Sun, 25 May 2003

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: 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 ( and Claims That Can Be Made for Conventional Foods and Dietary Supplements (

-- The Jakarta Post