Nam & Nam, Inc. t/a Sam Sung Tofu FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

Your Sam Sung Tofu label bears a “Cholesterol Free” claim but fails to meet the requirements of 21 CFR 101.62(d)(i)(D), which states that if the food contains less than 2 mg of cholesterol per reference amount customarily consumed without the benefit of special processing, alteration, formulation, or reformulation to lower cholesterol content, then the product needs to be labeled to disclose that cholesterol is not usually present in the food (e.g., “applesauce, a cholesterol-free food”).

In addition, your Sam Sung Tofu product bears a “Good Source of Protein” nutrient content claim. Under 21 CFR 101.13(n), nutrition labeling in accordance with 21 CFR 101.9 must be provided for any food for which a nutrient content claim is made. Under 21 CFR 101.9(c)(7)(i), a statement of the correct amount of protein per serving expressed as percent of Daily Value (DV) must be given if a protein claim is made for the product. However your Sam Sung Tofu product fails to provide the percent DV of protein as required under 21 CFR 101.9(c)(7)(i).  Therefore, your product is misbranded under section 403(r)(1)(A) of the Act and section 403(q) of the Act [21 U.S.C. § 343(q)], because it does not provide information in accordance with 21 CFR 101.9(c)(7)(i) on the percent DV of protein for which a

Potential Health Risks

Consumers should be aware of potential risks associated with products from Nam & Nam, Inc. t/a Sam Sung Tofu.

Regulatory Context

The net quantity of content declaration is not in accordance with 21 CFR 101.7(j)(1) which requires the declaration to be expressed both in ounces, with identification by weight or by liquid measure and, if applicable (1 pound or 1 pint or more) followed in parentheses by a declaration in pounds for weight units, with any remainder in terms of ounces or common or decimal fractions of the pound.