Rockville, Md., November 12, 2007 — On September 10, 2007, ConsumerLab.com issued a report stating that several multivitamin supplements did not contain label amounts of folic acid. One of these products, B-50 Tablets, manufactured by IVC, Industries, Inc., is part of U. S. Pharmacopeia’s (USP) Dietary Supplement Verification Program and carries the USP Verified mark. In response to the report, USP studied the verified product to confirm the announced results. USP’s testing found that the B-50 Tablets do in fact contain the required amount of folic acid, as claimed on the product’s label. The testing also demonstrated that the tablet in question meets USP dissolution requirements. USP’s analysis showed that using appropriate test methods for the type of material under assessment, as provided in the United States Pharmacopeia and National Formulary (USP–NF), is key to getting accurate results.
“The importance of ongoing testing of dietary supplements to a public monograph is hard to overstate,” said Roger L. Williams, M.D., executive vice president and CEO of USP. “For this reason, USP acknowledges ConsumerLab.com’s marketplace surveillance efforts. At the same time, these efforts require careful follow-up, which USP was able to do via its USP Verified agreement with the manufacturer of the B-50 Tablets.” USP understands that further studies may be conducted by manufacturers and the Food and Drug Administration (FDA) based on the September 10 report.
The USP Verified program for dietary supplements and their ingredients provides a rigorous array of tests, resulting in manufacturer and consumer confidence that “what’s on the label is what’s in the bottle.” Via its voluntary, fee-based agreements with manufacturers, USP has a continuing commitment to monitor the quality of verified ingredients and products. USP was pleased to be able to clarify some of the findings of ConsumerLab.com.
In a separate report dated October 12, 2007, ConsumerLab.com called into question the therapeutic interchangeability of two marketed extended release formulations of Buproprion Hydrochoride. For these drugs, primary responsibility for original and continuing market availability rests with the FDA working with manufacturers. USP notes that it does have drug product monographs for the involved formulations in the United States Pharmacopeia and that these monographs allow different dissolution requirements. This is appropriate on the assumption that the FDA has reviewed and found acceptable bioequivalence studies for formulations conforming to the monographs. USP does not verify drug products approved by the FDA.
USP—Advancing Public Health Since 1820
The United States Pharmacopeia (USP) is a private, non-profit, standards-setting organization that advances public health by ensuring the quality and consistency of medicines, promoting the safe and proper use of medications, and verifying ingredients in dietary supplements. These standards, which are recognized worldwide, are developed by a unique process of public involvement through the contributions of volunteers representing pharmacy, medicine, and other health care professions, as well as science, academia, government, the pharmaceutical industry, and consumer organizations. For more information about USP and its four public health programs, visit www.usp.org/newscenter.