The NAD+ battles continue. In this National Advertising Division (NAD) competitor challenge case, several claims were challenged, and because the defending company did not properly respond to NAD with a compliance statement, NAD referred the case to the “proper” authorities, such as the FTC or state ...
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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Mar 25
Podcasts Are Marketing
I’m sometimes asked about “what are the risks and best practices” when company officials appear on podcasts discussing ingredients, products, ...
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Mar 18
Pet Food’s “Human Grade” Implied Claims Challenged
Pet food is big business, which means competitors sometimes challenge each other’s claims at the National Advertising Division (NAD). In ...
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Mar 11
Disease Population + Disease Endpoints = Drug Intent
Clinical study parameters can turn a dietary supplement study into a drug study in FDA’s view, triggering Investigational New Drug ...
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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