A voluntary protocol could prompt "a major paradigm shift for many in the [dietary supplement] industry by moving away from unique individualized questionnaires towards standardized documentation and information exchange," trade groups say.

The Standardized Information on Dietary Ingredients (SIDI) program, announced Oct. 18, was created to simplify and standardize the exchange of information between ingredient suppliers and product manufacturers, the groups state.

The program results from a cooperative effort between the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition and the Natural Products Association.

The trade groups and industry members such as Bayer, Kemin, Leiner Health Products, NBTY, Perrigo and Pharmavite developed SIDI through the joint Standardized Ingredient Information Protocol (SIIP) working group.

Passage of the Food Allergen Labeling & Consumer Protection Act of 2004 led to the inception of the information standardization program. The act "created the need for additional information to be shared between manufacturers and suppliers," said CHPA Associate Director-Scientific Affairs Marcia Howard, PhD.

FDA in October 2005 issued a guidance for industry on compliance with the allergen labeling requirements mandated by the law (¹ Also see "FDA Guidance Clarifies Labeling For Supplements Containing Food Allergens" - Pink Sheet, 24 October, 2005., p. 10).

The SIDI protocol also may aid companies in preparing for FDA's long-awaited final rule for dietary supplement good manufacturing practices.

"This initiative will increase productivity and assist in understanding, analyzing, controlling and documenting the manufacturing process all the way through the supply chain, which will be mandated when the GMPs are posted for dietary supplements," Natural Products Association's VP-Scientific Affairs Daniel Fabricant states in the groups' joint statement.

"Although the initial impetus for SIDI had nothing to do with GMPs, we think the project could be beneficial when GMPs become final," Howard said.

Manufacturers currently garner information on dietary ingredients from suppliers through detailed and lengthy questionnaires to determine the source and quality of ingredients.

"These questionnaires vary from manufacturer to manufacturer and ingredient to ingredient, sometimes leading to discrepancies and confusion," as well as possibly resulting in delays to resolve discrepancies, the trade associations state.

If SIDI proves successful in the supplement sector, other future applications of the program could be in the functional food and retail industries, which could benefit from increased efficiency and quality information about ingredients and product, said CRN VP-Scientific Affairs Andrew Shao, PhD.

SIDI was modeled on the International Pharmaceutical Excipients Council's (IPEC) Standardized Excipient Information Protocol User Guide, the groups said.

"Without the template from IPEC and guidance of IPEC, this process would have been much more labor intensive and may not have even succeeded from a development standpoint," Howard stated.

The initiative includes three standardized information sheets to facilitate communication among industry members: the Product Information Data Sheet, the Site Quality Overview and the Supply Chain Security Overview.

The Data Sheet contains spaces to list product-specific physical, manufacturing and regulatory information and includes separate sub-sections for botanical and non-botanical ingredients.

The second part of the protocol "is designed to evaluate the fundamental site-specific manufacturing practices and quality systems of suppliers," the groups say.

SIDI's third element "provides an overview of a supplier's plans to protect ingredient and supply continuity while preserving proprietary details of security controls."

The Data Sheet is available on the trade groups' websites. The other sections are not completed and will be released "in the coming months," the supplement associations say.

SIIP will meet at CHPA on Dec. 5 to review the Site Quality and Supply Chain sections, Howard said.

- Jessica Lake

SIDI Program Will Standardize Ingredient Protocol – Supplement Trade Groups

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