Tag: FDA

  • Gold Nuggets

    Gold Nuggets

    Photo: Stokkete | Dreamstime.com

    Gaining insights from the FDA’s final PMTA rule

    By Willie McKinney and Cheryl K. Olson

    On Jan. 19, the U.S. Food and Drug Administration finalized a “foundational rule” about the “minimum requirements for the content, format and review of premarket tobacco product applications (PMTAs).” Within days, before many of us had a chance to download the 516-page document, let alone read it, the rule disappeared. The link says, “page not found.”

    Don’t worry. This is part of a normal review by the incoming Biden administration of recent rules from the old regime. Given that little FDA staff turnover is expected, their thinking, and the rule, will probably stay the same. The document will be back, nicely formatted.

    What to do while we wait for the final-final rule to appear on the FDA’s site? Well, the bulk of the document addresses “about 1,000 comments” (!) the FDA received on the proposed rule issued in 2019, including many questions from industry folks confused about PMTAs.

    Understanding the subtleties and subtext of the FDA’s responses to comments can dramatically increase your chances of getting a marketing granted order. Ignoring them can lead to a significant waste of time and money.

    Let’s wade into the FDA’s responses and see what gold nuggets of insight we can pan. What fuzzy areas affecting your strategy are now clear? What costly studies or paperwork might be trimmed or skipped?

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    A PMTA is not a box-ticking exercise

    We can begin with how the FDA thinks and what that means for PMTA strategy. Remember, interacting with tobacco product makers and sellers is still relatively new for the FDA’s staff and consultants. As they read comments, held conversations and began reviewing the recent flood of PMTAs, they realized that companies couldn’t figure out what the FDA was asking for. We know this because the PMTA rule lays out, much more clearly than in previous documents, what the FDA needs from companies. There are details on required content and format. The rule contains dozens of “musts”—must list, must include, must state and so on.

    The FDA also says what can happen if you don’t meet minimal requirements: Do this, and we won’t accept or file. Or: This will slow the review process. Think of it as a series of red lights (“FDA will refuse to accept a PMTA … where it lacks constituent testing information required by § 1114.7(i)(1)(v)”) and yellow lights (“FDA may refuse to accept or file an incomplete application for review”). All of this is welcome clarity.

    That doesn’t mean, as we’ve heard it described, that having a PMTA accepted and filed is a check-the-box exercise. Parts of a PMTA are like that, but the substantive review of data definitely is not.

    Many of the comments to the FDA hint at frustration. “Why can’t they just tell me what studies to do so I can market my product?” The short answer is that a PMTA is partly a checklist of required information, but it’s also a narrative. You’re telling a story about why your product is appropriate for the protection of public health (APPH), illustrated by data. An effective PMTA is driven by story—explaining why your product on balance is likely to benefit public health—and merely organized by the PMTA format. 

    If you try to follow the rule document like a cookbook recipe—add a cup of pharmacokinetics (PK) studies and a tablespoon of label comprehension, and it’s baked—you will likely fail. That’s because the rule is descriptive but not prescriptive; it doesn’t tell you how to deliver. Why? First, because each product is different, with its own particular characteristics and target customers and therefore a distinctive set of potential public health benefits and risks that need to be demonstrated or mitigated. Second, a how-to list would tie the FDA’s hands as they make and rethink decisions about what is APPH. In Response 105, the agency notes that “Due to the nature of the Federal rulemaking process … FDA may not be able to update such standards in a timely manner.”

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    Expect APPH to evolve

    APPH is about relative health risks; it’s about “net benefit to the health of the population as a whole.” A definition like that, based on comparing ever-evolving tobacco products, will create a moving target. See FDA’s Response 123: “Because market conditions will change over time, what might be APPH at one point in time may no longer be APPH in the future.”

    A static approach for granting marketing orders means the FDA couldn’t keep riskier products off the market, “thus undermining its core statutory mandate to reduce the harm caused by tobacco product use.” Basically, if you can show that your novel tobacco product is less risky than today’s cigarettes, that’s great. But as more tobacco users move to reduced-risk products, both the comparators and the risk equation will change. And if your tobacco product has, say, slightly more of a potentially harmful chemical than others in its category, adding your product to (or keeping it among) consumers’ options is not reducing harm.

    Save with bridging, bundling and master files

    Another reason the FDA “declines to require that an applicant conduct a list of new studies as part of every application” (Response 59) is that shortcuts are allowed. Applicants can also “provide scientific data to inform FDA’s review” through bridging. Rather than generating all new data on your product, you can sometimes leverage the research literature to show your product is APPH. Just a little new data connects you to more.

