Category: Regulation

  • Durbin Decries Menthol Vape Order

    Durbin Decries Menthol Vape Order

    Senator Dick Durbin
    Credit: Dick Durbin

    When the U.S. Food and Drug Administration authorized the marketing of four Njoy brand menthol e-cigarette products, Senator Dick Durbin was disappointed. He said the agency should have done better. The move marks the first nontobacco-flavored e-cigarette products to be authorized by the FDA.

    “Flavors like menthol are used by Big Tobacco companies to mask the harsh taste of their dangerous products. FDA knows this from its own experience seeking to ban the production of menthol cigarettes to protect the public health,” Durbin stated. “We’ve seen that children begin nicotine use with menthol. Today’s authorization of menthol-flavored vapes will create an opening for more children to become addicted to harmful products.”

    Earlier this month, Durbin, chair of the Senate Judiciary Committee, held a committee hearing titled “Combatting the Youth Vaping Epidemic by Enhancing Enforcement Against Illegal E-Cigarettes.” The hearing underscored the alarming level of youth e-cigarette use and the role that flavors—such as menthol—play in youth use of tobacco products and examined how federal agencies have failed to enforce laws designed to protect children from a lifetime of nicotine addiction.

    Tony Abboud, executive director of the Vapor Technology Association, who also spoke at Durbin’s hearing, said he applauds the FDA’s decision to “finally follow the massive body of science” that shows flavored e-cigarettes help people quit smoking. However, Abboud said the move does little to address the massive problems surrounding the regulatory agency’s authorization process.

    “The reality is that this news, while a tiny step in the right direction, again reveals a more troubling pattern—the FDA acting only in self-interest to quell political pressure rather than acting in the interest of the American people,” said Abboud. “The only vapes authorized today are all owned by the biggest cigarette companies.

    “Today’s authorizations once again demonstrate Brian King and the FDA’s hypocritical allegiance to those cigarette companies whose deadly cigarettes and other combustible products that the FDA continues to flood the market with at a record pace.”

  • Vape Registry Rule Slipped Into NC Bill

    Vape Registry Rule Slipped Into NC Bill

    North Carolina State House of Representatives Chamber (Credit: J Zehnder)

    A new bill in North Carolina, if passed, would require the state to certify vaping and other next-generation tobacco products for sale.

    The Senate Judiciary Committee approved the proposal Wednesday. It was slipped into HB 900, which deals with Wake County leadership academies and their ability to maintain state designations. The House passed it without objection.

    To become law, the bill would need to pass the Senate and then the House before the end of the session. Senate leaders have said they plan to complete their work by the end of the month, local media reports.

    The chambers, both controlled by Republicans, have been unable to come to an agreement on budget modifications for the fiscal year that begins July 1.

    A North Carolina lawmaker wrongly told other lawmakers during debate that the U.S. Food and Drug Administration regulates the products, but the regulatory agency does not have the ability to check which products are being sold.

    The bill would fine retailers who sell products that aren’t on the registry for initial violations. The legislation could also suspend or revoke the establishment’s license.

    Vaping industry representatives warned lawmakers that the bill will cost people jobs and money.

    PMTA registry laws are already being enforced in Alabama, Louisiana and Oklahoma. Wisconsin passed a registry law in December and will become effective July 1, 2025. 

    Utah also passed a registry bill that included a flavor ban that will become active on Jan. 1, 2025, and Florida has a unique registry that also begins Jan. 1, 2025.

  • Romania Bans E-cig and Pouch Advertising

    Romania Bans E-cig and Pouch Advertising

    Photo: xpable

    Romania’s Chamber of Deputies adopted a bill banning advertising of electronic cigarettes and nicotine pouches this week, reports Romania Insider.

    “It is prohibited to explicitly advertise tobacco products, electronic cigarettes, including vape types, products intended for inhalation without burning from tobacco substitutes, electronic devices for heating tobacco, and products intended for inhalation without burning from tobacco substitutes as well as nicotine pouches for oral use (pouches) broadcast within radio and television programs and on public transport tickets,” the bill states. 

    The bill also bans advertising for these products within educational institutions and healthcare facilities or within 200 meters of their entrances. Advertising is also banned in publications primarily intended for minors and in theaters before, during and after performances intended for minors. Ads are banned that target minors, depict minors consuming these products, suggest these products have therapeutic properties or have a stimulating, sedative effect or can solve personal problems, give a negative image of abstinence or do not contain warning inscriptions in Romanian.

  • South Africa Urged to Beef Up Tobacco Laws

    South Africa Urged to Beef Up Tobacco Laws

    Photo: poco_bw

    Nearly one third of South Africans smoke, according to the 2021 Global Adult Tobacco Survey (GATS) South Africa report, which was released by the Department of Health on June 13, 2024.

