As the dietary supplements and nutraceutical markets continue to grow and expand, companies must meet consumer’s demands both in terms of quantity and quality of their products. The regulations around dietary supplements and nutraceuticals have helped define the required testing and test kits and testing systems from Neogen® allow for companies to follow “current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements” (USP 21 CFR 111).
Neogen test kits not only help companies comply with regulations, but helps them implement programs, develop testing protocols and also supports them through audits and other regulatory challenges. This support, coupled with the improved time to results, the rapid use of information and ease of use, all help make Neogen a company to partner with for dietary supplement and nutraceutical testing.
Allergen control continues to gain momentum in the eyes of regulatory and government agencies across food commodities, including the dietary supplements and nutraceuticals industry. Neogen has developed assays for all types of these products, including environmental and nutraceutical items.
To assist in educating the industry, Neogen has created best practice documents including the Food Allergen Handbook and Best Practices for Food Allergen Validation and Verification, both of which are available to Neogen customers and those in the industry. These handbooks cover components of an allergen control program and best practices including when to test, how to test, and recommendations for testing frequency. They also incorporate Neogen’s industry leading products such as Alert®, Reveal® 3D and Veratox®, all of which can be used to solidify your allergen testing program.
Sanitation and hygiene is a critical part of cGMPs and the 21 CFR part 111 regulations for dietary supplements.
Neogen’s ATP system, AccuPoint® Advanced, delivers a sanitation program that allows you to gain metrics and begin improving and verifying SSOPs, environmental cleanliness, and sanitation requirements. This can help with 21 CFR part 111.14 (record keeping) as well as part 111.15 (e). Throughout 21 CFR 11 there are also multiple references to sanitation and hygiene (i.e. 111.25, 111.95 and others) in which Neogen’s AccuPoint Advanced system can help. AccuPoint Advanced leads the industry as the first ATP system to be approved by the AOAC Research Institute and includes RFID technology, liquid stable enzymes to improve accuracy and reliability and industry leading Data Manager software.
Microbiological testing for nutraceuticals is a critical part of the cGMPs and adhering to quality standards. Neogen manufactures and distributes the BioLumix® microbiological testing system for microbiological testing which follows USP <2021>, <2022>, and <2023> and allows for rapid results. The BioLumix system automatically generates a Certificate of Analysis in 48 hours, and allows for faster release of products from inventory. In addition to BioLumix, Neogen supplies all the peripheral equipment and supplies needed to help run a new microbiological testing lab, or an existing lab.
Natural toxins and/or mycotoxins are a concern in raw materials for nutraceutical and herb companies. Often these diagnostic tests are a critical control point for keeping natural toxins from the final product. Neogen’s natural toxin tests are part of a critical verification program for verifying raw materials are free from aflatoxin, DON, fumonison and other mycotoxins.
Because of its ease of use and clarity of result, many companies prefer to utilize our self-contained protein detection tests for their sanitation monitoring programs. AccuClean® Advanced is intended to be used as a simple method to determine the cleanliness of food contact surfaces and equipment. AccuClean Advanced is housed in a fully self-contained cartridge that once activated, changes color to indicate the relative level of protein detected on a sampled surface.
After 10 seconds, the solution is compared to a color comparison chart for interpretation. If no protein is detected, the solution in the bottom of the cup will remain copper-colored to indicate the surface is clean. A color change to gray indicates low level protein has been detected, while a change to green/blue or blue indicates a higher level of protein detected.