Category: Regulation

  • ‘FDA Took Unfair Shortcuts in Reviewing PMTAs’

    ‘FDA Took Unfair 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.”

  • New York Lawmaker Proposes Cessation Classes for Youth

    New York Lawmaker Proposes Cessation Classes for Youth

    Credit: Gary L Hider

    Under new legislation proposed in New York’s state Assembly, children caught vaping in school may be required to attend a state-created smoking cessation program.

    Assemblyman Keith Brown introduced A.10547 to amend the state Public Health Law to require those caught using electronic cigarettes or vapor products in schools to attend an Electronic Cigarette or Vapor Product Prevention, Control or Awareness Program, according to news reports.

    Attendance in the program would be part of a bigger state effort to create an educational program used in schools throughout the state to discourage electronic cigarette use.

    Children under the age of 21 who are found using or in possession of an electronic cigarette or vapor product will also have their parents or guardians notified, according to the bill text.

    “Electronic cigarettes are a relatively recent product and manufacturers had previously geared marketing toward non-smoking youth, with a large assortment of sweet flavors of e-liquid and ad campaigns,” Brown wrote in his legislative justification. “Additionally, certain youth-targeting e-cigarettes were designed to be small and sleek, and refillable with user-friendly pre-filled pods of liquid-making the device easy to conceal from authority figures.”

  • Generational Vape Ban Violates Basic Rights say Critics

    Generational Vape Ban Violates Basic Rights say Critics

    Malaysia’s proposed Control of Tobacco Product and Smoking Act breaches basic human rights, according to the nation’s leading tobacco industry group. Tabled for its first reading on July 27, the bill bans individuals born in 2007 or later from smoking, buying or possessing tobacco and related products. Offenders face stiff penalties, including imprisonment.

    The Confederation of Malaysian Tobacco Manufacturers (CMTM) says adult Malaysians are protected under Section 6 of the Consumer Protection Act 1999, which allows them to make their own choices without worry of prejudice or repercussions.

    “Moreover, these laws give the authorities too much power as it allows them to check your personal details, raid your home, inspect your telephone or luggage and access your personal details,” the group said in a statement dated July 31 and cited by the Malay Mail.

    “Then you will have to give them your password, face arrest, be subject to body checks and see your home entered without permission for inspection.

    “In the end, instead of creating a smoke-free generation, we are creating a generation of criminals who are being punished for buying a product others can buy.”

    The CMTM also argued that prohibition will boost the illegal tobacco trade, which currently supplies 60 percent of the market estimated at MYR5 billion ($1.12 billion). The group said individuals will have to hide their habit and be stigmatized as criminals.

    Meanwhile, the Special Parliamentary Select Committee on Health, Science and Innovation has urged the government to ease the punishment for teenagers caught smoking cigarettes, according to the New Straits Times.

    Instead of threatening jail time, the law should penalize juvenile offenders in practical and positive ways, through community service or mandatory counseling sessions for example, the committee argued.

    “We are also concerned over aspects of enforcement power in the bill itself, especially involving juveniles and even children,” said committee chairman Kelvin Yii.

    “The power to inspect, possibly conduct body checks and punish a child for possession must be heavily controlled to prevent abuse. This is why the guidelines for enforcement must be very clear and specific on this to ensure the vulnerable, especially the poor, are not victimized by the law.”

  • D.C. Court Rejects Prohibition Juice Co. Appeal of MDO

    D.C. Court Rejects Prohibition Juice Co. Appeal of MDO

    On July 26, the United States Court of Appeals for the District of Columbia rejected an appeal by four e-liquid manufacturers that challenged the FDA’s denial of their premarket tobacco product applications (PMTAs), ruling that the agency acted within Congress’ authorization, and its decisions were supported by evidence.

    Prohibition Juice Co., Cool Breeze Vapor, ECig Charleston, and Jay Shore Liquids argued that the FDA lacked statutory authority to require that the manufacturers establish that their flavored liquids carry greater public health benefits than unflavored liquids.

    According to the motion, the companies also challenged the PMTA denials as arbitrary and capricious, asserting that the FDA: (1) departed from an earlier guidance document, changing both the types of evidence the agency would accept and the substantive showing it expected parties to make; (2) underscored the potential importance of marketing plans including measures to limit youth access to their products but then failed to consider the plans petitioners submitted; and (3) overlooked various other aspects of the problem.

    “We deny the petitions for review. The FDA plainly had statutory authority under the Tobacco Control Act to regulate as it did. As to the arbitrary and capricious challenges, we hold that the FDA did not change the evidentiary or substantive standard from its 2019 Guidance,” the court wrote in its motion. “We also hold that any error in the FDA’s failure to consider the marketing plans was harmless because the manufacturers failed to identify how individualized review of the plans they submitted could have made any difference.

