An approved design file is not yet a released production label.

Worked Supplement Facts checks

Amino acid blends: the panel may not disclose the ratio

Individual amino acids have no established Daily Value. Under the proprietary-blend rules, these other dietary ingredients can be listed by descending weight with their combined amount, rather than an amount for each amino acid (21 CFR 101.36(b)(3), (c)).

For a fictional example, 3,000 mg of BCAAs in a leucine:isoleucine:valine ratio of 2:1:1 by weight means 1,500 mg, 750 mg and 750 mg respectively. A blend total and ingredient order alone cannot establish that ratio. Keep the individual amounts and their measurement basis in the approved specification, even when they are not individually disclosed on the panel. This is arithmetic, not a formulation recommendation or a complete sample label.

Protein requires separate review. The rule excludes a Protein declaration for products consisting only of individual amino acids, apart from ingredients added solely for technological purposes (101.36(b)(2)(i)). This can concern a mixture of individual amino acids, not just a single-amino-acid product. Ask your regulatory reviewer how the complete formula, including any protein-containing gelling agent, fits that condition; do not decide from the blend's name alone.

Before approving artwork, identify each amino acid's amount, free-form or compound basis, and the purpose of any other protein-containing ingredient. This section approves neither the panel nor a protein or performance claim.

Related decision: how blend headings relate to nutrient declarations.

When a formula does declare protein, the grams and the % Daily Value use different bases, as the following separate collagen illustration shows.

When a collagen gummy declares protein

For a collagen gummy with a declarable amount of protein, the protein grams and its % Daily Value use different calculation bases. The example below is for adults and children four years and older, not products specifically intended for infants, younger children, pregnancy or lactation.

For a dietary supplement, the % Daily Value for protein is based on the corrected amount of protein: the actual protein per serving multiplied by its protein digestibility-corrected amino acid score (PDCAAS), capped at 1.00, determined by the method the regulation specifies (21 CFR 101.36(b)(2)(iii); 21 CFR 101.9(c)(7)(ii)). For products intended for adults and children four years and older, the reference is 50 g of protein. Products for infants, children one through three years, or pregnant or lactating women follow different provisions.

Collagen protein lacks the indispensable amino acid tryptophan. A published analysis notes that, in theory, PDCAAS equals zero when an indispensable amino acid is missing, as with collagen protein, while arguing that collagen's score in isolation has little practical meaning within a mixed diet (Paul et al., 2019). That work models whole diets; it is not a test of any gummy. The article reports no external funding, and its first author disclosed research services for a supplement manufacturer.

An arithmetic illustration

Every value below is hypothetical. The score of zero is an assumption for this illustration; a real product's score must be established for its own protein content, including any other protein source in the formula. This is not final label artwork.

How that result is displayed on the panel is a separate question. For nutrients with a Daily Reference Value, FDA's rule addresses percentages that round to zero; confirm the applicable display with your regulatory reviewer.

Before approving any protein wording, ask:

• What is the protein content of the collagen ingredient, and on what nitrogen-to-protein basis was it determined?
• Does the formula contain any other protein source that would change the score of the protein mixture?
• Who will establish the product's score, and by which method?

This section does not approve a label, a protein claim or any benefit statement.

Translate IU, mcg and raw-material milligrams before approving a D3 + K2 specification

A D3 + K2 brief can mix three kinds of numbers: International Units for vitamin D, micrograms for vitamin K, and milligrams of the powders that carry them. They describe different things: nutrient amounts, optional equivalent units and source-material mass must be kept separate.

On a Supplement Facts panel, vitamin D is declared in micrograms. An IU amount may be added, but only in parentheses after the microgram figure. The Daily Values for adults and children four years and older are 20 mcg for vitamin D and 120 mcg for vitamin K (21 CFR 101.9(c)(8)(iv)). One microgram of vitamin D equals 40 IU (NIH Office of Dietary Supplements). The declared amount is the weight of the vitamin itself, not of the ingredient that supplies it; a source such as menaquinone-7 can be identified in parentheses after the vitamin name (21 CFR 101.36(b)(2)(ii) and (d)).

A fictional translation

Suppose a brief requests 2,000 IU of vitamin D3 and 100 mcg of vitamin K2 as menaquinone-7 per two-gummy serving. The raw-material potencies below are invented for arithmetic, not typical or recommended values.

