Supplement Analytical Methods Should Be User-Friendly, Revisable – Industry

A searchable database of validated dietary supplement analytical methods would be useful for raw materials, but such methods for multi-ingredient, finished products likely will rest with the manufacturer, according to a Wyeth Consumer Healthcare representative.

For finished products containing a single component, "you can mimic the raw material method usually pretty" well, Wyeth Analytical Development Group Manager James Frazier, PhD, said at an analytical methods workshop in Bethesda, Md. April 18.

"But when you start getting to the multi-component products where you've got 40 or 50 actives...and we deal with those in Centrum Performance, you've got a whole bunch of stuff in there, so each one of the methods becomes specific to what you make," he said.

"I would love to see us be able to have a database of methods for ginseng or ginkgo or black cohosh where we could pull it down and that's the raw material method and you could use that with your supplier. And you could use that to start when you look at your finished product," Frazier said.

"But a lot of the methods for the finished product...are going to have to be in-house," he said, adding they would be "specific to the flavors" of each product.

The workshop was sponsored by AOAC International, the Consumer Healthcare Products Association and NIH's Office of Dietary Supplements. The meeting stemmed from an FY 2002 congressional directive for ODS to "speed up" ongoing collaborations to develop, validate and disseminate analytical methods and reference materials for supplements (¹ (Also see "ODS Methods, Reference Materials Program To Be Directed By AHPA’s Betz" - Pink Sheet, 17 Dec, 2001.), p. 14).

Such analytical methods have been under development by groups such as AOAC and the Institute for Nutraceutical Advancement, which was acquired by NSF International in November.

AOAC's Electronic Compilation of Analytical Methods database system for rapid validation and distribution of methods is expected to debut later this year. The standards-setting group also is developing testing methods for ephedra and aristolochic acid under a contract with FDA and ODS (² (Also see "AOAC Supplement Analytical Methods Electronic Database In Development" - Pink Sheet, 18 Feb, 2002.), p. 13).

A methods database will save both time and expense for supplement manufacturers and contract laboratories retained to perform quality assurance work, and will ensure consistent results among labs, regulatory and industry representatives said.

Frazier noted validated dietary supplement analytical methods "have to be somewhat user-friendly, because if you're making six or seven billion tablets a year, that's a whole lot of stuff you're testing every day. You can't afford to have a lot of issues."

In addition, analytical methods should be open for future revisions, suggested Frank Jaksch, president and CEO of ChromaDex, a Santa Anna, Calif.-based laboratory. "This is a dynamic process. The methods have to be changeable, depending upon circumstances in the future - maybe a technology change, maybe someone finds a better way to do something."

American Herbal Pharmacopeia President & CEO Roy Upton suggested analytical methods should not just focus on a botanical's single analyte but, rather, should look at the active or marker compound "within the context of the fingerprint of the whole plant."

Upton called for a unified approach to development of dietary supplement analytical methods, including ultimate adoption by FDA, industry and standards-setting bodies such as the U.S. Pharmacopeia.

"Maybe there are different methods for different compounds, maybe there are different methods for matrices, but we all have to be on the same page," Upton said. "If we don't, then the manufacturers and the marketers are going to continue to shop around labs until they get...the value they're looking for, regardless of the quality of the product."

Validated analytical methods also will lend credibility to clinical trials and reduce the need for repeating studies, said FDA Senior Advisor for Science Bernard Schwetz, PhD, who stressed the importance of thoroughly understanding product composition before moving on to safety and efficacy testing.

"When you do studies, whether they're humans or animals, and whatever the effect is that is seen - beneficial or harmful - people are going to question the results because they don't know and you don't know what you tested," he said.