Tag: regulation

  • FDA Received Nearly 1 Million Synthetic PMTAs, No Approvals

    FDA Received Nearly 1 Million Synthetic PMTAs, No Approvals

    Credit: JHVEPhoto

    One month into his new job, Brian King is already praising his agency’s hard work. The director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) released a statement that he wanted to make it “unequivocally clear” that the agency was “working diligently” to process synthetic nicotine premarket tobacco product applications (PMTAs).

    “A substantial number of applications were submitted by May 14 – nearly one million from more than 200 separate companies – with some several thousand pages long,” King stated. “Preparing these applications for review takes several steps and submissions varied widely in their organization, size, and completeness of data, which impacts the time it takes to process the information.”

    Amanda Wheeler, president of the American Vapor Manufacturers Association (AVM), Tweeted, “Read between the lines: Millions of applications submitted, ZERO approved, yet King assures us the system is working. We do know the only thing preventing vape products from saving lives is the FDA itself, rigging the system in favor of prohibition over harm reduction,” in response to King’s statement.
     
    Despite the challenges of reviewing PMTAs, King stated that the agency was “making significant progress” in processing and reviewing the applications. The FDA has issued refuse-to-accept (RTA) letters for more than 88,000 products for applications that “do not meet the criteria” for acceptance. Applications are required to provide important information needed for processing and reviewing.

    “Without the required information, applications cannot proceed past the acceptance phase of the review process,” King stated. “The RTA letters state that it is illegal to sell or distribute in the U.S. marketplace any new tobacco product that has not received premarket authorization.

    Of the nearly a million applications submitted by May 14, the FDA only accepted an estimated 350, with the vast majority being for e-cigarette or e-liquid products, according to the statement. Accepted applications are then evaluated in the filing stage before going under scientific review.

    “The substantive review phase includes evaluation of the scientific information and data in an application, which often results in follow-up questions and conversations with companies, including in situations where elements of an application raise questions needing clarification,” stated King. “It is only after the substantive phase that a company may be granted a marketing order. If no marketing order is granted, it remains illegal to market the product. To date, no non-tobacco nicotine product has received a marketing granted order.”

    All bark, no bite

    After July 13, 2022, a non-tobacco nicotine product can only be legally marketed in the United States if it has received a marketing order from the FDA. This means that it is illegal for a retailer or distributor to sell or distribute a synthetic nicotine products is in violation of the law and its manufacturer, retailer, or distributor may be subject to FDA enforcement. 

    King stated that the agency’s compliance and enforcement work is a multi-step process that cannot “happen overnight.” it takes time to ensure that any enforcement taken is supported by the available evidence with respect to the legal standards. Typically, the FDA will first issue warning letters to promote compliance and then follow up to ensure the violations addressed in the warning letter are corrected. If firms continue to violate the law, the FDA can pursue further actions, such as civil money penalties, seizures, and injunctions.

    Many retailers simply ignore the FDA warnings. One owner told Vapor Voice that they “know” the agency is overworked and understaffed and is unlikely to follow up or pursue further steps. The agency has also made some very public mistakes over the past month, including its reversal of Juul’s marketing denial order (MDO), that has damaged  the agency’s public perception.

    While there isn’t much data surrounding what tobacco products remain on the market that have received warning letters, however, numerous companies on the agency’s MDO list still market products in the U.S.

    It isn’t only for tobacco products that the agency doesn’t enforce its warnings. A considerable proportion of  drug supplement products remain available for purchase after issuance of FDA warning letters, according to a research letter published in the July 26 issue of the Journal of the American Medical Association. Researchers found that the FDA issued warning letters regarding 31 supplement products. Only one of these 31 products was recalled by the manufacturer.

    At a mean of six years following the issue of warning letters, nine of the products (29 percent) remained available for purchase online, according to the authors. Four of these nine products (44 percent) listed the presence of at least one prohibited ingredient on the label: One label declared the prohibited ingredient included in the FDA warning letter and three listed other FDA-prohibited ingredients. Five of the nine products were found to contain at least one FDA-prohibited ingredient after chemical analysis: Four products contained one prohibited ingredient and one product contained three. Two products contained the ingredient for which the FDA issued the warning letter.

    Despite its challenges, the FDA issued 17 new warning letters on Aug. 1 to manufacturers for marketing products without FDA approval. On July 28, the agency issued 102 warning letters to retailers for illegally selling non-tobacco nicotine products to underage purchasers.

    “Our goal is clear communication and transparency, and toward that end, we intend to include information about non-tobacco nicotine products in our regular metrics reporting in the future,” stated King. “To keep stakeholders and the general public informed, we also launched a non-tobacco nicotine product webpage that includes information about how synthetic nicotine is made and our regulation of non-tobacco nicotine products.”

  • Chill to Pull All Synthetic Products From U.S. Market

    Chill to Pull All Synthetic Products From U.S. Market

    Chill Brands Group PLC said Wednesday that it will end future development and U.S. sales of its tobacco-free nicotine product line in response to additional U.S. regulatory restrictions for synthetic nicotine products.

    The London-listed cannabidiol-products company said the additional restrictions for the products would incur substantial costs to manufacturers and retailers, and that it is working with international partners to transfer remaining synthetic nicotine inventory for sale, according to Market Watch.

    All of Chill’s other products are unaffected.

    The company said a federal funding bill amending the definition of a tobacco product was passed by U.S. Congress in March, giving the U.S. Food and Drug Administration authority over synthetic nicotine–including Chill’s “tobacco-free nicotine” chew pouch products, launched in December.

