SELF-CARE

Watch for new seals of approval on dietary supplements

The United States Pharmacopeial (USP) Convention is launching a dietary supplement verification program that will enable dietary supplement manufacturers to sport a verification mark on their products' labels.

According to a USP spokesman, this mark will indicate to consumers, practitioners, and retailers that the product contains the dietary supplement ingredients in the designated amount, meets acceptable limits of undesirable elements, and is manufactured appropriately.

"In the past couple of years, there has been confusion at the consumer level in differentiating quality dietary supplements from the ones that are not meeting quality standards. Lots of questions have been raised regarding the purity and quality standards, label accuracy, safety, and efficacy of these products," said Forouz Ertl, v.p. of USP's dietary supplement verification program.

Noting that USP began to work on establishing the program more than a year ago, Ertl said that a pilot phase of the program was launched a few months ago. During the pilot, USP evaluated eight products from the following four dietary supplement manufacturers: Leiner Health Products, Pharmavite, Rexall Sundown, and Perrigo.

The verification program is voluntary and open to all dietary supplement manufacturers in the United States. Manufacturers will be required to sign a licensing agreement with USP, but USP would not disclose the fees they will be charging companies.

"We ask the manufacturers to give us documentation—to establish the fact they already have a quality standard system in place," Ertl said. "If they can't establish their quality standards to us, the company will not qualify for our program. After we qualify the company, we go through product qualification. We ask for documentation specific to every product the firm wants us to certify. We arrange for a Good Manufacturing Practice [GMP] audit of their facility to be conducted by USP. We look for compliance with the USP General Chapter Manufacturing Practices and compliance with Advanced Notice of Proposed Rulemaking [ANPR] for dietary supplements," she said.

"Once we give the products the verification mark, we will randomly pull those products off the shelf to test them to make sure they are still meeting the criteria we set," Ertl continued.

In a separate but related development, the National Nutritional Foods Association (NNFA) and NSF International have formed an alliance to promote a certification program for dietary supplements. NSF, a not-for-profit organization dedicated to improving public health, safety, and the protection of the environment, will use NNFA's GMP materials as part of its dietary supplement program. NSF will recognize NNFA's GMP audits as meeting the requirements for the NSF Dietary Supplements Certification program. NNFA's GMP program was launched in 1999. Once certified, manufacturers are allowed to use NNFA's GMP seal on their products.

The cooperative effort is intended to do the following: ensure consumer safety by using expert contaminant testing, confirm regulatory acceptance by verifying manufacturing consistency and accuracy, verify the identity and quantity of dietary ingredients on product labels, ensure the product does not contain undeclared ingredients, and demonstrate conformance to industry GMPs for dietary supplements.

"The alliance for dietary supplements certification will help all healthcare practitioners, including pharmacists, as they serve in the role of recommending products because they will know that the products have been thoroughly tested and the plants where they were made have been inspected to make sure they comply with GMPs," said Kathleen Pompliano, business development manager, NSF International.

Sandra Levy

Sandra Levy. Watch for new seals of approval on dietary supplements.

Drug Topics

2002;1:29.