United States of America (USA) is the largest market for dietary supplements across the globe. The dietary supplements are regulated by United States Food and Drug Administration (US FDA). The FDA does not review and approve dietary supplements based on their safety and efficacy, but rather evaluates them through adverse event monitoring and research. The products require a notification to FDA, 75 days prior to their marketing. FDA is also responsible for regulating dietary supplement ingredients and dietary supplement label requirements.
Aligning with the updated food and food supplements or dietary regulations of the US FDA including new nutrition facts label, Freyr assists manufacturers to adhere to the FDA label compliance.
- US FDA Food Registration
- Product Classification – Food and Dietary Supplements
- Formula Review/Ingredients Assessment
- Label and Claims Review
- Nutritional fact and Supplement Fact panel – compliance and Update
- USFDA NDIN (New Dietary Ingredient Notification)
- Nutrition Facts Label
- USFDA Label compliance updates (of Nutritional Fact and Supplement Facts Panel)
- Prop 65 requirements – Consulting/Advise (California -CA, USA)
- Claims Consultation and Substantiation
- Regulatory Intelligence Report
- Product-specific Regulatory Guidelines/ Standards
- Master Manufacturing Records for Dietary Supplements
- Food Facility Registration Support (FFR)
- US Agent Services (US FDA)
Qualified team of experts with hands-on experience on FDA supplement label compliance and on across all categories of foods like health supplements, dietary supplements, nutraceuticals, health functional foods, health functional beverages, foods for special dietary use, etc
Support for region-specific Regulatory activities
Extensive partner network across the globe
Strong relationship with different health authorities viz. US FDA
Structured and cost-effective approach to ensure speed to market for the products.