Just before the start of July 4th holiday the U.S. Food and Drug Administration released a Draft Guidance for Industry, which is entitled, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. While it does not carry the authority or the enforceability of a law or regulation, it does when finalized, represent the Food and Drug Administration’s (FDA’s) current thinking on this topic of NDIs.

The FDA has asked for comments to be provided within the 90 day period that follows its issuance. We will be contacting our clients to discuss this matter with them, to assess how this Guidance will affect the products they manufacture and sell and to get their input to be included as part of a response which we will be filing. We will also assist them to prepare their own comments, which we encourage every manufacturer, distributor, retailer or supplier of dietary ingredients to submit.

There are some highlights to what FDA has put forth that you should be aware of:

To get a flavor of what FDA’s intention and thinking is here is what FDA said about the purpose of the document that published:

The purpose of this guidance is to give manufacturers and distributors of these products information and recommendations to help them decide when a NDI notification is necessary and to improve the quality and quantity of NDI notifications. There are an estimated 55,600 dietary supplement products on the market, and FDA has received approximately 700 NDI notifications since we began reviewing NDI notifications approximately 16 years ago. Additionally, the Institute of Medicine has estimated that 1,000 new dietary supplements are introduced to the market each year These figures, coupled with recent concern by both the agency and industry regarding the presence of undeclared active ingredients in products marketed as dietary supplements, highlight the necessity for marketers of dietary supplements to submit NDI notifications as an important preventive control to ensure that the consumer is not exposed to potential unnecessary public health risks in the form of new ingredients with unknown safety profiles.

Reading between the lines it appears that FDA believes and what is called for in the law is that if you are going to release products with new ingredients you are going to have to spend the time and money to submit a proper NDI.

As the guidance is currently stated, almost any ingredient that was not marketed prior to 1994 or that you have altered in any manner (including using extraction methods other than water or alcohol and even baking) will be considered to be altered such that it is a new dietary ingredient for which a notification must be filed.

This document seems to create a much greater responsibility for supplement companies to provide safety data on their “dietary supplement products” that contain NDIs, than what industry has been accustomed to, or than what industry may even be capable of. We know this will be a difficult process for many but we will work with our clients to help them with their compliance. Currently we are reviewing and analyzing the document to provide our clients with a thorough response and direction on how to address the requirements contained therein.