FDA cracks down on unsubmitted NDI ingredient hordenine
Ensure ingredients are not on FDA’s “naughty list”
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.
Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.