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Welcome to Warning Letter Wednesday

A weekly exploration of FDA warning letters and enforcement trends

Every Wednesday Asa reviews interesting warning letters and other enforcement trends. He’s been writing this each week for 4+ years, and it is a labor of regulatory love.


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Current Post November 12, 2025
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Online Product Marketplace Cited for Non-Compliant Products

Companies are responsible for the products they distribute

FDA issued a warning letter to an online marketplace that sells international products, including Korean skincare and miscellaneous household items, for distributing motion sickness patches that contained undisclosed drug ingredients. This is an interesting letter which shows that companies are responsible for the products they ...

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Asa Waldstien the author of Warning letter Wednesday

Who is Asa Waldstein?

Asa Waldstein is a 24-year veteran of the dietary supplement industry, with experience spanning manufacturing, marketing, and regulatory compliance. He is the principal of Apex Compliance, a software company dedicated to streamlining regulatory marketing compliance for the dietary supplement and natural products sectors. Asa also leads Supplement Advisory Group, a boutique consultancy focused on marketing risk analysis, labeling, and practical compliance strategies for websites and social media. Asa has helped oversee three FDA GMP inspections with no 483s and was honored with the 2023 AHPA Herbal Hero Award and the 2024 What's Up Supps Policy and Change Agent Award. He currently serves as Chair of the American Herbal Products Association’s (AHPA) Technology & AI Innovation Committee.

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