This one is a shocker! I’ve been reading warning letters for years, but I’ve never seen one this bad with rodent, pest, and cat issues. In May, the Kentucky Department for Public Health (KDPH) issued a Cease Operation and Blanket Quarantine order for a food ...
Welcome to Warning Letter Wednesday
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.
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Recent Warning Letter Wednesday Posts
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Jan 07
SARM “Research Only” Products Cited
SARMs (selective androgen receptor modulators) are potentially dangerous, and FDA issued six SARM-related warning letters in December. Warning letters sometimes ...
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Dec 31
Precautionary Major Allergen Labeling Not Sufficient Disclosure
As we close out this year, taking a pause and reflecting is a good thing. This WLW marks my 232nd ...
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Dec 24
FTC Crackdown on Misleading Reviews
FTC just sent 10 warning letters to companies alleging potential violations of its Consumer Review Rule, a “shot across the ...
Who is Asa Waldstein?
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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