Last verified 16 Sep 2026 · Sources
FDA’s own compliance test in 21 CFR 101.9(g) is a lab analysis of a composite sample, not a review of your spreadsheet, but the same regulation lets you build your labels from a nutrient database instead of paying for lab work, as long as the database is developed the way FDA’s guidance describes. Added nutrients (Class I) have to reach at least 100% of what’s declared; naturally occurring nutrients (Class II) only need to reach 80%; and calories, sugars, fat, saturated fat, cholesterol, and sodium can’t exceed 120% of the declared value. Most small and mid-size brands meet that standard with a well-built database, not a lab invoice.
| Quick facts | Database vs Lab Analysis |
|---|---|
| Regulation | 21 CFR 101.9(g) |
| Applies to | Any manufacturer deciding how to determine the nutrient values it puts on a Nutrition Facts panel |
| Key numbers | Class I nutrients: ≥100% of declared; Class II: ≥80% of declared; calories/sugars/fat/sat fat/cholesterol/sodium: ≤120% of declared |
The rule
21 CFR 101.9(g) describes how FDA determines whether a label is accurate if it ever tests the product: it draws a composite sample (in the regulation’s terms, made up of subsamples “taken 1 from each of 12 different randomly chosen shipping cases” from a single lot) and analyzes it in a lab. That’s the enforcement standard, not a requirement that you run this exact test before going to market.
The regulation separates nutrients into two classes for that analysis, per 21 CFR 101.9(g)(3): Class I nutrients are “added nutrients in fortified or fabricated foods”: vitamins, minerals, protein, or fiber a manufacturer puts in rather than nutrients the food already had. Class II nutrients are the naturally occurring versions of the same list. The compliance threshold differs by class: under (g)(4)(i), Class I vitamins, minerals, protein, and dietary fiber must come in at or above (at least 100% of) the declared amount, while under (g)(4)(ii) Class II vitamins, minerals, protein, total carbohydrate, dietary fiber, and polyunsaturated/monounsaturated fat only have to reach 80% of what’s declared. A separate paragraph, (g)(5), covers calories, total sugars, added sugars, total fat, saturated fat, trans fat, cholesterol, and sodium: a composite sample exceeding the declared value by more than 20 percent (i.e., more than 120% of it) is treated as misbranded.
Separately, 21 CFR 101.9(g)(8) allows compliance to be shown alternatively through use of an “FDA approved database” computed following FDA’s guideline procedures, but that approval isn’t automatic. It requires CFSAN to agree to the specific database in writing, and it’s granted only where there’s a clear need (FDA’s own example is raw produce and seafood) and typically for a limited time, such as 10 years. That means a commercial label-building database, NutriLabels’ included, is not an “FDA approved database” in this regulatory sense. Database analysis is how most labels get built in practice; it’s just not the same thing as the narrow (g)(8) approval, and if FDA tests the finished product, it’s the (g)(4)–(g)(5) thresholds above that apply to what’s actually in the package.
The numbers
- Class I (added) nutrients: composite must be ≥100% of the declared value.
- Class II (naturally occurring) nutrients: composite must be ≥80% of the declared value.
- Calories, total sugars, total fat, saturated fat, cholesterol, sodium: composite must be ≤120% of the declared value.
- Sample basis: a composite of subsamples from 12 different randomly chosen shipping cases of a lot, per FDA’s testing protocol under 21 CFR 101.9(g).
- Guidance for databases: FDA’s “Guidance for Industry: Guide for Developing and Using Data Bases for Nutrition Labeling” (FDA, March 1998) is the reference document FDA points to for building a database that supports label values without direct lab analysis of every batch (fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-nutrition-labeling-manual-guide-developing-and-using-data-bases).
