the end of 2023, following receipt and consideration of public input.

    Beginning at 10 a.m. EDT, the CTP virtual listening session will give the public an opportunity to verbally provide open public comment on the development of the 5-year strategic plan, including proposed strategic goals.

    CTP will begin with an overview of the process used to develop the center’s strategic plan, including proposed goal areas. Registered speakers will then have approximately 4 minutes each to verbally share their comments on any topics related to the strategic plan.

    Live closed captioning and ASL interpreters will be provided during the listening session. If you have issues registering or have any questions, please email malini.runnells@fda.hhs.gov or call 1-877-CTP-1373 between 9 a.m. and 4 p.m. EDT.

    A transcript and recording will be made available after the listening session.

    Use this link to view the session.

  • U.S. FDA to Hold Public Meeting on PMTA Process

    U.S. FDA to Hold Public Meeting on PMTA Process

    The U.S. Food and Drug Administration will hold a two-day public meeting on the agency’s premarket tobacco product application (PMTA) process on Oct. 23–24, 2023.

    The meeting will be held on the FDA’s White Oak Campus in Silver Spring, Maryland, and will be in a hybrid format with the option to attend virtually.

    Staff from the Center for Tobacco Products’ Office of Science will present on topics related to the PMTA process and be available to respond to questions received from stakeholders on the topic, according to a press note.

    Additional information, including registration and question submission processes, will be available soon.

  • FDA Tobacco Chief Discusses Relative Risk of Vapes

    FDA Tobacco Chief Discusses Relative Risk of Vapes

    CTP Director Brian King

    In an article published in Addiction magazine, Brian King, director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), explores the chances and considerations for informing adults who smoke cigarettes about the relative dangers of tobacco products, including e-cigarettes. He collaborated with Benjamin Toll, director of the Medical University of South Carolina Tobacco Treatment Program and co-director of the Lung Cancer Screening Program.

    The commentary highlights the findings of a recent survey about misperceptions of tobacco product harms, including cigarettes and e-cigarettes. The survey found that only about 20 percent of adults who smoke cigarettes believed e-cigarettes contain fewer harmful chemicals than cigarettes. While there are no safe tobacco products, the available scientific evidence indicates that tobacco products exist on a continuum of risk, with cigarettes being the most harmful. 

    The commentary notes that opportunities exist to educate adults who smoke about the relative risks of tobacco products, including e-cigarettes. However, these efforts should be accompanied by efforts to prevent youth tobacco product use; encourage first-line use of FDA-approved cessation therapies; and for adults who both smoke and use e-cigarettes, reinforce the importance of completely transitioning to e-cigarettes.

    The commentary further emphasizes that any education efforts on the relative risks of tobacco products must be evidence-based. In particular, it is important to assess the benefits among the intended population (i.e., adults who smoke) and risks among unintended populations (e.g., youth). Currently, FDA is in the early stages of a research effort to assess messaging about the continuum of risk of tobacco products among adults who smoke.

    Last week, the FDA announced a virtual listening session opportunity to verbally provide open public comment on the development of the new strategic plan, including proposed strategic goals. After introductions, the center will begin the listening session with an overview of the process used to develop the CTP’s strategic plan, including proposed goal areas.

    Registration is open for the virtual listening session on the development of the CTP’s five-year strategic plan, which will take place on Aug. 22 beginning at 10 a.m. EDT.

  • Registration Open for US FDA Tobacco Strategic Plan

    Registration Open for US FDA Tobacco Strategic Plan

    Registration is open for the virtual listening session on the development of the Center for Tobacco Products’ (CTP) five-year strategic plan, which will take place on Aug. 22 beginning at 10 a.m. EDT.

    The virtual listening session is an opportunity to verbally provide open public comment on the development of the new strategic plan, including proposed strategic goals. After introductions, the center will begin the listening session with an overview of the process used to develop the CTP’s strategic plan, including proposed goal areas.

    Registered speakers will then have approximately four minutes each to verbally share their comments on any topics related to the strategic plan. Submit a request to verbally provide open public comment by Aug. 14 at 11:59 p.m. EDT.

    Registration also includes a “listen-only” option for those who want to attend the session but do not request to speak. Listen-only registration slots are unlimited, but registration is required. There is no deadline to register for listen-only slots.

    In addition to this listening session, the public can submit electronic or written comments to the Federal Register notice. Electronic comments must be submitted, and written comments must be postmarked, by Aug. 29.

  • Biden Opposed to Limiting FDA Power to Regulate Flavors

    Biden Opposed to Limiting FDA Power to Regulate Flavors

    Credit: Lux Blue

    The Biden administration has published a Statement of Administration Policy outlining its opposition to parts of a proposed funding bill that would limit the U.S. Food and Drug Administration’s ability to ban flavored cigars and menthol cigarettes, reports Halfwheel.

    The proposed bill would prevent the FDA from receiving funding if it introduced bans on flavored cigars and menthol cigarettes or introduced rules limiting the amount of nicotine a product can have.

    The policy statement does not mention nicotine limits, although the FDA has proposed limiting nicotine.

    The Statement of Administration Policy is not binding.

