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 love it when warning letters reveal how interconnected marketing can be. In this example, FDA cites a social media post that discusses and links to a blog on the company’s website. That link functions as the “commercial bridge,” connecting the promotional content to commerce ...
Celebration! Today is 250 consecutive weeks of this Warning Letter Wednesday® post! Before we get into this week’s post, I ...
WLW# 249 If I list “Magnesium Glycinate Gummies 200 mg per serving,” does a reasonable consumer think there is 200mg ...
This is a bizarre one. It involves a functional mushroom and herbal company that received a warning letter for claims ...
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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