    “Finally, the FDA did not otherwise fail to consider important aspects of the problem. We accordingly deny the petitions for review.”

    The D.C. Circuit has not stayed the enforcement of any MDO.

  • Philippine President Allows Vaping Bill to Lapse Into Law

    Philippine President Allows Vaping Bill to Lapse Into Law

    Photo: Dang

    A bill seeking to lower the purchase age for e-cigarettes and heated-tobacco products has lapsed into law in the Philippines, reports ABS-CBN, citing a tweet sent by Presidential Press Secretary Trixie Cruz-Angeles.

    The measure moves the regulation of vapes to the Department of Trade and Industry from the Food and Drug Administration. It also lowers the age of sale from 21 to 18.

    The proposal was reportedly submitted to the Presidential Palace on June 24, days before then President Rodrigo Duterte stepped down from office.

    A bill will lapse into law if the chief executive fails to act on it 30 days after receipt from Congress, according to the Official Gazette.

    The vape regulation bill was approved by both the Senate and the House of Representatives of the 18th Congress in January but remained on the Speaker’s table until the final days of the Duterte administration. As a consequence of its delayed transmission to the presidential office, the bill was inherited by President Ferdinand “Bongbong” Marcos Jr.

    In addition to lowering the purchase age for e-cigarettes and heated-tobacco products, the bill removes a two-flavor limit on the products’ flavors or juices, allows sponsorships beyond industry associations and trade events and allows tobacco companies to conduct corporate social responsibility-related activities.

    Anti-vape advocates vowed to contest the new legislation in court.

  • Court Denies Stay of Fontem’s Marketing Denial Order

    Court Denies Stay of Fontem’s Marketing Denial Order

    Fontem US had its request for an emergency motion for a stay of its marketing denial order (MDO) denied by the United States Court of Appeals for the District of Columbia. The court denied the stay mainly because Fontem waited too long to file the motion. The denial was filed July12.

    Fontem Ventures, a subsidiary of Imperial Brands PLC and parent to Fontem US, owns the global e-cigarette brand blu. The ruling means that legally, Fontem should have to pull its Myblu products from store shelves that received MDOs from the FDA while the appeal of its MDO goes through the legal process.

    “Fontem has demonstrated that the marketing denial order is causing it harm, but by waiting more than two months after the marketing denial order’s issuance to seek emergency relief, Fontem weakened its claim of irreparable harm,” the court wrote. “That delay also suggests it may have been practicable to seek a stay from the agency.”

    The court stated that Fontem “has not made a strong showing” that it is likely to succeed in its appeal of the MDO issued by the U.S. Food and Drug Administration on merits, noting that as to the multiple bases for the MDO identified by the FDA, the agency likely afforded Fontem fair notice.

    “Fontem US, LLC has not satisfied the stringent requirements for a stay pending court review,” the court wrote.

    The FDA issued MDOs to several myblu brand products manufactured by Fontem US. Tobacco and vaping products subject to a negative action regarding a premarket tobacco product application (PMTA) submission, including those subject to an MDO, may not be offered for sale, distributed or marketed in the US. 

    “On April 8, FDA issued MDOs to Fontem US, LLC 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,” the FDA stated in a release.

    Fontem’s appeal is expected to move forward and the court is requiring the case to be expedited
    and the following briefing schedule is to apply:

    • Petitioner’s Brief August 10, 2022
    • Respondent’s Brief September 9, 2022
    • Petitioner’s Reply Brief September 30, 2022
    • Deferred Appendix October 7, 2022
    • Final Briefs October 14, 2022

    “The Clerk is directed to calendar this case for oral argument on the first appropriate date following completion of briefing. The parties will be informed later of the date of oral argument and the composition of the merits panel,” the court wrote.

  • FDA in Philippines Wants Control of Vaping Devices

    FDA in Philippines Wants Control of Vaping Devices

    Credit: Carsten Reisinger

    Regulation of e-cigarettes, vaping devices and other heated tobacco products (HTPs) must remain with the Food and Drug Administration (FDA) and not be transferred to the Department of Trade and Industry (DTI) in the Philippines because these products concern public health, according to the FDA.

    The FDA made its position clear in a statement it released in support of the Department of Health (DOH)’s request for a presidential veto of the Vape Bill (Senate Bill No. 2239 and House Bill No. 9007), which transfers regulatory jurisdiction of the products to the DTI, according to PhilStar Global.

    “It is the DOH, through the FDA, which bears the constitutional mandate to protect every Filipino’s right to health, through establishing effective regulatory systems,” the FDA statement read.

    Contrary to the proposed measure, the FDA said vape products and HTPs must be considered as health products instead of consumer products.

    “This is especially as such products are being marketed by the industry as an alternative to conventional cigarettes, with some even claiming or implying that these products as being safer or less harmful,” the FDA said.

