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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There seem to be three major issues in this dietary supplement warning letter. Inadequate product specifications, lack of documentation, and incomplete 483 responses. Let’s see what we can learn. Inadequate product specifications: From warning letter. “Your “(b)(4)” document for your Ashwaghanda Gummies lists appearance, color, ...
Comparing pricing to other companies can lead to issues if not substantiated. One retail grocery chain was challenged through the ...
Anxiety claims continue to attract FDA warning letter attention. In 2025, there were ten “supplement-related” anxiety warning letters. Let’s see what ...
This one is a shocker! I’ve been reading warning letters for years, but I’ve never seen one this bad with ...
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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