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 4+ years, and it is a labor of regulatory love.
Ensure all data is defensible when making comparisons
Comparing pricing to other companies can lead to issues if not substantiated. One retail grocery chain was challenged through the National Advertising Division (NAD) competitor challenge process. They were claiming a 25-30% savings for the “exact same basket,” which NAD determined as unsubstantiated. I learned ...
Anxiety claims continue to attract FDA warning letter attention. In 2025, there were ten “supplement-related” anxiety warning letters. Let’s see what ...
SARMs (selective androgen receptor modulators) are potentially dangerous, and FDA issued six SARM-related warning letters in December. Warning letters sometimes ...
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.