We check your food, supplement, cosmetic, drug or medical device label against FDA rules. Corrections are marked on your own artwork, with a written report your designer can follow.
Quick answer: FDA does not pre-approve labels. They are checked at the port and on the market, and a label that breaks FDA rules makes the product misbranded. Misbranding is one of the most common reasons FDA refuses imported food, and undeclared allergens are a leading cause of food recalls. A review before printing costs far less than relabeling a shipment.
Pay online now, or send the form first and we invoice you. Work begins within 1 business day.
All nine major allergens must be declared: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans and sesame. Sesame was added in 2023 and is often missed on older labels.
Food labels need both metric and U.S. units (for example "Net Wt 16 oz (454 g)"), in the lower 30% of the main display panel.
The panel must use the current format, with added sugars, vitamin D and potassium, and realistic serving sizes.
Words like "cures", "treats" or "prevents" a disease make FDA treat the product as an unapproved drug.
Required information must be in English. If you add another language, all required information must appear in it too.
Since MoCRA, cosmetic labels must show a U.S. address, phone number or electronic contact for adverse event reports.
Choose your product type and upload your label artwork (PDF or images).
Every element is checked against the FDA rule for that product type.
Corrections marked on your artwork, plus a written report with rule references.
Your brand stays yours. We only change what compliance requires.
🏷️ Registering at the same time? Food label review is often bundled with food facility registration and FSVP. For product-specific rules, see our product guides.
No. FDA does not pre-approve food, supplement or cosmetic labels. Labels are checked when products are offered for import and when they are on the market. A label that breaks the rules makes the product misbranded, which can lead to refusal at the port, detention or a recall. That is why an independent review before printing is worth doing.
Yes. Required label information must appear in English. You may add other languages, but then all required information must also appear in each of those languages (21 CFR 101.15(c) for food).
No. We mark the corrections directly on your existing artwork and explain each one in a written report. Your designer makes the final file, so your brand look stays the same.
Basic checks the mandatory elements: name, ingredients, allergens, net quantity and the name and address. Standard adds the Nutrition Facts panel and claims. Advanced adds health and nutrient content claims, implied claims and bilingual labels. Most exporters choose Standard.
Missing allergens (especially sesame, a major allergen since 2023), net quantity in grams only, an outdated Nutrition Facts format, ingredients not in order of weight, health or 'cure' claims that turn a food into a drug, and cosmetics labels without a U.S. contact for adverse event reports.
Choose your product type below and fill in the review form. You can upload your artwork as PDF or image files. Work begins within one business day of payment.
Send your artwork for review before it goes to print.