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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This is a story about a homeopathic manufacturer that was cited for several GMP issues, and about a discarded “sticky note” containing an out-of-trend result that was not properly investigated. Let’s see what we can learn. Homeopathics are largely manufactured as drugs (CFR 211), which ...
A nicotine and caffeine drink company was cited for making disease claims and for selling a “new tobacco product.” I’ve ...
This is a precautionary tale on how to correctly set up a product testing program, run a quality management system, ...
There seem to be three major issues in this dietary supplement warning letter. Inadequate product specifications, lack of documentation, and ...
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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