WLW# 249 If I list “Magnesium Glycinate Gummies 200 mg per serving,” does a reasonable consumer think there is 200mg of elemental magnesium in each serving? This recent NAD case is a good lesson in net impression, which is how consumers view advertising. In this ...
Welcome to Warning Letter Wednesday
A weekly exploration of FDA warning letters and enforcement trends
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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Recent Warning Letter Wednesday Posts
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Apr 22
Clinical Study Names Can Be Marketing Claims
This is a bizarre one. It involves a functional mushroom and herbal company that received a warning letter for claims ...
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Apr 15
Men’s Fertility Supplement Claims Challenged
Greetings from SupplySide Connect! If you are attending, please stop by booth #723 and say hello. We have some fun ...
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Apr 08
Rare eBay Warning Letter
There have been only four eBay-related warning letters in recent years, and two of them occurred this week. This shows that ...
Who is Asa Waldstein?
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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