(P01-005-25) Coming Full Circle on Science, Regulatory and Sustainability – A Case Study of the Tagetes erecta Botanical Extract as a Source of Macular Carotenoids
Vice President OmniActive Health Technologies Mountain Lakes, New Jersey, United States
Disclosure(s):
Deshanie Rai, PhD: No relevant financial relationship(s) with ineligible companies to disclose.
Objectives: When it comes to plants as a nutrient source, sustainability and environmental impact are important - but sustainability also encompasses processing and manufacturing, safety and efficacy data to support registrations, education programs for health care professionals and consumers, and giving back to the community. This abstract will address why the product lifecycle of the Tagetes erecta botanical extract, a practical and efficient source of lutein and zeaxanthin (LZ) is multi-dimensionally sustainable. LZ are macular carotenoids established for vision performance and cognition through the lifecycle.
Methods: A vertically integrated supply chain starts with non-GMO seeds, harvesting of marigold flowers, followed by dehydration, extraction and processing under good manufacturing practices (GMP) and in FDA cGMP compliant facilities. The resulting marigold oleoresin is made into oil suspensions and beadlets for use in food and supplement applications. Quality control checks throughout the process ensure the specifications and analytical parameters are in alignment with regulatory requirements. The LZ marigold extract (Lutemax 2020TM) is tested in toxicity, safety and clinical studies as per ICH guidelines to confirm its safe, efficacious use in adults and children.
Results: Agricultural practices and production and manufacturing processes have been successfully tailored to support environmental sustainability of LZ from Tagetes erecta with benefits to the famer. Validated methodologies confirms authenticity at the species and active levels. Toxicity, preclinical, and clinical studies including in children, support the safety of Lutemax 2020TM along with benefits for vision performance and cognition. These data have supported product and claims registrations in many countries, e.g., Canada, Australia, Korea, Japan, USA. Education campaigns are in place to highlight importance of LZ in the diet.
Conclusions: Consumers are keen to understand how botanical extracts are sourced, what are the agricultural practices including the treatment of farmers, how the extracts are processed, manufactured, effects on the environment, and data to support claims. The Tagestes erecta extract (Lutemax 2020TM) is an excellent case study of the multi-dimensional aspects of responsibly sourced LZ.
