The keto (ketogenic) diet, paleo diet, and low-carb diets for diabetics are not well-served by FDA’s food labeling regulations presently. A nutritional tenet of each of these diets is keeping carbohydrate consumption low. A low-carb diet limits foods that are significant sources of carbohydrates, such as cereal grains (e.g., breads, pasta, rice, corn chips), foods containing refined sugars (e.g., cookies, candy, pastries, soda pop) and starchy vegetables (e.g., potatoes, carrots, beets).
The problem is that food labeling claims (e.g., “low-carb”) about the carbohydrate content of a food are legally impermissible currently. If a “low-carb” claim was made in labeling, the food bearing such nutrient content claim (NCC) could be deemed by a regulatory or legal authority to be misbranded. E.g., 21 U.S.C. § 343(r)(1)(A), (r)(2)(A)(i).
“Low” (and synonyms) NCCs are authorized for other nutrients, including “low calorie,” “low fat,” “low saturated fat,” “Low cholesterol,” and “low sodium.” 21 C.F.R. §§ 101.60(b)(2), 101.61(b)(4), 101.62(b)(2), (c)(2), (d)(2). However, “low-carb” is not defined and, therefore, impermissible in labeling food. FDA’s regulations even explicitly provide:
[A] claim about the level of a nutrient in a food in relation to the Reference Daily Intake (RDI) established for that nutrient in §101.9(c)(8)(iv) or Daily Reference Value (DRV) established for that nutrient in §101.9(c)(9), (excluding total carbohydrates) may only be made on the label or in labeling of the food if …
21 C.F.R. § 101.54(a) (emphasis added).
Changing this legal landscape would entail petitioning FDA to promulgate a regulation defining “low-carb,” and possibly other emphatic (e.g., “carb free”) and comparative (e.g., “[reduced/less] carbs”) claims about the total carbohydrate content of a food. See 21 C.F.R. § 101.69. FDA’s present NCC regulations were promulgated in the early 1990s and are a bit dated. The FDA Nutrition Innovation Strategy could be used as an opportunity to update NCCs for total carbohydrates.