    Suppose you show from chemistry that your product releases nicotine in the same way and has the same nicotine concentration as another product already tested in published literature. That may let you bridge to their PK and abuse liability studies, saving you hundreds of thousands or even millions of dollars. In Response 62, the FDA “declines to define” bridging but instead gives useful examples of how to do it.

    Another cost-saving and time-saving shortcut is bundling or combining applications. Let’s say that you have four flavors or two nicotine strengths. The FDA sees them as separate products. But the FDA allows you to submit one PMTA for all of them. A bundled PMTA includes “a single, combined cover letter and table of contents across all products” (Response 19).

    You still need to provide unique information about each product, but you can collect and present it more efficiently. For example, you might conduct and present one bundled perception and intention survey that asks noncustomers about perceptions of the labeling of each of your four flavors in turn. But be aware that the FDA will break up your bundle for review, so list in tables which parts of the PMTA apply to which products. 

    Bundling isn’t always best. Are your harm reduction story and target audiences the same across products? A high nicotine vape may appeal to a heavily addicted smoker, but it has different health implications than a lower nicotine sister product. Combining the two into one PMTA might muddy your case for APPH status.

    A third PMTA shortcut to know about is called a tobacco product master file (TPMF). A master file contains information you can reference again and again for multiple applications. In Response 17, the FDA defines a TPMF as “contain[ing] trade secret and/or confidential commercial information about a tobacco product or component that the owner [e.g., manufacturer, ingredient supplier] does not want to share with other persons” but is willing to share with the FDA. That’s useful if your new tobacco product uses an e-liquid made by a manufacturer who doesn’t want to share their formulation but who will give you a letter of authorization to cite their master file in your PMTA. 

    There are other TPMF options. “When companies want to rely on the same pool of data, FDA encourages the use of shared resources, such as tobacco product master files, where appropriate” (Response 18). This might be the fruits of a thorough literature review on a particular topic. Rather than cite and submit 150 articles over and over, you can reference the master file.

    More information is not always better

    PMTA applicants now need to provide “only high-level marketing plan information” (Response 30) rather than detailed consumer research. The FDA’s main concern is youth exposure. It emphasizes descriptions of intended audiences and how they’ll be targeted. Note, however, that if you have already done consumer research, “the results of such research will be required” to go to the FDA. 

    As Comment 14 notes, “the tobacco industry has a history of marketing its products to … vulnerable populations,” which may include low-income communities, racial/ethnic minority group members, rural residents and youth, among others. Your PMTA story should include how your product might improve (or not worsen) the well-being of some of these vulnerable populations. Harm and benefit to subgroups that are more likely to start, less likely to stop and/or more likely to get sick from using tobacco products “are an important part” of the FDA’s APPH calculations. Groups of interest “will vary depending on type of tobacco product and may change over time.”

    However, the FDA does not clearly state that conducting research with some of these subgroups is unethical or unsafe. This includes people under the age of 21 and women “who are pregnant or trying to become pregnant.” (The document mentions the need for special attention to vulnerable populations, including children and incarcerated persons, when discussing FDA plans to issue future regulations concerning use of Institutional Review Boards for tobacco product clinical studies.)

    In Response 79, the FDA allows for “studies using individuals under the minimum age of sale” with extra protections and parental consent but “does not require it [or] anticipate that it will be necessary.” Don’t go there. Instead, over-sample young adults in your studies as a proxy for youth. Report, for example, whether intentions to use your product were different for people under age 25 compared to the rest.

     

    Cheryl K. Olson is a California-based public health researcher and consultant who specializes in behavioral health issues. She spent 15 years on the faculty of Harvard Medical School.
    Willie McKinney is the founder of McKinney Regulatory Science Advisors. He’s held senior regulatory roles at major tobacco product companies and served for three years as the industry representative on the FDA’s Tobacco Products Scientific Advisory Committee.
  • U.S. Mail Ban Claims its First Victim

    U.S. Mail Ban Claims its First Victim

    Photo: Ian Allenden – Dreamstime.com

    The Prevent All Cigarette Trafficking (PACT) Act, which prohibits the shipping of vapor products through the U.S. Postal Service (USPS), has claimed its first victim.

    In a letter to its business partners, Securience announced it would be closing its doors at the end of March. Securience is the parent company of vapor brands such as DuraSmoke, Forge, AmericaneLiquidStore and VapeMoar.

