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Added Sugars Labeling Requirements

21 CFR 101.9(c)(6)(iii) defines added sugars, carves out four exceptions, fixes the wording and indent of the declaration, and triggers a recordkeeping duty. All four jobs, in the order a label reviewer checks them.

Baking station with flour, sugar cubes and a cracked egg in a bowl

The added sugar label requirements sit in one dense paragraph of the Code of Federal Regulations, 21 CFR 101.9(c)(6)(iii), and it does four jobs at once: it defines what counts as an added sugar, carves out four situations where a sugar that looks added is not, dictates the exact wording and placement of the declaration, and triggers a recordkeeping duty reaching most foods that contain any sugar. This article works through it in that order, then covers the records provisions in 101.9(g)(10) and (g)(11). Every fact below comes from the current text of 21 CFR 101.9.

Sugars from one ingredient Added during the processing of the food, or packaged as such? No Does not count Yes A juice concentrate used for 100% juice, Brix, or the fruit part of a jam or spread? Yes Does not count No Counts, a juice sweetener only the excess Includes 9 g Added Sugars18%
The test in 101.9(c)(6)(iii) applied to one ingredient. Two questions decide it, and everything surviving both is summed, rounded and declared on the indented Includes line, shown here for a sauce with 9 g of added sugars per serving against the 50 g Daily Value.

What the regulation defines as an added sugar

The definition is one sentence with three inclusion limbs and four exclusions, quoted closely from 101.9(c)(6)(iii): "Added sugars are either added during the processing of foods, or are packaged as such, and include sugars (free, mono and disaccharides), sugars from syrups and honey, and sugars from concentrated fruit or vegetable juices that are in excess of what would be expected from the same volume of 100 percent fruit or vegetable juice of the same type, except that fruit or vegetable juice concentrated from 100 percent juices sold to consumers, fruit or vegetable juice concentrates used towards the total juice percentage label declaration under 101.30 or for Brix standardization under 102.33(g)(2) of this chapter, fruit juice concentrates which are used to formulate the fruit component of jellies, jams, or preserves in accordance with the standard of identities set forth in 150.140 and 150.160 of this chapter, or the fruit component of fruit spreads shall not be labeled as added sugars."

Read the opening clause carefully. "Either added during the processing of foods, or are packaged as such" is a two-part test. The first part is obvious: you put sugar into the formula. The second catches products where nothing was added to anything, because the sugar is the product. A bag of table sugar, a bottle of agave, a jar of syrup: no processing step added sugar to them, but they are packaged as sugar, so their whole sugar content is added sugars.

The three inclusion limbs say what forms qualify. Sugars meaning free mono and disaccharides: sucrose, glucose, fructose, dextrose, maltose, in any commercial form. Sugars from syrups and honey: corn syrup, high fructose corn syrup, malt syrup, rice syrup, molasses, maple syrup, honey. The regulation names honey explicitly, which forecloses the argument that it is a natural sweetener outside the definition. And sugars from concentrated fruit or vegetable juices, but only the excess over what the same volume of 100 percent juice of the same type would contribute. A concentrate reconstituted to single strength contributes nothing to the line; the same concentrate used undiluted as a sweetener contributes the difference. Note "of the same type": apple juice concentrate is measured against apple juice, not a generic figure.

Then the four exclusions, all concerning juice concentrates and none concerning cane sugar, honey or syrups:

  1. Fruit or vegetable juice concentrated from 100 percent juices sold to consumers: frozen concentrate a shopper reconstitutes at home.
  2. Juice concentrates used towards the total juice percentage declaration under 21 CFR 101.30.
  3. Juice concentrates used for Brix standardization under 21 CFR 102.33(g)(2), bringing a juice back to its standard sugar level rather than sweetening it.
  4. Fruit juice concentrates used for the fruit component of jellies, jams or preserves under the standards of identity in 21 CFR 150.140 and 150.160, and the fruit component of fruit spreads.

Two categories sit outside the definition: sugar alcohols, which are not sugars and have their own voluntary line under 101.9(c)(6)(iv), and naturally occurring sugars never added and never packaged as sugar, such as the lactose in milk or the fructose in a diced peach.

