USP FCC Comment Period Opens

ROCKVILLE, MDThe U.S. Pharmacopoeia (USP) will open a public comment period for its proposed Food Chemicals Codex (FCC) in late December, a move to encourage stakeholders to contribute comments, suggestions and ideas towards the final  version of the edition, due out in August 2012 (effective date of November 2012). The FCC compendium is recognized around the world for its purity and identity standards across more than 1,100 monographs covering food and supplement ingredients, as well as compounds used in production processes.  According to USP, the comment period for the new edition, which contains some new proposed standards for hot-button food and supplement areas,  will open Dec. 28, 2011 and run through March 30, 2012.

I each edition of FCC, there are key changes and additions. The 2012 edition will feature new standards for Stevia glycosides, probiotics and benzoic preservatives. Jeff Moore, Ph.D., senior scientific associate in the department of standards development at USP, explained rebaudioside A (reb A) has been a marketing focus for stevia sweetener products, but there has been increased interest in other glycosides, and the analytical methods for these compounds have been problematic. "The goal is to find a method to separate and measure these glycosides, which required development of a better HPLC assay," he said, adding USP looks forward to getting solid input on how to measure purity and authenticity in this area.

On benzoic acids are used as preservatives in some foods. Markus Lipp, Ph.D., director of food standards at USP, said this edition tweaks the existing standard, in an effort to make it more specific and effective.  Identity and authenticity are key drivers in such foods, he noted. "Unless we know no one has tampered with the food, such as with economically motivated adulteration, or if there was an accidental switch of ingredients, we can't say anything conclusive about the safety of  the product," he said, noting the old methods were not effective and needed to be updated with a new HPLC process.

The popular probiotic category needs methods to prove strain type and dosage, according to Lipp. The USP's goal in this area is not related to health claims for probiotics, Lipp cautioned,  but rather to prove identity and amount relative to label claim.

When an ingredient, such as probiotics or stevia, becomes the hot segment, there can be a great disparity in knowledge and capability amongst the companies involved. "Innovators and companies on the leading edge may have a good idea of the product, supply chain and even the science on a  hot ingredient like probiotics," Lipp said. "However, as the ingredient takes off in the marketplace, many companies flock to the space but may not have the right knowledge; the segment may also end up with more companies and products than can be effectively monitored. These conditions can greatly increase the risk of adulteration.

To participate in the FCC forum and submit comments, visit USP's FCC Forum site. Registration is required but is free.