Page 30 - August 2019 SP Product Guide

About Us Technical Operations

How the Dietary Supplement
Industry Is Regulated

The dietary supplement industry has often been
incorrectly criticized for being “unregulated.” That
perception is incorrect. The U.S. Food and Drug
Administration (FDA) has always been able to
regulate the dietary supplement industry
according to food regulations.
Prior to the 1994 Dietary Supplement Health and
Education Act (DSHEA), the FDA could conduct
regular routine physical inspections of
manufacturing facilities, regulate label claims to
make sure they are truthful and not misleading,
ensure the safety of ingredients used in the products,
and disallow new ingredients or remove existing
ingredients for safety reasons. The following
information shows the regulatory-compliance
timeline for the dietary supplement industry.

1994 | DSHEA Act
Prior to 1994, dietary supplements were regulated as
foods under the Food, Drug, and Cosmetic Act. After this
act was promulgated, it provided a dietary-supplement
classification for the first time. It acknowledged the
importance of nutrition and the benefits of dietary
supplements to promote health and prevent disease,
provided guidelines for labeling, and allowed statements
of nutritional support. The act also established an Office
for Dietary Supplements in the National Institutes of
Health. The office’s purpose is to explore the potential
role that dietary supplements have to improve health
care and to promote the scientific study of the benefits
of dietary supplements in maintaining health and
preventing chronic disease.
To learn more: visit www.health.gov/dietsupp/ch1.htm

Standard Process scientists work meticulously to ensure
product quality and safety.

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