Council for Responsible Nutrition executive Jim Griffiths hopes dietary supplement industry stakeholders take better advantage of their latest “golden opportunity” to advise U.S. Pharmacopeia about reference standards for their ingredients.

Griffiths, CRN’s VP for scientific and international affairs, is chairman for USP’s second Dietary Supplements Stakeholder Forum May 16 at its headquarters in Rockville, Md. He was USP’s VP for food, supplements and excipients when the standards-setting organization hosted the first forum in August 2011.

“USP wants to hear from those most affected by their standards,” he said in an interview.

However, USP sometimes gets an underwhelming response to its announcements for food, supplement or excipient industry stakeholders to discuss reference standards.

Jim Griffiths, CRN’s VP for scientific and international affairs, will chair USP's Dietary Supplements Stakeholder Forum May 16.

Photo courtesy of the Council for Responsible Nutrition

“We would put out a call … for industry to show up and talk to USP and a lot of times there was a lot of frustration because industry just couldn’t or wouldn’t, so USP would still have to conduct the meetings, but often times USP would then try to wear both hats,” he said.

“They’d put on one hat saying, ‘Here’s what we think industry needs to know,’ and then, ‘Here’s how USP is either fulfilling that need or putting out a call for a new type of analytical method or gen chapter, etc.’”

USP currently offers nearly 800 monographs in its Dietary Supplements Compendium and more than 200 reference standards for use in the development and testing of dietary supplements.

Griffiths suggested, though, there could be some disconnect between some supplement finished product or ingredient firms and USP. While FDA requires that pharma industry firms’ ingredients match USP’s reference standards, the same requirement is not made for the non-governmental organization’s supplement ingredient standards.

USP “continues to set these standards, public standards for food and supplements and a lot of times the industry either isn’t tracking this stuff, they aren’t even aware that these things are happening or I guess at worse they just ignore them because there’s no requirement that they actually do anything.”

However, supplement firms should consider USP standards required reading because they often are the standards third-party labs use when they test products, Griffiths added. Information from third-party tests ends up in media reports or research studies critical of supplement brands for not formulating their products as described on labels, or for using ingredients not included on labels.

“Supplement companies are finding themselves pulled onto the front page of USA Today or somewhere because somebody has pulled the USP analytical method, pulled supplements off shelves and begun to do testing,” he said.

“The industry realizes that they can’t afford to just obliviously ignore these standards; that even if they don’t have imprimatur of legality, there’s still the need to understand what’s happening and be part of the process.”

CRN members, he added, are showing interest in the process. Members are asking him “to help them engage in discussions with USP, that if they’re developing or even refining a method that’s on the books, take advantage of some of the industry’s best practices on these methods,” Griffiths said.

USP said for the first time the stakeholders forum will be broadcast online via a WebEx presentation, allowing participation from stakeholders who do not travel to the meeting.

The agenda also should attract stakeholders, Griffiths said. One topic, “How and Why to Work with USP,” is “the ultimate agenda item” for supplement firms, he said.

“To me that’s the big one – how and why to work with USP, because if you don’t, things are going to continue to progress with or without you. So you might as well be a player in the activities.”

A USP spokeswoman also noted industry input is needed. “We need to keep requesting their feedback to make sure we are of value to them.”

USP standards are proposed for public comment in the USP-National Formulary every two months, the most frequent portal for stakeholders to participate in the process. “In order to even develop a standard, we seek manufacturers to sponsor ingredient and products monographs and reference standards. The stakeholder forum is one more way in which we collect feedback,” the spokeswoman added.

Participation this year could get a boost from the forum being scheduled the day after the end of the International Vitamin Conference, May 13-15, in Washington, D.C. The third annual conference, in the U.S. for the first time, is organized by the National Institutes of Health’s Office of Dietary Supplements and the National Institute of Standards and Technology.

Long History With Supplement Ingredients

Although it was not until 1990 that USP voted to publish separate chapters on supplement ingredients in its National Formulary for excipients, since its beginning in 1820 the organization addressed the standardization of botanicals and minerals because the content of the first USP reference standards contained mostly botanicals and other natural drugs.

After the passage of the Dietary Supplements and Health and Education Act in 1994, the NF’s supplement section was expanded significantly and renamed with the addition of many new monographs for botanical and non-botanical dietary ingredients and dietary supplement articles.

USP purchased the Food Chemicals Codex in 2006, after the National Academy of Sciences ended its management of the standards document, and added to its portfolio of standards relevant to supplements.

Considering the changing needs of a growing global supplement industry, USP in 2009 published the USP Dietary Supplements Compendium with the intention of providing a comprehensive resource for supplement manufacturers, suppliers and regulators. The DSC combines the dietary supplements section and other relevant monographs from USP–NF with monographs from the FCC.

USP’s nutritional product work also includes the 1930 launch of its Vitamin Advisory Board to establish the first pharmacopeial assays and reference standards for vitamins A and D; by 1942, USP established monographs for all vitamins recognized at that time.

As it does with other types of ingredients, USP coordinates its supplement standards and sets priorities for its work with an Expert Committee of volunteers from academia, industry and regulatory.

In addition to USP, organizations including NSF International and Underwriters Laboratories develop methods for testing supplement and food product ingredients that third-party labs use.

“There are many folks that are getting into that space on doing various types of verification, validation types of proposals and programs and they each have merits, probably have some pros and cons,” Griffiths said.

USP Door Open For Input On Supplement Ingredient Reference Standards

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