Warning Letter Wednesday® Posts

A weekly exploration of FDA warning letters and enforcement trends

September 7, 2022

YouTube Claims Lead To Warning Letter

Takeaway -

Claims in videos are “fair game” for enforcement

YouTube video claims lead to a warning letter. The claims cited in this letter are not from people talking but from image text on the screen. This is the first ...
August 31, 2022

A Review of 56 Diabetes Related Warning Letters

Takeaway -

Warning letters show claims made in socials, blogs, testimonials & hashtags

I reviewed all diabetes and blood sugar related FDA warning letters since the beginning of last year and found some interesting results. These findings provide a snapshot of where the ...
August 24, 2022

Uncompliant Product Name Leads To Warning Letter

Takeaway -

Citing ingredient research is a marketing claim

This company received a warning letter for claims made in a product name. The product “Covid-19 Immune Support” is a bold Covid prevention and treatment claim. This is a basic ...
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 ...