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Flavoured pod attachments score big as FDA fails to enforce premarket review
  1. Natalie Hemmerich
  1. Public Health Law Center, Saint Paul, MN 55105, USA
  1. Correspondence to Natalie Hemmerich, Public Health Law Center, Saint Paul, MN 55105, USA; natalie.hemmerich{at}mitchellhamline.edu

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On 2 January 2020, the US Food and Drug Administration (FDA) released a final guidance for the tobacco industry that restricted the sale of some flavoured pod or cartridge-based e-cigarettes.1 After this guidance was issued, many raised the alarm that novel and concerning products like PUFF Krush and PUFF bar were evading the guidance because they are not pod or cartridge-based e-cigarettes and continue to be sold in prohibited flavours and in retail outlets accessible to youth.2 3 While there were many gaps in the guidance, the fact that PUFF Krush (a flavour additive not containing nicotine) and PUFF bar (a flavoured disposable e-cigarette) remain on the market is not because of the flavour guidance, instead it is due to a failure by the FDA to prevent these products from entering the market after 8 August 2016 (the effective date of the FDA’s deeming regulation) without a marketing order from the FDA. While the FDA’s deeming regulation clearly required marketing orders for any product entering the market after 8 August 2016, the FDA has failed to identify and remove those products that have been illegally marketed after that date. As products like PUFF Krush and PUFF bar become more popular and continue to be sold illegally, the FDA should act decisively and quickly to remove them from the market. Doing so addresses the danger of these products to perpetuate youth use of e-cigarettes. Without action, these products undermine the purpose of the FDA’s flavour guidance in reducing youth access to flavoured e-cigarettes.

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Footnotes

  • Contributors Author is the sole contributor to this work.

  • Funding This study was funded by Robert Wood Johnson Foundation.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Commissioned; internally peer reviewed.

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