Best of 2011 Services Provider: U.S. Pharmacopeia


USP continues to provide industry with analytical tools to ensure product quality and safety.

At a time of heightened concern over product quality and safety, the work of the U.S. Pharmacopeia (USP) has become increasingly valuable. It is primarily a volunteer-based organization, comprising different committees that work toward developing testing methods, analytical tools, and standards to help define and ensure the identity, quality, and purity of food ingredients, dietary supplements, and pharmaceuticals.

“We rely heavily on experts who volunteer their time as we seek to develop science-based public standards that can be used by all parties, including manufacturers, suppliers, and regulators,” says Markus Lipp, director of food standards, USP. “Part of our mission is to provide companies with the necessary tools to verify an ingredient is what it should be.” The more complex the ingredient, the more difficult identification is.

This year, USP’s efforts have resulted in developing the first monograph for beta-glucan, as well as developing standards for natural ingredients, infant formula ingredients, sweeteners, and food coloring. USP developed a standard for monk fruit extract and krill oil, while also working on a pomegranate juice concentrate identity standard. It added five new color monographs to its existing six, and formed a skim milk advisory group to develop new standards.

USP is also creating certified reference materials for vitamins and new botanical reference materials. Another new tool is its steviol glycosides monograph and testing kit. In addition, a food ingredient “adulteration database” documenting known cases of economically motivated adulteration worldwide will be included in its Food Chemicals Codex 8, which will be released March 1, 2012, and offered online.

Jeff Moore, PhD, senior scientific liaison, says that as each new challenge arises, the work can be fascinating for an analytical team. “As a food scientist, it’s an extremely fulfilling job because there’s nothing cookie-cutter about it. We’re always discovering or learning about new ingredients and developing new solutions.”

USP’s recently developed method for confirming the authenticity of natural ingredients provides the industry with an easy tool to determine if an ingredient is bio-based in origin.

“We used a simple carbon-isotope dating method, which is a principle that has been around a long time. Ingredient and supplement manufacturers now have an easy way to confirm a product or ingredient’s natural origin. It can be a way to reduce fraud, which is a common problem for ingredients such as vanilla,” says Moore. A company can also use this tool to substantiate a product’s natural claims.

USP is currently planning a May 2012 workshop to discuss the probiotic food trend. “Consumers are being led to rely on food items for all sorts of alleged health claims regarding probiotics,” says Lipp.

He says some of the challenges are multifaceted. “Often, the wording on a label describes a strain of live cultures in such a general, generic way, it is like using the word plant. So we start out by simply determining what type of probiotic it is and how much the product contains. Then we need to determine how to test for it.” Other challenges include determining whether or not live organisms do what the product claims and whether they are still beneficial if a product is frozen.

“Through these workshops, we hope to learn about new issues affecting the industry, discuss solutions, and see if we can agree on standards. We must decide ways to move forward that benefit stakeholders as well as consumers,” says Lipp.

The safety issues surrounding adulterated ingredients are not taken lightly. USP held a workshop this November to discuss possible solutions to this growing concern. “We can use different combinations of techniques to ensure authenticity. We have to consider what adulterants might be added in order to create tests that will rule out those contaminants, requiring us to ‘think like the bad guys,’” says Moore.

Kristie Laurvick, MS, scientific liaison, points out the value of USP’s tools to the industry, in addition to consumer health. “Without the development of these tools that can identify adulterated products, honest manufacturers would be discouraged and potentially driven out of the market. It’s less expensive to cheat.”

More companies are beginning to recognize USP’s work and bring the organization new, innovative ingredients to collaborate on developing standards for, something USP encourages.

“The bottom line is that the USP is working to define the intersection where quality meets safety-and is making sure those lines aren’t crossed,” says Lipp.

Protecting the consumer is the most fulfilling part of the job, says Laurvick. “At the end of the day, we all enjoy the fact that the work we do helps ensure that store shelves contain safe, quality food.”

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