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Warning Letter Wednesday Posts

A weekly exploration of FDA warning letters and enforcement trends

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 ...
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, ...