Product Tests Select a Review CL Answers  Warnings  Encyclopedia Where to Buy News

Review Article: Inactive Ingredients in Supplements
 

Initial Posting: 5/11/07  Updated: 4/12/14

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.



Want to see more?

To view this article in its entirety, please click below on the "Log In" button if you are already a subscriber or the "Subscribe" button to learn how to subscribe.




#63#
 
 
Join |  Sign In
   
Join Us on Facebook! Join Us on Instagram! Join Us on Twitter! Join Us on Google+! Join Us on YouTube! 
Product Tests
Brands Tested
Health Conditions
Encyclopedia
CL Answers
Clinical Updates
News
Recalls & Warnings
RDAs
Where to Buy Products
Raw Materials Tests
Testing Program
Join CL Today
Testimonials
Join Free Newsletter
Group Subscriptions
Gift Membership
About Us
The CL Seal
CL Survey
Privacy Policy
Sitemap
Contact Us/Help

©2017 ConsumerLab.com, LLC. All rights reserved. A single copy of a report may be printed for personal use by the subscriber. It is otherwise unlawful to print, download, store or distribute content from this site without permission.
ConsumerLab.com name and flask logo are both registered trademarks of ConsumerLab.com, LLC. This site is intended for informational purposes only and not to provide medical advice.
 
Join our FREE Newsletter and Become a Member to View
Inactive Ingredients in Supplements !
First Name 
Last Name 
Email* 
Retype Email* 
ConsumerLab.com Member Benefits:

Instant Access to All Product Review Reports Covering Over 1,000 Products
Quality Ratings and Product Comparisons by Brand
Expert Tips on Using Supplements
 
Membership fee required for full benefits.
Price Checks on Popular Brands
e-Newsletter with Updates and Alerts
New and Archived Recalls and Warnings