USA
May 12, 2022
WHAT DOES THIS MEAN?
The FDA’s New Plant Variety consultation is a voluntary, yet rigorous, evaluation of safety and regulatory compliance. Nuseed Nutritional consulted with the Food and Drug Administration (FDA) for a comprehensive safety, nutritional and regulatory assessment of Nuseed Omega-3 Canola, including using Nutriterra® in food markets.
We collect a lot of data in creating a new-to-the-world source of total omega-3 nutrition. Our safety evaluations included tests for allergens, pesticides, toxins, and other contaminants you wouldn’t want in your food. We analysed environmental impact and performed animal feeding trials and human clinical trials. Nutriterra undergoes multiple quality and content tests every time we turn seed grain into oil.
We voluntarily submitted over 350 pages of data and more than 100 references to support our assertions that Nutriterra is safe for use in food and delivers increased omega-3 over conventional canola. At the conclusion of the review, the FDA issued a letter that they have no further safety, regulatory or compliance questions.
DOES THIS MEAN NUTRITERRA IS FDA APPROVED?
The result of this consultation is that Nutriterra does not require FDA approval. FDA’s letter acknowledges our conclusion that its use in food is Generally Recognized As Safe (GRAS) and does not raise issues that would require premarket review or approval by FDA.
WHY DOES NUTRITERRA NEED TO BE EVALUATED FOR SAFETY?
The New Plant Variety Consultation is a voluntary premarket review. While there is no requirement, we value the insights and expertise of the FDA in evaluating the safety and legality of foods produced from new plant varieties. We pursued this consultation because Nuseed Omega-3 canola is distinctly different from conventional canola. It offers increased omega-3s and improves the ratio of omega-6 to omega-3 (from 2:1 to 1:4) when compared to conventional varieties. Derived from Nuseed Omega-3 Canola, Nutriterra Total Omega-3 oil provides seven omega-3 polyunsaturated fatty acids including DHA, EPA, and ALA.
While we are confident in our products, the additional FDA scrutiny provides assurance to our customers that including NUtriterra in their formulations will not present any safety or regulatory challenges.
This validation means US food manufacturers can confidently use Nutriterra as a plant-based alternative to marine oils for these essential nutrients.
DOES THE WORLD NEED A NEW OMEGA-3?
Fewer than 20%* of US consumers are meeting the daily recommended intake of omega-3. Our proprietary research indicates that taste, tolerability, and dietary preference lead objections to fish oils. Moreover, many consumers prefer functional food to meet their nutritional needs. Nutriterra’s mild taste ensures ease of formulation.
The FDA’s affirmation reinforces the importance of our plant-based innovation and supports our advancement into functional food. By providing a good source of omega-3 nutrition, Nutriterra can attract new consumers and help more people meet their dietary requirements through everyday food and drinks.
OTHER REGULATORY ADVANCEMENTS
Nuseed previously obtained human food and animal feed approvals in Australia, New Zealand, and Canada and is progressing with additional regulatory applications in other key markets around the world. Last year the FDA recognized Nutriterra as a New Dietary ingredient. Plant based is a rapidly growing omega-3 category, and Nutriterra provides a safe and effective alternative to marine oils for food or supplementation.
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