Category: Regulation

  • SBA Wants FDA to Ask Judge for PMTA Extension

    SBA Wants FDA to Ask Judge for PMTA Extension

    Photo: Grispb

    The U.S. Small Business Administration (SBA) has urged the Food and Drug Administration to allow nicotine products to remain on the market for another year while their premarket reviews are in progress, reports Vaping 360.

    In a letter sent to the FDA on June 7, the SBA Office of Advocacy asked the agency to seek a court order extending for an additional year the current freeze on enforcement actions against small vape manufacturers who submitted Premarket Tobacco Applications (PMTAs) before last year’s Sept. 9 deadline.

    In the current situation, manufacturers who submitted PMTAs on time may leave those products on the market until Sept. 9, 2021. The SBA advocacy office is asking the FDA to request that U.S. District Court Judge Paul Grimm allow the agency to extend the deadline until September 2022.

    Considering the large volume of PMTAs submitted—the FDA says it received more than 6 million applications—It is unlikely that the agency will be able to process all submissions before manufacturers are required to pull their products off the market.

    “Small ENDS manufacturers cannot afford to have their products pulled from store shelves while the FDA continues to review the timely submitted PMTAs for millions of ENDS products,” the SBA writes. “Most small ENDS manufacturers do not have the resources to absorb the losses from having their products pulled from the marketplace for several months or more. Once the FDA orders small ENDS manufacturers’ products removed from the market, those small businesses will close permanently.”

    The letter also urges the FDA to end its current practice of processing PMTAs in order of manufacturer market share. By doing so, the FDA all but guarantees that small vaping companies will be unable to have their reviews completed in time to remain on the market, according to the SBA.

    The SBA is a federal agency represents the views of small business to the various branches of government.

  • Ohio Indoor Ban Allows Exemption for Vape Shops

    Ohio Indoor Ban Allows Exemption for Vape Shops

    The Ohio Senate passed its version of the two-year state operating budget, House Bill 110. In Governor Mike DeWine’s budget proposal, he wants to expand the statewide indoor smoking ban to include vaping. James Jarvis, president of the Ohio Vapor Technology Association (OHVTA) said the organization did not oppose this measure. Both the House and the Senate retained the language. The Senate, however, included an amendment to provide and exemption to stand-alone vapor stores from the indoor ban.

    Credit: Spirit of America

    “This exemption is about consumer education and safety. The devices that stand-alone stores sell are technical pieces of electronics and if not used properly can cause harm,” said Jarvis. “Our store owners pride themselves on providing customers a full wealth of knowledge on how to not only use the device, but also change our important components of the device. This exemption allows our store owners to continue this education to properly advise consumers on how to use their device, whether with or without nicotine, in the store.”

    The exemption only applies to stores who’s gross receipts are from sales of 80 percent or more of electronic smoking devices and accessories as currently defined in Ohio Law. The rule would not apply to convenience, grocery or other multi product stores.

    The bill now moves on to a Conference Committee where the House and Senate will find common ground before sending it to Dewine’s desk for final approval.

  • Louisiana 21-to-Vape Bill Heads to Governor’s Desk

    Louisiana 21-to-Vape Bill Heads to Governor’s Desk

    A bill proposing to raise the legal age for vaping in Louisiana from 18 to 21 cleared its last hurdle in the Louisiana Legislature. The House gave final passage to House Bill 473 authored by state Rep. Buddy Mincey by a vote of 91-0.

    Credit: Gustavo Frazao

    The bill now heads to the desk of Gov. John Bel Edwards. It is unclear if Edwards will sign the bill into law or veto it, according to The Advertiser.

    Mincey said he was asked by a high school administrator to bring the bill because of rampant vaping on the Denham Springs High School campus. “I really wasn’t sure I wanted to do it because a similar bill got killed in the House two years ago, but then I saw a survey showing kids are vaping 100 times a day,” Mincey said in an interview with USA Today Network. “The results made it really obvious we needed to do something.”

    Mincey said all but 17 states have already raised the age to 21 to comply with federal law. The bill makes it illegal for people younger than 21 to buy or use the products. “Vaping has become so prevalent among young people; my concern is on the long-term health impacts,” Mincey said. “It’s clear what smoking does to your health, but we don’t know all of the long-term impacts of vaping.”

