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March 15, 2023 By: Asa Waldstein

Digestive & Cholesterol Claims Cited in Warning Letter

Takeaway -

Remove testimonials with claims

Digestive system claims like Crohn’s and IBS occasionally show up in warning. Diseases like Crohn’s Disease or syndromes like Irritable Bowel Syndrome should be removed, or if accurate, replaced with statements about stomach and digestive health support.

From warning letter: “I used to have terrible knife-like sharp pains in my stomach from the Crohn’s and IBS, and a great deal of discomfort from the acid reflux. Dr. Miller’s Holy Tea has cleared all of this up….”

I’m writing this from a Soulshine retreat in Bali, so today’s Warning Letter Wednesday will be brief.

Testimonials are also cited in this warning letter. I expect many product reviews and testimonials to be called out in warning letters this year. I talk about engaging with testimonials here.

Blood pressure and cholesterol claims enforcement are not slowing down, and I expect this trend to continue. Here is a post about this.

From warning letter: “Regular use of Youthin Fat Burners may help control High Blood Pressure and Cholesterol”

Read the full post 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