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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I’ve seen a lot of dietary supplement manufacturing facilities in my life, and within a few minutes you can usually determine how seriously a company takes GMPs. In this warning letter, a supplement manufacturer received several GMP-related 483 violations. Today, I’ll focus on sanitation issues. ...
A few weeks ago, I wrote about a “#1 Best Selling Beets Brand” NAD case. This week, let’s look at ...
In the past couple of months, FTC recently sent warning letters to eight companies that appear to have misrepresented certain ...
This one is OTT. FDA inspected a South Korean drug manufacturer and found major GMP violations, including some alleged falsified records issues. ...
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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