How to make an FDA nutrition label for a homemade protein bar

A homemade protein bar still uses the serving-size rules in 21 CFR 101.12 and 21 CFR 101.9(b), protein rounding in 21 CFR 101.9(c)(7), and the sugar alcohol and dietary fiber lines in 21 CFR 101.9(c)(6). The worked example below is a hypothetical bar with made-up unrounded numbers, so the rounding is visible. It is not a laboratory analysis, not FDA approval, and not a decision that your bar fits a particular product category.

Open the label maker and type the per-serving numbers after you have chosen the serving. The same rounding functions are listed on the rounding rules page.

There is no “protein bar” reference amount

Table 2 of 21 CFR 101.12(b) does not name protein bars. Two nearby rows are the ones small makers usually compare:

Product category in 21 CFR 101.12Reference amount
Grain-based bars with or without filling or coating, for example breakfast bars, granola bars, and rice cereal bars 40 g
All other candies 30 g

The reference amount follows the category the food fits, based on dietary use and product characteristics. An oat bar with a grain base is the grain-based bar row in this illustration. A bar that is a confection is the candy row. This page does not classify a particular recipe.

Turn 40 grams into a serving size

21 CFR 101.9(b)(2)(i) sets the serving for a discrete unit, such as one bar in a box:

A bar packaged and sold by itself that contains less than 200 percent of the reference amount is a single-serving container. The whole bar is one serving. 21 CFR 101.9(b)(6). If that single bar is more than 150 percent and less than 200 percent of the reference amount, a second column for the household measure closest to the reference amount is voluntary, not required.

21 CFR 101.9(b)(7) puts the serving size in a common household measure followed by the gram weight in parentheses, except on a single-serving container. A multi-bar box can read “1 bar (55 g)”. Servings per container is the number of bars.

Worked example

Illustration only: an oat-and-peanut bar weighs 55 g. Against the 40 g grain-based-bar reference amount, 55 ÷ 40 is 137.5 percent. That is at least 67 percent and under 200 percent, so the serving is one bar. It is also under 200 percent, so a bar sold alone is still one serving, and it is not above 150 percent, so the voluntary extra column in 101.9(b)(6) does not apply. In a box, the statement is 1 bar (55 g).

These unrounded amounts are hypothetical numbers for that one bar. “This label prints” is the same function the Nutrition Facts panel on this site uses. Sugar alcohol is the exception: the regulation rounds it to the nearest gram, and this tool does not draw a sugar alcohol line. You still follow 21 CFR 101.9(c)(6)(iv) if the line is required.

NutrientUnrounded, per barWhat prints
Calories214210
Total fat9.4 g9 g
Saturated fat2.4 g2.5 g
Trans fat0 g0 g
Cholesterol3 mgless than 5 mg
Sodium146 mg150 mg
Total carbohydrate22.4 g22 g
Dietary fiber4.6 g5 g
Total sugars6.4 g6 g
Added sugars5.2 g5 g
Erythritol3.4 g3 g on the sugar alcohol line, when that line is declared
Protein15.6 g16 g

Total carbohydrate grams still include fiber and sugar alcohols. 21 CFR 101.9(c)(6) calculates total carbohydrate by subtracting protein, total fat, moisture, and ash from the weight of the food. Fiber and sugar alcohol are indented lines under that total. They are not subtracted from the carbohydrate gram declaration. Total sugars are only free mono- and disaccharides, so erythritol is not a sugar. 21 CFR 101.9(c)(6)(ii).

Protein rounding, and the percent Daily Value

21 CFR 101.9(c)(7): protein is stated to the nearest gram. If a serving has less than 1 gram, the label may say “Contains less than 1 gram” or “less than 1 gram.” If it has less than 0.5 gram, the content may be expressed as zero. Protein may be calculated as 6.25 times nitrogen, unless an official method requires a different factor. In the example, 15.6 grams rounds to 16 grams. This site’s panel uses that nearest-gram step for 1 gram and above. For a positive amount under 1 gram it prints “<1”, including 0.4 gram, which the regulation would also allow as zero. Details are on the rounding rules page.

A percent Daily Value next to protein is optional. It is required if the label makes a protein claim, or if the food is represented for infants through 12 months or children 1 through 3 years. 21 CFR 101.9(c)(7)(i). For adults and children 4 and older, the Daily Reference Value is 50 grams of protein. 21 CFR 101.9(c)(7)(iii). When the percent is required, it uses the corrected amount: the grams of protein multiplied by the protein digestibility-corrected amino acid score, capped at 1.00. 21 CFR 101.9(c)(7)(ii). A percent calculated from uncorrected grams is not that figure.

