SIDI Protocol and Supply Chain Management

In today’s complex global supply chain, the demand and need for information is at an all-time high. As the world faces wide reaching incidents of contaminated or adulterated consumer products and foods, the ability to trace products back through their respective distribution chains and assure raw materials are sourced from reputable suppliers has become a priority for the U.S. FDA, Congress and regulated consumer products’ industries.

For the dietary supplements industry, the same situation applies. Indeed, properly qualifying ingredient suppliers and distributors is an essential component of the new dietary supplement GMPs (good manufacturing practices).While FDA emphasizes this need, the agency has provided no guidance on how suppliers should be qualified. Furthermore, although manufacturers of dietary supplements are subject to the new GMPs, ingredient suppliers are still held to food GMPs, considered a less stringent standard. Combine that with the majority of raw materials sourced globally, and a very difficult and complex supply chain management challenge presents itself. One thing is clear: an enormous amount of information must be gathered, processed and evaluated.

In an effort to fill the void of ingredient supplier qualification, the Council for Responsible Nutrition (CRN), American Herbal Products Association (AHPA), Consumer Products Healthcare Association (CHPA) and Natural Products Association (NPA) jointly developed the Standardized Information on Dietary Ingredients (SIDI™) protocol, a tool to assist with information exchange between ingredient suppliers and dietary supplement manufacturers.

The protocol provides manufacturers with standards on relevant information needed on raw dietary ingredients in a voluntary, standardized system. It is not a questionnaire or a template; rather it’s a guideline that defines the minimum type and scope of information that should be covered, including ingredient origin, manufacturing process, potential contaminants and quality control measures, as well as a comprehensive glossary that points to key terms and authoritative bodies where users can access further information. In short, it puts everything in one place and provides a guideline for how to best compile all of the information.

Collecting information is the first step in the critical process of knowing and qualifying your suppliers. SIDI is designed to assist with compiling and exchanging this information, and its use represents a critical initial step in the supplier qualification process.

Current industry practice involves manufacturers requiring ingredient suppliers to fill out various forms or questionnaires. This outdated approach for information gathering is inefficient, ineffective and exposes manufacturers to liabilities associated with unanswered or incorrectly answered questions. For ingredient suppliers, the advantages of using SIDI include having complete ingredient information in one standardized format. With this comes reduced completion times, increased accuracy, reduction of liability and potential for electronic data to be interchanged more easily, whether forms being available for download or being able to be retrieved more readily.

A number of large manufacturers and ingredient suppliers have adopted SIDI as an important self-regulatory step; but, since the protocol is a free and voluntary program, its reach is likely even more broad. The associations strongly encourage the use of the SIDI protocol by all of their members, in hopes that this will become an industry-wide standard. SIDI has also been presented to FDA. While the agency is not willing to officially endorse or require SIDI at this time, FDA has responded favorably to use of the program and suggested other uses for SIDI, including in the drafting of New Dietary Ingredient Notifications (NDIs). Compiling ingredient information according to SIDI can have other uses as well, such as for international registrations or even for use by retailers.

Regardless of the end purpose (GMP compliance, avoiding questionnaires, audits, NDI notifications, product registrations) or end user (manufacturers, third party auditors, FDA or retailers), the same information is needed. SIDI is a tool to assist in compiling and organizing this information.

For more an in-depth review of the SIDI protocol, Dr. Shao will be co-presenting an informative seminar on approaches for increasing the awareness and improving the utility of the SIDI on April 18, as part of the dietary supplement educaiton track at SupplySide East in Secaucus, N.Y. Visit SupplySideShow.com/East for more details.

Andrew Shao, Ph.D., is vice president, scientific and regulatory affairs of the Council for Responsible Nutrition (CRN), a Washington-based trade association representing dietary supplement industry ingredient suppliers and manufacturers.