A weekly exploration of FDA warning letters and enforcement trends
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.
Submitting an NDI notification does not replace adequate safety support
Amanita mushrooms are great to look at in nature, but do they have a place in dietary supplements? Let’s see what we can learn. FDA recently issued a warning letter to a company selling Amanita muscaria “supplements.” This is at least the second Amanita-related warning ...
A baby monitor company challenging another makes for an interesting compliance discussion. This National Advertising Division (NAD) case includes popularity, ...
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.