Printing “16 g protein,” “high protein,” or another statement about the level of protein outside the Nutrition Facts label is a nutrient content claim. 21 CFR 101.13(b). “High” and “good source” have their own thresholds in 21 CFR 101.54. A claim also removes the small-business nutrition-label exemptions. See the exemption page.

Sugar alcohols and fiber

21 CFR 101.9(c)(6)(iv): grams of sugar alcohol may be declared voluntarily. The line becomes mandatory when the label or labeling makes a claim about sugar alcohol, or about total sugars or added sugars when sugar alcohols are in the food. The line is indented under total carbohydrate and rounded to the nearest gram. Under 1 gram, “less than 1 gram” may be used. Under 0.5 gram, zero may be used. If only one sugar alcohol is present, its name, such as “erythritol,” may replace the words “sugar alcohol.”

Do not assign every carbohydrate 4 calories per gram when the bar contains sugar alcohols or non-digestible carbohydrate. 21 CFR 101.9(c)(1)(i)(C) allows 4 calories per gram for protein, for total carbohydrate minus non-digestible carbohydrates and sugar alcohols, and 9 for total fat, then 2 calories per gram for soluble non-digestible carbohydrates. 21 CFR 101.9(c)(1)(i)(F) sets the sugar-alcohol factors, in calories per gram: isomalt 2.0, lactitol 2.0, xylitol 2.4, maltitol 2.1, sorbitol 2.6, hydrogenated starch hydrolysates 3.0, mannitol 1.6, and erythritol 0. The label maker rounds the calorie number you enter. It does not apply these factors for you. Enter calories only after the factors that fit the recipe have been used.

Dietary fiber on the label is non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units), and lignin, that are intrinsic and intact in plants, plus isolated or synthetic non-digestible carbohydrates that FDA has determined have a beneficial physiological effect. 21 CFR 101.9(c)(6)(i). The regulation names beta-glucan soluble fiber, psyllium husk, cellulose, guar gum, pectin, locust bean gum, and hydroxypropylmethylcellulose. FDA’s Questions and Answers on Dietary Fiber also lists additional isolated fibers, including inulin and inulin-type fructans, for which FDA has said it intends to exercise enforcement discretion until a further rule. An added fiber that is not intrinsic and intact, and that is not one FDA has determined meets the definition, stays in total carbohydrate and is not added to the dietary fiber grams. Soluble fiber and insoluble fiber are voluntary lines unless a claim is made about them.

Fiber, total sugars, and added sugars round to the nearest gram. Under 1 gram, the label may say less than 1 gram, and declaration of dietary fiber is not required. Under 0.5 gram, zero may be used. 21 CFR 101.9(c)(6)(i) through (c)(6)(iii). On this label, 0.6 gram of fiber prints “<1” and 4.6 grams prints 5.

Questions

What serving size does a homemade protein bar use?

21 CFR 101.12 has no row named protein bar. A grain-based bar, such as a breakfast bar, granola bar, or rice cereal bar, uses a 40 gram reference amount. All other candies use 30 grams. A 55 gram bar is 137.5 percent of 40 grams, so 21 CFR 101.9(b)(2)(i)(C) makes the serving one bar. An individually packaged bar under 200 percent of the reference amount is one serving under 21 CFR 101.9(b)(6).

How does protein round on the Nutrition Facts label?

21 CFR 101.9(c)(7) expresses protein to the nearest gram. Under 1 gram, the label may say less than 1 gram. Under 0.5 gram, it may say zero. In the worked example, 15.6 grams prints 16. A percent Daily Value for protein is optional unless the package makes a protein claim or the food is for infants or children under 4. A claim uses the protein digestibility-corrected amount and a 50 gram Daily Reference Value for adults and children 4 and older.

When must sugar alcohols and fiber be listed?

21 CFR 101.9(c)(6)(iv) makes a sugar alcohol line voluntary unless the label makes a claim about sugar alcohol, or about total sugars or added sugars when sugar alcohols are present. Dietary fiber is declared when the amount is 1 gram or more, and only carbohydrates that meet the 21 CFR 101.9(c)(6)(i) definition count. Erythritol is 0 calories per gram under 21 CFR 101.9(c)(1)(i)(F). Other sugar alcohols use the factors in that paragraph, not 4 calories per gram.

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