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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.