  • Trade Body Slams German Vapor Tax

    Trade Body Slams German Vapor Tax

    Photo: katatonia

    The German association for the e-cigarette trade VdeH has sharply criticized the passage by specialist committees in Parliament of a tobacco tax reform bill that calls for significant tax hikes on vapor products including nicotine-free variants.

    The plans will not only boost the black market but also destroy numerous small and medium-sized businesses, according to VdeH.

    “The mere fact that e-cigarette liquids are generally taxed more heavily than tobacco cigarettes and thus ignore the 95 percent lower potential for damage is insane health policy,” said VdeH managing director Michal Dobrajc in a German-language statement. Taxing nicotine-free products as well as cigarettes defies common sense, he added.

    If you are serious about reducing the smoking rate, then you have to support the industry that is making a significant contribution to reducing it instead of destroying it.

    Michal Dobrajc, managing director, VdeH

    Dobrajc said Germany should learn from the experience of other countries that were forced to lower their vapor taxes as vapers returned to smoking and anticipated revenues failed to materialize.

    “The Tobacco Tax Modernization Act is a disaster in both health and economic terms,” said Dobrajc. “If you are serious about reducing the smoking rate, then you have to support the industry that is making a significant contribution to reducing it instead of destroying it.”

  • MPs Urged to Champion Vaping During Tobacco Control Debate

    MPs Urged to Champion Vaping During Tobacco Control Debate

    Photo: Gerry

    The U.K. Vaping Industry Association (UKVIA) is asking members of parliament to champion the public health benefits of vaping as the Department of Health and Social Care looks to publish a new Tobacco Control Plan (TCP) later this year, to support the government’s Smokefree 2030 ambition

     The U.K. House of Commons will debate the “Recommendations for the forthcoming Tobacco Control Plan” on June 10.

    According to the UKVIA, the upcoming debate is a huge opportunity to refocus efforts in ensuring that England achieves its aim of becoming smokefree by 2030. The U.K. is estimated to have a smoking prevalence of 14.1 percent and the forthcoming Tobacco Control Plan is a chance to see this number decrease further, particularly in light of an uptake during the pandemic period, the association writes in template letter to local MPs.

    The UKVIA letter urges MPs to make the following points during the debate:

    • The government must seize the opportunity presented by the U.K. having left the European Union. With the ongoing review of the Tobacco and Related Products Regulations (TRPR), and the forthcoming TCP, the government has the opportunity to diverge from EU law governing tobacco and nicotine policy to level up on health inequalities across the U.K. Independence allows for U.K. regulations to stay relevant, be easily adapted to changing consumer trends and any market and technological developments, with greater ease and less bureaucracy.
    • The government’s forthcoming TCP should be based on the significant and growing body of evidence showing vaping to be an effective alternative for smokers looking to quit and should cement the concept of harm reduction, placing the U.K. as the global leader in tobacco harm reduction. Vaping is twice as effective as other nicotine replacement therapies, such as gum and patches. Research from University College London has found that e-cigarettes, in one year alone, helped an additional 50,000-70,000 smokers in England quit. Despite the overwhelming and growing evidence in support of e-cigarettes, perceptions of harm from vaping among smokers are increasingly incorrect and out of line with the evidence. This is despite ONS data from Great Britain showing that over half of smokers want to quit.
    • Misinformation and misperceptions about the relative risk of e-cigarettes must be challenged at every opportunity. To do so, the government must work with industry leaders to develop a series of policies that can help the vaping industry communicate directly with existing adult smokers. It is suggested that approved health claims and switching messages, alongside nicotine health warnings, should be available to vape manufacturers and retailers, to communicate the facts about vaping. Such claims and messages could be used on both device and e-liquid packaging, as well as on posters and leaflets. Similar proposals have been made by the governments of New Zealand and Canada.
    • In light of the University of East Anglia’s study to trial e-cigarettes in NHS A&E departments, greater support is also needed for medical practitioners. The new TCP should support medical professionals by ensuring that clinicians are signposted to the latest clinical evidence on e-cigarettes and that local stop smoking clinics adopt a consistent approach to the advice given smokers looking to switch to less harmful alternatives and/or quit smoking combustible cigarettes.

