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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 ]
The Dietary Supplement Health and Education Act of 1994 is a 1994 statute of United States Federal legislation which defines and regulates dietary supplements. [4] Under the act, supplements are mainly unregulated, without proof of effectiveness or safety needed to market a supplement, as well as dietary supplements being classified as foods ...
Senator Orrin Hatch of Utah introduced the Health Freedom Act of 1992 which would have blocked the FDA from using health claims as a reason to regulate dietary supplements as drugs. The senator said he "entered the controversy after hearing from constituents in his home state, including both consumers and makers of dietary supplements".
Because of the passing of the Proxmire amendment and Dietary Supplement Health and Education Act, the dietary supplement industry has had a large increase in revenue and sales, around $30 billion. Back in 2015 they had more than 85,000 products selling in stores that didn’t help improve health in any way. [8]
In the United States, the Dietary Supplement Health and Education Act of 1994 provides this description: "The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines the term "dietary supplement" to mean a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other ...
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Dietary Supplement Health and Education Act (1994), PL 103-417, 108 Stat 4332; Food Quality Protection Act of 1996; Food and Drug Administration Modernization Act of 1997, PL 105-115, 111 Stat 2296; Food and Drug Administration Amendments Act of 2007, PL 110-85, 121 Stat 823 [1] Over-the-Counter Hearing Aid Act of 2017; Sunscreen Innovation Act