    The study found that 21.2 percent of adults in South Africa smoke daily, while 4.6 percent smoke occasionally. Daily smokers light up an average of 8.5 cigarettes per day.

    The data also revealed that a higher percentage of men (41.7 percent) are currently using tobacco compared to women (17.9 percent).

    Meanwhile, 2.2 percent of survey respondents said they were currently using e-cigarettes, of which 3.8 percent are men and 0.7 percent are women.

     Of those using e-cigarettes, 70.3 percent cited enjoyment, 67.5 percent cited flavor, 45.1 percent perceived it as less harmful than tobacco, while 43.5 percent said their use was influenced by friends or family members who use e-cigarettes.

    The study also found that 3.1 percent of adults reported smoking hookah pipe.

    Data also shows that 74.4 percent of adults who visited public places were exposed to second-hand smoke.

    The Department of Health’s Deputy Director of General Primary Healthcare, Jeanette Hunter urged the government to adopt new measures to discourage tobacco use, including stronger tobacco taxes, smoke-free laws, graphic health warnings and bans on advertising.

    “Effective strategies to reduce tobacco use, including putting in place more comprehensive laws that are compliant with the WHO Framework Convention on Tobacco Control, should be implemented to protect more people from exposure to SHS, and provide cessation services to help more people who smoke to quit,” Egbe was quoted as saying by the South African Government News Agency.

  • U.S. Top Court May Tame ‘Chevron Doctrine’

    U.S. Top Court May Tame ‘Chevron Doctrine’

    Photo: maurice norbert

    The U.S. Supreme Court may overturn a legal doctrine that according to some vapor industry advocates has allowed the Food and Drug Administration to reach beyond its legal authority, reports Reuters, citing legal scholars.

    Known as Chevron deference, the doctrine calls for judges to defer to federal agency interpretations of U.S. laws that are deemed to be ambiguous. This doctrine, among the most important principles in administrative law, arose from a 1984 Supreme Court ruling involving oil company Chevron.

    It is opposed by conservatives and business interests but supported by liberals who favor robust corporate regulation. Vaping activists contend that the Chevron doctrine has, among other things, enabled the FDA to essentially ban all nontobacco-flavored e-cigarettes.

    The U.S. Chamber of Commerce, which represents more than 300,000 businesses, has argued that Chevron deference has let Congress “outsource core policy decisions (particularly controversial ones) to agencies through broadly worded statutes.” That has given the agencies, it added, “free rein to enact their own new regulatory requirements through sweeping rulemakings or after-the-fact enforcement actions.”

    Many legal scholars expect the Supreme Court, which has a 6-3 conservative majority, to scale back or overturn the Chevron doctrine in a case in which fishing companies are seeking to avoid bearing costs associated with a government-run program to monitor for overfishing of herring off New England’s coast. The suit is part of a broader conservative project to strip away regulatory power from federal agencies.

    The justices heard arguments in the case on Jan. 17 and are expected to rule on the case by the end of June.

  • Juul Ban Reversal Welcomed

    Juul Ban Reversal Welcomed

    Photo: Juul Labs

    The potential return of Juul to U.S. store shelves would represent a win for consumers and tobacco harm reduction, according to the Consumer Choice Center (CCC).

    On June 6, the U.S. Food and Drug Administration rescinded its 2022 marketing denial order. While the move is neither an authorization nor a denial, it places the company’s premarket tobacco product application back into scientific review, meaning it could potentially be authorized at some point.

    “This is a step in the right direction for consumers who want more nicotine alternatives to combustible tobacco,” said CCC U.S. Policy Analyst Elizabeth Hicks.

    The FDA said in its June 6 statement that it had “conducted additional substantive review of the applications in a number of disciplines, including toxicology, engineering, social science and clinical pharmacology” and that their change of course is based on a “review of information provided by the applicant” plus new case law based on court decisions involving MDOs for e-cigarette products.

    “With over 26 million applications submitted to the FDA, less than 10 e-cigarette devices have been approved by the agency. Vaping is 95 percent less harmful than smoking combustible tobacco, and the FDA has an opportunity to help drastically improve public health by allowing consumers a choice when it comes to alternatives to combustible cigarettes,” said Hicks.

    The FDA decision opens the door for Juul to return to the market in the future and allow U.S. consumers the same choice as those in the U.K. and Canada.

    “We hope the FDA provides a clear and transparent pathway for Juul Labs and the thousands of other companies who submitted product applications to finally gain authorization to offer their products to consumers in a regulated market,” concluded Hicks.

  • FDA Rescinds Juul Marketing Denial Order

    FDA Rescinds Juul Marketing Denial Order

    Photo: steheap

    The Food and Drug Administration Thursday rescinded its 2022 ban on Juul Labs’ e-cigarette products. However, the agency has not yet made a final decision on whether Juul can remain on the U.S. market. The move does open the door for Juul to receive marketing authorization from the regulatory agency.

