Green tea catechins receive ‘no questions’ GRAS approval
The U.S. Food and Drug Administration (FDA) has issued a “no questions” GRAS letter to Kemin Industries, a global ingredient manufacturer, for its palmitoylated green tea catechins (PGTC).
The U.S. Food and Drug Administration (FDA) has issued a “no questions” GRAS letter to Kemin Industries, a global ingredient manufacturer, for its palmitoylated green tea catechins (PGTC). Kemin has branded the oil-soluble green tea extract has GT-FORT and it is available for use as an antioxidant in a variety of food and beverage products.
In its letter to the FDA, Kemin provided an estimate of the dietary exposure to PGTC based on the intended uses in food at the maximum use level and food consumption data from the National Health and Nutrition Examination Survey. The company reports that the dietary exposure to PGTC for the total U.S. population is estimated to be 135 mg/person/day at the mean and 270 mg/person/day at the 90th percentile.
Based on results of studies indicating that PGTC would be hydrolyzed to green tea catechins and palmitic acid in the body, Kemin provided estimates of dietary exposure to green tea catechins and epigallocatechin gallate (EGCG) from the intended uses of PGTC. The dietary exposure to green tea catechins is estimated to be 63 mg/person/day at the mean and 126 mg/person/day at the 90th percentile.
The dietary exposure to EGCG is estimated to be 33 mg/person/day at the mean and 66 mg/person/day at the 90th percentile. Kemin stated that these estimates are lower than the amounts of green tea catechins and EGCG typically consumed from a 240 mL serving of green tea (i.e., 316 mg and 168 mg, respectively). In addition, Kemin noted that the quantity of PGTC used would be self-limiting due to unpalatability.
The FDA’s letter concluded that “based on the information that Kemin provided, as well as other information available to FDA, we have no questions at this time regarding Kemin’s conclusion that PGTC is GRAS under its intended conditions of use.”
“We are pleased the FDA recognizes oil-soluble green tea extract as a safe ingredient,” said Courtney Schwartz, marketing director, Kemin Food Technologies. “Our brand of oil-soluble green tea extract, GT-FORT, has a body of science proving it to be efficacious as an antioxidant.”
FDA letter (pdf)