We are a small dietary supplement manufacturer of liquid mineral supplements. I am trying to understand how to list the ingredients on the label.
101.36(b)(2)(i) The (b)(2)-dietary ingredients to be declared, that is, total calories, calories from fat, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium and iron, shall be declared when they are present in a dietary supplement in quantitative amounts by weight that exceed the amount that can be declared as zero in nutrition labeling of foods in accordance with 101.9©. Calories from saturated fat and polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, sugar alcohol, and other carbohydrate may be declared, but they shall be declared when a claim is made about them. Any other vitamins or minerals listed in 101.9©(8)(iv) or ©(9) may be declared, but they shall be declared when they are added to the product for purposes of supplementation, or when a claim is made about them. Any (b)(2)-dietary ingredients that are not present, or that are present in amounts that can be declared as zero in 101.9©, shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals). Protein shall not be declared on labels of products that, other than ingredients added solely for technological reasons, contain only individual amino acids.
All our minerals are added for purposes of supplementation and most have claims made about them. So I can declare other minerals that are less than 2 percent of RDI or DRV, or don't have established RDI or DRV (b)(3).
However, it appears that I cannot declare sodium, calcium or iron when they are less than 2 percent of RDI. This is a problem because we have claims about them. Even our calcium liquid mineral product is less than 2% (just calcium and water).
(Please put aside the topic of "why small amounts". This is the formula I have to work with.)
Am I understanding this properly? Sodium, Calcium or Iron are not to listed if they are less than 2%. They can't even be listed with "less than 1% of DV".
I appreciate any advice offered.
Thanks,
Jane