USA: FDA CORNER
The U.S. Food and Drug Administration issued a revised draft guidance to improve dietary supplement companies’ new dietary ingredient (NDI) premarket safety notifications to the agency. These notifications help the agency identify safety concerns before products reach consumers.
Under the Dietary Supplement Health and Education Act (DSHEA), the manufacturer or distributor must notify the FDA at least 75 days before beginning to market a dietary supplement that contains a new dietary ingredient (one that was not marketed in the United States before Oct. 15, 1994), unless the NDI is used in the food supply without chemical alteration. Dietary supplements are considered adulterated if they contain an NDI not used in the food supply and the required notification has not been submitted to the FDA 75 days before marketing.
One key goal of this guidance is to improve the rate of compliance with the NDI notification requirement.
In 2012, FDA estimated that the number of dietary supplements on the market was 55,600 and that 5,560 new dietary supplement products come on the market each year. This is in contrast to the approximately 4,000 products that were on the market in 1994. As of December 2014, FDA had received and completed evaluation of just over 750 NDI notifications since the first notification was received in 1995. These figures, coupled with recent concern about the presence of undeclared active ingredients in products marketed as dietary supplements, highlight the importance of submitting NDI notifications as a preventive control to ensure that consumers are not exposed to unnecessary public health risks in the form of new ingredients with unknown safety profiles.
To improve public understanding of the NDI notification requirement, this guidance includes an in-depth discussion of the scope of the requirement, along with detailed examples of situations in which a notification would or would not be required.
What do the terms “dietary ingredient” and “new dietary ingredient” mean?
As defined in the regulations/ the FD&C Act, a “dietary ingredient” is any one of the following:
(A) A vitamin;
(B) A mineral;
(C) An herb or other botanical;
(D) An amino acid;
(E) A dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
(F) A concentrate, metabolite, constituent, extract, or combination of any ingredient described in (A), (B), (C), (D), or (E).
An NDI is defined as a dietary ingredient that was not marketed in the U.S. before October 15, 1994
The Role and Responsibility of Industry to Address This Problem
Manufacturers, distributors, importers and others in the supply chain of dietary supplements are responsible for ensuring that their products comply with the regulations FDA enforces. Therefore, responsible individuals should take appropriate steps to ensure that their products do not contain active ingredients that may cause the product to be an unapproved new drug, a misbranded drug and/or an adulterated or misbranded dietary supplement, such as: those in FDA-approved drugs, analogs of approved drugs, active pharmaceutical ingredients removed from the market for safety reasons, new chemical ingredients that have not been studied adequately in humans, or controlled substances.
Source: Food and Drug Administration new guideline (2016) on “Dietary Supplements: New Dietary Ingredient (NDI) Notifications (US-FDA Website)