Review Articles
Inactive Ingredients / Excipients in Supplements

Initial Posting: 5/11/07  Updated: 5/25/19

Consumers often wonder about ingredients they see listed as "Other Ingredients" on supplement labels. This article is designed to help you understand what these ingredients do and how they are regulated.

Where to Look on the Label:
When you look at a properly labeled dietary supplement, you will notice that ingredients are listed in two areas. The most prominent is a box known as the Supplements Facts panel. Listed there are the active ingredients, i.e., the compounds in a product intended to supplement the human diet (herbs, vitamins, minerals, bacteria, plant and animal extracts, etc.). Typically right after this box is a list of "Other Ingredients." Here you will find the "inactive ingredients" (also referred to as excipients), which are more or less inert substances used to help form and enhance the consistency of the dietary supplement product, (e.g., add flavor, color, bulk, help with stabilization, shelf-life, resistance to moisture, etc.).

How the FDA Regulates Inactive Ingredients in Supplements:
Dietary supplements are regulated as foods and all inactive substances used to make dietary supplements are regulated as food additives. Every inactive supplement ingredient must be (1) an approved food additive (this includes color additives) or (2) a generally recognized as safe (GRAS) substance based either on (a) the FDA GRAS list or (b) being a "self-affirmed GRAS substance," i.e., having been safely used in foods after 1997.

A dietary supplement manufacturer wishing to use an ingredient (active or inactive) that was not used as a food ingredient before 1994 must notify the Food and Drug Administration (FDA) along with evidence of the safety of the ingredient at least 75 days before marketing a product containing the ingredient. FDA will acknowledge the notification and within 75 days of receiving it inform the manufacturer if it considers the evidence provided inadequate to establish the safety of the substance. If FDA does not respond within 75 days of notification the ingredient may be used as described by the manufacturer in the notification. Because this is a notification, rather than an approval process, FDA may at a later date prohibit the use of the ingredient if new information indicating lack of safety becomes available.

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