DSHEA: 20 Years Later…from a Lab Perspective


If Alkemist Labs had a grandfather his name would be DSHEA. He would be 20 years old and have had already fathered a son named cGMPs, who would have fathered a handful of testing labs. Without either there would simply be no lab perspective.

In 1992, spearheaded by Loren Israelsen of UNPA and a small group of other legal warriors, the Health Freedom Act was born. Over the course of the next two years it matured and became what we now know as the Dietary Supplement Health and Education Act (DSHEA).

Prior to DSHEA the dietary supplement industry was all but a nameless sore point for the FDA. Perceived as a bunch of hippie snake oil salesmen, the FDA made it clear its mission was to prevent such trade. While good companies did exist back then—many matured into the banner companies of today—the industry was void of relevant regulation, definitions, and guidance. Food GMPs (21CFR 110) did exist but to apply them to the industry meant making sure no birds lived in your manufacturing facility and other important, but not fully relevant, rules.

From the perspective of quantum mechanics, the numbers we associate with fundamental observable properties do not exist independent of observation. In other words, the numbers for a given particle do not attain a specific value unless it has an interaction with another particle. Even the physical world does not exist unless it is “perceived” in this sense.

DSHEA made it possible to establish definitions for ingredients and combinations of such, giving rise to vocabulary used to describe the dietary supplement industry. From that point on, DSHEA established safeguards like cGMPs (21CFR 111) and NDIs. DSHEA helped to create the lab perspective—the reality—we know, love and thrive from. It not only put Alkemist Labs and our competitors on the map, it created the map.

Categories: Analytical Testing, Regulations