Warning Letter Wednesday® Posts

A weekly exploration of FDA warning letters and enforcement trends

July 16, 2025

Diseased Population Study Helps Trigger IND Requirement

Takeaway -

Dietary supplement clinical triggers should be thoughtfully considered

A dietary supplement company conducting a clinical study was investigated by FDA’s Bioresearch Monitoring Program and found violations. According to FDA “this program includes inspections designed to evaluate the conduct ...
July 9, 2025

NAD Case: Supporting Substantiation

Takeaway -

Ingredient studies may support product claims

Where is the line between needing an ingredient study or a full product study for substantiation? This National Advertising Division (NAD) case explores the nuances of reasonable consumer interpretation of ...
July 2, 2025

Dietary Supplement Manufacturing & Marketing Lessons

Takeaway -

Learn from others’ mistakes

Dietary supplement manufacturing and marketing issues are all cited in this warning letter. This feels like a trip way back in time when GMP regulations and compliance for “supplements” were ...
June 25, 2025

Failure to Report Serious Adverse Events

Takeaway -

Investigating customer complaints is a cornerstone of supplement safety and compliance

Investigating customer complaints and reporting serious adverse events (SAERs) is a cornerstone of dietary supplement safety and compliance. In this warning letter, a supplement company that makes products for young ...
June 18, 2025

When Topical OTC Manufacturing Goes Wrong

Takeaway -

Test glycerin for contaminants

This may be the oddest response to an FDA batch product record request.  From warning letter. “recipes and procedures have been followed for decades. Though not in writing, they have ...
June 11, 2025

Labeling Lessons

Takeaway -

Minor label issues signal deeper compliance issues

This warning letter has numerous examples of what not to do when labeling supplements. Here’s what we can learn. Incorrect statement of identity: The statement of identity is one of ...
June 4, 2025

Delta-8 Inhalable Product

Takeaway -

Dangerous products will be cited even if they do not contain disease claims

Shocking warning letter! After writing this post for over 200 weeks, I am rarely surprised. However, this warning letter highlights some truly audacious and potentially extremely unsafe THC and mushroom ...
May 28, 2025

Avoid Comparing Products to Drugs (most of the time)

Takeaway -

Use FDA’s helpful resource (criterion 6)

Comparing supplements to drugs is a great way to irritate FDA and attract a warning letter. In today’s Warning Letter Wednesday, I am exploring Criterion #6, “Claims to be a ...
May 21, 2025

Unallowable Ingredient Results in Warning Letter

Takeaway -

Here are tips on using FDA’s ingredient directory

FDA cited a company for marketing sulbutiamine, an unallowable ingredient in their dietary supplement. This is different than the standard “drug-spiked” warning letter, where companies were hiding sildenafil and diclofenac ...
May 14, 2025

3 Animal Product Companies Receive Warning Letters

Takeaway -

Extra attention is paid to animal CBD products

FDA has a low tolerance for animal product disease claims, especially when they include CBD. FDA recently issued three warning letters to companies marketing their CBD products as safe solutions ...
May 7, 2025

Celebrating 200 Weekly WLW Posts!

Takeaway -

Learning from others' mistakes helps you be compliant

200 weeks of writing this weekly post. Wow, what a journey it’s been! Finding my voice on LinkedIn and beyond was not easy. I didn’t want to create drama and ...
April 30, 2025

Best Practices When Making Competitor Comparison Claims

Takeaway -

Ensure statements are not disparaging

Calling out the differences between your product and competitor products is permitted, but “poking the bear” often leads to competitor challenges. This NAD case involves a well-known mattress company challenging ...