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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 April 22, 2026
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Clinical Study Names Can Be Marketing Claims

Use caution when using scientific literature to sell products

This is a bizarre one. It involves a functional mushroom and herbal company that received a warning letter for claims made in clinical study and other citations in the “Newspaper” tab of its website. Typically, citations are not mentioned in warning letters unless they are ...

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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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