The two powders together weigh 70 mg per serving. In a hypothetical 6 g serving, the vitamin D3 powder would be about 0.3% of the gummy mass. This illustrates why mixing and sampling questions belong in the specification, and why a quote should state both the vitamin amount and the material potency and basis it assumes.

Separate formulation targets from compliance checks

For vitamins meeting the Class I definition, the rule relates the nutrient content of the composite to at least the declared value. Dietary-supplement sampling uses a representative composite of 12 consumer packages or 10% of the packages in the inspection lot, whichever is smaller (21 CFR 101.36(f)(1); 21 CFR 101.9(g)(3)-(4)). This is not an assertion that every gummy must individually equal the label amount, nor that a composite result proves within-batch uniformity. Have the reviewer specify the applicable sampling, method and acceptance requirements. Reasonable excesses remain subject to current good manufacturing practice; this page sets neither an overage percentage nor a safe upper dose or shelf-life conclusion.

Before approving the specification, record:

• Each vitamin's label amount in the label unit, and any IU figure shown in parentheses.
• Each raw material's stated potency, its units and basis, and the supplier document it comes from.
• The planned formulated amount relative to the label value, with its rationale.
• The finished-product method and acceptance rule for each vitamin.

Label wording, including how vitamin K is named, needs your regulatory reviewer's approval. This section does not recommend an intake or support a health claim.

Recalculate reference percentages when adapting an England-market label

A percentage on an existing food-supplement label is not ready to copy into a U.S. panel. First reconcile the portion and nutrient amount, then use the reference value for the intended U.S. population.

In England, regulation 6 requires numerical amounts for the relevant substances per recommended daily portion, based on the manufacturer's average analysis. Listed vitamins and minerals also carry a percentage of their reference value. For the comparison below, the reference annex supplies adult values. The U.S. column uses values for adults and children four years and older, not infant, younger-child, pregnancy or lactation panels (21 CFR 101.9(c)(8)(iv)).

For a fictional example, 25 mcg vitamin D ÷ 5 mcg × 100 = 500%, whereas 25 mcg ÷ 20 mcg × 100 = 125%. These percentages compare the same nutrient amount only when the U.S. serving equals the England-market recommended daily portion. If the daily portion is two gummies but the proposed U.S. serving is one, recalculate the amount too; do not just change the percentage. A serving cannot be selected merely to obtain a preferred percentage.

Record the existing daily portion, proposed U.S. serving in pieces, nutrient amount on each basis, intended population, and the reviewer responsible for the recalculation. U.S. serving and %DV presentation must follow 21 CFR 101.36(b), including applicable rounding and exceptions.

This is a separate arithmetic example from the D3/K2 powder calculation above, not a recommended intake, complete label or market-entry approval. It does not assess rules elsewhere in the UK or the rest of either market's labeling requirements.

Before the front panel says "sugar free"

A sweetener choice does not approve a label claim. Before releasing artwork, ask your U.S. regulatory reviewer to document the three conditions in 21 CFR 101.60(c)(1):

1. Sugars evidence: less than 0.5 g of sugars per reference amount customarily consumed and per labeled serving. Record both bases and the analytical support. For supplements, the reference amount is the maximum recommended amount per eating occasion, or one unit if no recommendation is given.
2. Ingredient review: identify any ingredient that is sugar or generally understood to contain sugars. Where the rule's exception applies, an asterisk after that ingredient must point to the specified negligible-sugar statement below the ingredient list.
3. Calorie route and placement: document qualifying low-calorie, reduced-calorie or relative-claim labeling under paragraph (c)(1)(iii)(A); its special alternative for supplements that meet the low-calorie definition but are prohibited from making that claim; or one of the specified accompanying statements under (B), placed immediately beside every use of the sugar-free claim. Merely replacing sugar does not select this route.

Keep the formula revision, ingredient specifications, sugars results, calorie basis and marked-up artwork together. Under 21 CFR 101.36(b)(2)(i), total sugars at an amount eligible for declaration as zero must not be listed in Supplement Facts; an absent sugars line is therefore not the supporting test record. Separately document the reviewer's decision on sugar-alcohol declaration for the actual wording and composition.

Treat "no added sugar" and "reduced sugar" as separate claim reviews, not interchangeable alternatives. This checklist is a preparation aid, not approval of a formula, label or Sucotond manufacturing capability.