FDA

DSHEA Grows Up

DSHEA (the Dietary Supplement Health and Education Act) is no longer a teenager. This does not mean the drama is over. Despite having just turned 20 years old, DSHEA is still challenging to pin down and, apparently, difficult to follow.

DSHEA (the Dietary Supplement Health and Education Act) is no longer a teenager. This does not mean the drama is over. Despite having just turned 20 years old, DSHEA is still challenging to pin down and, apparently, difficult to follow.

Those who created and fought so hard to pass DSHEA saw it as a defining moment for dietary supplements, but parts of the law remains woefully misunderstood. While DSHEA provided an official definition of dietary supplements and mandated various regulations to ensure safety, quality and consistency to and open access of dietary supplements, the interpretation of the language in DSHEA has challenged implementation and compliance.

INSIDER's Digital Issue, “Celebrating 20 Years of DSHEA," looks at how the law overlaps with the Food, Drug & Cosmetic Act (FD&C) of 1938—which DSHEA amended—and the more recent Food Safety Modernization Act (FSMA). It also examines the influence of FDA’s interpretation and application of the safety standard from DSHEA, relative to NDI (new dietary ingredient) notification and GRAS (generally recognized as safe) status. In addition, this issue outlines the ongoing threats to DSHEA, many of which are based on industry’s own actions, and explores ways companies can work with FDA on improving oversight and compliance with many of the requirements mandated by DSHEA, including claims and GMPs (good manufacturing practices).

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