    A new study has found that smokers who get help picking flavored e-cigarettes and receive supportive text messages are more likely to quit smoking.

    Last month, the FDA gave the Center for Tobacco Research at The Ohio State University Comprehensive Cancer Center a $3.9 million grant to evaluate the effects of e-cigarette flavors on smoking behaviors of current adult smokers.

  • FDA Warns 3 Major Flavored Disposable Distributors

    FDA Warns 3 Major Flavored Disposable Distributors

    The U.S. Food and Drug Administration today issued warning letters to three distributors for selling and/or distributing multiple brands of unauthorized e-cigarette products.

    The illegal products listed in the warning letters sent to ABS Distribution Inc., EC Supply, Inc. and Easy Wholesale, LLC include the popular and youth-appealing e-cigarette products Elf Bar/EB Design, Esco Bars, and Puff Max (Puff Bars).

    “FDA is committed to keeping a finger on the pulse of the rapidly evolving e-cigarette landscape, including through a variety of scientific assets equipped to quickly identify products with high youth appeal,” said Brian King, director of FDA’s Center for Tobacco Products (CTP). “We will continue to use this data-driven approach to inform actions across the entire supply chain, including against those who distribute illegal products between manufacturers and the point of sale.”

    The distributors receiving warning letters sell and/or distribute e-cigarettes in the United States that lack authorization from FDA, which is a prohibited act under the Federal Food, Drug, and Cosmetic Act, according to an FDA release.

    All of the brands cited in these warning letters have been identified as being among the most popular e-cigarettes among U.S. youth.

    “Warning letters are generally the first step once an inspection reveals a violation of the law,” said Ann Simoneau, director of the Office of Compliance and Enforcement within CTP. “We will monitor to ensure these violations are corrected, and if they are not, the recipient is at risk of further actions such as civil money penalties, seizures, and injunctions.”

    The FDA has stepped up enforcement of flavored disposable products after several lawmakers complained the agency wasn’t fulfilling its duties.

    Credit: Pastel Cartel
  • Amicus Brief Supports Limiting ‘Chevron Deference’

    Amicus Brief Supports Limiting ‘Chevron Deference’

    Image: Tobacco Reporter archive

    Keller and Heckman has filed an amicus brief with the U.S. Supreme Court on behalf of members of the electronic nicotine-delivery system (ENDS) industry in support of petitioners in a case to overturn or limit the so-called Chevron deference.

    Named after a landmark Supreme Court decision dating from 1984, the Chevron deference is a legal doctrine that generally requires courts to defer to an administrative agency’s interpretation of ambiguous statute so long as that interpretation is reasonable. 

    In practice, Chevron deference often gives agencies broad leeway to reach beyond the limits of a statute’s plain language, often bypassing the rulemaking process otherwise required under the Administrative Procedure Act and making it more difficult to challenge an agency action in court.

    In the years since ENDS became subject to Food and Drug Administration regulation, the vast majority of courts reviewing ENDS industry challenges to premarket application denials, as well as FDA rulemakings and guidance documents, have rubber-stamped the agency’s interpretation of the Family Smoking Prevention and Tobacco Control Act (TCA) and the “appropriate for the protection of the public health” standard, Keller and Heckman wrote on its blog.

    Critics contend that the Chevron deference has enabled the FDA to impermissibly interpret the TCA to implement a de facto ban on all nontobacco-flavored ENDS products without any requisite notice and comment rulemaking or congressional amendments to the TCA.

    The filers on the amicus brief urge the Supreme Court to at least restrict the application of Chevron deference so that it is the exception, not the rule. The Supreme Court will hear oral arguments in the case in its fall 2023 term.

    The petition to overturn or limit the Chevron deference was brought by a group of fishing companies challenging the National Marine Fisheries Service’s construction of the Magnuson-Stevens Act to require the industry to pay the salaries of federal monitors.

    The ENDS industry amici include the American Vaping Manufacturers Association, the American Vapor Group and Bidi Vapor.

  • FDA Seeks Input on 5-Year Tobacco Center Strategic Plan

    FDA Seeks Input on 5-Year Tobacco Center Strategic Plan

    Credit: FDA

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) will hold a virtual listening session on Aug. 22 to give the public an opportunity to comment on the five-year plan it developed to advance its mission.

    As part of its response to the Reagan-Udall Foundation evaluation, the CTP plan includes five proposed goal areas that are interconnected with the themes of health equity, science, transparency and stakeholder engagement.

    The proposed goals and the questions that the CTP would like commenters to address are on the agency’s virtual listening session event page.

    Following receipt and consideration of public input, the CTP intends to publish its strategic plan by the end of 2023.

    After introductions, the center will begin the listening session with an overview of the process used to develop the CTP’s strategic plan. Registered speakers will then have approximately four minutes each to verbally share their comments on any topics related to the strategic plan.

    Request to verbally provide open public comment must be submitted by Aug. 14 at 11:59 p.m. Eastern Time.

    In addition to this listening session, the public can submit electronic or written comments to the Federal Register notice. Electronic comments must be submitted and written comments must be postmarked by Aug. 29.