In September, the SIDITM Workgroup released an updated version (Version 3.0) of the Standardized Information on Dietary Ingredients (SIDITM) Protocol. A group comprised of the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), and the United Natural Products Alliance (UNPA), and their member companies produced this most recent version. CRN, CHPA, the Natural Products Association (NPA), and the American Herbal Products Association (AHPA) developed the initial version in 2006 and Version 2.0 in 2008.
The purpose of the Protocol is to offer a standardized format for dietary supplement ingredient suppliers to use when providing qualifying information to dietary supplement manufacturers who purchase the ingredients. Before the creation of the SIDI™ Protocol, dietary supplement manufacturers each provided suppliers with qualifying questionnaires resulting in suppliers filling out a different questionnaire for each manufacturer, each requiring much of the same information. The SIDITM Protocol attempts to provide an industry-wide supplier qualification process and supporting documentation thereby allowing suppliers to complete information for each ingredient in a single format to send to each manufacturer interested in their ingredients.
The text of the Protocol reads, “(t)he SIDITM Protocol defines the type and scope of information that manufacturers typically seek from ingredient suppliers. The primary goal of the SIDITM Protocol is to provide standards, for voluntary use, in the exchange of relevant and required information between ingredient suppliers and dietary supplement manufacturers that enable both parties to maximize resources.
Ingredient suppliers will be able to deliver consistent information more proactively and efficiently, and dietary supplement manufacturers will be able to anticipate the type and format of the standard data that they need.”
The SIDITM Workgroup drew up the Protocol to comply with FDA Dietary Supplement cGMPs (21 CFR Part 111) to ensure the information required by the Protocol would be sufficient for manufacturers marketing products in the United States, as well as other countries that accept FDA compliant supplements.
The Protocol consists of two sections. Part I addresses Product Information and outlines important manufacturing, physical, chemical, labeling, and regulatory information specific to the dietary ingredient. Part I is divided into non-botanical and botanical dietary ingredients due to the unique characteristics of each product type. Part II, Site Quality Review, provides information on qualifying the production facility. The Protocol includes templates for use in executing both parts of the guideline.
Use of the Protocol, and accompanying templates is strictly voluntary and is not intended to replace a supplier audit. The Workgroup based the SIDITM Protocol on the International Pharmaceutical Excipients Council (IPEC) Excipient Information Protocol (EIP). The EIP was created for drug excipients but many principles of the document are useful for dietary ingredients as well.
In addition to the recently-updated SIDITM Protocol, the SIDITM Workgroup offers two additional resources for registered users of their website. A Certificate of Analysis (CoA) Guideline to assist with ensuring CoAs serve their intended role in the assessment of dietary component qualities and specifications, and a Dietary Supplement Component Supplier Qualification guideline to assist manufacturers of dietary supplements (or other users of dietary supplement components) with supply chain integrity and compliance with dietary supplement cGMPs. Templates for use with these guidelines are also available.
To view SIDITM Protocol Version 3.0 Click Here