In 2006 following the passage of the Food Allergen Labeling and Consumer Protection Act of 2004 (Public Law 108-282, Title II), the leading dietary supplement trade associations launched a voluntary industry-wide initiative — the Standardized Information on Dietary Ingredients (SIDI)™ Protocol — to facilitate efficient exchange of information between ingredient suppliers and finished product manufacturers. The SIDI Work Group was formed to bring volunteers with ingredient and manufacturing expertise together to identify and develop useful tools to help ensure regulatory compliance. Soon after the June 25, 2007, release of the dietary supplement good manufacturing practices (GMPs), the SIDI Work Group, expanded its focus to address issues associated with GMP compliance (21 CFR Part 111).
Since its inception, the SIDI Work Group has released two voluntary industry guidelines to assist members of the dietary supplement industry with efforts to comply with U.S. FDA dietary supplement GMPs:
- SIDI™ Protocol (a tool to standardize information exchanged between manufacturers and suppliers) and
- Certificate of Analysis (CoA) Guidelines (a tool designed to assist with ensuring CoAs serve their intended role in assessment of dietary component specifications)
A third voluntary guideline, on supplier qualifications, is under development and is now available in draft form for stakeholder comment and review.
All SIDI-related information, including how to join the SIDI Work Group, and documents are available to the public at http://sidiworkgroup.com/.