See Asa at Microbiome & Probiotic R&D & Business Collaboration Forum - La Jolla, California 10/13/2025
November 10, 2021 By: Asa Waldstein

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 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.”

Read the 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.

Written by

Asa Waldstein
Asa Waldstein
Asa Waldstein is a 24-year veteran of the dietary supplement industry, with experience spanning manufacturing, marketing, and regulatory compliance. He is the principal of Apex Compliance, a software company dedicated to streamlining regulatory marketing compliance for the dietary supplement and natural products sectors. Asa also leads Supplement Advisory Group, a boutique consultancy focused on marketing risk analysis, labeling, and practical compliance strategies for websites and social media. Asa has helped oversee three FDA GMP inspections with no 483s and was honored with the 2023 AHPA Herbal Hero Award and the 2024 What's Up Supps Policy and Change Agent Award. He currently serves as Chair of the American Herbal Products Association’s (AHPA) Cannabis Committee, helping shape policy and industry best practices
Read all my posts
«
»