Under 21 CFR 101.9(g)(3)(i), added sugars would be a nutrient in a fortified or fabricated
food. Added sugars is not a nutrient listed in 21 CFR 101.9(g)(4)(i). The nutrients listed in
this regulation include: vitamins, minerals, protein, and dietary fiber.
When a food contains sugars that are indigenous and not exogenous sugars, the nutrient
content of the composite for “Total Sugars” and “Added Sugars” would be subject to 21 CFR
101.9(g)(5). Section 101.9(g)(5) requires that the nutrient content of the composite be no
greater than 20 percent in excess of the value for that nutrient declared on the label and states
that no regulatory action will be based on a determination of a nutrient value that falls above
this level by a factor less than the variability generally recognized for the analytical method
used in that food at the level involved.
However, because there are no generally recognized analytical methods available to quantify
added sugars in a food when the food contains sugars that do and do not meet our definition
of added sugars, the parenthetical after “added sugars” in § 101.9(g)(5) states that, “when the
only source of sugars in the food is added sugars.” The parenthetical is intended to clarify
that the requirement in § 101.9(g)(5) for the added sugars declaration would only apply when
there is an analytical method available to quantify the added sugars. When a food contains a
combination of sugars that do and do not meet our definition of added sugars, we would
verify the declaration of added sugars in a food using the records required by § 101.9(g)(10)
and (11).
With respect to the total sugars declaration, § 101.9(g)(5) would apply whether the food
contains only added sugars, only sugars that do not meet our definition of added sugars, or a
combination of these sugars in a food because there would be an analytical method to
quantify “Total Sugars” under these circumstances.
A food that already contains some indigenous sugar and additional added sugars, either
directly or as a component in an ingredient, such as sweetened fruit added to yogurt, would
be misbranded if the actual “Total Sugars” amount is greater than 20 percent in excess of the
value for that nutrient declared on the label, or the records requirements for “Added Sugars”
are not met (see § 101.9(g)(11)).
