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 love puffery. In advertising, puffery is described as an exaggerated, boastful, or subjective promotional claim about a product or service that a reasonable consumer would not take as a factual, measurable representation requiring substantiation. Think “World’s best cup of coffee” from the crummy coffee ...
FDA inspected this supplement manufacturer and marketer in November 2025 and issued some 483s related to sanitation and GMP documentation ...
I often use this example to explain how FDA enforcement works. A single disease-type claim is unlikely to trigger a ...
This dietary supplement company was inspected by FDA in November and issued 483s and several months later, the FDA reviewed ...
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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