The Dietary Supplement Health and Education Act is a US federal law that regulates the safety and efficacy claims of dietary supplements. It holds manufacturers accountable and treats supplements as food items subject to similar regulations. The law requires scientific evidence to support health benefit claims and mandates labeling of all ingredients, including warnings for certain populations. The FDA investigates adverse health effects and new ingredients, and manufacturers must notify the government of any health and safety claims.
The Dietary Supplement Health and Education Act is a United States federal law enacted in 1994 that defines dietary supplements and regulates claims of safety and efficacy. It holds manufacturers accountable for the safety of these products and protects consumers from being misled about their intended purposes. The Dietary Supplement Health and Education Act treats dietary supplements as food items subject to some of the same regulations as foods.
This legislation amended a Food, Drug, and Cosmetic Act to address dietary supplements separately. The Dietary Supplement Health and Education Act led to the formation of the Office of Dietary Supplements at the US National Institutes of Health to coordinate research and report findings to the federal government. He also created a commission to review dietary supplement labels and make recommendations to improve the accuracy of publicly available information.
Under the law, manufacturers of supplements, which include herbs, extracts, vitamins, and minerals, must notify the Food and Drug Administration (FDA) of any serious adverse health effects reported by consumers. The FDA is mandated to investigate these reports before removing a product from the market. When a dietary supplement manufacturer makes claims about a product’s health benefits, they must be supported by scientific evidence under the Dietary Supplement Health and Education Act. The law prohibits advertising that claims supplements can cure, prevent, or cure a certain disease or disorder. Manufacturers can explain the function of the vitamin or mineral in the human body and how the product might support, maintain, or regulate those functions.
This law also changed the labeling regulations on dietary supplements. Under the Dietary Supplement Health and Education Act, labels must list all the ingredients used to make the product. These include any additives, preservatives, colors and flavors added to the main ingredient. Labels must also include warnings if evidence points to adverse health effects in certain segments of the population, such as pregnant women.
Dietary supplements do not need FDA approval before being marketed and sold. The agency receives notification of any new ingredients that emerge as well as supporting statements that bolster a supplement’s effectiveness. The Dietary Supplement Health and Education Act requires manufacturers to notify the government by letter if they make a statement about a new product’s health and safety benefits. These letters become public documents available for review.
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