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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Today's WLW mentions claims in TikTok Shop, another Amazon letter, and a “disease-oriented” warning letter that does not include high-risk disease claims. Oye vey! When I read this next warning letter, I thought to myself, “Why did FDA issue this letter?” The reason for this is ...
Any product marketed online is “fair game” for FDA enforcement. In this warning letter, a dietary supplement company was cited ...
Everyone uses AI, and in many cases it is wonderful. However, this warning letter highlights that using AI is not ...
It is important to respond to FDA 483 requests before they lead to a warning letter. In this example, the ...
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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