Hearing on potential changes to Redbook to take place tomorrow

NOI urges FDA to end attempts to regulate dietary supplements as food additives

08-Dec-2014 - Last updated on 08-Dec-2014 at 17:47 GMT

Marc Ullman

The Food and Drug Administration should finalize the revised draft guidance for New Dietary Ingredients (NDIs) and stop attempting to regulate the products and their ingredients as ‘food additives’, says Marc Ullman on behalf of Natural Organics, Inc.

The FDA will host a public meeting tomorrow, December 9, in College Park, MD to discuss updating the Industry Guidance “Toxicological Principles for the Safety Assessment of Food Ingredients” (the CFSAN ‘Redbook’) to include dietary supplements. The day’s agenda can be found here.

Presenting on behalf of NOI, Marc Ullman from Ullman, Shapiro & Ullman, LLP, will tell the hearing that these revisions contravene the express will of Congress and the Dietary Supplement Health and Education Act (DSHEA).

“Reasonable expectation of safety”

Dietary supplements and the ingredients therein are presumed safe under the terms of DSHEA if they were on the market prior to October 15, 1994. Those introduced after that date are subject to a 75-day pre-market notification requirement – a New Dietary Ingredient Notification (NDIN) – to show that there is a ‘reasonable expectation’ that the ingredient will be safe for its intended use.

“Beyond violating the specific provisions of DSHEA, adoption of the food additive standard of ‘reasonable certainty’ will have serious potential for stifling innovation by discouraging development of new supplement ingredients,” says Ullman. “Increased costs, possible loss of intellectual property protections because the ‘reasonable certainty’ standard may create a framework wherein dietary ingredient marketers are unable to rely on proprietary/unpublished studies as is currently permitted with NDI notifications, and higher burden of proof will likely cause fewer companies to pursue the introduction of new ingredients with substantial public health benefits-for example astaxanthin - into the marketplace thus harming both the trade and the public health.”

Ullman will conclude his presentation by stating: “NOI urges FDA to stop the illegal, unproductive waste of resources involved in its apparently never ending effort to dismiss DSHEA and regulate dietary supplements as food additives. Instead, these resources should be devoted to publishing the promised revised draft guidance for New Dietary ingredients as well as adequate, fair enforcement of DHSEA as Congress intended it to be implemented over 20 years ago.”

Ullman’s presentation is also supported by the Nutritional Health Alliance.