    In its letter, Securience cites its inability to mail product to consumers; however, the PACT Act also prevents business-to-business shipments by the USPS, according to a representative from the Bureau of Alcohol, Tobacco and Firearms who spoke during the recent Tobacco and Vapor Law Symposium presented by the Keller and Heckman law firm.

    “Because of the complexity of these new shipping rules, FedEx, UPS and DHL have all informed us that they will stop shipping vaping products completely—including our shipments to you, our wholesale vape shop customers and distributors,” wrote Securience owner Don Muehlbauer. “While we have looked at some alternatives, given the geographic locations of our customers, the significant increase in compliance costs, and our capabilities as a small business, we have been unable to find a feasible alternative and have been left in a situation that makes continuing business impossible.”

    Securience opened its doors in 2008 and has since been a staple in the vaping industry. Muehlbauer stated that he anticipates the PACT Act will not only impact his company, but many small e-liquid manufacturers. “Those manufacturers who are able to afford the increased compliance costs will have increased shipping costs that may impact [retail] shops,” he wrote. “The last day we will be able to accept orders for shipping is March 25 or until supplies run out.”

  • A Mixed Record

    A Mixed Record

    FDA Center for Tobacco Products Director Mitch Zeller explains the agency’s compresive plan on tobacco and nicotine regulation during the 2017 Global Tobacco and Nicotine Forum in New York City.
    (Photo: David Parker)

    FDA’s comprehensive plan on tobacco and nicotine regulation, three years later

    By Beth Oliva and Philip Langer

    In July 2017, FDA unveiled its “Comprehensive Plan on Tobacco and Nicotine Regulation”—a plan that, in FDA’s words, “places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulations.”1 While the comprehensive plan outlined several areas of focus (such as regulation of flavored products and the use and impacts of premium cigars), in announcing the comprehensive plan, FDA placed significant emphasis on two specific issues. First was the prospect of reducing nicotine levels in combustible cigarettes to nonaddictive levels through “achievable products standards;” second was “fostering innovation where innovation could truly make a public health difference.”2 When introducing the plan, former FDA Commissioner Scott Gottlieb said this:

    Looking at ways to reduce nicotine levels in cigarettes so that they are minimally or nonaddictive, while not altering the nicotine content of noncombustible products such as e-cigarettes, is a cornerstone of our new and more comprehensive approach to effective tobacco regulation.

    [W]e must recognize the potential for innovation to lead to less harmful products, which, under FDA’s oversight, could be part of a solution. While there’s still much research to be done on these products and the risks that they may pose, they may also present benefits that we must consider.3

    Nearly 3.5 years after FDA’s rollout of the comprehensive plan, it is worthwhile to explore what FDA has done—and not done—in pursuing its quest to reduce nicotine in combustible cigarettes and foster innovation for noncombustible products. Has FDA made meaningful progress toward achieving the ambitious goals it set in 2017? Or has FDA simply paid lip service to the comprehensive plan without any serious action? A review of FDA activity over the last few years suggests a mixed record of accomplishment in the development of a national reduced nicotine standard and progress toward turning the vision of reduced-risk tobacco products into a reality. FDA in its public-facing comments remains steadfastly committed to the initiative, and while progress on complex issues such as these must be measured over years rather than months, it has been slow. Recent developments and the current posture of tobacco regulation, however, suggest the coming years will be critical to the success or failure of the comprehensive plan.

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    2018—Progress in the exploration of a reduced nicotine standard

    There is no question that FDA has taken steps to explore the reduction of nicotine in combustible cigarettes since announcing the comprehensive plan in July 2017. The first significant step was in March 2018 when FDA issued an Advance Notice of Proposed Rulemaking (ANPRM), seeking public comment on the development of a reduced nicotine product standard.4 Specifically, FDA sought comments, research and data on myriad topics, including a potential appropriate maximum nicotine level; whether a nicotine product standard should cover other combustible tobacco products; and what unintended consequences could result from a nicotine product standard (such as illicit trade or increase in smoking). The comment period remained open for about four months and by its close, the public docket had garnered nearly 8,000 comments.5 

    Around the same time, FDA funded research and an article by agency researcher Benjamin Apelberg and others in The New England Journal of Medicine titled “Potential Public Health Effects of Reducing Nicotine Levels in Cigarettes in the United States.”6 The article acknowledged “a continuum of risk for products that deliver nicotine” and used a simulation model to conclude that “enacting a regulation to lower the nicotine content of cigarettes to minimally addictive levels in the United States would lead to a substantial reduction in tobacco-related mortality, despite uncertainty about the precise magnitude of the effects on smoking behaviors.”7

