(WASHINGTON, D.C.) — The dietary supplement industry’s self-regulatory coalition, the SIDI Work Group, today released an updated version of the Standardized Information on Dietary Ingredients (SIDI TM) Protocol. Originally published in 2006, and previously updated in 2008, the newly-released SIDI Protocol provides a standardized format for dietary ingredient suppliers to communicate consistent regulatory and quality information on their ingredients and facilities to inquiring manufacturers. In addition to features that enable enhanced customizability, the newly-released Protocol makes available templates for dietary ingredient datasheets and a site quality overview as companion tools.
“The updated SIDI Protocol helps ensure suppliers and manufacturers can exchange comprehensive ingredient information consistently and reliably,” said Duffy MacKay, N.D., chair of the SIDI Work Group’s executive committee, and senior vice president, scientific & regulatory affairs, Council for Responsible Nutrition (CRN). “Ingredient suppliers recognize the need to provide accurate ingredient information to manufacturers, but a high volume of customer questionnaires asking for the same information in myriad ways can complicate the process. Using the standardized format presented in the SIDI Protocol, dietary supplement ingredient suppliers can proactively deliver information more efficiently, and manufacturers have a trusted framework for requesting the standard data that they need.”
As required by 21 CFR 111, current Good Manufacturing Practices (cGMPs) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, dietary supplement manufacturers must qualify their ingredient suppliers to ensure that specifications for the identity, purity, strength, composition, and limits on potential contaminants for dietary supplements are consistently met to produce quality products. The primary purpose of the SIDI Protocol is to help stakeholders satisfy cGMP requirements by establishing a standard format for communicating crucial information so that a manufacturer can properly assess a supplier’s suitability as a provider of raw materials. To enhance customizability, the updated Protocol 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, 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), 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’s goal is to provide tools that industry can use to maintain the integrity of the supply chain by helping supplement manufacturers work with quality suppliers and source quality ingredients,” continued Dr. MacKay. “The SIDI Protocol can be adopted across the industry so that companies of any size and budget are operating on an equal playing field, ensuring all stakeholders supply and receive the same level and quality of information. As a result, companies have the tools they need to ensure the products sent to market meet the stringent standards and expectations of regulators—and their consumers.”
The updated SIDI Protocol and accompanying documents are available at www.SIDIworkgroup.com.
Contacts:
CRN: Holly Vogtman (hvogtman@crnusa.org/202.204.7665)
UNPA: Frank Lampe (frank@unpa.com/720.398.8172)
