Episode #4: Wellness Claims Confessions: Legal Insights with Heather Bustos, an Expert FDA Compliance Lawyer

04/07/2023 45 min

Listen "Episode #4: Wellness Claims Confessions: Legal Insights with Heather Bustos, an Expert FDA Compliance Lawyer"

Episode Synopsis

In this product claims-focused episode, Susanne and Heather Bustos discuss:


What brands get wrong about product claims
What a warning letter from the NAD (National Advertising Division) really means
Can a consumer bring a claim against a brand with the NAD?
Your best prevention method for warning letters from the NAD
Getting into the specifics behind cosmetic claims language
How much substantiation do you need behind your claims?
When should supplement brands enroll in randomized controlled trials
Risk level questions to ask yourself when deciding which claims to list
Are randomized controlled trials the gold standard for making health claims?
Are consumer perception studies enough to back up claims?
What you should do if you conducted your own study as a brand before these new regulations came out 
Can you make structure-function claims on superfoods?
And at the end, Susanne and Heather go over some general claims language that can be acceptable to use that won’t get you in trouble


Reminder: Everything included in this podcast is not legal advice and you should always consult with an attorney before making product claims. 

About Heather Bustos
Heather Bustos founded Bustos Law Group, an FDA compliance law firm that works with companies in regulated industries like food, supplements, cosmetics, devices, and OTC drugs. They help companies succeed by reviewing their products for compliance with FDA, FTC, and CBP regulations.

​Heather has helped numerous companies get into grocery chains and worked with foreign Fortune 100 cosmetic companies to expand their brands to the U.S. by reviewing their full line of products and marketing for federal compliance.

To learn more about Heather, you can visit her website at bustoslawgroup.com, email her at [email protected], or give her a call, at 832-592-7851.

To learn more about Citruslabs or to discuss how to begin testing your wellness product, visit citruslabs.com and contact us!

Send us your questions and we'll answer them in a future episode. Email us at [email protected]

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