Warning Letter Wednesday® Posts

A weekly exploration of FDA warning letters and enforcement trends

November 30, 2022

FDA sends 7 Cardiovascular Disease Related Warning Letters

Takeaway -

Discussing cholesterol or LDL levels is a disease claim

Social media engagement is back in warning letters! It has been some time since FDA cited “Liking” a post as an endorsement of the “testimonial.” One of the companies was ...
November 23, 2022

FDA Issues Five CBD-Related Warning Letters

Takeaway -

CBD enforcement is top of mind for FDA

CBD-related FDA warning letters are up over 420% this year, and this recent batch of five warning letters has some excellent learning opportunities. The biggest news is one of these ...
November 16, 2022

Product “Tags” With Disease Claims Elevate Risk

Takeaway -

Ingredient research can be considered a marketing claim

Ingredient research on a commercial website can be considered a marketing claim, which continues to be cited in warning letters. The key point that turns “research” into a marketing claim ...
November 9, 2022

Supplement Labeling Errors lead to Warning Letter

Takeaway -

Common labeling errors can be avoided

This warning letter has numerous labeling teaching opportunities, which is really exciting! I don’t think any of these violations would attract a warning letter on their own, but altogether they ...
October 26, 2022

Ayurvedic Product Company Receives Covid Warning Letter

Takeaway -

Discussing ingredient benefits is a marketing claim

This company was cited for making immunity and Covid support claims, which remain top of mind for the authorities. There is never a suitable time to discuss Covid support claims ...
October 19, 2022

Kratom Claims Enforcement Increasing

Takeaway -

Opioid support claims are high risk

There have been four kratom warning letters this year compared to just one last year, a 400% increase. This shows there has never been a riskier time than now to ...
October 12, 2022

Common Labeling Errors Lead to Warning Letter

Takeaway -

Following label format is important

Warning Letter Wednesday focuses on label violations that helped lead to a warning letter. These are basic but important reminders. This company was inspected by FDA when they collected product ...
October 5, 2022

Small Herbal Company in Big Trouble for Disease Claims

Takeaway -

“Brain Fog” claims related to Covid will attract scrutiny

This is yet another example of a well-intentioned herbalist-owned, very small company being cited for disease claims. I write about how no company is “too small to be off FDA ...
September 28, 2022

Blood Sugar, Arthritis & Immunity Claims Lead to Warning Letter

Takeaway -

Scan socials and websites for risky words like “hordenine”

The warning letter has a unique “we offer the following comment” section. FDA references bitter orange extract (Citrus aurantium) as an ingredient in the Supplement Fact Panel. It then refers ...
September 21, 2022

Anxiety Claims Enforcement Review

Takeaway -

Increase in claims cited in blogs and social media

Anxiety claims enforcement continues to be top of mind for the FDA. In this Warning Letter Wednesday I compare 2022 anxiety claims enforcement with the same time last year. I ...
September 14, 2022

Discussing Ingredient Benefits Leads to a Warning Letter

Takeaway -

No such thing as “too small to be on FDA’s radar”

Small herb company cited for elderberry-oriented disease claims. This is a good reminder there is no such thing as “too small to be on the FDA’s radar.” Claims in the ...