ChromaDex partners on new ID method for glandulars
ChromaDex Corp. and American Laboratories, Inc. (ALI) have developed a Fourier Transform Near Infrared (FT-NIR) based identification method for the positive identification of desiccated bovine and porcine glandular tissues used in nutritional product formulations.
ChromaDex has developed a FT-NIR algorithm and cluster based analysis model under its ComplyID program to individually identify eighteen bovine and porcine glands provided by ALI. The ComplyID model has the ability to find unique spectral differences with each of the 18 glandular materials for proper identification and verification of glandular material. ChromaDex’s ComplyID program is designed to help dietary supplement companies meet the minimum identity testing requirements under the FDA’s Dietary Supplement Current Good Manufacturing Practice (cGMP) Rule FDA 21 CFR Part 111.
Glandular ingredients have always occupied a small niche of the dietary supplement industry. The importance of verifying that these ingredients are what they say they are was highlighted in 2014 when a report in the journal Thyroid that was publicized via a blog posting in The New York Times found that a number of thyroid support supplements made with glandulars had detectible levels of the hormones thyroxine and triiodothyroxine. Ingredients made from desiccated glands of animals were on the market in 1994, and so are legal dietary ingredients grandfathered in under DSHEA. But to be legal they must have the hormones removed.
“Compliance with the FDA 21 CFR part 111, the Dietary Supplement cGMPs, continues to be a critical issue for the industry. Staying in compliance is an ongoing effort for all companies because interpretation and enforcement continues to evolve. Many companies have been surprised to find that their initial quality systems are no longer adequate in today’s regulatory climate. We are pleased to collaborate with ALI to provide the industry with an identity test for glandular related ingredients,” said ChromaDex CEO Frank Jaksch Jr.
