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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FDA recently sent a group of herpes-support product warning letters. This one caught my eye since FDA used secondary marketing, such as imagery and website claims to further support their premise that the product, “Herpes B Gone” is an unapproved new drug. Let’s see what we ...
Amanita mushrooms are great to look at in nature, but do they have a place in dietary supplements? Let’s see ...
A baby monitor company challenging another makes for an interesting compliance discussion. This National Advertising Division (NAD) case includes popularity, ...
FDA just posted a group of ten warning letters about homeopathics and other unapproved products marketed for sexually transmitted infections ...
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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