The Label is
The Contract.
FDA treats your label as a legal document. One wrong word, font size, or formatting error can trigger a warning letter or import detention. We validate every pixel.
The Misbranding Trap.
Using words like “Healthy”, “Natural”, or “Cures” without meeting strict FDA definitions renders your product misbranded. Misbranded products are illegal to sell. We flag these triggers instantly.
”Cures Insomnia“
Marketing thought it sounded great.
Unapproved Drug
Disease claims trigger drug regulation. Product deemed misbranded.
The Big 9 Allergens.
Undeclared allergens are the #1 cause of FDA food recalls. We scan your ingredient list against the FALCPA/FASTER Act database to catch hidden sources of milk, soy, sesame, and more.
2016 Format Compliance.
Is your Nutrition Facts panel outdated? FDA updated the format in 2016 (bold calories, added sugars). Using the old format is an immediate red flag to inspectors.
BRAND
Size matters to FDA.
Net quantity statements must be at least 1/16th or 1/8th of an inch high depending on PDP area. We calculate the exact requirement for your package size to prevent technical misbranding.
Supplement Facts.
Supplements have their own set of rules (21 CFR 101.36). We check for correct proprietary blend formatting, %DV calculations, and the mandatory “This statement has not been evaluated” disclaimer.
Proprietary blend weights must be listed in descending order. Sub-ingredients missing quantity ratios.
DSHEA disclaimer text matches statutory requirement exactly. Font size compliant (1/16“).
Common or
Usual Name.
You can't just list “Sugar” as “Evaporated Cane Juice.” FDA requires specific nomenclature. We scrub your ingredient list for improper names that attract regulators.
Call it what
it is.
If it doesn't meet the Standard of Identity for “Milk” or “Juice,” you can't call it that. We help you find the correct, legal name for your product to avoid “Economic Adulteration” charges.
JUICE
DRINK
Bilingual
Compliance.
Selling in Puerto Rico or Hispanic markets? If you add a second language, all mandatory info must appear in both languages. We check for translation parity compliance.
Comprehensive 50-Point Check
We check every element of your label against 21 CFR Part 101.
Net Quantity
Must appear in bottom 30% of PDP. Dual units (metric/US) required.
Identity Statement
Common or usual name must be prominent and bold.
Ingredient List
Descending order by weight. Common names used.
Assurentry vs. Designers.
Designers make it look good. We make it legal. You need both.
Don't print a mistake.
Reprinting packaging costs thousands. Our review costs $249.
Frequently Asked Questions
Common questions about this regulatory requirement.
Secure Your Supply Chain.
Don't let a clerical error stop your shipment at the border. Join 2,800+ food companies who trust Assurentry for automated compliance.