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FDA Issues PMTA Guidance Outline

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The Food and Drug Administration made headlines again this month as it has released its latest guidance for ENDS manufacturers who are planning on tobacco product application submissions. The premarket tobacco application (PMTA) covers e-cigarettes, liquid nicotine, nicotine-containing e-liquids and other vapor products. Convenience Store Decisions broke down some of the guidance outline explanations:

  • Products to which this guidance applies
  • When a PMTA is required under the statute and regulations
  • General procedures for review of an ENDS PMTA
  • What information the FD&C Act requires you to submit in a PMTA
  • What information FDA recommends you submit in an ENDS PMTA to show that permitting your new tobacco product to be marketed would be appropriate for the protection of the public health (APPH)

Under this guidance for approval application, companies must show that their products “would be appropriate for the protection of the public health,” according to the FDA. The agency said that moving forward its considerations include “how vaping products may change people’s behaviors, including the prospect of nonsmokers picking up the e-cig habit, as well as how often e-cig users tend to quit.” Further, companies would not be able to make smoking cessation claims unless approved as a drug or medical device. Those products are recommended to be submitted to the Center for Drug Evaluation and Research or the Center for Devices and Radiological Health in order to be approved for those claims.In addition, the agency plans on further examining ingredients in products, labeling, packaging and how products are manufactured.The FDA has asked the court in a filing to amend the product review process of a timeline “of not less than 10 months to submit the applications after a final ruling,” Reuters reports. 

The FDA also asked for a one-year period for review. Anti-tobacco groups reportedly want e-cigarette companies that submit applications “to stay on the market within 120 days of the ruling.” Previously, manufacturers would have had until August 2021 to submit their applications.To date, the FDA has yet to approve any e-cigarette product on the market. To read the guidance in its entirety, click here.

Washington State, Illinois Adopt Tobacco 21

Illinois becomes the first Midwest state to adopt Tobacco 21, thanks to Gov. J.B. Pritzker’s passage. Gov. Bruce Rauner previously vetoed the bill last year. The purchase law goes into effect July 1, but it’s important to note there will be no penalties for underage possession. Illinois joins California, Hawaii, Maine, Massachusetts, New Jersey, Oregon [...]

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FDA Commissioner Makes Most 'Direct Threat' Yet to Vaping Industry

In either a shocking or predictable move this week — depending on what side of the fence you are on — Food and Drug Administration Commissioner Scott Gottlieb has “made his most direct threat yet against e-cigarette companies,” reports NBC News.Gottlieb’s statement at a hearing held at FDA headquarters continued, saying that companies face an [...]

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Altria-Juul Deal Brings Holiday Surprise to Employees

The vaping world is filled with news big and small — let’s be honest, mostly big — and this one that’s been unfolding over the past couple of months is no different. However, it’s bigger than most.We head back to the end of October, when USA Today reported that Altria, maker of Marlboro and parent [...]

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​Progress is Progress: Vaping and Harm Reduction

While nicotine is the addictive substance in traditional cigarettes, it is the long-term exposure to the additional ingredients in cigarettes (smoke, tar and a variety of toxic components) that inflames the airways and makes them dangerous. Over the years there have been a handful of smoking cessation tools made available to the general public (nicotine [...]

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Love Your Vape and Your Android? Download These Apps.

If you’re like most of us, then throughout the course of any given day you are looking up the latest news and gossip via your most-loved apps. If it exists, there’s an app for it – unless you're an Apple user that is. Thanks to the continued growth of the industry, vaping apps are becoming [...]

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Tips for Traveling Vapers

The unofficial start to summer is here, and while we know our blog readers are a savvy bunch, we also think it’s important to do a check on certain things — like summer travel with an e-cigarette and e-liquid. Whether you are traveling by plane, train or automobile, we have you covered with the do’s [...]

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Keller and Heckman Announces Vaping Product Manufacturing Audit and Inspection Program

In early February, we shared our Q&A with Azim Chowdhury, partner, FDA Group at Keller and Heckman LLP. As a follow up to the firm’s symposium news, this month marked another step forward in vaping regulation with the launch of the Audit and Inspection Program (AIP) for Tobacco and Vapor Product Manufacturing Establishments. The AIP, [...]

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