OS105

FactsReady

Disclaimer

FactsReady estimates nutrient values from the ingredient data you select (mostly USDA FoodData Central) and applies the FDA rounding and format rules in 21 CFR 101.9 / 101.36. These are calculated estimates, not laboratory results, and USDA FoodData Central is not an FDA-approved nutrition labeling database under 21 CFR 101.9(g)(8). Under FDA policy the manufacturer is responsible for the accuracy of the label values. FactsReady is not affiliated with FDA or USDA, and nothing here is legal advice or an FDA approval. Check your label, your allergen statement and any exemption with a qualified food-labeling professional before printing.

What this means in practice

The numbers are estimates

  • Label values are calculated by adding up ingredient data and dividing by the batch weight you enter.
  • Real foods vary by crop, supplier, recipe execution, moisture loss and processing.
  • We don't apply nutrient-loss factors for cooking.

FDA tests labels against lab analysis of a composite of 12 consumer units (21 CFR 101.9(g)(2)). Certain nutrients must not exceed 120% of the label value, and others must reach at least 80% or 100% of it (101.9(g)(4)–(5)).

The data has limits

  • USDA FoodData Central is public-domain reference data (please cite it as "USDA FoodData Central").
  • Its "Branded" entries are calculated from other companies' rounded labels.
  • Values you type in are only as good as their source.

FDA says it "does not specify acceptable sources for the labeled values." Manufacturers who use ingredient databases "should be assured of the accuracy of the databases and validate the resulting calculations," and "are responsible for the accuracy of the nutrition labeling values on their products" (FDA, A Food Labeling Guide, N37).

You are responsible

FDA's long-standing policy assigns the manufacturer the responsibility for the validity of a label's nutrient values (FDA, Guide for Developing and Using Data Bases for Nutrition Labeling). That covers:

  • the label as a whole, including the Nutrition Facts or Supplement Facts box
  • the allergen statement and ingredient list
  • any claims
  • whether any exemption applies.

No approval, no affiliation

  • FDA doesn't approve nutrition labels or label software.
  • FactsReady is an independent tool, not affiliated with or endorsed by FDA or USDA.
  • We never describe our output as "FDA approved," "FDA certified" or "guaranteed compliant."

Not legal or professional advice

The guides on this site summarize public regulations and FDA guidance as of the date shown on each page. FDA guidance is nonbinding, and rules change. For decisions about your product, consult a qualified food-labeling professional or attorney.

No claims are generated

The tools don't create nutrient content claims, health claims or structure/function claims. If your packaging makes any claim, other rules apply. A claim also removes the small-business exemptions.