We discuss label and marketing claims which impact the dietary supplement and hemp industries. This is reviewed from a legal, regulatory, and marketing viewpoint.

2:25 Made in the USA: What can you say and what is the risk?
11:26 All Natural: What can you say and what is the risk?
15:02 What are different types of claims such as structure-function?
22:02 Review of 9th Circuit ruling on structure-function claims.
31:41 What defines clinically proven?
37:06 Review nutrient content claims: Free Of, Good Source, High In
38:38 Quick primer on Prop 65
42:51 Can I make a Made in the USA claim if the bottles are from China?
43:38 Who is liable when making Made in the USA claims?
46:15 Can I say “Crafted in the USA,” or, “Assembled in the USA”?
48:10 What are the risks of using terms like simple ingredients, real ingredients, real food ingredients?
-Risks associated with making claims
-We will be taking audience questions in this fireside chat format.

I am joined by two expert guests.

-Douglas Kalman Ph.D., RD, FACN, FISSN, is the Vice President of Scientific Affairs for Nutrasource, a nutrition-centric Contract Research & Service Organization. Historically, Dr. Kalman has been involved in over 200 clinical trials and projects within the pharmaceutical, medical and exercise – nutrition fields. He has published over 80 abstracts and more than 50 peer-reviewed manuscripts. He is also a Co-Editor of one journal (JISSN) and on the editorial board of three scientific journals. http://www.nutrasource.ca/

-Erica W. Stump is the owner and founder the Erica W. Stump, P.A. law firm. They focus on the legal challenges that face dietary supplement and food companies, primarily intellectual property prosecution and litigation, regulatory compliance, and contract negotiation, review and drafting. She brings extensive experience in the dietary supplement and food industries, including her experience as General Counsel of Bodybuilding.com and former Chair of AHPA’s Sports Nutrition Committee. ericawstump.com.

Here are the resource links shared during the event.


Made in the USA lawsuit reference: https://www.truthinadvertising.org/by-the-numbers-made-in-the-usa-class-action-lawsuits/

Natural Claims: https://www.nutraingredients-usa.com/Article/2021/01/07/Company-with-naturals-as-part-of-name-agrees-to-qualify-its-marketing#

Made in the USA (Great Podcast!) https://www.nutraingredients-usa.com/Article/2020/09/11/NutraCast-Podcast-Atty-Pooja-Nair-on-industry-impact-of-Made-in-USA-rule

FTC’s Tips for Made in the USA: https://www.ftc.gov/tips-advice/business-center/advertising-and-marketing/made-in-usa

AHPA Hemp CBD Supplement Congress videos! https://www.youtube.com/playlist?list=PLznc1DBkNh2oqDmbTWyWIqnaKn1ugac2F />
9th Circuit Ruling:

FDA Label Claim Guidance: https://www.fda.gov/food/food-labeling-nutrition/label-claims-conventional-foods-and-dietary-supplements

Regulatory: Blog, Events, Resources: https://www.asawaldstein.com/regulatory-blog

AHPA Labeling Guidance Document: http://www.ahpa.org/Portals/0/PDFs/Policies/Guidance-Documents/AHPA_Herbal_Supplements_Labeling_Guide.pdf

cGMP Basics for Hemp-CBD Companies Free Webinar: http://www.ahpa.org/News/LatestNews/TabId/96/ArtMID/1179/ArticleID/1237/Free-webinar-Supplement-cGMP-Basics-for-Hemp-CBD-Companies.aspx

AHPA Prop 65 Guidance: http://www.ahpa.org/Portals/0/PDFs/Committee/CC/AHPA_Prop65_Cannabis_Guidance.pdf

Regulatory Hints YouTube Channel and Prop 65 Webinar: https://www.youtube.com/c/dietarysupplementcbdregulatorycompliance/videos

AHPA’s Cannabis Committee: http://www.ahpa.org/aboutus/committees/cannabiscommittee.aspx

Asa’s Regulatory Consulting Company. Reducing regulatory risk in web & social media marketing. https://www.asawaldstein.com/supplement-advisory-group

Kind regards,
Asa Waldstein

Supplement Advisory Group

-The comments by myself and any presenters are considered educational only and are not intended as legal or regulatory advice.

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