    “Whilst on one hand the current regulations and the existing TCP have allowed the vaping industry in the U.K. to flourish, on the other, they have hindered the ability of the vaping sector to promote vaping as an effective way of switching to a less harmful alternative, thereby preventing the government achieving the aims set out in the Tobacco Control Plan,” the UKVIA wrote. “Parliamentarians should therefore be advocating for fair and proportionate policies and regulations of e-cigarettes to help reduce inequalities and improve public health.

  • JVapes has PMTA Accepted by FDA for 992 SKUs

    JVapes has PMTA Accepted by FDA for 992 SKUs

    After submitting its premarket tobacco product application (PMTA) application to the U.S. Food and Drug Administration (FDA) on or before Sept. 9, 2020, Arizona-based JVapes announced that it had received a PMTA acceptance letter from the regulatory agency. The company submitted PMTAs for 992 SKUs of its JVapes e-liquids.

    Credit: JVapes

    The company now waits for a filing letter from the FDA. Following acceptance, applications undergo a more thorough review to determine if they include the data outlined in Section 910(b)(1) of the Tobacco Control Act (TCA). A filing status will only be received by brands that have submitted an application that contains all the necessary components with enough data included to justify a complete scientific review.

    Filing is a critical milestone for a brand because once this status is reached, it is legal for products to remain on market till September 2021 while FDA completes its review.

    During the substantive review phase of the PMTA process, FDA performs a detailed inspection of the documents and research that a brand has provided. This review considers whether or not an applicant product is safe for consumers and if it will be manufactured and marketed to FDA standards, with the ultimate goal of determining if a product is appropriate for the protection of public health.

    Substantive review typically takes 90 days from notification of entering the review phase to receiving the first set of questions and comments from the FDA, according to the FDA. The majority of applications will receive follow-up questions and/or requests for additional data that may extend the timeline of the review phase.

  • FDA Clarifies Purpose of PMTA Deficiency Letters

    FDA Clarifies Purpose of PMTA Deficiency Letters

    The U.S. Food and Drug Administration (FDA) has issued a statement that it has updated the language used in its deficiency letters. The new language is intended to clarify the purpose of the letters that are related to its premarket tobacco product application (PMTA) process. In an email on June 3, the FDA explained that such letters are only meant to communicate information gaps identified during review. The letter offers the applicant an opportunity to provide further information.

    Credit: Araki Illustrations

    “The language further clarifies that the letter is not intended to convey a list of concerns about the product, and a complete response to the deficiency letter does not guarantee that the applicant will receive a positive marketing order,” the agency states. “Importantly, a final decision regarding marketing of the product(s) will be made at the end of FDA’s scientific review. FDA will base the final decision on the applicable public health standard in the Federal Food, Drug, and Cosmetic Act after reviewing the totality of all the information included in the original submission and amendments.”

    Following last year’s Sept. 9 PMTA deadline for most deemed new tobacco products, including vapor and e-cigarette products, that are currently on the market, the FDA’s job is to process, review, and take action on as many applications as possible before September 9, 2021, according to the agency. The substantive review process is the longest and most thorough phase of FDA’s review. Substantive review includes the evaluation of the scientific information and data in an application and often includes identification of follow-up questions for the applicant.

    Before a final decision is made based on substantive review, the FDA generally sends a deficiency letter, which allows one opportunity for applicants to provide any additional information that the FDA needs to continue its scientific review. The agency typically allows 90 days for an applicant to respond to a deficiency letter.

  • FDA Issues 3 Warning Letters for PMTA Violations

    FDA Issues 3 Warning Letters for PMTA Violations

    The U.S. Food and Drug Administration (FDA) has issued three more warning letters for illegal e-liquids. The regulatory agency issued the letters on May 28 and June 3 and posted them to its website on the same days. Companies that received the latest round of letters have a combined 750 products registered with the FDA. The agency has now issued 123 letters to vapor companies for marketing vapor products without having submitted a premarket tobacco product application (PMTA) by Sept. 9, 2020.

