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9/19/2000

USP Proposes Quality Program for Dietary Supplements

Cheryl A. Thompson

In a move that might be viewed as taking the organization in a new direction, the United States Pharmacopeia (USP) has proposed starting a business that would allow companies to place a certification mark on dietary supplement products that meet standards of quality set by the quasi-governmental group.

USP's "Quality Demonstration Program for Dietary Supplements," unveiled Sept. 5 by Executive Vice President Roger L. Williams and other staff members, would operate as a business, with companies signing a licensing agreement on a product-by-product basis. 

The proposed program is "very much of a draft concept right now," said Williams, who took the helm at USP in April, after nine years at the Food and Drug Administration (FDA). "Our hope is that we work in a complementary, synergistic way" with the Center for Food Safety and Applied Nutrition (CFSAN), the FDA unit responsible for regulating dietary supplements that are not sold as drugs. 

Under the proposed program, USP and appropriate groups would develop specifications for dietary supplement ingredients and products. Included in the specifications would be tests for undesired components, such as heavy metals, in addition to desired components. 

Tests for identity and amount of specific components would be developed through analysis of authenticated plant reference material obtained from the Missouri Botanical Garden and the Smithsonian Institution, said V. Srini Srinivasan, director of USP's dietary supplements department. High-performance liquid chromatography of an extract of the reference plant material would then be used to produce a "fingerprint" that can be compared with chromatograms of dietary supplement products claiming to contain the botanical. 

CFSAN's forthcoming rule on current good manufacturing practices (cGMP) for dietary supplements will provide the basis for the manufacturing standards in USP's program. This part of the program, however, would not directly involve USP employees or its large corps of volunteers. "We would be considering cGMP inspections and product surveillance" conducted by contractors, said Thomas P. Layloff, director of USP's activities and excipients department. 

CFSAN was said to be publishing its proposed cGMP for dietary supplements sometime this month. Food and Drug Administration employees present for USP's announcement did not dispute the expected time of publication. 

Companies having a licensing arrangement with USP would be allowed to place the program's certification mark on the dietary supplement products conforming to program requirements for ingredients and manufacturing processes. 

USP Chief Counsel Joseph G. Valentino said that the certification mark will be proprietary to USP and distinct from the "USP" or "NF" designation that a product can bear if it meets compendial requirements. A company that improperly uses the certification mark could face legal action from USP, he said. 

Each participating company will be required to indemnify USP from adverse consequences resulting from consumers' use of the dietary supplement, said Valentino. 

R. William Soller, senior vice president of Consumer Healthcare Products Association, a 119-year-old trade organization, said the proposed program "offers manufacturers a way to differentiate themselves in the marketplace" but needs more work. He asked USP to consider a way of recognizing a validated company method that, in the end, does not become the analytical method selected by the program. High-quality products can be manufactured, he said, without matching the fingerprint chromatograms of botanical garden specimens. 

USP's Williams pointed out that if a product does not meet the program's requirements, the conclusion should not automatically be "it's a bad product." 

Leiner Health Products' Greg Pennyroyal called the proposed program "a real step forward." The Carson, Calif.-based company manufactures nutritional supplements under its own label and private labels. 

Pennyroyal said that companies producing high-quality products have had difficulty setting these products apart from competitors' poor-quality products. Sales of botanicals have dropped 38 percent in value from a year ago, he said, mostly due to negative press by the media. 

Leiner encouraged USP to work with outside contractors such as ConsumerLab.com L.L.C., a private company that tests dietary supplements for content. 

ConsumerLabs, based in White Plains, N.Y., started its independent testing program in August 1999. Products that pass the tests are eligible to bear the ConsumerLabs certification seal. 

Williams acknowledged that "USP is setting up a business that would compete with" ConsumerLabs but that his organization is "committed specifically to working with" that company. 

Whether USP decides to pursue this new line of business depends primarily on two factors: sufficient funding and approval by the board of trustees. 

According to the 11-page draft proposal, start-up funds could be raised by assessing an enrollment fee on companies and accepting contributions from trade organizations. 

"We're going to have to fund it through our friends that will benefit from the program," said USP Chief Operating Officer John T. Fowler. "We'll need some 'seed' money for this." 

The enrollment fee would fund the hiring of new staff, said Fowler, with the licensing fee used to fund ongoing operations. USP expects the industry to donate the products to be tested. 

Williams declined to specify the amount of money that USP believes must be promised by outside companies and groups before the organization pursues development of the program. 

USP already has experience running a business—its sale of reference standards. In fiscal year 1999, USP had $21 million in revenues from the sale of reference standards. 

Williams said the board of trustees will meet in early October and decide whether to endorse the draft proposal for the program.