United States: Recordkeeping for Added Sugars
Records are how FDA verifies Added Sugars. Failing to keep them is itself misbranding.
For most nutrients, records are supporting material. For Added Sugars they are the compliance mechanism itself, because there is no analytical method FDA can fall back on. The declaration is verified through the records you keep under 21 CFR 101.9(g)(10) and (11).
Why records carry the weight here
No analytical method can verify this number, so 21 CFR 101.9(g)(5) routes around it. A parenthetical there removes Added Sugars from tolerance testing whenever your food also contains naturally occurring sugars — which is nearly always.
FDA explains the reasoning directly:
because there are no generally recognized analytical methods available to quantify added sugars in a food when the food contains sugars that do and do not meet our definition of added sugars… When a food contains a combination of sugars that do and do not meet our definition of added sugars, we would verify the declaration of added sugars in a food using the records required by § 101.9(g)(10) and (11).
— FDA Q&A guidance (November 2018, revised December 2019), question 17
There is no certificate of analysis that can substantiate this number. Your records are the substantiation.
Added Sugars is not quite alone in this. 21 CFR 101.9(g)(10) sets up records-based verification for a handful of declarations whose added and intrinsic forms cannot be told apart analytically — certain dietary fiber blends, some forms of vitamin E, and folate mixed with folic acid.
When records are required
Two triggers, both in 21 CFR 101.9(g)(10).
A mixture of naturally occurring and added sugars — (g)(10)(iv). You must keep written records of the amount of Added Sugars put into the food during processing, and as packaged where packaged as a separate ingredient. Almost every formulated food with any fruit, dairy or grain in it meets this trigger.
Fermentation or non-enzymatic browning — (g)(10)(v). Additional requirements depending on which of the three routes you take. See Fermentation and browning.
What counts as a record
FDA names the acceptable types in the opening line of (g)(10):
The manufacturer must make and keep written records (e.g., analyses of databases, recipes, formulations, information from recipes or formulations, or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label…
Your formulation is a record. So is a supplier specification sheet stating an ingredient's Added Sugars content, a batch record, or a documented database analysis. FDA is not asking for a novel artifact — it is asking you to retain and be able to produce the reasoning you already did.
Where you relied on a permitted simplification, document that too. If you used the Brix values in 21 CFR 101.30 to estimate single-strength juice sugars, FDA states you must document this information in the records (Q&A question 8).
What form must records take, and for how long?
The operative requirements are in 21 CFR 101.9(g)(11):
| Requirement | Detail |
|---|---|
| Retention | At least 2 years after introduction or delivery for introduction into interstate commerce |
| Access | Provided to FDA on request, during an inspection, for review and reproduction |
| Acceptable formats | Originals; true copies (photocopies, pictures, scans, microfilm, microfiche); or electronic records kept per 21 CFR part 11 |
| Quality | Accurate, indelible, and legible |
There is no filing deadline and nothing to submit proactively. The obligation is to have them and to hand them over when asked.
Does a correct declaration satisfy the records requirement?
No. The two obligations are separate, and failing the records one is itself a violation. The regulation states the consequence directly:
Failure to make and keep the records or provide the records to appropriate regulatory authorities, as required by this paragraph (g)(11), would result in the food being misbranded under section 403(a)(1) of the act.
Neither substitutes for the other. The record never appears on the package, and the panel is not evidence of how its number was derived.
What a useful record contains
The regulation sets a purpose but not a template. 21 CFR 101.9(g)(10) requires written records "to verify the declared amount of that nutrient on the Nutrition Facts label," and names the kinds of documents that count — "analyses of databases, recipes, formulations, information from recipes or formulations, or batch records" — without prescribing any fields.
The checklist below is not FDA's. FDA publishes no template for this. Each row is derived from what verification requires: reproducing the declared figure from the formulation, and showing where each value came from. The right-hand column gives the reason for each row, so you can drop any that does not apply to your product.
| Item | Why it is there | |
|---|---|---|
| ☐ | Product and formulation version the record describes | A record that does not identify its formulation version cannot substantiate a label after reformulation |
| ☐ | Declared Added Sugars — grams per serving and percent Daily Value | The number being substantiated |
| ☐ | Serving basis — serving size and servings per container | Makes the per-serving figure reproducible |
| ☐ | Per ingredient: amount used | The input to the calculation |
| ☐ | Per ingredient: Added Sugars value attributed | The determination itself |
| ☐ | Per ingredient: where that value came from — supplier specification, the single-ingredient rule, a Brix calculation, or reasoning from the ingredient statement | This is the substantiation; the number alone is not |
| ☐ | Supporting documents attached — supplier specification sheets, certificates, correspondence | FDA expects you to work with suppliers for values only they hold |
| ☐ | Any judgment you made, with its basis | Where the determination was not mechanical |
| ☐ | For fermented or browned products: which route (A, B or C), and for Route A the supporting data plus the written narrative | 101.9(g)(10)(v) requires the narrative, not just the data |
| ☐ | Any simplification relied on — for example the 21 CFR 101.30 Brix values | FDA permits these and requires them documented |
| ☐ | Who determined it, and when | Establishes provenance |
Note the formulation-version line. A record that does not identify which version of the formulation it describes cannot substantiate the label that came from that version, so a reformulation leaves the earlier record unable to support either panel.
The reasoning can be recorded compactly. One shape it can take: "Added Sugars of 17g per serving comprises granulated sugar (149.7g per batch) and honey (49.26g per batch, 82.1g sugars per 100g); banana, blueberries and milk contribute naturally occurring sugars only." Whether that is sufficient depends on your product — a determination resting on judgment or supplier data needs those attached too.
What if a supplier will not provide a value?
Document the determination you made instead — and do not record the value as zero. FDA acknowledges that you may not hold the information yourself:
Manufacturers may need to work with their suppliers to determine the amount of free mono- and disaccharides in ingredients used in a food's formulation.
Suppliers are not obliged to give you unrounded per-100g data, and some will not. Where a supplier value is unavailable, the resolution is a documented determination — not a zero. Record what you asked for, what you received, and what you concluded.
Where to go next
- How to determine Added Sugars — the determination the record substantiates
- Fermentation and browning — the additional records each route requires
This page is educational and is not legal advice. FDA guidance documents cited here state FDA's current thinking and are not binding — you may use an alternative approach that satisfies the regulation. Verify every rule against the current regulation and your own regulatory counsel before relying on it for a commercial label.