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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It is important to respond to FDA 483 requests before they lead to a warning letter. In this example, the company was inspected and issued a 483 by FDA in December. The company never responded! Then, four months later, FDA reviewed their website and found ...
Many products sprayed into the nose are considered OTC drugs, which allow companies to make designated claims about them. This ...
This warning letter is an example of how online ingredient/product education crosses the line into disease-claim marketing. There are numerous ...
I love it when warning letters reveal how interconnected marketing can be. In this example, FDA cites a social media ...
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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