Dietary supplement industry outlines new pedigree protocol – Drug Store News

WASHINGTON — The dietary supplement industry’s self-regulatory coalition, the SIDI Work Group, on Thursday released an updated draft of the “Standardized Information on Dietary Ingredients Protocol,” and is seeking feedback from industry stakeholders and regulators by July 3.


“The SIDI Work Group convened regularly over several months developing an updated draft that addresses new food safety regulations implemented since version 2.1 was released in 2008,” stated Duffy MacKay, chair of the SIDI Work Group executive committee and SVP, scientific and regulatory affairs, Council for Responsible Nutrition. “We welcome comments from industry stakeholders and regulatory officials for consideration as we finalize this next edition of the Protocol, slated for release by the end of 2017.”


The SIDI Protocol has gained significant traction within the industry since its original release in 2008. The Protocol provides an outline representing the type and scope of information about a dietary ingredient that an ingredient supplier typically needs to provide to a manufacturer. The primary goal of the Protocol is to recommend a standard format for presenting this information — which facilitates compliance with current good manufacturing practices — so that information exchange can be accomplished in a simplified and streamlined manner.


The updated draft SIDI Protocol reflects changes in the U.S. Food and Drug Administration’s regulatory requirements, including updates related to the 2011 Food Safety Modernization Act . In addition, the updated draft addresses issues such as economically motivated adulteration and pre-Dietary Supplement Health and Education Act status of dietary ingredients.


To enhance customizability, the updated draft also includes additional examples of the type of information that could be offered for dietary ingredients, including safety studies and history of safe use data for demonstrating safety and information on sourcing and sustainability.    


The SIDI Work Group is a joint initiative of three dietary supplement industry trade associations — in additionto CRN, there are the Consumer Healthcare Products Association and the United Natural Products Alliance.


The draft Protocol and comment form are available on the SIDI Work Group website.

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