Comments sought for soy claim

FDA is seeking public comment on its record-retention products that make a health claim on food labels linking soy protein with reducing the risk of heart disease.

To bear the claim, foods must contain at least 6.25 grams of soy protein per reference amount commonly consumed.

Analytical methods currently exist to quantify the amount of soy protein in foods that contain soy as the sole source of protein, but there are no similar analytical methods for quantifying the amount of soy protein in foods containing other sources of protein as well. For these foods, FDA relies on information known only to the manufacturer to ensure that the food contains the required amount of soy protein. As a result, manufacturers must keep records to substantiate the amount of soy protein in a food that bears the health claim. The information required include nutrient databases or analyses, recipes or formulations, purchase orders for ingredients, or any other data that can substantiate the ratio of soy protein to total protein.

FDA is asking for comment (by September 10, 2002) on whether the proposed information retraction is necessary; whether the agency’s estimates of the burden to manufacturers are accurate; how this burden could be minimized; and how to enhance the quality, usefulness, and clarity of the information.

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