![]() Under section 403(a) of the FD&C Act, a food is misbranded if its labeling is false or misleading in any particular. In describing the intended use of chromium polynicotinate and in describing the information that Exponent relies on to conclude that chromium polynicotinate is GRAS under the conditions of its intended use, Exponent raises a potential issue under the labeling provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). ![]() Exponent cites published studies showing that chromium polynicotinate is not mutagenic or genotoxic.īased on the available scientific evidence, Exponent concludes that chromium polynicotinate is GRAS under the conditions of its intended use. Based on published sub-chronic, two-generation reproduction, and developmental toxicity studies on chromium polynicotinate, Exponent concludes that orally consumed chromium polynicotinate is well tolerated and does not cause adverse effects up to a dose of 5.86 mg/kg bw/day. Exponent concludes from these studies that the oral bioavailability of chromium is low (0.5-2%), irrespective of the chromium compound administered, including chromium polynicotinate. population aged two years and older to be 202 µg/person/day (p/d) (or 3.1 µg/kilogram body weight per d (kg bw/d) at the mean, and 342 µg/p/d (or 5.6 µg/kg bw/d) at the 90th percentile.Įxponent discusses published studies in rats and humans addressing the oral bioavailability and safety of chromium polynicotinate. Exponent calculates the mean and 90th percentile dietary exposures to chromium polynicotinate for users-only in the U.S. ![]() Data from five nonconsecutive batch analyses of chromium polynicotinate demonstrate that the product meets specifications.Įxponent estimates the dietary exposure to chromium polynicotinate using food consumption data included in the 2011-2012 National Health and Nutrition Examination Survey (NHANES). Exponent states that the remainder of the final product is sodium chloride. Specifications for chromium, niacin, and water in the final product add up to less than 78%. Specifications include moisture (<8 %), chromium (≥100 milligrams per gram (mg/g)), niacin (≥600 mg/g), arsenic (<1 µg/g), cadmium (<0.3 µg/g), lead (<0.5 µg/g), and mercury (<0.3 µg/g), as well as limits for potential microbial contaminants. After drying and grinding, the final product contains chromium polynicotinate and sodium chloride.Įxponent provides specifications for chromium polynicotinate. Sodium hydroxide is used as a processing aid to adjust the pH. Chromium polynicotinate is synthesized from niacin and chromium chloride in an aqueous solution. 1Įxponent describes the method of manufacture of chromium polynicotinate produced in accordance with cGMP. Exponent states that chromium polynicotinate is a mixture of chromium dinicotinate and chromium trinicotinate, with the latter being the predominant form. Exponent describes chromium polynicotinate as an oxygen-coordinated, niacin-bound trivalent chromium complex. Based on this review and the totality of scientific evidence, Exponent’s GRAS panel concluded that chromium polynicotinate, produced in accordance with current good manufacturing practice (cGMP) and meeting described specifications, is GRAS under the intended conditions of use.Įxponent provides information on the identity and composition of chromium polynicotinate. Exponent’s GRAS panel reviewed the identity and composition, method of manufacture, specifications, and intended use and dietary exposure to chromium polynicotinate, as well as publicly available studies supporting the safety of chromium polynicotinate. Exponent considers the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. ![]() (Exponent) that chromium polynicotinate is GRAS, through scientific procedures, for use as an ingredient in enhanced water beverages at a maximum use level of 575 micrograms per liter (µg/l).Īs part of its notice, Exponent includes a statement from a panel of individuals (Exponent’s GRAS panel) that evaluated the data and information that are the basis for Exponent’s GRAS determination. The notice informs FDA of the view of Exponent, Inc. The subject of the notice is chromium polynicotinate. FDA received the notice on December 9, 2015, filed it on December 15, 2015, and designated it as GRAS Notice No. The Food and Drug Administration (FDA) is responding to the notice, dated December 8, 2015, that you submitted in accordance with the agency’s proposed regulation, proposed 21 CFR 170.36 (62 FR 18938 ApSubstances Generally Recognized as Safe (GRAS) the GRAS proposal). See also Generally Recognized as Safe (GRAS). Return to inventory listing: GRAS Notice Inventory
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