When is a dual column label required?

For conventional foods, 21 CFR 101.9(b)(12)(i) requires per-serving and per-container columns for individually packaged and sold products containing 200% through 300% of the applicable RACC, subject to exceptions (A)-(C). Section (b)(2)(i)(D) separately covers discrete units in that range, using per-serving and per-individual-unit columns. Individually sold packages below 200% RACC are generally one serving under (b)(6); the 150%-200% range permits the specified voluntary household-measure comparison. These are RACC ratios, not simply 1-2 declared servings. A per-100g or per-100mL column may be voluntary under (b)(10); it does not replace a required package/unit column. Confirm package type, RACC, physical-fit conditions and applicable exceptions before choosing a layout.

Supplement Facts follows 21 CFR 101.36. Separate %DV columns are required when the product is represented for more than one RDI group under (b)(2)(iii)(E). A per-serving/per-container comparison has a different purpose and must use meaningful headings and amounts. The food package/RACC dual-column trigger must not be automatically applied to dietary supplements. A bottle containing multiple servings does not by itself require a per-container comparison.