HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

100% Potency Standard For "Added" Supplement Ingredients Upheld By FDA

This article was originally published in The Tan Sheet

Executive Summary

A substance "intentionally introduced" into a dietary supplement in an amount determined by a manufacturer must meet a 100% potency standard for the product's shelf life, FDA says in an Oct. 19 letter denying an industry petition for a 90% shelf life labeled potency minimum.

You may also be interested in...



USP Supplement Potency Lower Limit Of 90% Retained

The lower potency limit dietary supplements are required to meet for the duration of their shelf life will remain at 90% of the labeled amount, the U.S. Pharmacopeia Subcommittee on Non Prescription Drugs and Nutritional Supplements voted Dec. 8 in Rockville, Md.

USP Supplement Monograph Revisions Opposed By Trade Groups

The U.S. Pharmacopeia should adopt a flexible approach to nutritional supplement potency limits allowing for variations based on analytical methods, rather than set a minimum 100% limit, the Consumer Healthcare Products Association maintains.

Dietary Supplement 90% Shelf Life Potency Standard Requested In Petition

A reduction in the shelf life potency minimum for dietary supplements from 100% to 90% is requested in a May 3 citizen petition to FDA filed on behalf of Warner-Lambert's Capsugel Division, General Nutrition Companies, Twinlab and Consac Industries. The FDA dietary supplement labeling regulation that includes the 100% potency standard became effective March 23.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS140470

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel