The SIDI Protocol
By Marian Zboraj | 12.01.06
Four trade associations have come together to streamline the process of sourcing raw materials for dietary supplements.
With thousands of raw dietary ingredients in use today, and thousands of buyers and sellers of these ingredients, identifying and properly qualifying the appropriate ingredient from a trustworthy source is a time- and resource-consuming process. The current practice of requiring vendors to fill out lengthy product questionnaires from manufacturers isn't helping matters. Besides including questions that may often be irrelevant to the product, the questionnaires vary from manufacturer to manufacturer and ingredient to ingredient, sometimes leading to discrepancies and confusion. This can result in lengthy delays while representatives from both parties sort through the issues.
Well, there may be a solution. The American Herbal Products Association (AHPA), Silver Spring, MD, the Consumer Healthcare Products Association (CHPA), Washington, D.C., the Council for Responsible Nutrition (CRN), Washington, D.C., and the Natural Products Association, Washington, D.C., have joined forces in October to create a system to eliminate the need for cumbersome questionnaires. This voluntary industry-wide protocol-Standardized Information on Dietary Ingredients (SIDI)-is designed to facilitate the exchange of information between ingredient suppliers and finished product manufacturers by providing standards for the exchange of raw ingredient information.
The SIDI initiative was actually inspired by the work of the excipients industry, led by the International Pharmaceutical Excipients Council (IPEC), which addressed similar questionnaire issues. These questionnaires were frequently filled out incorrectly, requiring a manufacturer or user to go back and ask for more information. This back-and-forth period usually resulted in lost time and resources. So the excipients industry came up with a similar standardized system and brought the concept to the dietary supplement industry.
Upon hearing the concept, Andrew Shao, PhD, vice president, Scientific & Regulatory Affairs, CRN, who has been leading the SIDI initiative, enlisted the assistance of AHPA, CHPA, the Natural Products Association and a combination of manufacturer and supplier members who were interested in forming a working group. "The working group set out to tackle the issue similar to the way the excipients folks did," said Dr. Shao. "We collaborated to put together a guideline document that covers the type and scope of information that a manufacturer would want to know about a vendor's ingredient." The SIDI protocol or guideline addresses the same areas covered in a questionnaire, except it's all outlined. The intent is for the supplier to use the guideline to develop their own information packages on their ingredients and then provide them to their customers proactively in lieu of filling out questionnaires.
"Not only can vitamin and mineral companies rely on SIDI, it can be applied to botanicals as well since the protocol includes a separate sub-section to address botanical ingredients," said Dr. Shao.
So what are these guidelines? The SIDI protocol includes three standardized sections-Product Information Data Sheet, Site Quality Overview and Supply Chain Security Overview-along with a comprehensive glossary containing definitions of key terms and links to relevant websites.
Intended to facilitate the use of the ingredient in finished products, the Product Information Data Sheet includes important physical/chemical, labeling, manufacturing, regulatory and miscellaneous product information specific to the ingredient. The Site Quality Overview assists in evaluating the manufacturing practices and quality systems of ingredient suppliers. Intended to address the foundation of the requirements, this section communicates the level of quality control employed at a supplier's site. The final section, the Supply Chain Security Overview, is designed to provide manufacturers with information concerning the ingredient supplier's plans to ensure the protection of the product (i.e. compliant with bioterrorism act, security systems in place) and the continuity of supply.
The first section of the protocol, Product Information Data, is available at the websites of the participating trade associations. The final two sections are under review and will be posted in the coming months. Once all three sections have gone through review, SIDI will be provided to the FDA for comment (unofficial statements from the agency suggest the protocol is an excellent idea).
In addition to the guideline documents, there are blank example template forms as well as completed sample forms to serve as examples for users. The protocol is not designed to address every possible piece of information that a manufacture might desire for a given ingredient; it provides the basic type and scope of information that ingredient suppliers should consider providing to their customers. If the manufacturer desires additional information, it can be requested and provided separately in the form of a separate attachment or cover letter.
