Complete FDA 21 CFR 101.36 Supplement Facts, DSHEA disclaimer, Prop 65 Lead safe harbor, and Amazon FNSKU barcode generator for supplement brands.
Enter raw lab or recipe values below. Our mathematical engine applies strict FDA 21 CFR 101.9(c) rounding increments and 2026 Daily Reference Values (%DV) in real time.
| Mandatory Nutrient | Raw Input | FDA Rounded Label Value | 2026 %DV | 21 CFR 101.9 Rounding Rule Applied |
|---|
Generate combined or standalone compliance stickers with the mandatory yellow exclamation triangle (⚠️ WARNING), CPSIA permanent tracking fields (15 U.S.C. § 2063(a)(5)), and true Code-128B FNSKU bars for Dymo/Rollo thermal printers.
Use the FDA %DV & Prop 65 compliance auditors 100% free. Unlock unlimited commercial vector exports with a single one-time license key.
Supplement brands launching on Amazon FBA, TikTok Shop, or Shopify must pass strict automated label audits. A single formatting error—like using 'Nutrition Facts' instead of 'Supplement Facts', missing the DSHEA disclaimer box, or omitting California Prop 65 warnings for botanical powders—can freeze your inventory.
| Compliance Checkpoint | Governing Rule | Mandatory Requirement |
|---|---|---|
| Panel Header | 21 CFR 101.36(e) | Must read 'Supplement Facts' (never 'Nutrition Facts') |
| Statement of Identity | 21 CFR 101.3(g) | Must include the term 'Dietary Supplement' on the front panel |
| Structure/Function Claim Disclaimer | 21 CFR 101.93(b)–(e) | Bold box: '*These statements have not been evaluated by the FDA...' |
| Other Ingredients | 21 CFR 101.4(g) | Listed immediately below the Supplement Facts box in descending weight |
| Domestic Contact Info | 21 U.S.C. § 343(y) | Must include a US street address or US phone number for adverse event reporting |
Yes! Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act (21 U.S.C. 343(y)), every dietary supplement label marketed in the US must include a domestic address or domestic phone number through which the responsible person can receive serious adverse event reports.
California's Prop 65 Maximum Allowable Dose Level (MADL) for reproductive toxicity of lead is 0.5 micrograms/day—far stricter than federal FDA action levels. Soil-grown botanicals and plant proteins naturally absorb trace minerals, so brands Selling into California frequently apply the 27 CCR § 25607.2 Food/Supplement Safe Harbor warning.
Explore dedicated calculators and regulatory guides by food category, label geometry, and federal/state statute: