US FDA Food Facility Registration - Overview
For companies planning to market a dietary supplement or supply a new ingredient to the United States, it is important to determine when a New Dietary Ingredient Notification (NDIN) is required and what type of information is required to support a successful notification to the United States Food and Drug Administration (USFDA). In the United States (US), food ingredients are considered either food additives or are Generally Recognized as Safe (GRAS) for explicit uses. A New Dietary Ingredient Notification (NDIN) is a notification that must be submitted to the FDA for a dietary ingredient that was not marketed in the US as a dietary supplement before October 15, 1994.
In the United States (US), food ingredients are considered either as food additives or are Generally Recognized as Safe (GRAS) for explicit uses. The significant distinction between a food additive and GRAS is the inclusion of the US Food and Drug Administration (FDA), which is required for the assessment of the safety and security of food additives. There are two separate routes for getting GRAS acknowledgment: a GRAS Notification submission to the FDA and (or) a Self-GRAS Determination or Independent GRAS Determination. To set up this recognition, a total update on safety should be examined.
The Freyr Regulatory team is experienced and proficient in NDIN process requirements and supports clients in reviewing the ingredient data and compiling the required information, identifying the gaps, preparing, and submitting the notification, and responding to FDA questions post submission. Freyr also provides Regulatory assistance on GRAS notification.
US FDA Food Facility Registration - Freyr Expertise
- Expertise in managing FDA communication with foreign establishments.
- Proficiency in responding promptly and accurately to FDA inquiries regarding food and dietary supplements imported into the USA by foreign establishments.
- Skilled in coordinating and facilitating inspection scheduling for foreign establishments, ensuring timely and efficient assessments of Regulatory compliance.
- US FDA food facility registration.
US FDA Food Facility Registration - Freyr Advantages
- Cost-effective services.
- Continued Regulatory support for US FDA food facility registration.
- Qualified team of experts with hands-on experience across all categories of health foods like health supplements, dietary supplements, nutraceuticals, Health Functional Foods (HFFs), health functional beverages, foods for special dietary use, and much more.
- Support for region-specific Regulatory complexities.
- Extensive partner network across the globe.
- A strong relationship with global Health Authorities (HAs).
- A structured approach to ensure quick market access.