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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Many products sprayed into the nose are considered OTC drugs, which allow companies to make designated claims about them. This also requires nasal OTC drugs to follow strict monographs. These are recipes that clearly specify which ingredients can be used and which claims can be ...
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 ...
Celebration! Today is 250 consecutive weeks of this Warning Letter Wednesday® post! Before we get into this week’s post, I ...
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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