Diet Coke Plus violating US FDA food safety law

The US Food and Drug Administration (FDA) reviewed the label for Diet Coke Plus 20 FL OZ (1.25 PT) 591ml. Based on the review, FDA concluded that this product is in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

Diet Coke Plus product is misbranded within the meaning of the Act because the product makes a nutrient content claim but does not meet the criteria to make the claim.

The product bears the term “Plus” as part of its name, and the principal display panel of the product label also includes the language, “Diet Coke with Vitamins & Minerals.” The ingredient list includes the following added vitamins and minerals: magnesium sulfate (declared at 10% of the Daily Value (DV) for magnesium in the Nutrition Facts panel), zinc gluconate (declared at 10% of the DV for zinc), niacinamide (declared at 15% of the DV for niacin), pyridoxine hydrochloride (declared at 15% of the DV for vitamin B6), and cyanocobalamine (declared at 15% of the DV for vitamin B12).

The product is misbranded within the meaning of section 403(r)(1)(A) of the Act because it bears the nutrient content claim “plus” but does not comply with the regulations governing the use of this claim.

The term “plus” in “Diet Coke Plus,” read in conjunction with the language “Diet Coke with Vitamins & Minerals,” meets the definition of a nutrient content claim because it characterizes the product’s level of vitamins and minerals, which are nutrients of the type required to be in nutrition labeling (21 CFR 101.13(b)).

This term may be used on the label or in labeling of foods to describe the level of nutrients (such as vitamins and minerals) in the food, provided that
(1) the food contains at least 10 percent more of the Reference Daily Intake or Daily Reference Value for the nutrient per reference amount customarily consumed than an appropriate reference food,
(2) where the claim is based on nutrients that are added to the food, that the fortification is in accordance with the policy on fortification of foods in 21 CFR 104.20, and
(3) the claim bears the required information for relative claims as described in 21 CFR 101.13(j)(2) and 101.54(e)(1)(iii).

A company spokesman said the label on Diet Coke Plus complies with FDA policies and regulations and that it plans to reply in detail to the complaint in early January, Reuters reported.

Source: U.S. Food and Drug Administration, USA

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