Regulatory services for new foods in the USA – regulatory positioning, strategies and FAP, GRAS and NDI registration applications
US food legislation differs significantly from EU regulations. Before placing a new food, ingredient or dietary supplement on the market, it is essential to identify the required registration pathway. In the USA, foods and dietary supplements are regulated under the Federal Food, Drug, and Cosmetic Act.
Medfiles supports you throughout the entire process – from determining regulatory status and conducting gap analyses to preclinical and clinical studies, dossier preparation, and final approval. Our experts have extensive experience with US registrations (FAP, GRAS and NDI) and we also collaborate with local partners to ensure a smooth process.
Free webinar: Q&A on termination of self-affirmed GRAS pathway
Massive regulatory developments in the United States are in process of terminating the self-affirmed GRAS pathway. In this Q&A session our experts respond to questions on how to prepare for potential reforms and what is changing and when in the regulatory landscape.
Regulatory Positioning and Registration Strategy for New Ingredients
Correct classification of a new ingredient is a decisive step for successful market entry. We help you determine whether the product can be marketed in the US without a separate registration, or whether a regulatory process is required – and which pathway applies. If applicable, we prepare the documentation to demonstrate that no registration is needed.
For food and dietary supplement ingredients, the key registration routes are GRAS (Generally Recognized As Safe) and NDI (New Dietary Ingredient). For dietary supplements, correct pathway selection is particularly important. If the product does not meet GRAS criteria, a Food Additive Petition (FAP) is required – a more demanding and lengthy process than GRAS.
Medfiles designs the best possible regulatory strategy for your product, also considering other markets such as the EU and UK. This allows us to build cost-efficient, harmonised registration pathways for international market access.
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Gap Analyses and Registrations for the US Market
Preparation of registration dossiers, notifications and applications (GRAS, FAP, NDI): gap analyses, literature reviews and pre-submission consulting
The preparation of registration documentation begins with the assessment of existing data. With a gap analysis, we determine what information you already have and what additional data is required to meet FDA standards. A comprehensive gap analysis includes review of existing analyses, reports and documents. We evaluate their quality and suitability for the dossier and compare them against US regulatory requirements. If our client is interested in registration of the same ingredient also to the EU/UK, we take all requirements into account.
Based on this, we provide a detailed report specifying:
- which data already complies with requirements
- what additional data is needed
- what gaps remain to be filled
We also conduct comprehensive literature reviews to ensure that all relevant information is included in the dossier.
Before drafting the application, we offer pre-submission consulting. We help collect missing data and studies and guide you in data generation. Through our extensive laboratory and research network, we identify the right organisations to provide the required results (e.g. compositional analyses and preclinical studies). We also assist in pre-submission discussions with the US Food and Drug Administration (FDA).
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Clinical Studies for Registrations
US registration of new ingredients may also require clinical studies to prove the safety of the new ingredient. Medfiles’ Clinical Trial Services team provides full-service support. We help you evaluate what type of study best suits your product and objectives. Our team has expertise in clinical food trials assessing human safety of new ingredients, as well as intervention studies supporting health claims.
We support you in study design, ethics approvals and regulatory submissions, and manage the full study process if required. Our experienced clinical team also ensures final reporting and preparation of scientific publications. Studies are carried out in collaboration with trusted research organisations – and when required, with US-based clinical institutions.
Food and Dietary Supplement Registrations in the USA
A well-prepared dossier is the key to a smooth regulatory process. GRAS registration can be completed either as self-affirmed GRAS (self-affirmed, without FDA notification) or as FDA-notified GRAS. NDI notifications (NDIN) must be submitted to FDA. We ensure that your dossier meets all requirements from the outset, drafting all necessary sections: product information, background, estimated dietary intake calculations, scientific data and a comprehensive safety assessment.
All documentation is prepared in accordance with US legislation and FDA guidance. GRAS registration also requires an expert panel evaluation (GRAS Panel). Medfiles assembles and coordinates the GRAS Panel on your behalf.
FAP applications must always be submitted to FDA for review. Medfiles manages the entire process, including FDA pre-meetings, responses to authority questions, and supplementary data requests.
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Registration Team
Medfiles’ food regulatory experts have nearly 30 years of experience in food safety regulation and more than 10 years of experience with food registrations in the USA. Since the underlying food safety principles in the US are largely the same as in the EU, our EU experience provides a strong foundation for supporting US market access. We may also prepare the US and EU dossiers parallel.
Our expertise in legislation, registrations, market entry, and safety and risk assessment has been built through work in EU Member State authorities, EFSA, the European Commission, and the food industry. Our dedicated team includes registration specialists, a toxicologist, a risk assessor, nutrition experts, and other food safety professionals.
Free webinar: EFSA’s new novel food guidance – what to know about the updates
The new novel food guidance related to Regulation (EU) 2015/2283 brings new practices and requirements for companies applying for novel food authorisation. In our practical webinar you will learn what are the major changes of new novel food guidance compared to old guidance.
Algiecel & Medfiles: Collaboration to shed light on the regulation of novel ingredients in the EU
”The Medfiles regulatory specialists clearly knew what they were doing and were very organised. We felt that we could trust them and that they would be honest with us. They were also able to point out the regulatory pitfalls. We felt that if we needed to ask any further questions, we would choose Medfiles again.” – Claus Rosensparre
News and insights on GRAS, NDI and FAP
Our expert team regularly writes blogs about food registrations in the US. Topics include product classification and GRAS, NDI and FAP registrations.
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