Every Wednesday Asa reviews interesting warning letters and other enforcement trends. He’s been writing this each week for 5 years, and it is a labor of regulatory love.
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FDA inspected this supplement manufacturer and marketer in November 2025 and issued some 483s related to sanitation and GMP documentation issues. The company then sent four 483 responses to FDA from December 2025 to May of this year. In May, apparently after the last 483 ...
I often use this example to explain how FDA enforcement works. A single disease-type claim is unlikely to trigger a ...
This dietary supplement company was inspected by FDA in November and issued 483s and several months later, the FDA reviewed ...
5 years of WLW posts! I appreciate you! For five years, every week, I’ve written this newsletter. We plan our ...
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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