Companies intending to market new food ingredients in the United States – whether in conventional foods or dietary supplements – must register their products either through a GRAS (Generally Recognized as Safe) determination or a New Dietary Ingredient Notification (NDIN). It is also legal to use the self-affirmed GRAS route without filing with the FDA. However, GRAS Notices are often submitted to the FDA, primarily at the request of U.S. clients. There is no equivalent self-affirmed registration pathway for NDIs; filing a notification with the FDA is always required.
The US Health Secretary Robert F. Kennedy Jr. has initiated a major regulatory shift by directing the FDA to close the self-affirmed GRAS loophole, aiming for greater transparency and safety in the U.S. food supply.
The process is still in its early stages, with rulemaking and legislative efforts expected to follow. For now, the current GRAS system remains unchanged, but significant reforms can be on the horizon.
In this webinar, you will hear about complex US food regulations and how they can change. You will learn how to choose the correct registration route for your food ingredient, GRAS or NDI. We will also summarise the main requirements of GRAS and NDI registration and highlight the differences.
The webinar is aimed at all interested parties who are planning the US registration for their new food ingredient from startups to SME and big companies.
You will learn:
- How GRAS and NDI registrations work and how they differ
- How to choose the correct registration pathway for your food ingredient or dietary supplement
- What upcoming FDA changes may mean for future US market access
The live webinar was fully booked and received excellent feedback. The average rating for the live session was 4.82 / 5.
“Very good and intense webinar full of information.”
“It was technically well executed; everyone was well prepared, on time, and presentations were clear and precise.”
“I liked the structure and quality of content and in depth knowledge. Thanks!”
Speakers
Mari Lyyra, M.Sc. | Regulatory Affairs Manager, Food and Feed
Mari Lyyra has worked for Medfiles since 2014 and led the Medfiles Food & Feed team in 2019-2025. Currently she is working as Regulatory Affairs Manager.
Mari holds an M.Sc. in Public Health, specialising in clinical nutrition, and is a licensed nutritionist. Early in her career, Mari began focusing on food regulatory tasks in the EU. With over 25 years of extensive experience, she is well-versed in regulatory and scientific work related to traditional foods, food supplements, functional foods with health claims, food additives, food enzymes, and innovative ingredients. Since 1999, Mari has concentrated particularly on novel foods, which has become her primary area of expertise. She has been involved in dozens of favourable novel food projects and dossiers in the EU. In addition to EU legislation and novel foods, she has also mastered US food legislation and practices, including GRAS and NDI for last 10 years.
Over the past decade, she has also trained in animal feed regulations and contributed to numerous animal feed projects. Mari brings extensive experience in expert and strategic consulting for clients across various projects in both the EU and the United States. She has authored numerous articles for food journals and contributed to peer-reviewed scientific publications. In recent years, Mari has delivered several lectures on food regulation at various Nordic and international events.
Mari Eskola, Ph.D. | Team leader, Regulatory Science and Reports // Senior Regulatory Affairs Expert, Food and Feed
Mari Eskola joined Medfiles in 2021 and leads the Regulatory Science and Reports Team. Since starting at Medfiles, she has been involved in a wide range of projects relating to food, feed, and cosmetics safety.
Mari has nearly 30 years of broad international expertise in the chemical and regulatory safety of food and feed, acquired across the European Union, national authorities, and industry. At Medfiles, she brings over 15 years’ experience as a regulatory food and feed risk assessor. Mari developed her risk assessment expertise working for 10 years at the European Food Safety Authority (EFSA), where she conducted regulatory risk assessments of contaminants in food and feed. She also served as Acting and Deputy Head of the EFSA Contaminants Unit. She is a food chemist specialising in analytical chemistry and obtained her PhD in food science in 2002.
In addition, Mari has extensive food and feed research and regulatory experience from several European institutes, including the European Commission Joint Research Centre (EC JRC), the European Chemicals Agency (ECHA), Teagasc in Ireland, the University of Natural Resources and Life Sciences in Austria, and the former Finnish Food Safety Authority. She has international experience in project and people management and has authored numerous scientific publications, including many EFSA scientific opinions and risk assessments.
Ingrid Hagberg, M.Sc. | Regulatory Affairs Expert & Toxicologist, Food and Feed
Ingrid joined Medfiles in autumn 2023 as a Toxicologist and Regulatory Affairs Expert. Since then, she has been involved in projects related to food, feed, and cosmetics. Before joining Medfiles, Ingrid worked at Health Canada, where she evaluated and managed risks associated with chemical substances in food.
During this time, she developed strong expertise in the regulatory risk assessment of food-related substances such as contaminants and food flavourings. This has given Ingrid deep knowledge in using toxicology in risk assessment which she expertly uses in her food, feed, and cosmetics projects at Medfiles. She also has several years of experience as a food inspector for the Government of Canada, where she carried out regulatory tasks in food safety and labelling.
As a native English speaker, Ingrid excels in communicating with international agencies and preparing high-quality reports. She holds a B.Sc. in Food Science from Carleton University (Canada) and an M.Sc. in Toxicology from the University of Eastern Finland. Her combined background in food science and toxicology offers a rare and valuable skillset that directly benefits our clients.
Medfiles GRAS and NDI services in the USA
Medfiles supports you throughout the entire Food Additive Petition (FAP), GRAS and NDI registration process in the USA – from determining regulatory status and conducting gap analyses to preclinical and clinical studies, dossier preparation, and support through to final approval.
Our regulatory experts bring nearly 30 years of experience in food safety regulation and over 10 years of hands-on experience with food registrations in the US. As the underlying food safety principles in the US are largely aligned with those applied in the EU, our EU expertise provides a strong foundation for successful US market access. Where appropriate, we can also prepare US and EU dossiers in parallel to streamline timelines.
Our expertise in legislation, registrations, market entry, and safety and risk assessment is grounded in experience gained through work with EU Member State authorities, EFSA, the European Commission, and the food industry. Our multidisciplinary team includes registration specialists, a toxicologist, a risk assessor, nutrition experts, and other experienced food safety professionals.
See also:
- Blog: Is the self-affirmed GRAS pathway coming to an end?
- Blog: GRAS – the faster regulatory pathway to food and feed market
- Free webinar: EFSA’s new novel food guidance – what to know?
- Meet our people: Expertise in food and feed toxicology and risk assessment in Canada, the US and EU
- Blog: Consultation request may save you from the novel food authorisation process in the EU
- Blog: Novel foods in the European Union explained
- Food and feed innovation funding: key programmes and requirements
