NORTHRIDGE, Calif., Dec 11, 2006 (BUSINESS WIRE) -- Pharmavite LLC, maker of Nature Made vitamins, today praised the U.S. Congress for its bipartisan efforts in passing S. 3546, "The Dietary Supplement and Nonprescription Drug Consumer Protection Act." The legislation requires dietary supplement and over-the-counter drug manufacturers to report any reports they receive of serious adverse events (AERs) to the Food and Drug Administration (FDA). The legislation was introduced to the U.S. Senate in June of this year by Senators Orrin Hatch (R-UT), Tom Harkin (D-IA), Richard Durbin (D-IL), Mike Enzi (R-WY) and Edward Kennedy (D-MA), and in the U.S. House by Representatives Chris Cannon (R-UT) and Frank Pallone (D-NJ).
"We commend Senators Hatch, Harkin, Durbin, Enzi and Kennedy and Representatives Cannon and Pallone as well as their staff for their leadership in winning passage of this ground-breaking legislation," said Paul Bolar, vice president, regulatory affairs, Pharmavite. "This law provides the 150 million Americans who use dietary supplements an important new consumer protection. We anticipate the bill will also validate the dietary supplement industry's strong safety record."
-- Mandates serious adverse event reporting by over-the-counter drug and supplement manufacturers to FDA within 15 business days of receipt;
-- Requires companies to maintain all adverse event reports received for six years;
-- Makes knowingly submitting false reports a punishable offense.
Adverse event reporting does not associate a cause to the adverse event, but does let the FDA know that an event occurred. Federal legislation will pre-empt state and local laws, and provide clear, understandable guidelines to consumers, health care professionals and manufacturers.
Pharmavite has long advocated for mandatory reporting of serious adverse events as a part of responsible regulation of dietary supplements. The company has voluntarily reported such events to FDA since 2004. As a part of its commitment to quality, Pharmavite has also long supported implementation of dietary supplement good manufacturing practices and increased funding for FDA oversight.
For more than 30 years, Pharmavite has earned and maintained the trust of pharmacists, consumers, and retailers by manufacturing high-quality vitamins, minerals, herbs and other dietary supplements that are safe, effective and science-based. As an industry leader, Pharmavite adheres to manufacturing standards recommended by the United States Pharmacopeia (USP), a not-for-profit organization that has set pharmaceutical and dietary supplement quality standards since 1820. In addition, Pharmavite participates in USP's Verification Program for dietary supplements.
The dietary supplement industry is regulated by the U.S. Food and Drug Administration and the Federal Trade Commission, as well as by government agencies in each of the 50 states.