creation of uniform production and testing standards for dietary
supplements is an ongoing process. While several trade organizations
have been active in defining and implementing standards, no national
organization or authority currently oversees a general standard.
Numerous economic and technical issues must be resolved before a
general standard can be set. Supplements, unlike pharmaceuticals,
are often largely natural in origin and thus are not subject to
patent protection. Without economic incentive, clinical testing
is left to academic research, rather than the well-funded corporate
trials associated with pharmaceuticals.
Dietary Supplement Quality Initiative actively supports the development
of high quality standards. See our mission
statement for more information.
manufacture and sale of dietary supplements is regulated in the
United States by federal and state laws and regulatory agencies.
On the federal level, the Food and Drug Administration (FDA) regulates
product labeling and other safety and quality-related practices.
The Federal Trade Commission (FTC) regulates advertising. Other
federal agencies such as the National Institutes of Health (NIH),
the Centers for Disease Control and Prevention (CDC), U.S. Department
of Agriculture (USDA), and the National Academy of Sciences (NAS)
impact regulations. In addition, a growing number of state laws
affect dietary supplements.
the Dietary Supplements Health and Education Act (DSHEA) was passed
in 1994, dietary supplements fell under the same regulations as
food. DSHEA changed things considerably by establishing specific
authority for the FDA to oversee product labeling, package inserts,
product literature, manufacturing practices, and product safety.
This served to free manufacturers to make health claims that previously
had been banned.
restrictions on health claims established by the Nutrition Labeling
and Education Act (NLEA) passed in 1990 and other laws still govern
product labeling as well.
authorizes the FDA to regulate Good Manufacturing Practices (GMPs)
which they have not as yet taken beyond the point of a proposal.
The FDA was also granted authority to ban products that are proven
to be unsafe--which they have exercised very little since DSHEA's
FDA has concentrated its efforts on regulation of product labeling.
For a breakdown of current labeling requirements, see new
regulations are constantly impacted by new legislation, new FDA
and FTC regulations, and court rulings. A controversy came to light
surrounding the FDA's rejection of several health claims that a
manufacturer wished to make. A January 1999 court ruling found the
FDA's refusal was an infringement of the manufacturer's First Amendment
rights of free speech (read
details). As another example, new FDA product labeling requirements
went into effect in March of 1999.
find out more about standards and regulation issues, click on a
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