The mandatory declaration and where it goes on the panel

The regulation is specific about the form of words. Added sugars content "shall be indented under Total Sugars and shall be prefaced with the word Includes followed by the amount (in grams) Added Sugars". So the line reads: the word Includes, the number, a space and the letter g, then the words Added Sugars. Not "Added Sugars 9g", not "of which added sugars". It is mandatory for every food bearing a Nutrition Facts label that contains 1 g or more of added sugars per serving. Placement and typography come from 101.9(d), and those rules produce a line that looks different from the one above it:

RequirementWhat it means on the panelSource
Indented under Total SugarsBelow Total Sugars and inset from it, inside the carbohydrate block101.9(c)(6)(iii)
Name not highlightedOnly non-indented nutrient names are bold, so the Includes text is regular weight101.9(d)(1)(iv)
Percentage highlightedEvery percent Daily Value is bold, so the percentage is bold beside non-bold text101.9(d)(1)(iv)
Type size floorNo smaller than 8 point101.9(d)(1)(iii)
AbbreviationIncludes may be shortened to Incl., including on the dual column displays101.9(j)(13)(ii)(B)

The percentage in that bold column comes from the Daily Value table in 101.9(c)(9): 50 g for adults and children 4 years and older and for pregnant and lactating women, 25 g for children 1 through 3, none for infants through 12 months. Under 101.9(j)(5)(ii)(A), labels for infants through 12 months show no percent Daily Value for added sugars at all and carry no footnote. Labels for children 1 through 3 do carry one, against that 25 g Daily Value, and 101.9(j)(5)(iii) requires a footnote stating that 1,000 calories a day is used for general nutrition advice. Take the sauce in the figure: 9 g per serving divided by the 50 g Daily Value is 18 percent, so the line reads Includes 9 g Added Sugars with 18% beside it. On a label for children 1 through 3 the divisor is 25 g and the same 9 g is 36 percent. The grams do not move; the percentage doubles.

Added sugar label requirements for rounding

Added sugars uses the plain gram ladder, the same one total sugars, dietary fiber and protein use. Three rungs, no others.

Analytical amount per servingWhat you may declareWorked example
1 g or moreExpressed to the nearest gram8.6 g declares as 9 g
0.5 g up to but not including 1 g"Contains less than 1 gram" or "less than 1 gram"0.7 g declares as less than 1 g
Less than 0.5 gMay be expressed as zero0.3 g declares as 0 g

Three details trip people up. The symbol "<" may replace "less than" under 101.9(d)(7)(i), so "Incl. <1 g Added Sugars" is compliant on a panel short of room. The sub-0.5 g rule is permissive: the content "may be expressed as zero", so declaring 0 g is a choice, and omitting the line is the alternative covered next. And these rules govern the gram amount only. The percentage has its own rule in 101.9(d)(7)(ii): nearest whole percent, from either the amount declared on the label or the actual amount before rounding. Both inputs are permitted, so two compliant labels for the same sauce can differ by a percentage point. Pick one method and apply it everywhere; which nutrients use which ladder is set out in FDA rounding rules explained.

One constraint is not in the rounding rules but follows from 101.9(g)(10)(v)(B): in no event shall the amount of added sugars declared exceed the amount of total sugars on the label. A panel where the indented line is larger than the line above it is wrong on its face.

When the line may be omitted, and the statement you owe instead

Label declaration is not required for products containing less than 1 gram of added sugars in a serving, but only "if no claims are made about sweeteners, sugars, added sugars, or sugar alcohol content". Both halves must be true: make any claim in that family and you declare the line even at 0.2 g. Our claim validator lists which sugar and sweetener claims are defined, the quickest way to check whether a phrase on your front panel has pulled the line back in.

If the declaration is not required and, as a result, not declared, the panel cannot stay silent. The statement "Not a significant source of added sugars" shall be placed at the bottom of the table of nutrient values in the same type size. The wording is prescribed, so a paraphrase such as "contains no added sugars" does not discharge the obligation and is in any case a claim, which reinstates the declaration. The type size must match the table, not be shrunk to fit.

One carve-out is signalled by the opening words "Except as provided for in paragraph (f) of this section": the simplified format, available when a food contains insignificant amounts of eight or more of the fifteen listed nutrients, or six or more of twelve for foods intended for infants through 12 months and children 1 through 3. There the statement takes the consolidated form under 101.9(f)(4), naming every nutrient present in insignificant amounts in one line.

So a food with 0.3 g of added sugars per serving and no sugar claims has three compliant treatments: declare Includes 0 g Added Sugars with 0% Daily Value, omit the line and carry the "Not a significant source of added sugars" statement, or use the simplified format if it qualifies. Panel space decides.

The recordkeeping obligation, and what FDA expects to see

Added sugars carries an explicit recordkeeping duty, for an analytical reason: a laboratory measuring sugars in a finished yogurt cannot tell the fructose that arrived in the fruit from the fructose that arrived in the cane sugar. The declared value is a formulation figure, not a measurement, so the regulation requires you to show the formulation.

The trigger sits at the end of 101.9(c)(6)(iii): when a mixture of naturally occurring and added sugars is present, and for foods where the added sugars are subject to fermentation or non-enzymatic browning, the manufacturer must make and keep records under 101.9(g)(10) and (11). The second trigger is broad. Non-enzymatic browning is the Maillard reaction, so bread, baked goods, roasted products and anything with a browning step are in scope; fermentation brings in yogurt, sourdough, vinegar-based products and fermented beverages.

