Nutritional Engineering Inc FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in Nutritional Engineering Inc's operations or product claims.

Potential Health Risks

The “(b)(4)” label fails to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol must follow the quantitative amount by weight for each dietary ingredient listed in accordance with 21 CFR 101.36(b)(3)(iv);

Regulatory Context

Written instructions, including specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.210(h)(1).

The product declares “preservatives” in the list of ingredients. A food to which a chemical preservative(s) is added must, except when exempt pursuant to 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function in accordance with 21 CFR 101.22(j).

The “(b)(4)” label’s serving size is expressed in a common household measure, but the measure is not followed by the equivalent metric quantity in parentheses in accordance with 21 CFR 101.9(b)(7).