US FDA Food Registration - Overview
The United States (US) is a compliance-based market for food and dietary supplements. The products are regulated by the Federal Register and the Code of Federal Regulations (CFR), Title twenty-one (21). It is the legal authority of the US Food and Drug Administration (USFDA). Food and dietary supplements do not require pre-market approval, but the USFDA has a strict Regulatory policy for evaluating these products through adverse event monitoring and research. Manufacturers of novel products and novel ingredients are required to submit a pre-market notification to the USFDA via the Generally Recognised as Safe (GRAS) notification and the New Dietary Ingredient Notification (NDIN).
The facilities that are used to manufacture, process, pack, and store food, beverages, or dietary supplements that are meant to be consumed in the US must be registered in the FDA Food Facility Registration (FFR) system. The facility must also have a US agent with a local address for communication purposes with the FDA. Freyr experts help manufacturers navigate through the complex Regulatory process in the US.
US FDA Food Registration
Expertise
- FDA Label Compliance.
- FFR and Renewals.
- GRAS Notification for Novel Food or Novel Food Ingredients.
- Submission Identification Number (SID) for Low-acid Canned Food (LACF) and Acidified Food.
- Food Packaging Labels Requirements.
- Food Label and Claims Review.
- FDA Product Classification – Food and Dietary Supplements.
- Formula Review/Ingredients Assessment – Food and Dietary Supplements.
- Dietary Supplements Label and FDA Nutrition Claims Review.
- Nutritional Fact and Supplement Fact Panel – Compliance and Update.
- FDA New Dietary Ingredient Notification (NDIN).
- FDA Nutrition Facts Label.
- Prop 65 Requirements – Consulting/Advise (California – CA, US).
- Claims Consultation and Substantiation.
- US Agent Services (USFDA).
- Prior Notice.
- Food supplements Regulatory Marketing Strategy and Regulatory Intelligence (RI) Report.
Advantages
- Successful industry experience in food and dietary supplements in the US.
- Support in region-specific Regulatory activities.
- In-house toxicology experts for the evaluation of pre-clinical and clinical studies.
- An extensive partnership network across the globe.
- A strong relationship with different Health Authorities (Has,) viz., the USFDA.
- A structured and cost-effective approach to ensure speed to market for the food products.
- Effective data management and organization.
- Flexibility and responsiveness.
- A qualified team of Regulatory professionals with in-depth experience working across all categories like food, health supplements, dietary supplements, nutraceuticals, Health Functional Foods (HFFs), health functional beverages, Foods for Special Dietary Use (FSDU), etc. for the US. We have a successful track record of submitting pre-market notifications (NDIN and GRAS) to the USFDA on behalf of our clients.
