FDA Warning Letters

Covers major FDA compliance actions, analysis of warning letters, common pitfalls.

August 10, 2022

300%+ Increase in CBD Warning Letters This Year

Takeaway -

Companies marketing CBD products should avoid making disease claims

This year there have been 26 CBD-related warning letters. This is up from just seven in all of 2021. That is over a 300% increase, and we are only in ...
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 ...