In 1994, Congress passed the Dietary Supplements Health and Education Act (DSHEA). According to the legislation, a dietary supplement is a product intended to supplement the diet and is not represented for use as a conventional food or as the sole item of a meal or a diet. Under DSHEA, the U.S. Food and Drug Administration (FDA) has several post-marketing responsibilities to ensure the safety of dietary supplements. In addition, the U.S. Federal Trade Commission regulates dietary supplement advertising.
CHPA fully supports full implementation and enforcement of DSHEA and is pleased that FDA released the final rule for dietary supplement Good Manufacturing Practices (GMPs) on June 25, 2007. This rule establishes uniform standards needed to ensure quality throughout the manufacturing, packaging, labeling, and holding of dietary supplement products.
CHPA also strongly supports mandatory adverse event reporting for dietary supplements. In 2006, Congress passed the Dietary Supplement and Nonprescription Drug Consumer Protection Act, requiring that dietary supplement manufacturers promptly communicate serious adverse events to FDA. This requirement went into effect December 22, 2007.
On May 25, Senators Tom Harkin (D-Iowa) and Orrin Hatch (R-Utah) introduced the Dietary Supplement Full Implementation and Enforcement Act of 2010, legislation which seeks to provide the FDA with additional funding; directs FDA to inspect facilities to ensure compliance with the new dietary supplement good manufacturing practice regulations; directs FDA to use the authority under the Dietary Supplement Health and Education Act (DSHEA) to protect the public from unsafe dietary supplements; and directs FDA to ensure that claims made for dietary supplements are truthful, non-misleading, and substantiated. CHPA sent a letter of support for the proposed legislation.
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