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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Homeopathic products continue to be targeted by FDA. In this group of five warning letters FDA reinforced their position that homeopathics are drugs and must follow drug rules, including FDA approval. From warning letter. “(the products) are labeled as homeopathic drugs. Under section 201(g)(1) of ...
I’m sometimes asked what types of herbal products are safe and good to purchase. A first step is to ensure the company ...
FDA issued a warning letter to an online marketplace that sells international products, including Korean skincare and miscellaneous household items, ...
“Buzzwords” or “trigger words” in marketing are one of the reasons companies receive warning letters. In today’s Warning Letter Wednesday, ...
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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