October 28, 2024 - Newsletter Plans Moving Forward

Issue #21 - Deep Dive: What Constitutes Appropriate for the Protection of Public Health (APPH) Evidence for a PMTA?

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I wanted to share some news - I've recently accepted an exclusive consulting engagement that will be taking up a significant portion of my time. While I'm excited about this opportunity, it means I'll need to adjust the frequency of this free newsletter moving forward.

1️⃣ Data released from the 2024 National Youth Use Tobacco Survey (NYTS)

2️⃣ $76M in unauthorized e-cigarettes seized by U.S. FDA in collaboration with U.S. Customs and Border Protection

3️⃣ Theoretical Framework for Modern Oral Nicotine Pouch Standards

4️⃣ Recap of Nicotine Headlines over the Last 2 Weeks

🤿 Deep Dive - What Constitutes Appropriate for the Protection of Public Health (APPH) Evidence?

The CDC and FDA analyzed data from the 2024 National Youth Tobacco Survey to assess tobacco product use among U.S. middle and high school students. Key findings include:

Overall Tobacco Use

  • Current use of any tobacco product decreased from 10.0% in 2023 to 8.1% in 2024 among all students

  • E-cigarettes remained the most commonly used tobacco product (5.9%), followed by nicotine pouches (1.8%)

High School Students

  • Current use of any tobacco product declined from 12.6% to 10.1%

  • E-cigarette use decreased from 10.0% to 7.8%

Key Takeaway: The 2024 data represents the lowest level of youth tobacco product use recorded in 25 years. Youth e-cigarette use has declined by approximately two-thirds since its peak in 2019.

  • The seized products originated from China and were often mislabeled to avoid detection

  • Various brands were seized, including Geek Bar and others

Key Takeaway: The operation, in July 2024, involved months of preparation, including reviewing shipping invoices and identifying potentially violative shipments. Dr. Brian King, director of the FDA's Center for Tobacco Products, warned that this operation is part of ongoing efforts to pursue those attempting to smuggle unauthorized e-cigarettes.

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