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.
We'll never share your email with anyone else. Cancel at any time.
Dietary supplement labeling can be confusing, but I’ll run through some key issues from a recent warning letter today. Address or Phone Number From warning letter. “The label fails to bear a domestic address or domestic phone number through which the responsible person (as described ...
There are some interesting learning opportunities in this warning letter. Let’s explore. FDA does not like homeopathics. This company sells ...
When is a product that is labeled as a "dietary supplement" not a supplement? The answer is "When it is ...
This warning letter is a great teaching lesson of what not to do. Here are some extreme examples where the ...
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) Cannabis Committee, helping shape policy and industry best practices.
Upcoming Events
See Asa in person
