FDA cracks down on unsubmitted NDI ingredient hordenine

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

FDA cracks down on unsubmitted NDI ingredient hordenine

The FDA is starting to crack down on unsubmitted NDI's.


Today's #WarningLetterWednesday reviews a recent hordenine warning letter.


Hordenine and higenamine warning letters also include high risk disease claim language. This is a good opportunity for companies selling these high risk ingredients to stop sales immediately and also to clean up their uncompliant marketing.


From warning letter:

On your product webpage for “OPTIMUM-CLA”:

“Conjugated linoleum Acid (CLA): is a potent . . . anti-carcinogen, and anti-catabolic . . . Some of the common accolades of CLA are . . . is a cancer fighter.


From warning letter:

On your product webpage for “ADIPROPEN ULTRA”:

“ADIPROPEN ULTRA is our new and improved version of Adipropen with added Vinpocetine, commonly referred to as ‘Viagra for the Brain.’ [I]t is more effective than Clenbuterol.”


Full warning letter here.

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