SIDI Article

Download as pdf or txt
Download as pdf or txt
You are on page 1of 2

Nutraceuticals World - Serving the Dietary Supplement, Functional Food and Nutritional Beverage Industries

Beauty Packaging | Coatings World | Contract Pharma | HAPPI


Rodman Publications Online: Ink World | Label & Narrow Web | Medical Product Outsourcing | Nonwovens Industry
Nutraceuticals World | Orthopedic Design & Technology | Pharma & Bio Ingredients
Home The SIDI Protocol
Current Issue
Four trade associations have come together to streamline the
Table of Contents
process of sourcing raw materials for dietary supplements.
From the Editor
By Marian Zboraj
Nutraceuticals Association Editor
Research
Crossword Solutions With thousands of raw dietary ingredients in use today, and thousands of
buyers and sellers of these ingredients, identifying and properly qualifying the
Top of the News appropriate ingredient from a trustworthy source is a time- and resource-
Meetings Calendar 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
Ad Index irrelevant to the product, the questionnaires vary from manufacturer to manufacturer and ingredient to ingredient,
Archive sometimes leading to discrepancies and confusion. This can result in lengthy delays while representatives from both
parties sort through the issues.
2007 Buyers' Guide
Well, there may be a solution. The American Herbal Products Association (AHPA), Silver Spring, MD, the Consumer
Subscription Services
Healthcare Products Association (CHPA), Washington, D.C., the Council for Responsible Nutrition (CRN),
Webinars 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
Media Info
Information on Dietary Ingredients (SIDI)—is designed to facilitate the exchange of information between ingredient
Advertising Print/Online suppliers and finished product manufacturers by providing standards for the exchange of raw ingredient information.
2007 Media Planner
The SIDI initiative was actually inspired by the work of the excipients industry, led by the International Pharmaceutical
BPA Audit 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
Literature Showcase
usually resulted in lost time and resources. So the excipients industry came up with a similar standardized system and
Company Capabilities brought the concept to the dietary supplement industry.
Professional Resources
Upon hearing the concept, Andrew Shao, PhD, vice president, Scientific & Regulatory Affairs, CRN, who has been
About Us 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
Staff
group set out to tackle the issue similar to the way the excipients folks did,” said Dr. Shao. “We collaborated to put
Editorial Advisory Board 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,
Columnists
except it’s all outlined. The intent is for the supplier to use the guideline to develop their own information packages on
Privacy Statement 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.
Join our email
mailing list 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.

subscribe Intended to facilitate the use of the ingredient in finished products, the Product Information Data Sheet includes
unsubscribe 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
Submit 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

http://www.nutraceuticalsworld.com/articles/2006/12/the-sidi-protocol.php (1 of 2)12/29/2006 12:02:03 PM


Nutraceuticals World - Serving the Dietary Supplement, Functional Food and Nutritional Beverage Industries

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.”

*Interested parties can access SIDI through the four trade associations’ websites: www.ahpa.org, www.chpa-
info.org, www.crnusa.org and www.naturalproductsassoc.org.*

http://www.nutraceuticalsworld.com/articles/2006/12/the-sidi-protocol.php (2 of 2)12/29/2006 12:02:03 PM

You might also like