Warning Letter Wednesday® Posts

A weekly exploration of FDA warning letters and enforcement trends

August 3, 2022

Citing Clinical Studies & Labeling Errors Lead To Warning Letter

Takeaway -

Citing studies leads to increased scrutiny

I’m sometimes asked if supplements can make disease claims with competent and reliable scientific evidence. Unfortunately not; even if a Randomized Controlled Clinical Study (RCT) was conducted on a supplement, ...
July 27, 2022

Supplement & CBD company cited for disease claims

Takeaway -

Words like “may help with” is not a get-out-of-claims-jail-free card

FDA inspected the company facility in October 2021, then six months later reviewed the website for disease claims, finding many that resulted in a warning letter. This is a trend. ...
July 20, 2022

MLM Company Cited For Claims Made By Their Affiliates

Takeaway -

Companies that compensate influencers or affiliates may be responsible for claims they make

This is the one-year anniversary of Warning Letter Wednesday. I have written this post every week, even when having Covid, on a tropical vacation, or under a massive work deadline. ...
July 6, 2022

FDA & FTC Crackdown on Products Marketed For Opioid Withdrawal

Takeaway -

Find high-risk words lurking in old blogs, testimonials, and socials

FDA and FTC crackdown on products marketed for opioid withdrawal. FDA and FTC recently sent five joint warning letters to companies marketing products for opioid withdrawal. Joint FDA/FTC warning letters ...
June 22, 2022

Ingredient Company Cited For Refusing An FDA Inspection

Takeaway -

Plan for inspections with an “FDA Inspection” SOP

International ingredient company cited for refusing an FDA GMP inspection, a serious prohibited act. What are the repercussions of denying inspections? All products from the facility are deemed adulterated, and ...
June 15, 2022

PTSD Claims Enforcement Increasing

Takeaway -

Find and remove high-risk “buzzwords”

FDA enforcement of PTSD claims is increasing. This year there have been five PTSD-related warning letters, up from just three PTSD-related letters in all of 2021. This is an example ...
June 8, 2022

Twitter Claims Enforcement Increasing

Takeaway -

Claims made on social are top of FDA’s mind

Claims cited on Twitter are increasingly appearing in warning letters. This year there have been eight letters mentioning disease claims made on Twitter, up from just 12 Twitter-related letters in ...
June 1, 2022

FDA Crackdown on CBD in Animal Products

Takeaway -

Product review engagement leads to a warning letter

FDA crackdown on CBD in animal products. This month, we saw the fourth warning letter that mentions CBD in animal products.  This is the 20th CBD-related FDA warning letter this ...
May 25, 2022

Disease Claims Turn Supplements Into Unapproved New Drugs

Takeaway -

Screen all blogs and social media for disease claims

This Warning Letter Wednesday is an excellent lesson about turning a supplement into an “unapproved new drug” by making disease claims. Other lessons here are: From Warning Letter: “Ayurveda has ...
May 18, 2022

GMP Violations & Unanswered 483s Lead to a Warning Letter

Takeaway -

Ensure 483 responses are complete

Today’s Warning Letter Wednesday involves a company inspected by the FDA last year that received several 483s for common violations like not having proper component and product specifications. The company submitted ...