    In 2022, the FDA ordered Juul to stop its sales, but later paused the order while the vaping company appealed. The agency announced that it would reinitiate a scientific review of Juul’s products, essentially returning them to their regulatory status before the initial ban.

    In the time since the MDOs were administratively stayed in 2022, the FDA has gained more experience with various scientific issues regarding e-cigarette products, and there have been new litigation outcomes in cases about MDOs for e-cigarette products from other manufacturers,” the FDA stated in a release. “Some of these court decisions establish new case law and inform the FDA’s approach to product review to maintain the agency’s commitment to issuing final decisions that are appropriate on both the scientific merits and the law.”

    Rescission of the MDOs is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied. Rescission of the MDOs returns the applications to pending status, under substantive review by the FDA. The FDA’s regulations significantly limit what the agency can disclose regarding the content of pending applications.

    Juul Labs welcomed the move. “We appreciate the FDA’s decision and now look forward to re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for Juul products, the company wrote in a statement. “We remain confident in the quality and substance of our applications and believe that a full review of the science and evidence will demonstrate that our products meet the statutory standard of being appropriate for the protection of public health.”

     

  • Hong Kong Mulls New Anti-Smoking Measures

    Hong Kong Mulls New Anti-Smoking Measures

    Photo: ChenPG

    Hong Kong announced several new anti-tobacco policies on June 6, reports The Standard.

    Among other measures, the city plans to introduce a new duty-paid labeling system, ban “smoke-and-queue” behavior in public, and prohibit all flavored cigarettes and alternative products including vapes and heated cigarettes.

    The rules are meant to help the government lower smoking prevalence to 7.8 percent by 2025 and ultimately achieve a “Tobacco-free Hong Kong” after the completion of a public consultation exercise launched last year.

    Other measures include raising the maximum penalty for evading tobacco duty to a HKD2 million ($256,082) fine and seven years’ imprisonment; a ban on providing cigarettes to underage teens and children; and continuous reviews on the adjustment of tobacco duty.

    The government will also maximize the area reserved for health warnings on cigarette packaging to 100 percent; expand non-smoking areas and increase fines for violations.

    Secretary for Health Lo Chung-mau said the government strives to table the new policies to the Legislative Council before the end of this year and expects they will be passed within this legislative year.

    More than 90 percent of respondents to the public consultation agreed with further lowering the smoking prevalence.

    There are more than 570,000 daily smokers in Hong Kong and the latest prevalence stands at 9.1 percent, according to Director of Health Ronald Lam Man-kin.

  • Swedish Match MRTP Comments Due July 5

    Swedish Match MRTP Comments Due July 5

    The U.S. Food and Drug Administration posted the final set of application materials related to renewing existing modified-risk tobacco product (MRTP) orders for Swedish Match U.S.A.’s General Snus products.

    The agency announced a deadline for public comments. To ensure they receive consideration by FDA, the applications must be submitted to the docket by 11:59 p.m. EDT on July 5, 2024.

    The application materials, redacted in accordance with applicable laws, can be found on the FDA’s website. “Before making a final determination on an MRTP application, FDA considers all information available to the agency, including public comments and recommendations from the Tobacco Products Scientific Advisory Committee (TPSAC),” a release states.

    The FDA recently announced a TPSAC meeting to discuss these renewal applications, scheduled for June 26, 2024, which the public is able to attend in person at the FDA White Oak Campus or virtually. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

    Written submissions may be made to the contact person on or before June 20, 2024.

  • FDA Updates Vaping Products ‘Red List’

    FDA Updates Vaping Products ‘Red List’

    Photo: xy

    The U.S. Food and Drug Administration has updated its import alert, which includes a “red list” of vapor products that may be detained “without physical examination,” the agency announced.

    The alert authorizes U.S. Customs and Border Protection to detain new tobacco products that do not have the required marketing authorization under the Federal Food, Drug and Cosmetic Act, which gives the FDA the authority to regulate all tobacco products.

    The list of products now includes Chinese manufacturers and distributors as well as U.S. importers and distributors.

    The FDA announced last week that it is taking stronger enforcement actions against unauthorized e-cigarettes. The agency is seeking civil money penalties (CMP) against nine brick-and-mortar retailers and one online retailer for selling unauthorized Elf Bar brand vaping products. The FDA is seeking a penalty of more than $20,000 from each retailer.

    “In order to remove a firm’s product from the red list, information should be provided to the agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation,” the FDA wrote. “The purpose of this is so that the agency will have confidence that future shipments/entries will be in compliance with the Federal Food, Drug and Cosmetic Act.”