Paragraph (g)(10) names the evidence FDA has in mind: "analyses of databases, recipes, formulations, information from recipes or formulations, or batch records". For the ordinary case, 101.9(g)(10)(iv) requires written records of the added sugars put into the food during processing, and, if packaged as a separate ingredient, as packaged. That is the formulation file, and it is what an investigator asks for first.

Where the amount of sugars is reduced through non-enzymatic browning or fermentation, 101.9(g)(10)(v) gives three routes and you must take one:

  • Route A. Keep all relevant scientific data demonstrating the added sugars remaining after browning or fermentation, plus a narrative explaining why it is sufficient. It must be specific to the type of food subject to the reaction, so a general paper on Maillard losses in baked goods will not support a figure for your sourdough.
  • Route B. Keep records of the amount added before and during processing, and as packaged if packaged as a separate ingredient, and declare on that basis. This route ignores the losses: you declare the sugar you put in, subject to the ceiling that the declared amount may not exceed total sugars.
  • Route C. Petition under 21 CFR 10.30 for an alternative means of compliance, showing why the reduction is likely to be significant, meaning large enough to affect the declaration by more than the reasonable deficiency allowed under 101.9(g)(6), and why you cannot determine a reasonable approximation.

Route B is the pragmatic default for bakers and fermenters: a slightly conservative number, and no burden of proving a loss.

Paragraph (g)(11) sets the terms of custody, and this is the part that most often fails an inspection even when the records exist. They must be kept for at least 2 years after introduction or delivery for introduction of the food into interstate commerce, and provided to FDA on request during an inspection for review and copying. They may be originals, true copies such as photocopies, scans or microfilm, or electronic records kept under 21 CFR part 11, and must be "accurate, indelible, and legible". Failure to keep or produce them would result in the food being misbranded under section 403(a)(1) of the act. The label can be perfectly correct and the product still misbranded because the file behind it is not there.

Single-ingredient sugars and syrups, in outline

Pure honey, pure maple syrup, table sugar and other single-ingredient sugars and syrups sit awkwardly inside the definition. They have no naturally occurring sugars to distinguish from added ones and are "packaged as such", so on a literal reading the Includes line would simply repeat the Total Sugars figure. FDA addressed this in final guidance issued 18 June 2019, "The Declaration of Added Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars and Syrups, and Certain Cranberry Products": these products need not declare the gram amount on the Includes line, but must still declare the percent Daily Value.

That is guidance, nonbinding and not codified in 101.9; the regulation quoted above is what binds. The dagger symbol, the footnote wording and the cranberry products provision are worked through in added sugars on the Nutrition Facts label.

Once the ingredient-by-ingredient call is made the rest is mechanical, and the nutrition label generator will sum the qualifying sugars, apply the gram ladder, divide by the right Daily Value for your age group, and set the indented Includes line in the standard, dual column and small package formats.

Frequently asked questions

Is fruit juice concentrate in my recipe an added sugar?

It depends how much you used. Under 101.9(c)(6)(iii) the added sugars are those in excess of what the same volume of 100 percent juice of the same type would contribute. Reconstitute to single strength and the excess is zero; use it undiluted as a sweetener and the excess is most of it.

Do I have to declare added sugars if my product has 0.4 g per serving?

No, provided you make no claims about sweeteners, sugars, added sugars or sugar alcohol content. You then choose: declare 0 g, since amounts below 0.5 g may be expressed as zero, or omit the line and place "Not a significant source of added sugars" at the bottom of the table of nutrient values in the same type size. Make any sugar or sweetener claim and the exemption falls away.

Can the added sugars figure be larger than total sugars?

No. 101.9(g)(10)(v)(B) states that in no event shall the amount of added sugars declared exceed the total sugars on the label. The usual cause is a fermentation or browning step that consumed sugar you are still counting, or an added sugars figure built from ingredient inputs while total sugars came from analysis of the finished product.

How long do I have to keep the records?

At least 2 years after introduction or delivery for introduction of the food into interstate commerce, under 101.9(g)(11). They must be produced to FDA on request during an inspection, may be originals, true copies or part 11 compliant electronic records, and must be accurate, indelible and legible. Failure to keep or produce them would result in the food being misbranded under section 403(a)(1) of the act, whatever the declared number was.

Does the Includes line have to be bold?

The words are not bold; the percentage is. Under 101.9(d)(1)(iv) only the names of nutrients that are not indented get bold or extra bold highlighting, and added sugars is indented. The same paragraph requires every percent Daily Value to be highlighted, and the whole line must be at least 8 point under 101.9(d)(1)(iii).