    In a continued show of dedication to the prospect of developing a reduced nicotine standard, in May 2018, Center for Tobacco Products Director Mitch Zeller submitted an article to the Society for Research on Nicotine and Tobacco titled “The Future of Nicotine Regulation: Key Questions and Challenges.”8 In the article (eventually published in 2019), Zeller stated that FDA’s “renewed focus on nicotine” was premised on the “continuum of risk” and invited FDA’s stakeholders to contribute perspective as FDA continued to “shape its tobacco regulatory strategy.” In the article, Zeller stated that a policy centered on nicotine was the priority in FDA’s tobacco regulatory strategy and that “FDA’s strategic regulatory approach is designed to support innovation in developing products with net public health benefits.”9

    Overall, throughout 2018, FDA appeared to “hit the ground running” in exploring reduced nicotine levels in cigarettes through a national product standard. The ANPRM, along with funding research and submitting content to scientific journals, indicated a strong start. Yet at the same time, little was being done publicly on the second prong of the comprehensive plan—encouraging innovation in new products with potential public health benefits.

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    2019—FDA hits a stall

    While 2018 showed commitment to the first prong of the plan, 2019 did not build on the prior year’s advances. The agency did, however, move forward in certain ways in encouraging innovation for potentially reduced-risk products.10 In 2019, FDA issued the draft guidance on enforcement priorities for e-cigarettes (March 2019); the proposed substantial equivalence (SE) rule (April 2019); the proposed premarket tobacco product applications (PMTA) rule (September 2019); and the final guidance document for PMTAs for e-cigarettes. These documents showed an expanded FDA focus from the reduced nicotine prong of the comprehensive plan to also encouraging at least some limited innovation in potentially reduced-risk products. The agency also, helpfully, began to look at providing more transparency and predictability to tobacco regulation. While FDA has issued draft rules, however, nothing has been finalized; in addition, the final PMTA guidance document for e-cigarette products is just that—only useful for those products and not any other potentially reduced-risk product.11 Further demonstrating that FDA’s focus shifted is that while FDA’s spring 2019 unified agenda included a potential regulation to reduce or “cap” nicotine in cigarettes (as did the 2018 agenda), such a regulation was entirely absent from FDA’s fall 2019 unified agenda.

    What FDA most notably accomplished in 2019 was the approval of two PMTAs and the granting of the first modified-risk tobacco product (MRTP) order. First, in April 2019, FDA issued PMTA marketing orders for the IQOS tobacco-heating system and charger along with the Marlboro Heatsticks in regular, smooth menthol and fresh menthol flavors, finding that “the marketing of the products is appropriate for the protection of the public health.”12 In December 2019, FDA authorized the marketing of 22nd Century’s two reduced nicotine cigarettes—Moonlight and Moonlight Menthol, similarly finding that “the marketing of the products is appropriate for the protection of the public health.” Second, in October 2019, FDA issued the first MRTP orders, authorizing Swedish Match North America to use specific modified-risk messaging on its General snus products—the culmination of a five-year process for the company and FDA.

    Regarding the reduced nicotine standard, however, there was no public indication by FDA of progress toward promulgation of a standard. In response to inquiries from the public on why the initiative did not appear on the fall 2019 unified agenda, FDA stated that the omission of a reduced nicotine standard regulation did not mean FDA was not continuing to work on the initiative. Still, this shift change was understandably interpreted by the public as a possible wavering in FDA’s dedication to the initiative.

    2020—A continued stall and concern from the public

    In response to a reduced nicotine regulation being absent from FDA’s fall 2019 unified agenda, Congressman Frank Pallone submitted a letter to FDA Commissioner Stephen Hahn in February 2020 to “voice [his] concern” that FDA “appears to be reconsidering regulations that would set a maximum nicotine level in cigarettes in order to make them less addictive.”13 In a similar vein, John Pritchard—vice president of regulatory science at 22nd Century—penned an op-ed in November 2020 noting, “late last year, without warning or significant explanation, the FDA abruptly removed the proposed rule-making to reduce nicotine levels in cigarettes from its regulatory agenda. Even before the Covid-19 pandemic struck, policymakers decided there were more immediate priorities than cigarette addiction and the roughly half [a] million Americans who die from it each year.”14 Pritchard pleaded with FDA to revisit its plan and accelerate its own actions.

