A: The two most relevant pathways for human consumption are GRAS (Generally Recognized as Safe) and NDIN (New Dietary Ingredient Notification). SGS understands all alternate pathways and will utilize them based on client business goals. We also provide services for livestock feed, cat and dog food, and pet supplements.
Companies with an in-depth understanding of the food industry’s regulatory framework can take advantage of important market opportunities. Our knowledgeable team guides you through these regulations so you can mitigate risk and expand sales.
Food ingredient regulatory compliance services
Working as an extension of your regulatory, and research and development teams, we support you with:
- Claim substantiation
- GRAS/NDIN dossier review and notifications
- Master file submissions for Health Canada
- Novel food dossiers for the UK, EU and Canada
- IP protection strategies
- Branded ingredient strategies
- Marketing whitepapers and content
- Globally relevant efficacy study design and execution for both standard and branded ingredients
- Laboratory-based product certifications
Why choose SGS?
Consider us an extension of your teams. We are happy to take ownership of all deliverables and to assist on an hourly basis to augment your existing resources. With over 2,900 regulatory filings completed to the US FDA and Health Canada, our team provides the expert guidance you need.
FAQs
A: This decision depends on the intended use for the ingredient. If the intended use is for both food and dietary supplements, GRAS is the best pathway. If the ingredient is intended only for dietary supplements, then NDIN is also an option. Both pathways require similar safety data. The decision on the best pathway is determined through a gap analysis and consideration of strategic goals. Each pathway has advantages in terms of marketing and also IP protection. This blog provides advice. We provide a full service to help you make this decision.
A: The typical process includes:
- GAP assessment
- Assembly of any required safety and/or manufacturing data
- Final dossier preparation
We provide full services for all stages, as well as placement and oversight of any required testing.
A: The structure and content of the dossier is very similar. A notified GRAS is sent to the FDA, a self-affirmed GRAS is sent to an Expert Panel. SGS provides a full service to help clients decide which pathway is best suited to them. Note that a self-affirmed dossier can also be notified to the FDA.
A: No. These regulatory dossiers prove safety not efficacy. Claim substantiation is a separate dossier and is necessary in order to make structure/function claims. We provide claim substantiation services via literature review of existing published data and can also design and execute new clinical trials in both humans as well as companion animals.
A: Many finished product claims are substantiated based on research conducted on individual ingredients. We also provide full regulatory services for finished products including labeling, notifications and also claim substantiation.
A: Each target species has a unique pathway for regulatory compliance. We provide full regulatory services for ingredient inclusion in livestock feed, as well as cat and dog food. Coverage is provided for the US, Canada, the EU, UK and select Asian countries.
A: Common pathways to sell ingredients in Canada include Novel Food and Master File Applications. The pathway is dependent on the end use for the ingredient. Novel Food may be necessary for inclusion in Food, Master File application is the most strategic regulatory pathway for ingredient inclusion in Natural Health Products.
A: The most common pathway for the EU and UK is a Novel Food dossier. We provide oversight and guidance for these countries.
A: No. The US FDA, as well as the EU and UK regulatory authorities, will accept safety studies, regardless of the location of testing, as long as required standards are met. Typically, these standards are OECD and GLP. We can help clients determine the validity of their safety data. This is typically completed in the gap analysis phase of the project. Should there be deficiencies, we provide guidance and instructions for specific testing.
A: Contact us
A: Yes. Product claims must be truthful and not misleading, and worded appropriately for regulatory compliance. Consumers today also actively fact-check and demand scientific evidence for the products they are purchasing. Proper substantiation provides strategic risk mitigation.