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US FDA enforcement: an analysis of the warning letters issued in 2023

Published: 31st January 2024 | No. pages: 12
$2,000.00

Description

One of the main Food and Drug Administration (FDA) enforcement priorities for 2023 was to remove unauthorised tobacco products from the market, specifically e-cigarettes, which received many more warning letters than any other tobacco product. Since 2020, the agency has prioritised enforcement against unauthorised e-cigarettes, as stipulated in the FDA guidance for industry. This has not changed in 2023, with the agency issuing the most warning letters to the manufacturers, retailers and distributors of disposable flavoured e-cigarettes.

This report examines FDA enforcement measures taken in relation to unauthorised tobacco products, and analyses the warning letters sent out throughout 2023.

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Table of contents

  1. Executive summary
  2. Introduction
  3. When did the FDA issue more warning letters in 2023?
  4. Disposable e-cigarettes remain top for FDA enforcement
  5. E-cigarettes that have youth appealing packaging
  6. Results of 2023 National Youth Tobacco Survey
  7. What are the FDA plans regarding future enforcement?

Methodology

Our research is completely independent and original. It is conducted by ECigIntelligence’s multilingual legal analysis team, all specialists in this sector, and goes through a rigorous review and editing process before publication. Research draws on multiple sources, including: online and offline resources and data, specialist legal software, our own extensive databases and report archives, interviews with key stakeholders and government officials, and collaboration with local legal firms and on-the-ground professionals in the jurisdictions covered.

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Description

One of the main Food and Drug Administration (FDA) enforcement priorities for 2023 was to remove unauthorised tobacco products from the market, specifically e-cigarettes, which received many more warning letters than any other tobacco product. Since 2020, the agency has prioritised enforcement against unauthorised e-cigarettes, as stipulated in the FDA guidance for industry. This has not changed in 2023, with the agency issuing the most warning letters to the manufacturers, retailers and distributors of disposable flavoured e-cigarettes.

This report examines FDA enforcement measures taken in relation to unauthorised tobacco products, and analyses the warning letters sent out throughout 2023.

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    “ US FDA enforcement: an analysis of the warning letters issued in 2023 ”