On the label
If you make jerky with beef from one supplier, you can build reliable nutrient values from that supplier’s spec sheet plus USDA FoodData Central data for the trim and seasoning: a database approach. If you started blending in a proprietary marinade with an unusual sugar-alcohol profile and no comparable database entry, that’s the point where a lab test earns its cost: there’s no reliable existing number to calculate from, and the risk of a Class II nutrient or the 120%-ceiling nutrients landing outside FDA’s compliance range is real rather than theoretical. For a straightforward soup or granola recipe built from well-documented ingredients, a properly assembled database calculation meets the same standard FDA’s guidance describes, without a lab invoice for every SKU.
Mistakes we see
- Treating “we didn’t lab test it” as itself a compliance problem. It isn’t, as long as the values come from a database built the way FDA’s guidance describes.
- Using generic average values for a proprietary or unusual ingredient instead of a supplier spec sheet or a value close to the actual formulation.
- Never revisiting database values after a recipe or supplier changes, so the label drifts away from what the composite sample would actually show.
- Assuming a Class II (naturally occurring) nutrient gets the same 100% floor as an added Class I nutrient, and over-correcting a naturally variable ingredient’s declared value as a result.
- Reaching for lab testing as a default “safe” choice for every new product, when the cost is rarely necessary for a well-documented recipe.
Related rules
Database-built values still have to land on the panel correctly once calculated. See rounding rules for how those numbers get displayed and percent daily value for how %DV is derived from them. Products crossing between FDA and USDA-FSIS oversight, like a meat-forward soup or a jerky blend, should also check USDA vs FDA jurisdiction, since FSIS applies its own version of this same compliance-tolerance structure to meat and poultry labels. If you’re not sure your current values would hold up, common label mistakes covers the errors that show up most often in database-built panels.
Build the database right, and audit it as you scale
NutriLabels’ builder calculates label values from USDA FoodData Central plus the supplier spec sheets you provide (a database approach, not lab testing), following the same rounding, %DV, and mandatory-nutrient rules in 21 CFR 101.9.
Seeing exactly what changed when a supplier or recipe shifts keeps your declared values inside FDA’s thresholds as you add products. If you run more than one SKU, the Studio plan ($299 a year: every product you make, plus the compliance binder and PDF reports) keeps that data organized with AI spec-sheet import, recipe costing, and change history, and the Co-packer plan ($1,199 a year: everything in the Studio plan plus client folders and white-label documents) covers labels you run for other brands. If one product is all you need right now, enter your recipe, then see your label: your calories, the claims you qualify for and your allergen line are free, no card required, every other value and %DV stays hidden until you unlock, and Single Product ($29) unlocks every other nutrient value and %DV, every FDA format your product qualifies for, and your ingredient statement and allergen declaration, ready to print. See pricing or build your label free to see the free preview first.
FAQ
Does FDA require every label to be lab-tested?
No. 21 CFR 101.9(g) sets the standard FDA uses if it tests a product, but it does not require you to send every product to a lab before printing your label; database-derived values are accepted when developed following FDA's guidance.
What is a Class I nutrient?
An added nutrient in a fortified or fabricated food: vitamins, minerals, protein, or fiber added during formulation. Its composite content must be at least equal to (100% or more of) the declared amount.
What is a Class II nutrient?
A vitamin, mineral, protein, or fiber that occurs naturally in the food rather than being added. Its composite content only needs to reach at least 80% of the declared amount.
What's the tolerance for calories, sugars, and fat?
Those, along with saturated fat, cholesterol, and sodium, are misbranded if a composite sample exceeds 120% of the declared value. There is no upper limit written the other way for these, but coming in low isn't the compliance risk the way exceeding 120% is.
When is lab testing actually worth paying for?
For a genuinely novel process or recipe where no reliable ingredient or database values exist, or for a claim (like a specific nutrient content claim) that depends on a precise number close to a threshold, not as a routine step for every SKU. FSIS's generic label approval for meat and poultry products is a separate process about label content, not a requirement for lab analysis; it mainly concerns special statements and claims.
Related rules
What is a RACC?, Rounding rules, Common Label Mistakes, USDA vs FDA Jurisdiction. See the full all labeling rules.