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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This week’s WLW brings us back to GMP basics and a black walnut hull labeling question. Let’s see what we can learn. FDA inspected this herbal supplement company from May 12 through June 8 of this year, which is a lengthy inspection period. At the ...
FDA just posted six warning letters involving unapproved drugs and hidden-drug safety concerns. There is a lot to learn here, ...
FDA recently sent a group of herpes-support product warning letters. This one caught my eye since FDA used secondary marketing, ...
Amanita mushrooms are great to look at in nature, but do they have a place in dietary supplements? Let’s see ...
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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