USP plans to unleash a multi-prong marketing/ advertising campaign to promote the full-fledged launch of its Dietary Supplement Certification Program.

Featuring a mix of mediums geared to both consumers and trade, promotional vehicles will include print, Internet and TV advertising, as well as trade show exhibits and press conferences.

The campaign will commence once the program has expanded nationwide. DSCP pilot phase results will be presented to USP's Board of Trustees by the end of October.

"As we evaluate those results and get approval for further progress, we will launch the program, hopefully in the final months of this year," U.S. Pharmacopeia Exec VP & CEO Roger Williams, MD, stated Oct. 12 at the Natural Products Expo East in Washington, D.C.

The pilot phase has involved four companies that each volunteered to have two products tested, USP VP Forouz Ertl said. The identities of the four firms will be disclosed once the full program gets underway.

Ertl took over USP's supplement quality program in May. A member of the organization's Dietary Supplements Botanicals Expert Committee, she formerly was with Zuellig Group North America (¹ Also see "USP" - Pink Sheet, 14 May, 2001.).

Explaining the certification process as it is currently conceived, Ertl said a manufacturer would first be required to sign an agreement reviewing the program's requirements, after which it would submit a list of products to USP that it would like certified.

"If the product that the manufacturer is submitting has an existing USP monograph or standard it can be introduced into our program. If it does not have an existing monograph then it has to go to a council of experts review," Ertl said.

The council would determine whether ingredients in the supplement in question are appropriate for certification, Ertl stated. "If there are any known safety concerns about a product, we are not going to certify that product or even initiate the certification process."

If the product is cleared to undergo the certification process, USP would ask the manufacturer to provide extensive records on manufacturing and quality control issues, as well as Good Manufacturing Practices documentation, Ertl said.

Internal USP and/or third-party "specialists" will be sent to the manufacturer's facilities to make sure it has well-established quality control systems in place. "Without that, no matter how much testing we do on the product, it will not justify the certification process," she noted.

The guidelines followed during the audit will consist of both the USP-NF general chapter on GMP requirements and FDA's advanced notice of proposed rulemaking on dietary supplement GMPs. The program will use the agency's new GMPs as soon as they are issued, Ertl noted.

Product testing will include measuring contaminant levels and assessing supplements' bioavailability after they have passed through the digestive system. Labeling also must disclose the plant species used for botanicals and the recommended dose to be certified.

If all the requirements are met, certification will be granted. However, USP "will go back to the market and test the [certified] product again on a random basis...to make sure that during the shelf life of the product it stays within the USP criteria," Ertl asserted.

DSCP will be financed by fees USP will charge to conduct the audit and product tests. Use of such a fee-based system will mark a change for USP, which heretofore has produced revenue via sales of USP-NF (² Also see "USP Supplement Certification Program Advisory Group Forming" - Pink Sheet, 26 February, 2001.).

Details about fee amounts were not disclosed "because they are being finalized and also because there is a lot of variability in them depending on what is being certified," Williams said.

"The costs are paid by the manufacturers who participate. For example, the cost of the audit, the testing, the documentation review and the standard licensing cost they will have to pay," Ertl explained. "So the total cost of the program depends on the number of products [manufacturers] have."

A company's fee also will reflect "the number of ingredients in the formula...because every one of them has to be tested," the USP rep added.

USP Supplement Certification Program Could Launch By Year-End

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