If a dietary ingredient was not marketed in the United States as a dietary supplement before October 15, 1994, then the Food and Drug Administration (FDA) considers it a “new dietary ingredient.” Such an ingredient cannot be used legally in a dietary supplement until the manufacturer or distributor submits a notification to FDA (at least 75 days before being marketed) that includes (1) what the “dietary ingredient” is and (2) the history of its use or other evidence to establish that it can “reasonably be expected to be safe.”

The definitions for these ingredients are strict; moreover, there is no list of pre-1994 ingredients, so a manufacturer/distributor has to do some homework. For more information, including the definitions mentioned above and the steps that manufacturers and distributors must take, see FDA’s “New Dietary Ingredients (NDI) Notification Process” page.

Because FDA doesn’t test dietary supplement products before they reach the market, the manufacturers and distributors of these products must provide information to show FDA that the product containing the proposed ingredient will “reasonably be expected to be safe.”

The identification of a substance as a new dietary ingredient for which no notification has been filed is one enforcement tool FDA can use against manufacturers who market products with unknown and new ingredients. This tool was used to remove DMAA from dietary supplement products in 2013 and also was used to invoke the recall of products containing aegeline, an ingredient that was associated with serious adverse events. Another important tool that FDA relies on—one you can be part of—is the reporting of adverse events; read the OPSS article to learn more.

Updated 26 February 2019

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