Warning Letter Wednesday® Posts

A weekly exploration of FDA warning letters and enforcement trends

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 ...
May 11, 2022

10 Companies Cited for NDIs and Impermissible Ingredients

Takeaway -

Supplement should contain safe ingredients

The FDA issued ten warning letters to companies selling products with New Dietary Ingredients (NDIs) and other impermissible ingredients such as hordenine HCl. I see these ingredients in two categories. ...
April 27, 2022

Product Tags & Metatags Attract FDA Attention

Takeaway -

Everything used to market products must be compliant

Website product tags and metatags continue to attract FDA attention in warning letters. This year three warning letters mention product tags or “category” tags. These tags help people find products ...
April 20, 2022

Best Practices For Reducing Risk in Blogs

Takeaway -

Blogs can easily cross the line from “education” to “disease claims”

This year, there have been five warning letters that include claims made in blogs, and the line between what is allowable and what is a claim continues to shrink. It ...
April 13, 2022

LinkedIn Posts Mentioned in Warning Letter

Takeaway -

All social media is “fair game” for enforcement

It is no surprise that company social media posts are considered marketing claims, as they are commonly mentioned in warning letters. Interestingly, this letter references posts made on LinkedIn. This ...
April 6, 2022

6-Year-Old Social Media Posts & Hashtags in Warning Letter

Takeaway -

Uncompliant hashtags attract FDA attention

Today’s Warning Letter Wednesday reminds us that the FDA considers old social media posts and hashtags marketing claims.  Six-year-old social media posts, uncompliant hashtags, and product tags are mentioned in ...