    As a result, Chill would have been required to submit premarket tobacco product applications for its products to legally remain on sale, a process that could exceed a full-cost of $400,000 per flavor and which it views as commercially unviable.

    “Naturally this is disappointing, but this decision will at least allow us to avoid expending further capital which will be better allocated to developing other products and potential revenue streams,” Chief Executive Callum Sommerton said.

  • 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.”

  • Altria Slashes Juul Investment Value to $1.3 Billion

    Altria Slashes Juul Investment Value to $1.3 Billion

    Credit: Steheap

    Altria Group reduced the value of its investment in Juul Labs by nearly 70 percent, to $1.3 billion, following the Food and Drug Administration’s decision to order the e-cigarette company off the U.S. market.

    The stake for which Altria paid $12.8 billion in 2018 is now valued at $450 million–below a level that allows Altria to exit a noncompete agreement and launch its own e-cigarettes. During a July 28 call with analysts and reporters, Altria said it had opted not to be released from that agreement because the arrangement was still beneficial to Altria.

    On June 23, the FDA ordered Juul Labs to pull its e-cigarettes from U.S. store shelves, saying the e-cigarette manufacturer had submitted insufficient evidence that they were “appropriate for the protection of the public health.”

    A federal appeals court then granted Juul Labs a emergency stay of the order to give the judges time to evaluate the merits of Juul’s appeal. The e-cigarette company separately asked the FDA to stay its own order pending the appeal, and the agency complied.

    In court filings last month, Juul said the FDA overlooked more than 6,000 pages of data the company had submitted on the aerosols that users inhale.

    On July 5, the FDA temporarily halted its ban on Juul Labs products, saying there were scientific issues unique to the Juul application that warrant additional review.

    The agency stressed that the stay suspends but does not rescind it the marketing denial order while the e-cigarette maker appeals the agency’s decision.

    Altria’s revenue fell 4.1 percent to $12.44 billion in the first half of 2022, as consumers facing high inflation bought fewer cigarettes or switched from premium to discount brands.

    Despite the challenges, Altria CEO Billy Gifford, was pleased with the results.

    “Our tobacco businesses performed well in a challenging macroeconomic environment for the first half of the year,” he said in a statement. “The smokeable products segment delivered solid operating companies income growth behind the resilience of Marlboro, and our moist smokeless tobacco brands continued to drive profitability.

    “Our financial plans for the year remain on track, and we reaffirm our guidance to deliver 2022 full-year adjusted diluted EPS in a range of $4.79 to $4.93.”

  • Smoore Opens Full-Scale PMTA Testing Lab in China

    Smoore Opens Full-Scale PMTA Testing Lab in China

    Credit: Timothy S. Donahue

    Smoore has opened China’s first non-clinical full-scale testing laboratory for U.S. premarket tobacco product applications (PMTA).

    Operated by Smoore’s Analysis, Testing and Safety Assessment Center, the laboratory provides all non-clinical evidence required to bring a new nicotine product to market, including material safety, hazardous components and potentially hazardous components (HPHC’s), and toxicology testing.

    This is the first PMTA testing laboratory to open in China, and will allow Smoore to further improve the safety of its products, and help the brands they work with to successfully pass PMTA certification.

    Prior to Smoore opening its new laboratory, vaping companies wanting to enter the U.S. would need to use third-party partners to complete their PMTA testing, which can be a costly and time-consuming process. With the new China facility, Smoore’s brand partners can more easily complete their PMTA certification and improve their accessibility to the US market.

    “The FDA is very concerned about HPHCs and has set out a list of 33 substances which must be tested for,” said Dr Long, the director of Smoore’s new Safety Assessment Center, in a statement. “Our new laboratory can do all this and more, and has the capacity to test for 37 substances; we are the only facility in China whose testing capabilities covers the full range of HPHCs substances.”

    According to Smoore, the laboratory tests against a world-leading new database of HPHCs, developed by Smoore and derived from international toxicity databases including those maintained by the U.S. Environmental Protection Agency (EPA).

    Advanced computational toxicology software is also used to predict for unknown and potentially hazardous ingredients not included in these databases, further increasing Smoore’s safety assessments.

    Since establishing its first research institute in 2017, Smoore has continued to lead the industry in evidence-based research. Its Safety Assessment Center has raised safety standards to medical grade, and works to constantly review product safety.

    A total of eight products have been approved for marketing by the FDA, many of which are manufactured by Smoore.

  • Thailand to Ban Sale of Cannabis Vaping Products

    Thailand to Ban Sale of Cannabis Vaping Products

    Credit: Kitty Fly

    Thailand’s National Tobacco Products Control Committee has moved to ban sales of vaping products products containing cannabis extracts, along with traditional cannabis cigarettes and cigars.

    The meeting was chaired by Deputy Prime Minister and Public Health Minister Anutin Charnvirakul. Following the decision, a new guideline will be introduced in the form of ministerial regulations, while rules for e-cigarettes fall under the responsibility of the police and the Ministry of Digital Economy and Society, according to Thai News..

    Concerning the reported sales and consumption of cannabis by a primary school student in Lampang, the minister said the consumption of cannabis products among people under the age of 20 is strictly prohibited.

    Charnvirakul reiterated the health ministry’s stance against recreational cannabis use, saying the draft cannabis and hemp bill proposed in Thailand’s National Assembly does not contain any clauses that explicitly permit recreational use.

    Thailand decriminalized the growing, sale, possession, and use of cannabis last month with very few rules or regulations in place to manage the newly legalized drug. Politicians soon announced that they had thought the legalization would be used mainly for medical purposes, and never intended for it to be a legal recreational drug.

  • 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.