Dietary Health Supplement Education Act
Under the act supplements are effectively regulated by the fda for good manufacturing practices under 21 cfr part 111.
Dietary health supplement education act. Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are. The dietary supplement health and education act of 1994 which spells out regulations regarding the manufacture and sale of dietary supplements defines a dietary supplement as a product other than tobacco intended to supplement the diet that bears or contains one of more of the following dietary ingredients. In addition the dietary supplement health and education act of 1994 introduced guidelines for the proper labeling of dietary supplements. Dshea is the acronym for the dietary supplement health and education act of 1994.
The dietary supplement health and education act is a u s. Whenever in this act an amendment or repeal is expressed in terms of an amendment to or repeal of a section or other provision the reference shall be considered to be made to a section or other provision of the federal food drug and cosmetic act. This included clearly labeling the product as a supplement that is meant to be ingested while differentiating the product from actual foods. Federal law enacted in 1994 that defines dietary supplements and regulates safety and effectiveness claims.
However with passage of the dietary supplements health and education act of 1994 dshea congress amended the fd c act to include several provisions that apply only to dietary supplements and dietary ingredients of dietary supplements. Under the dietary supplement health and education act of 1994 dshea. This act may be cited as the dietary supplement health and education act of 1994. It makes manufacturers responsible for the safety of these products and protects consumers from being misled about their intended purposes.
The law provides fda with appropriate regulatory authority and ample enforcement tools to protect consumers while still allowing them the desired access to a wide variety of affordable high quality safe and beneficial dietary supplement products. As a result of these provisions dietary ingredients used in dietary supplements are no longer subject to.