The New England Journal of Medicine has published an opinion piece written by Pieter Cohen of Harvard Medical School which is strongly critical of FDA’s approach to Dietary Supplement New Ingredient Notification. Readers who have access to the NEJM should read this article which has been misinterpreted by journalists in the industry press. We have seen this opinion piece erroneously referred to as a “study” in the press.

Serious students of food safety should read the NEJM article and refer to the July 2011 “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues”.

We post the Draft Guidance below noting that we cannot provide the NEJM article because of copyright restrictions. Readers with subscriptions or data base access to the NEJM will find the article in the January 2012 NEJM pre-publication listing. (Cohen, Pieter A., “Assessing Supplement Safety – The FDA’s Controversial Proposal”)