    Credit: Chris Titze Imaging

    North Carolina-based Asheville Vapor received letter on May 28 (50 registered products), while Kansas-based Tiger Vapes (100) and New York-based The Vapor Shop received the letters on Thursday, June 3.

    In May, the FDA issued a total of 19 warning letters to firms who manufacture and sell unauthorized e-liquids, advising them that selling products which lack premarket authorization is illegal and therefore they cannot be sold or distributed in the U.S.

    While each of these 19 warning letters cites specific products as examples of tobacco products that lack the required premarket authorization, collectively those firms have listed a combined total of more than 378,000 products with the FDA, according to an email from the agency.

    Since January 2021, FDA has issued a total of 123 warning letters to firms selling or distributing more than 1,280,000 unauthorized ENDS and that did not submit premarket applications by the Sept. 9 deadline.

    The FDA recently released its list of products that are legal for sale in the U.S. A total of 360 companies filed more than 6 million PMTAs. The FDA stressed it has not independently verified the information provided by applicants about the marketing status of their products. In addition, the list excludes entries of products from companies that did not provide information on current marketing status of their products to the FDA so that the agency could determine whether the existence of the application could be disclosed.

    The FDA often only lists a few products that a company is selling as illegal in the letter. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.

    Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.

  • 5 More FDA Warning Letters for Illegal E-liquids

    5 More FDA Warning Letters for Illegal E-liquids

    Five more vapor companies have received warning letters from the U.S. Food and Drug Administration (FDA) for illegal e-liquids. The regulatory agency issued the letters on May 21 and posted them to its website on May 27. Companies that received the latest round of letters have a combined 96,960 products registered with the FDA. The agency has now issued 120 letters to vapor companies for marketing vapor products without having submitted a premarket tobacco product application (PMTA) by Sept. 9, 2020.

    Credit: Jon

    Nicfixed d/b/a Good Karma Vapor-received letter on May 27 – (1,400 registered products), Soul Vapor (2,100), Nelson Endeavors d/b/a Liberty Vape Co. (60), Premium eJuice USA d/b/a Vapor Lab (92,000) and Capitol Hill Vapor Co. (400) all received letters for illegal e-liquids.

    Last week, the FDA released its list of products that are legal for sale in the U.S. A total of 360 companies filed more than 6 million PMTAs. The FDA stressed it has not independently verified the information provided by applicants about the marketing status of their products. In addition, the list excludes entries of products from companies that did not provide information on current marketing status of their products to the FDA so that the agency could determine whether the existence of the application could be disclosed.

    The FDA often only lists a few products that a company is selling as illegal in the letter. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.

    Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.

  • Oregon Governor Set to Sign Online Vapor Sales Ban

    Oregon Governor Set to Sign Online Vapor Sales Ban

    The Oregon Senate approved House Bill 2261 on Wednesday, a move that supporters said will limit Oregon’s youth from accessing nicotine products by closing loopholes that have allowed those underage to purchase vaping products. The legislation passed the Oregon House on April 10. It now goes to the governor for her signature, which she has said she will sign.

    Credit: Vlad

    “The use of vaping products by our youth is shocking,” said State Sen. Kathleen Taylor. “No matter how diligent our retailers are, there is still significant access to these products online.” Oregon prohibited the online sale of cigarettes and other tobacco products from taking place online in 2017. Oregon brings vaping products in line with that policy.

    E-cigarettes started to be taxed for the first time in Oregon beginning Jan. 1 after voters overwhelmingly approved Measure 108 in late 2020.

    In 2015, Taylor championed House Bill 2464 to make certain access and use laws around inhalant delivery systems aligned with that of other tobacco products. The bill added age restrictions on purchasing and defined where the use of vape products is allowed, according to KTVZ.com.

    “Vaping is harmful to our youth. Not only is it habit forming, the nicotine contained in these products can have lasting effects on kids’ still-developing brains,” said Taylor. “The use of these products continues to rise, and they contain products and chemicals that are highly addictive. Oregon’s licensed retailers have agreed to do the right thing, protect our kids, and sell only to those of legal age. Ensuring a face-to-face exchange is required for purchasing these products, we remove a loophole that may be used that can result in lifelong addiction and negative health outcomes.”