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The Dietary Supplement Health and Education Act of 1994 mandated that the FDA regulate dietary supplements as foods, rather than as drugs. Consequently, dietary supplements are defined as a kind of food under the statute, [ 39 ] with the caveat that this does not exempt them from being treated as drugs in the way that other foods are exempted ...
The Dietary Supplement Health and Education Act of 1994 ("DSHEA"), is a 1994 statute of United States Federal legislation which defines and regulates dietary supplements. [1] Under the act, supplements are regulated by the FDA for Good Manufacturing Practices under 21 CFR Part 111. [2]
These regulations usually have to deal with products in the pipeline for introduction into the American market. Here is an abbreviated list from the linked page that highlights the most important and influential actions regulation created by the FDA. It also deals with the expansion of the FDA's powers and the creation of the agency itself.
Following the Dietary Supplement Health and Education Act in 1994, dietary supplements were placed in a "special category under the general umbrella of 'foods,'" according to the FDA.
The FDA says about 4,000 dietary supplement products existed in the mid-90s. More than 80% of Americans have taken a dietary supplement at some point, according to the Pew Research Center.
Story at a glance Because supplements (i.e. vitamins and minerals) are regulated as food by the FDA, they do not need to undergo efficacy and safety testing prior to market entrance. This ...