By Riëtte van Laack –
On July 30, FDA announced the publication of a draft guidance titled “FDA’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels”. The draft guidance addresses an apparent conflict between FDA’s compliance guidelines and FDA’s rounding rules for nutrition labeling. The relevant regulations have been in effect for approximately two decades and the conflict is not new, so it is unclear what induced FDA to issue this guidance now.
So what is it all about? The nutrition labeling regulations, 21 C.F.R. §§ 101.9(c)(1)-(8); 101.36(b)(2)(ii), specify how to declare nutrients and dietary ingredients. Notably, the regulations specify the rounding of nutrients, e.g., the quantitative amount of total fat present at 5 g or less must be rounded to the nearest 0.5 increment. The regulations also specify how FDA tests for compliance. Paragraphs (g)(4)(ii) and (g)(5) of section 101.9 detail what is often referred to as the 20-20 rule. Specifically, under the compliance provisions a product declaring the amount of a nutrient or dietary ingredient is misbranded if:
- The amount of a naturally present vitamin, mineral, protein, total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated fat, monounsaturated fat or potassium is less than 80% of the declared value for that nutrient
- The amount of calories, sugars, total fat, saturated fat, trans fat, cholesterol, or sodium is more than 120% of the declared value for that nutrient.
For small amounts, however, it may not be possible to comply with the rounding requirements under 101.9(c)(1)-(8) and meet the compliance standard of 101.9(g), because the rounding may result in more than the permissible 20% deviation. For example, if a food contains 0.70 g of saturated fat per serving, this amount would be declared as 0.5 g, but this declaration would not comply with § 101.9(g)(5) because 0.70 g is more than 20 percent in excess of 0.5 g.
FDA advises that the label should declare nutrients and dietary ingredients in accordance with the rounding rules set forth in § 101.9(c)(1) through (8). In cases that a conflict may arise between the rounding rules regarding the declaration of nutrients and the compliance requirements, FDA intends to use its enforcement discretion.
FDA will evaluate whether it should change the nutrition labeling regulation (either the rounding rules or the compliance criteria) to address this potential conflict.
Although comments may be submitted at any time, to be considered in finalizing the guidance, they should be submitted by September 28, 2015.