    Last year brought the unexpected tragedy of the pandemic, which obviously and understandably impacted all FDA efforts. Perhaps partly as a result, it also brought little public progress with respect to FDA’s development of a reduced nicotine standard. There were no requests for proposal, research or articles released in conjunction with the nicotine reduction initiative, and the initiative continued to remain absent from FDA’s unified list and long-term actions list throughout the year.

    On the innovation front, in July 2020, FDA did issue an MRTP order authorizing IQOS to be marketed with a reduced exposure claim, but not a reduced-risk claim. The MRTP application by Philip Morris International included requests for MRTPs for both claims. While this second MRTP order is undoubtedly an important step, to date, FDA has still not decided upon the separate MRTP applications for the 22nd Century reduced nicotine cigarettes. Such an approval would be a significant endorsement of the reduced nicotine approach and its impact on harm reduction.

    Closing out 2020—a renewed interest?

    After this period of inactivity on the reduced nicotine standard, the end of 2020 brought an unexpected move from FDA: In December 2020, 22nd Century announced that FDA (along with the National Institute on Drug Abuse) submitted an order for 3.6 million very low nicotine research cigarettes. FDA stated that the cigarettes are to be used for numerous research initiatives, including the potential implementation of a national reduced nicotine standard. Further, at the Food and Drug Law Institute’s Tobacco and Nicotine Products Conference in September 2020, Zeller confirmed that FDA remained committed to everything contained in the comprehensive plan, including focus on reduction of nicotine in combustible cigarettes. Starting research on this issue would indicate a step toward that commitment.

    On the issue of potentially reduced risk products, however, FDA has not yet indicated how it will look at the hundreds of thousands (if not millions) of PMTAs it received in September 2020 for products across the continuum of risk. These include applications for e-cigarettes as well as tobacco-free nicotine pouches, nicotine toothpicks, nicotine dissolvable products and other innovative products to deliver nicotine without the combustion elements of cigarettes. No further guidance documents have been issued from the agency nor has the agency provided further clarity on how it will determine if these products are “appropriate for the protection of the public health.”

    Therefore, FDA closed out 2020 with continued public-facing dedication to the initiative as well as a potentially significant step toward achieving it. The reduced nicotine regulation continues, however, to be absent from FDA’s unified agenda and long-term actions list, including that released in December 2020. That unified agenda does, however, indicate FDA’s intention to continue to work on other important rules, such as the final rule for PMTAs, the final rule for SEs and a proposed rule for MRTPs.

    Looking forward

    In summary, FDA’s progress toward developing and implementing a reduced nicotine product standard and encouraging innovation for potentially reduced-risk products and products authorized to use modified risk or exposure claims has arguably been unsteady. Of course, the public does not have insight into FDA’s internal workings, and there is the distinct possibility (or perhaps probability) that progress is occurring (such as continued review of comments to the ANPRM, development of a proposed rule and other research initiatives as well as developing guidance documents for other noncombustible products) out of public sight.  

    FDA’s recent order of 3.6 million research cigarettes is a promising step as was the granting of the first MRTP orders. The new year, which will include agency evaluation of PMTAs, will hopefully demonstrate continued advancement toward the goals of the 2017 comprehensive plan. While some may have expected that the agency would already be much further along, measuring progress is a subjective exercise. There should be agreement by all, however, that in 2021, FDA must show—by action, not just word—its continuing commitment to the public health goals outlined in 2017.

    Beth Oliva is a partner at Fox Rothschild LLP
    Philip Langer is an associate at Fox Rothschild LLP

    References

    1 FDA news release, July 27, 2017

    2 Speech of former FDA Commissioner Scott Gottlieb, July 27, 2017.

    3 Id.

    4 FDA special announcement, March 15, 2018

    5 Federal Register Docket No. FDA-2017-N-6189, “Tobacco Product Standard for Nicotine Level of Combusted Cigarettes”

    6 Apelberg, Benjamin J., Feirman, Shari P., Salazar, Esther, et al., “Potential Public Health Effects of Reducing Nicotine Levels in Cigarettes in the United States,” May 3, 2018

    7 Id.

    8 Zeller, Mitch, “The Future of Nicotine Regulation: Key Questions and Challenges,” Nicotine & Tobacco Research, 2019, 331-332, Oxford

    9 Id. at 332.

    10 In order to receive a marketing order, any innovative new tobacco product must be found to be “appropriate for the protection of the public health” and thereby at least demonstrate the potential to be a reduced-risk product.

