The U.S. Pharmacopeia should hire third parties such as ConsumerLab.com to manage botanical supplement quality audits proposed under a new program, Leiner Health Products Director of Botanical Research Greg Pennyroyal suggested at a USP public meeting Sept. 5.

The USP Quality Demonstration Program, outlined in an Aug. 31 draft proposal and announced at the meeting, would enable manufacturers who meet certain content and purity standards to mark their labels with a new, undecided certification symbol distinct from the USP and USP-National Formulary icons. Post-certification audits to ensure products meet USP's criteria would be part of the program.

Pennyroyal described the auditing process as "an area that hasn't traditionally been in [USP's] scope of expertise" and encouraged USP "to think about possibly working with outside contractors."

Doing so would enable USP to take advantage of "existing expertise...and existing support," he said. Pennyroyal named ConsumerLab.com and Schuster Labs as examples of possible auditors.

USP CEO Roger Williams, MD, acknowledged the program "stretches USP beyond what it normally does" and said it was considering using outsider contractors to conduct post-certification audits.

Pennyroyal called the program "a real step forward," noting it would help "those companies that are really trying to do their best to put good products out into the marketplace and having to compete against other companies that don't."

The Leiner exec stressed all audits would need to be undertaken "within the matrix of the USP quality control guidelines," and maintained the key aim of the program should be to create consistent reviews.

"Right now, if [firms] get reviewed by two different companies, you have two very different reviews," Pennyroyal stated. If that problem is not addressed by USP's program, "I'm afraid...[USP] might get into a battle as to who's the better auditing group."

Establishing a consistent standard "would also create additional industry support and buy-in," an important issue for USP, which needs to raise funds for the proposed program (¹ Also see "USP Quality Demonstration Program "Supplements" Monograph Development" - Pink Sheet, 11 September, 2000.).

Another way USP could gain industry support would be to promote public recognition of the new certification mark by disseminating the information "to the professional health care community in a very aggressive manner, and also to the general public," Pennyroyal advised.

"Where you're probably going to get the most bang for your buck is with pharmacists," he added.

Short of that, the Quality Demonstration Program is "another great idea that doesn't have the market pay-off on the end," the Leiner exec cautioned. Williams noted a strong public relations effort behind the new program also could increase overall awareness of USP.

ConsumerLab.com VP-Research William Obermeyer, PhD, questioned how USP would distinguish its program from "other entities," such as ConsumerLab.com, that also perform similar tests and offer certification. Obermeyer also opined that USP's reliance on industry funding could affect its relationship with FDA.

Williams conceded "USP is setting up a business which could compete with your business....There should be no mistake about that." However, "I don't think USP is trying to create disincentives for you to conduct your business," he added. Williams assured Obermeyer USP would work with ConsumerLab.com as its program gets underway.

As for dealings with FDA, Williams asserted USP has no desire to create a rift with the agency. However, "at the same time, USP has to acknowledge...we have to have elements of it that are a business."

Indena USA East Scientific & Regulatory Affairs Manager Edward Croom, PhD, urged USP to consider a more comprehensive program that would address safety and efficacy "even if it includes a lock-out of all but one company."

"The problem in the American market is we've made generics where there are not generics, and if USP ends up contributing to that...USP's great credibility" could be harmed, he observed.

USP Botanical Quality Third-Party Audits Favored - Leiner Rep

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