Warning Letter Wednesday Posts

A weekly exploration of FDA warning letters and enforcement trends

November 10, 2021

FDA cracks down on unsubmitted NDI ingredient hordenine

Takeaway -

Ensure ingredients are not on FDA’s “naughty list”

The FDA is starting to crack down on unsubmitted NDI’s. Today’s Warning Letter Wednesday reviews a recent hordenine warning letter. Hordenine and higenamine warning letters also include high risk disease ...

November 3, 2021

Ingredient benefit discussions can be marketing claims

Takeaway -

Use caution when discussing ingredient benefits on a commercial webpage

Ingredient descriptions are considered marketing claims when used to sell a product. Today’s Warning Letter Wednesday highlights this common marketing mistake. This is an example of a well-intentioned writer and ...