New Supplement Regulations Most Important for Industry Since Passage of DSHEA
Jul 28, 2008 12:00 PM, By Michael McGuffin, American Herbal Products Association president
The dietary supplement industry experienced two once-in-a-decade events in 2007: the implementation of a serious adverse event reporting (SAER) law and the publication of the long-awaited final rule on good manufacturing practices (GMPs) for supplements. These are the most significant regulatory events to hit the dietary supplement industry since the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994.
Supplement companies' compliance with the serious adverse event reporting requirements of the Nonprescription Drug and Dietary Supplement Consumer Protection Act recently surpassed the six-month mark. And on June 25, 2008, manufacturers, packers, labelers and holders of dietary supplements with 500 or more employees became the first in the industry to be subject to the final GMPs. An enormous amount of time has been invested by companies and trade groups in preparation for compliance with both of these rules, and a large part of that preparation has involved the deciphering of gray areas of the rules.
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