U.S. regulations on food supplement protect users

U.S. regulations on food supplement protect users

Activists of Indonesian health and consumer watchdogs often refer
to the United States Food and Drug Administration (FDA) for a
firm regulation on the safety and distribution of dietary
supplements to protect consumers.

The FDA regulates dietary supplements under the specific
Dietary Supplement Health and Education Act of 1994 (DSHEA).

The act regulates that the manufacturer is responsible for
ensuring that a product is safe before it reaches the market.

It also regulates "dietary ingredients" and categorizes "new
dietary ingredients" as a substance that was not sold in the
country in a dietary supplement before Oct. 15, 1994, the
imposition date of the law. For more detailed information on new
dietary ingredients, go to: http://www.cfsan.fda.gov/~dms/ds-
ingrd.html.

The FDA is responsible for taking action against any unsafe
products, but manufacturers do not need to register with the FDA
or get FDA approval before producing or selling the products.
However, a manufacturer or distributor is required to notify the
FDA if it intends to market a product in the country that
contains a "new dietary ingredient".

Manufacturers must make sure that product label information is
truthful and not making any misleading claims.

The FDA is entitled to monitor the safety of the products
after marketing. The FDA regulates that a dietary supplement
label has to include: a descriptive name of the product stating
that it is a supplement; the name and place of business of the
manufacturer, packer or distributor; a complete list of
ingredients; and the net contents of the product. In addition,
each product must have nutrition labeling in the form of a panel
that lists the "Supplement Facts".

The FDA works closely with the Federal Trade Commission, which
regulates dietary supplement advertising.

Once a product is marketed, the FDA is responsible for showing
that the product is "unsafe," before it can take action to
restrict the product's use or to recall it.

Consumers are also invited to check FDA sites before buying
the products. For more information, visit: Tips For The Savvy
Supplement User: Making Informed Decisions And Evaluating
Information (http://www.cfsan.fda.gov/~dms/ds-savvy.html) and
Claims That Can Be Made for Conventional Foods and Dietary
Supplements (http://www.cfsan.fda.gov/~dms/hclaims.html).

-- The Jakarta Post