    11 On Dec. 31, 2020, FDA sent both the “Final Rule on Content and Format of Substantial Equivalence Reports” and the “Final Rule on Premarket Tobacco Product Applications and Record Keeping Requirements” to the Office of Management and Budget for its review.

    12 In December 2020, FDA issued a further PMTA order for the IQOS 3 device (the initial order was on the IQOS 2.4 device), finding “the similarities in the product designs of IQOS 2.4 and IQOS 3, as well as the fact that the same Heatsticks are used in both devices, make it unlikely there are new concerns related to health effects, product quality, human factors or product misuse for IQOS 3 as compared to IQOS 2.4. As the two devices have similar operating procedures, use the same tobacco sources and produce comparable aerosols, FDA has no reason to believe the IQOS 3 device will result in different nicotine exposure, use patterns, user populations or abuse liability.”

    13 Letter from Congressman Frank Pallone to Stephen Hahn, Feb. 25, 2020

    14 Pritchard, John, “It’s Time for the Government to Refocus on Respiratory Health,” Nov. 19, 2020

  • New Info on PMTA and SE Requirements

    New Info on PMTA and SE Requirements

    Photo: Jhvephotos | Dreamstime.com

    The U.S. Food and Drug Administration on Jan. 20 finalized two foundational rules for the premarket review of new tobacco products. These final rules provide additional information on the minimum requirements for the content, format and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports. PMTA and SE are two of the pathways through which a manufacturer can seek marketing authorization for a new tobacco product from the FDA.

    Stephen Hahn

    “The finalization of these foundational rules is an important milestone in the FDA’s regulation of tobacco products. The rules enable greater transparency and efficiency of the FDA’s critical task of reviewing applications for tobacco products before new products can be sold in the United States and they describe information that any company must provide if they seek to market a new tobacco product in this country, fulfilling the promise of the Tobacco Control Act,” said FDA Commissioner Stephen M. Hahn.

    Mitch Zeller

    “These final rules, together with our commitment to ongoing enforcement action against e-cigarettes and other tobacco products that illegally target youth, will help us continue to protect the public from the dangers of tobacco-related disease and death,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “These final rules will provide greater clarity and efficiency as we ensure that tobacco products are put through an appropriate series of regulatory gates so that products can be marketed only if they meet the standards under the law.”

    Both of these final rules are effective 30 days after publication in the Federal Register. 

    More information about the two foundational rules is available on the FDA website.

  • Illicit E-Cigarettes Seized at Dallas Airport

    Illicit E-Cigarettes Seized at Dallas Airport

    Photo: Flynt – Dreamstime.com

    U.S. Customs and Border Protection (CBP)  officers at the Dallas Fort Worth International Airport working in conjunction with agents from the U.S. Food and Drug Administration (FDA) have seized 33,681 units of e-cigarettes with a manufacturer’s suggested retail price of $719,453.

    In December 2020, CBP seized 42 separate shipments arriving from China destined to various Texas counties. The shipments included individual disposable flavored e-cigarette cartridges resembling the Puff Bar brand, including Puff XXL and Puff Flow.

    As part of an ongoing joint operation with FDA, officers and agents were looking to intercept counterfeit or other violative e-cigarettes, including certain flavored e-cigarettes imported to the U.S. that did not meet the Federal Food, Drug, and Cosmetic Act requirements, as amended by the Family Smoking Prevention and Tobacco Control Act.

    “Many counterfeit, unapproved or unauthorized products are likely produced in unregulated facilities with unverified ingredients posing a serious health concern to consumers. It is especially alarming when these types of counterfeit and unauthorized products find their way into the hands of children as studies indicate,” said CBP Port Director Timothy Lemaux in a statement. “We will continue to take every opportunity to work with our partners at the FDA to intercept and seize products that threaten U.S. consumers.”

    Tobacco products including e-cigarettes imported or offered for import into the U.S. must comply with all applicable U.S. laws.

    “The FDA continues to prioritize enforcement against e-cigarette products, specifically those most appealing and accessible to youth,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “We are very concerned about how popular these products are with youth. This seizure makes clear to tobacco product manufacturers, retailers and importers that the FDA is keeping a close watch on the marketplace and will hold accountable those companies that violate tobacco laws and regulations.”

    CBP’s trade enforcement mission places a significant emphasis on intercepting illicit products that could harm American consumers. In fiscal year 2020, CBP seized 93,590 units of e-cigarettes that did not meet U.S. federal regulations.

    In July 2020, the FDA issued a warning letter to Cool Clouds Distribution (doing business as Puff Bar), to remove their flavored disposable e-cigarettes and youth-appealing e-liquid products from the market because they do not have the required premarket authorization.