  • Numerous Public Comments on EU Tobacco Changes

    Numerous Public Comments on EU Tobacco Changes

    Credit: Savvapanf Photo

    An overwhelming majority of EU citizens who responded to a European Commission initiative say they support tobacco harm reduction products.

    The Commission’s “Call for Evidence” on the legislative framework for tobacco control received an unprecedented level of feedback, with consumers of alternatives to tobacco products – vaping, heated tobacco and oral nicotine pouches – making their voices heard in huge numbers, according to EU Political Report.

    More than 24,000 EU citizens responded to the call, launched by the Commission as part of its ongoing evaluation of what future EU tobacco laws will look like through revision of the Tobacco Products Directive.

    The massive interest in the issue may surprise some and may put the European Commission on the back foot as has been seen by some as having previously failed to support ‘tobacco harm reduction’.

    The 4-week public consultation, from May 20 May to June 17, had one of the biggest ever responses to a consultation. On average, calls of this length receive around 354 submissions. In recent years, only the “call for evidence” for a digital euro for Europe received a similar scale of a response, but still fell short of the 20,000 submission mark despite taking place over a longer period of time (10 weeks).

    Of the 24.000 submissions, more than 90 percent came from individual EU citizens, suggesting the extent to which this issue is a priority for the European public at large. Many submissions came from citizens in Germany, Italy and Romania.

    It showed that the biggest issue for citizens across all member states is the regulation of reduced-risk products such as e-cigarettes. On this, it has been argued that the Commission it out of sync with public opinion.

    The Commission has favored the introduction of new restrictions on reduced risk products, including flavor bans and sale restrictions but some in the industry hope the public response could now force it to reconsider these plans.

    In June, the Commission announced plans to prohibit the sale of flavored heated tobacco products in the EU. The proposal came, it said, in response to the “significant increase” in the volumes of heated tobacco products sold across the EU.

    A Commission report showed a 10 percent pick up in the sales volumes of heated tobacco products in more than five Member States and overall in the EU, heated tobacco products exceeded 2.5 % of total sales of tobacco products.

    An overwhelming majority of submissions supported tobacco harm reduction products, including vaping and nicotine pouches, as “critical tools” that have helped smokers to quit. Respondents were nearly unanimous in opposing any plans to restrict access to such products for adults over the age of 18.

  • JWEI Submits PMTA to U.S. FDA for New Vape Device

    JWEI Submits PMTA to U.S. FDA for New Vape Device

    China-based JWEI has announced today that they have successfully submitted a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration for a device created with “new innovative technology” that focuses on safety, harm reduction and is designed to curb underage use.

    “JWEI has been a leader in this industry from the start and this milestone again reiterates our commitment to the industry and public health: ensuring our adult customers continued access to less harmful alternatives to traditional tobacco products, while setting a new standard preventing underage youth access.” said VP of JWEI Group Jason Yao.

    JWEI is the parent to the brands Joytech, Eleaf, Wismec and Joyevita. The company did not offer additional information on the specific device submitted for the PMTA.

    JWEI developed a set of principles to guide through every step of its new product development, led by safety and effectiveness studies in early 2019. “The design philosophy is the foundation and guide rails for designing, manufacturing, verifying, validating, and continuously improving innovative, responsible, reliable, and high-quality products,” the release states.

    The limited product debut in the UK has received overwhelming recognition from users and commercial partners after a few months’ actual use, according to JWEI

    “As one of the world-leading device manufacturers and innovators of e-cigarette and vaping products, JWEI has over 3,600 granted patents and multiple internationally recognized manufacturing and quality certifications (GMP, HACCP, ISO9001, ISO13485, EHS, and ERP),” according to a press release.

  • FDA to Review Oversight Rules After Juul Debacle

    FDA to Review Oversight Rules After Juul Debacle

    Robert Califf / Credit: Modern Healthcare

    The head of the U.S. Food and Drug Administration Tuesday said he has commissioned an independent review of the agency’s food and tobacco programs following months of criticism over its handling of the baby formula shortage and e-cigarette reviews, according to AP.

    The announcement comes as FDA Commissioner Robert Califf attempts to push past several controversies that have dominated his second stint running the agency, including his issuing of a marketing denial order (MDO) to e-cigarette maker Juul Labs and later having to rescind that order.

    “Fundamental questions about the structure, function, funding and leadership need to be addressed” in the agency’s programs, Califf said in a statement. The agency’s Center for Tobacco Products (CTP) is facing challenges navigating policy and enforcement issues from “an increasing number of novel products that could potentially have significant consequences for public health.”

    Califf said the non-profit Reagan-Udall Foundation — a non-governmental research group created by Congress to support FDA’s work — would convene experts to deliver evaluations within 60 business days of both the food and tobacco operations.