Health Claims for Food and Dietary Supplements in the USA

Food Supplements

Upcoming Webinar

June 23, 2025

45 Minutes

Join the Webinar as per Your Time Zone

For the Americas, EU & Africa Region

 10:00 EDT | 9:00 CDT | 11:00 BRT | 16:00 CEST

For ROW 

18:00 AEST | 11:00 MSK | 16:00 MYT | 13:30 IST

Thank you for your interest in Freyr’s Webinar Series (FWS). We look forward to having you join us on June 23, 2025, for our session:

What is it all about?

In this focused session, we’ll provide an in-depth overview of the FDA’s regulations for health claims on food and dietary supplements. We’ll cover critical areas such as the Significant Scientific Agreement (SSA) standard, the Nutrition Labeling and Education Act (NLEA), FDA Modernization Act (FDAMA), and the role of third-party scientific determinations.
As health claims are tightly regulated in the U.S., understanding how to properly navigate the FDA's compliance framework is essential for anyone marketing food or supplements in this key market.

Overview of FDA’s SSA standard and health claim approval process
NLEA and FDAMA compliance requirements
The role of third-party government determinations in health claims
Practical strategies to ensure health claims are substantiated and compliant
Differences between the U.S. and other international health claim standards
Insights from industry experts to navigate the U.S. food and supplement market

This session is a must-attend for anyone looking to market food and dietary supplements in the U.S. with confidence!

Marin Vrhovac is a dedicated Regulatory Expert with a Master's in Pharmacy from the Faculty of Pharmacy and Biochemistry at the University of Zagreb. He has contributed to Freyr as the EUA MPR Business Development Manager. His role centers on guiding the company toward achieving strategic goals and leveraging regulatory expertise. Beyond his professional life, he fuels his development through reading and podcast listening. As a Business Development Manager, Marin excels in sales presentations, contract negotiation, and market trend analysis. His cross-functional teamwork experience ensures customer-centric services.

Francesco Digianni is an Industrial Biotechnologist with six (06) years of experience in the food industry in the areas of regulatory affairs and food safety. His experience in the food industry includes two (02) years of research and development of novel probiotic strains from plant-derived food matrices for the development of new functional strains for the fermentation industry and four (04) years of consulting for regulatory compliance of food ingredients and finished products, labeling, market access, surveillance, and vigilance activities for food operators.

Aspect	USA	EU	Australia	China	UAE
Regulatory Authority	FDA	EFSA & Member State Authorities	FSANZ	SAMR & NHC	ESMA & MOHAP
Major Regulation Governing Compliance	Federal Food, Drug, and Cosmetic Act (FFDCA); 21 CFR Part 110 (Current Good Manufacturing Practices)	Regulation (EC) No 178/2002 (General Food Law); Regulation (EU) No 1169/2011 on Food Information to Consumers	Food Standards Code (Australia New Zealand Food Standards Code)	Food Safety Law of the People's Republic of China (Revised 2015); GB Standards for Food Safety	UAE.S GSO 9:2017 (GCC General Requirements for Prepackaged Food)
Pre-market Approval Required?	No pre-market approval except for novel ingredients, color additives, or specific claims	No pre-market approval for general foods, but novel foods or health claims require EFSA approval.	No pre-market approval unless it's a novel food or makes health claims	Pre-market registration is required for novel foods, health foods, or products with new ingredients	Pre-market approval is required for certain foods, health products, and products with new ingredients
Processed Food Labeling Compliance /Labeling Requirements	Mandatory labeling as per FDA guidelines (Nutrition Facts, Ingredient Declaration, Allergens)	Must comply with EU Food Information Regulation (1169/2011); includes allergens, nutrition, and origin labeling.	Must follow FSANZ Food Standards Code for labeling; nutrition panels, allergens, and ingredient lists required	Must follow GB 7718-2011 (National Food Safety Standards) for labeling; mandatory nutrition facts, allergens, and shelf-life	Must follow GSO 9:2017 for pre-packaged food labeling; Arabic labeling, allergens, and nutrition facts required
Timeline for Registration	No fixed timeline: products can enter the market once compliant	No formal registration unless novel food; EFSA approval for health claims takes 12-18 months	No formal registration unless it's a novel food or makes health claims	Typically, 12-24 months for novel foods, shorter for regular processed foods	Approval may take 6-12 months for certain products. Regular processed foods can enter the market once label approval is obtained

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Health Claims for Food and Dietary Supplements in the USA