    “Protecting American consumers from illicit and especially harmful tobacco products, such as counterfeit or flavored e-cigarettes, is of utmost importance to the FDA,” said Judy McMeekin, FDA associate commissioner for regulatory affairs. “We will continue to investigate and remove from the marketplace products that pose a particular danger to the public health.”

    While the Puff Bar website appears to have recently stopped online sales and distribution in the U.S, it does not mean that the firm ceased distributing products to other retailers or selling products at brick and mortar retail stores, according to the FDA. The website’s store locators are still active, indicating that potential consumers can still search for products located for sale at retail stores.

  • Tobacco Firms Urged to Submit Health Warnings

    Tobacco Firms Urged to Submit Health Warnings

    Image: Tobacco Reporter archive

    The U.S. Food and Drug Administration (FDA) is encouraging tobacco companies to submit their plans for compliance with the agency’s upcoming graphic health warning requirements as soon as possible, and in any event by March 16, 2021.

    Following two postponements, the effective date for graphic health warnings is now Jan. 14, 22.

    The FDA’s final rule, “Required Warnings for Cigarette Packages and Advertisements,” establishes new required cigarette health warnings for cigarette packages and advertisements. Each required warning, comprising a textual warning statement and its accompanying color graphic, must be accurately reproduced as shown in the materials contained in “Required Cigarette Health Warnings, 2020.”

    The FDA says it intends to revise its relevant guidance documents related to the rule with the new effective date.

    Tobacco companies may contact CTP with questions about the effective date.

    The graphic health warning requirements had originally been scheduled to take effect on June 18, 2021. Due the Covid-19 pandemic, they were postponed to Oct. 16, 2021.

    In November, R.J. Reynolds Tobacco Co., Liggett Group and ITG Brands, along with cigarette retailers, asked for further postponement. The companies argued they would suffer irreparable harm if they were forced to spend millions of dollars to comply with a rule that might soon be invalidated.

    “These expenditures of resources for the purpose of meeting the rule’s requirements constitute irreparable harm because plaintiffs cannot recover money damages should the rule and/or the graphic-warning requirement in the Tobacco Control Act be invalidated,” the companies stated.

    On Dec. 2, the U.S. District Court for the Eastern District of Texas granted their request and postponed the effective date by an additional 90 days.

     

  • FDA Authorizes IQOS Holder and Charger

    FDA Authorizes IQOS Holder and Charger

    The U.S. Food and Drug Administration (FDA) has issued a marketing order to Philip Morris Products authorizing the sale of the IQOS 3 system holder and charger, the agency announced on Twitter.

    The newly authorized version has minor design differences from the previous version authorized in April, including how the holder inserts into the charger, changes to the charging connectors and LED indicator lights, a new touch feedback feature, and an option to reduce the perceived heat from the tobacco aerosol inhaled by users.

    Data on product use suggest no differences among user populations from the previous version, including no new concerns regarding product initiation or use among youth and young adults.

    “The issuance of this marketing granted order confirms that you have met the requirements of section 910(c) of the FD&C Act and authorizes marketing of your new tobacco product,” the FDA wrote in a letter to Philip Morris Products.

    “Under the provisions of section 910, you may introduce or deliver for introduction into interstate commerce the tobacco product, in accordance with the marketing order requirements outlined in this order, including all appendices.”

    The agency stressed that the marketing order does not mean any version of the IQOS system holder and charger can be marketed as “safe” or “FDA approved.”

    “There are no safe tobacco products,” the FDA wrote.

    The previous version of the IQOS system holder and charger was initially allowed for sale in the U.S. following the FDA’s issuance of a marketing order in April 2019. The company later submitted another premarket tobacco application requesting to market an updated version of the device holder and charger.

    On July 7, 2020 the FDA authorized the marketing of the IQOS 2.4 tobacco heating system as a modified risk tobacco product with a reduced exposure claim. IQOS 2.4 is the first next-generation inhalable tobacco product to be authorized as a modified risk tobacco product.

    “Altria’s 10-year vision is to responsibly lead the transition of adult smokers to a non-combustible future. IQOS is a key part of that future and we’re excited to build on our first-mover advantage with the enhanced IQOS 3 device which has performed successfully in international markets,” said Jon Moore, president and chief executive officer of PM USA, which has an exclusive agreement to commercialize the IQOS system in the U.S., in a statement.

    IQOS is currently available in the Atlanta, Georgia, Richmond, Virginia and Charlotte, North Carolina markets.

