We provide global regulatory and strategic consulting solutions for food and supplement companies worldwide. Food regulations and legislation have a major impact on successful product marketing and sales and a comprehensive regulatory strategy is one of the keys to success for any food company. This is especially true when considering selling products across several different territories and markets.
At SUMMITNUTRIHEALTH we have decades of experience in working with the major global food regulatory agencies including the US FDA and EFSA. We also have in-depth knowledge and experience in product and trademark licensing.
We can assist you with regulatory questions concerning:
General foods, food supplements, sports nutrition, medical foods
Cosmetics and medical devices
US FDA - GRAS applications etc
Preparation of dossiers for GRAS notices and New Dietary Ingredient notifications.
EU EFSA - Nutrition and Health Claims, Novel Food Applications etc
Nutrition and Health Claims
Preparing applications for EFSA review. Interaction with national competent authorities such as the FSAI in Ireland.
Reviewing labels and advertising for compliance with regulations.
Novel Food Applications
A ‘novel food’ is a food with no significant history of consumption within the EU before May 1997. A novel food application dossier includes the history of use, intended purpose, nutritional value, composition, and toxicological and nutritional data.
China CNCA GB Standards
Providing guidance on food regulatory standards and import requirements.
Labeling and Packaging Reviews
Review of labeling and promotional materials to ensure regulatory
compliance e.g. for nutrition and health claims.
Commercialisation Strategy Support
Intellectual Property Licensing
Monetizing of IP (Patents, Trademarks, Trade secrets), Licensing Agreements, Royalties, Milestone payments.