Ross Enterprise Resources

Dietary Supplement Good Manufacturing Practices Long Overdue; Mainstream Industry Ready, Willing and Waiting for GMPs

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Description:

When the Dietary Supplement Health and Education Act (DSHEA) was enacted in 1994, Congress authorized the Food and Drug Administration (FDA) to establish Good Manufacturing Practices (GMPs) modeled on food regulation but specific to dietary supplements. Notice of the proposed rule-making was issued in 1997 and a proposed rule was published in 2003. The final rule cleared FDA in late 2005 and was sent to the Office of Management & Budget (OMB) for review. To date, the GMP rule has been stalled at OMB for more than one year, with no public explanation for the delay.



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