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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I’m sometimes asked about “what are the risks and best practices” when company officials appear on podcasts discussing ingredients, products, and diseases. This warning letter involves a prescription cancer drug’s executive chairman appearing on a podcast and a TV ad, and FDA determined that he ...
Pet food is big business, which means competitors sometimes challenge each other’s claims at the National Advertising Division (NAD). In ...
Clinical study parameters can turn a dietary supplement study into a drug study in FDA’s view, triggering Investigational New Drug ...
This is a cautionary tale about a skincare company that relied on a third-party app score and before-and-after images, leading ...
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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