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The Standardized Information on Dietary Ingredients (SIDI) Work Group released an updated SIDI Protocol in September.
The Standardized Information on Dietary Ingredients (SIDI) Work Group released an updated SIDI Protocol in September. Last updated in 2008, the SIDI Protocol provides suppliers a standard format for communicating information about their raw materials to manufacturers who want to qualify their ingredient suppliers as part of 21 CFR 111, FDA’s current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.
Duffy MacKay, senior vice president, scientific and regulatory affairs, for the Council for Responsible Nutrition (CRN; Washington, DC), which initiated the SIDI Work Group, explains to Nutritional Outlook that SIDI provides a standardized questionnaire that companies can use to exchange raw material information. He says, “cGMPs say you can reduce the amount of product testing and ingredient testing you do if you qualify your vendors, but they don’t explain exactly what they mean, so they put a lot of flexibility on manufacturers.” As a result, raw material suppliers are often flooded with ingredient questionnaires from various manufacturers, with each questionnaire different from one another, which is highly burdensome for the raw material supplier.
“The questionnaires were a broad frustration rampant across the industry,” said MacKay, and that’s when industry trade groups came together to form the SIDI Work Group and develop the SIDI Protocol. Currently, the SIDI Work Group is made up of the United Natural Products Alliance, the Consumer Healthcare Products Association, and the Council for Responsible Nutrition.
Considering that the protocol was last updated in 2008, the Work Group had a great deal of work to do. “We started from scratch again, went through each line of it,” says MacKay. The updates regarded new terminology from the Food Safety Modernization Act, tightening up of best practices, and improving the protocol’s customizability, an important feature of the protocol as it will be utilized by many parties.
“[The protocol is] really beneficial to people whose job is sourcing ingredients, so they can develop a SIDI dossier about what information [they expect to be] provided by manufacturers of ingredients,” MacKay explains. “The other side of it is ingredient manufacturers will create SIDI documents that will explain their particular ingredient, and when they get contacted with questionnaires, they’ll respond by saying ‘We really appreciate your questionnaire, there are a lot of good questions but why don’t you look at this packet of information we have pre-prepared and see if you have any remaining questions?’ and that usually can satisfy most manufacturers’ needs.”