Mono- and diglycerides of fatty acids

Mono- and diglycerides are affirmed as generally recognized as safe (GRAS) as a direct human food ingredient under 21 CFR 184.1505, which describes them as "a mixture of glyceryl mono- and diesters, and minor amounts of triesters, that are prepared from fats or oils or fat-forming acids that are derived from edible sources" and provides that the ingredient "is used in food with no limitation other than current good manufacturing practice." That affirmation stands in the current Code of Federal Regulations. The FDA determination that removed GRAS status for the primary dietary source of artificial trans fat applies to partially hydrogenated oils, which are a separate regulatory class.

Mono- and diglycerides carry their own standing GRAS affirmation under 21 CFR 184.1505 - "no limitation other than current good manufacturing practice." The FDA action that removed GRAS status for artificial trans fat applies to partially hydrogenated oils, a separate class.

The Nutrition Facts panel defines its fat declaration in triglyceride terms: under 21 CFR 101.9(c)(2), total fat is "defined as total lipid fatty acids and expressed as triglycerides," and under 101.9(c)(2)(ii) trans fat is "the sum of all unsaturated fatty acids that contain one or more isolated (i.e., nonconjugated) double bonds in a trans configuration." Mono- and diglycerides are defined by the FDA's own regulation (21 CFR 184.1505) as "a mixture of glyceryl mono- and diesters, and minor amounts of triesters" - a different molecular form from the triglycerides the declaration is expressed as.

The Nutrition Facts fat declaration is defined "as triglycerides" (21 CFR 101.9(c)(2)); mono- and diglycerides are defined in the FDA's own regulation as glyceryl mono- and diesters - a different molecular form.