The dietary supplement industry’s self-regulatory coalition, the SIDI Work Group, recently released an updated draft of the “Standardized Information on Dietary Ingredients (SIDI) Protocol,” and seeks feedback from industry stakeholders and regulators by July 3, 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 (cGMPs)—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 (FDA) regulatory requirements, including updates related to the 2011 Food Safety Modernization Act (FSMA). In addition, the updated draft addresses issues such as economically motivated adulteration and pre-Dietary Supplement Health and Education Act (DSHEA) 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—the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN) and the United Natural Products Alliance (UNPA)—along with dietary supplement ingredient suppliers and finished product manufacturers with an interest in strengthening the industry’s self-regulatory practices.
“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,” said Duffy MacKay, ND, chair of the SIDI Work Group executive committee and senior vice president, scientific and regulatory affairs, CRN. “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 draft Protocol and comments form are available at www.sidiworkgroup.com.