Warning Letter Wednesday
A weekly exploration of FDA warning letters and enforcement trends
Product “Tags” With Disease Claims Elevate Risk
Ingredient research can be considered a marketing claim
Walmart & Amazon Issued Warning Letters for Adulterated Products & Disease Claims
Distributors are responsible for the products they sell
Ayurvedic Product Company Receives Covid Warning Letter
Discussing ingredient benefits is a marketing claim
Small Herbal Company in Big Trouble for Disease Claims
“Brain Fog” claims related to Covid will attract scrutiny
Blood Sugar, Arthritis & Immunity Claims Lead to Warning Letter
Scan socials and websites for risky words like “hordenine”
Discussing Ingredient Benefits Leads to a Warning Letter
No such thing as “too small to be on FDA’s radar”
A Review of 56 Diabetes Related Warning Letters
Warning letters show claims made in socials, blogs, testimonials & hashtags
Uncompliant Product Name Leads To Warning Letter
Citing ingredient research is a marketing claim
Supplement company’s brochures and online marketing lead to a warning letter
There are no FDA approved supplement facilities or supplement products
300%+ Increase in CBD Warning Letters This Year
Companies marketing CBD products should avoid making disease claims
Citing Clinical Studies & Labeling Errors Lead To Warning Letter
Citing studies leads to increased scrutiny
Supplement & CBD company cited for disease claims
Words like “may help with” is not a get-out-of-claims-jail-free card
MLM Company Cited For Claims Made By Their Affiliates
Companies that compensate influencers or affiliates may be responsible for claims they make
Company Cited For Selling Selective Androgen Receptor Modulators (SARMs)
The FDA regulates based on intended use
FDA & FTC Crackdown on Products Marketed For Opioid Withdrawal
Find high-risk words lurking in old blogs, testimonials, and socials
GMP inspection leads to a warning letter for disease claims and GMP violations
Plan for FDA inspections by addressing common violations
Ingredient Company Cited For Refusing An FDA Inspection
Plan for inspections with an “FDA Inspection” SOP