The potential advantages of using the SIDI Protocol are industry wide, benefiting the manufactures, ingredient suppliers and even consumers. Manufacturers may now be able to receive consistent and updated information from multiple suppliers, therefore being able to quickly retrieve/interpret information and achieve a reduction/reallocation of costs/resources. Other benefits for manufactures include change control; more accessible information to FDA; facilitation of FDA or other third party audits (all information is already assembled); and smoother merger/acquisition transitions. From the ingredient suppliers' perspective, they may now able to complete information packages in a standardized format (rather than filling out countless differing questionnaires), reducing completion time and increasing accuracy of information. Other advantages include change control/notification and liability risk is potentially reduced. Additionally, since standardization of any process can reduce risk of error, SIDI has the potential to benefit consumers as well. A more organized system of vendor qualification could increase safety/quality of the products consumers purchase.
Moving away from individualized questionnaires toward standardized documentation will represent a major shift for the industry, and Dr. Shao understands that acceptance won't be easy. "The issue is that manufacturers are accustomed to developing and providing their own questionnaires. It's a major paradigm shift because people are used to using the same procedures," he said. "Suppliers will need to begin compiling their information as their ingredients go through the product development process and as specifications are developed. They need to add that data into their information package, so that at launch and post-launch, the package is ready and available to be provided to customers." Manufactures also need more departments reviewing and signing off on the information package than just the purchasing manager. It's a more collaborative and interactive effort on both ends than it probably is today.
"The more it gets adopted and implemented, the easier it will be for manufacturers to use instead of sending out their own questionnaire," commented Dr. Shao.
Overall, SIDI's main goal is to streamline information exchange between suppliers and manufacturers, thereby helping to identify and properly qualify supplement ingredients from trustworthy sources. So although use of the SIDI protocol is completely voluntary, and there is no means of enforcing its use, companies are strongly encouraged to rely on it.
"All we can do is provide the guidelines to the industry and hope they will adopt the concept and implement it on their own," said. Dr. Shao. "The trade associations and companies that have been involved in the intensive process believe the SIDI protocol is a more effective, efficient, forward-thinking approach to communication between suppliers and finished product manufacturers to assure affordable quality product for consumers."
Well, there may be a solution. The American Herbal Products Association (AHPA), Silver Spring, MD, the Consumer Healthcare Products Association (CHPA), Washington, D.C., the Council for Responsible Nutrition (CRN), Washington, D.C., and the Natural Products Association, Washington, D.C., have joined forces in October to create a system to eliminate the need for cumbersome questionnaires. This voluntary industry-wide protocol-Standardized Information on Dietary Ingredients (SIDI)-is designed to facilitate the exchange of information between ingredient suppliers and finished product manufacturers by providing standards for the exchange of raw ingredient information.
The SIDI initiative was actually inspired by the work of the excipients industry, led by the International Pharmaceutical Excipients Council (IPEC), which addressed similar questionnaire issues. These questionnaires were frequently filled out incorrectly, requiring a manufacturer or user to go back and ask for more information. This back-and-forth period usually resulted in lost time and resources. So the excipients industry came up with a similar standardized system and brought the concept to the dietary supplement industry.
Upon hearing the concept, Andrew Shao, PhD, vice president, Scientific & Regulatory Affairs, CRN, who has been leading the SIDI initiative, enlisted the assistance of AHPA, CHPA, the Natural Products Association and a combination of manufacturer and supplier members who were interested in forming a working group. "The working group set out to tackle the issue similar to the way the excipients folks did," said Dr. Shao. "We collaborated to put together a guideline document that covers the type and scope of information that a manufacturer would want to know about a vendor's ingredient." The SIDI protocol or guideline addresses the same areas covered in a questionnaire, except it's all outlined. The intent is for the supplier to use the guideline to develop their own information packages on their ingredients and then provide them to their customers proactively in lieu of filling out questionnaires.