  • Regulation of E-cigs as Tobacco Upheld

    Regulation of E-cigs as Tobacco Upheld

    Photo: jessica45 | Pixabay

    A U.S. federal appeals court has upheld the Food and Drug Administration’s (FDA) decision to regulate e-cigarettes as tobacco products, reports Westlaw Today.

    Several vape shops and e-liquid manufacturers, represented by the Pacific Legal Foundation, a conservative legal group, had challenged the FDA’s decision claiming it violated the Constitution (Moose Jooce et al v. FDA).

    They argued that the FDA’s then-associate commissioner for policy, Leslie Kux, who issued the 2016 rule deeming e-cigarettes to be tobacco products, lacked the authority to do so because she was a career employee, not a principal officer appointed by the president.

    The FDA countered that the authority had been delegated to Kux by the agency’s commissioner. Furthermore, it said, her authority did not matter because the rule was ultimately ratified by two different FDA commissioners, most recently FDA Commissioner Scott Gottlieb in April 2019.

    A unanimous panel of the D.C. Circuit U.S. Court of Appeals ruled that the regulation did not run afoul of the Constitution’s Appointments Clause.

    Jonathan Wood of the Pacific Legal Foundation said he and his clients were disappointed by the ruling and considering next steps.

  • U.S. Graphic Warnings Postponed Again

    U.S. Graphic Warnings Postponed Again

    Illustration: FDA

    A Texas federal court Wednesday further postponed the effective date of the U.S. Food and Drug Administration’s (FDA) new requirement for graphic warning labels on cigarette packs to January 2022, reports Law360.

    In his ruling, U.S. District Judge J. Campbell Barker sided with the tobacco industry, which argued that questions over the validity of the rule remain unanswered. A hearing for pending motions for summary judgment and motion for a preliminary injunction is scheduled for next week,

    In November, R.J. Reynolds Tobacco Co., Liggett Group and ITG Brands, along with cigarette retailers, asked for the postponement. The companies argued they would suffer irreparable harm if they were forced to spend millions of dollars to comply with a rule that will soon be invalidated.

    “These expenditures of resources for the purpose of meeting the rule’s requirements constitute irreparable harm because plaintiffs cannot recover money damages should the rule and/or the graphic-warning requirement in the Tobacco Control Act be invalidated,” the companies stated.

    Barker has already pushed the rule’s effective date back once due to the coronavirus pandemic, at the request of tobacco companies and the FDA. In a May 8 order, the judge delayed the effective date from June 18, 2021, to Oct. 16, 2021.

    In March, the FDA released a final rule requiring new graphic warnings for cigarettes that feature some of the lesser-known health risks of smoking, such as diabetes, on the top half of the front and back of cigarette packages and at least 20 percent of the area on the top of cigarette advertisements.

    The warnings include statements that tobacco smoke can harm children and that smoking can cause bladder cancer and neck and head cancer.

    In April, the cigarette manufacturers and retailers sued the FDA, arguing that the graphic warning requirements amount to governmental anti-smoking advocacy because the government has never forced makers of a legal product to use their own advertising to spread an emotionally charged message urging adults not to use their products.

  • FDA Urged to Mandate Minimal Nicotine

    FDA Urged to Mandate Minimal Nicotine

    Photo: Martinmark – Dreamstime.com

    John Pritchard, 22nd Century’s vice president of regulatory science, has called on the U.S. Food and Drug Administration (FDA) to accelerate implementation of its comprehensive plan on tobacco and nicotine regulation, in particular to impose the mandate requiring all cigarettes sold in the United States to contain minimally or non-addictive levels of nicotine.

    The proposed rule was removed from the agency’s agenda late last year without significant explanation.

    “Despite the obvious harm of smoking, the staggering public health costs, and the millions of lives lost, we have never mustered the fortitude to enact policies that would make cigarettes less addictive and end this public health disaster, Pritchard wrote in a newsletter published by the global data intelligence company Morning Consult.

    “This is the perfect time to take that step.”

    22nd Century has invested heavily in nicotine-reduction technology, and the company stands to benefit greatly if the FDA mandates minimally addictive levels of nicotine.

    “Companies like the one where I work have developed technology to decrease the chances that future generations become addicted to cigarettes and to provide alternatives for smokers of highly addictive cigarettes,” Pritchard wrote.

    “Yet we continue to wait almost a year for a further authorization to allow us to communicate this breakthrough to adult smokers. The faster this can be achieved, the sooner and greater the public health benefit in the United States