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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Everyone uses AI, and in many cases it is wonderful. However, this warning letter highlights that using AI is not a shortcut for quality and reinforces the “trust but verify (and validate)” adage. This company makes homeopathic drugs, which, as a regulatory category, have been ...
It is important to respond to FDA 483 requests before they lead to a warning letter. In this example, the ...
Many products sprayed into the nose are considered OTC drugs, which allow companies to make designated claims about them. This ...
This warning letter is an example of how online ingredient/product education crosses the line into disease-claim marketing. There are numerous ...
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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