"Not only can vitamin and mineral companies rely on SIDI, it can be applied to botanicals as well since the protocol includes a separate sub-section to address botanical ingredients," said Dr. Shao.
So what are these guidelines? The SIDI protocol includes three standardized sections-Product Information Data Sheet, Site Quality Overview and Supply Chain Security Overview-along with a comprehensive glossary containing definitions of key terms and links to relevant websites.
Intended to facilitate the use of the ingredient in finished products, the Product Information Data Sheet includes important physical/chemical, labeling, manufacturing, regulatory and miscellaneous product information specific to the ingredient. The Site Quality Overview assists in evaluating the manufacturing practices and quality systems of ingredient suppliers. Intended to address the foundation of the requirements, this section communicates the level of quality control employed at a supplier's site. The final section, the Supply Chain Security Overview, is designed to provide manufacturers with information concerning the ingredient supplier's plans to ensure the protection of the product (i.e. compliant with bioterrorism act, security systems in place) and the continuity of supply.
The first section of the protocol, Product Information Data, is available at the websites of the participating trade associations. The final two sections are under review and will be posted in the coming months. Once all three sections have gone through review, SIDI will be provided to the FDA for comment (unofficial statements from the agency suggest the protocol is an excellent idea).
In addition to the guideline documents, there are blank example template forms as well as completed sample forms to serve as examples for users. The protocol is not designed to address every possible piece of information that a manufacture might desire for a given ingredient; it provides the basic type and scope of information that ingredient suppliers should consider providing to their customers. If the manufacturer desires additional information, it can be requested and provided separately in the form of a separate attachment or cover letter.
The potential advantages of using the SIDI Protocol are industry wide, benefiting the manufactures, ingredient suppliers and even consumers. Manufacturers may now be able to receive consistent and updated information from multiple suppliers, therefore being able to quickly retrieve/interpret information and achieve a reduction/reallocation of costs/resources. Other benefits for manufactures include change control; more accessible information to FDA; facilitation of FDA or other third party audits (all information is already assembled); and smoother merger/acquisition transitions. From the ingredient suppliers' perspective, they may now able to complete information packages in a standardized format (rather than filling out countless differing questionnaires), reducing completion time and increasing accuracy of information. Other advantages include change control/notification and liability risk is potentially reduced. Additionally, since standardization of any process can reduce risk of error, SIDI has the potential to benefit consumers as well. A more organized system of vendor qualification could increase safety/quality of the products consumers purchase.
Moving away from individualized questionnaires toward standardized documentation will represent a major shift for the industry, and Dr. Shao understands that acceptance won't be easy. "The issue is that manufacturers are accustomed to developing and providing their own questionnaires. It's a major paradigm shift because people are used to using the same procedures," he said. "Suppliers will need to begin compiling their information as their ingredients go through the product development process and as specifications are developed. They need to add that data into their information package, so that at launch and post-launch, the package is ready and available to be provided to customers." Manufactures also need more departments reviewing and signing off on the information package than just the purchasing manager. It's a more collaborative and interactive effort on both ends than it probably is today.
"The more it gets adopted and implemented, the easier it will be for manufacturers to use instead of sending out their own questionnaire," commented Dr. Shao.
Overall, SIDI's main goal is to streamline information exchange between suppliers and manufacturers, thereby helping to identify and properly qualify supplement ingredients from trustworthy sources. So although use of the SIDI protocol is completely voluntary, and there is no means of enforcing its use, companies are strongly encouraged to rely on it.
"All we can do is provide the guidelines to the industry and hope they will adopt the concept and implement it on their own," said. Dr. Shao. "The trade associations and companies that have been involved in the intensive process believe the SIDI protocol is a more effective, efficient, forward-thinking approach to communication between suppliers and finished product manufacturers to assure affordable quality product for consumers."
