Home / What we do / Market entry & FDA compliance
FDA registration, labeling, claims review, import paperwork and liability coverage — completed before production runs, not after a container is sitting at the port.
The problem
A brand arrives with packaging printed to its home market's rules. The panel format is wrong, the serving size is expressed the wrong way, the allergen statement doesn't match U.S. convention, and there is no domestic address on the pack. None of it is a formulation problem. All of it means reprinting.
Then there are the claims. Language that is ordinary marketing in Europe or Australia can make a product an unapproved drug in the United States. A buyer's compliance team catches it, or worse, nobody catches it and the product ships.
Meanwhile the facility isn't registered, there is no U.S. agent on file, prior notice hasn't been filed against the shipment, and the product liability certificate the retailer's vendor onboarding requires doesn't exist. Each of these is a small piece of administration. Together they are the reason a launch slips a year.
What we do
Formula, ingredients, panel, artwork and marketing language reviewed against U.S. requirements before anything goes to print. You get a written list of what has to change and what can stay.
Facility registration and the domestic agent requirement completed and documented, so the paperwork exists before a retailer or a customs broker asks for it.
The Supplement or Nutrition Facts panel rebuilt to U.S. format — serving sizes, nutrient declarations, allergens, net contents, and the domestic address that has to appear on pack.
Every claim on pack, on the website and in the sales deck sorted into what is defensible here and what is not. Structure-function language is workable. Disease language is not, however it is phrased.
Prior notice, customs entry, duty classification, freight and the supplier verification requirements that apply to your category — arranged so the first container clears rather than sits.
Product liability coverage at the limits chains require, plus the tax, banking and vendor-onboarding paperwork that has to be complete before a purchase order can be raised.
How it works
The order matters here more than anywhere else on this site. Registration before entry, claims before print, insurance before onboarding.
We review the product, the pack, the claims and the manufacturing documentation, and return a written gap list with each item marked blocking or non-blocking.
Panels rebuilt, claims rewritten, artwork corrected. This is the stage where a formula change, if one is genuinely needed, is cheapest to make.
Facility registration, U.S. agent, insurance, and the vendor documentation pack assembled and filed.
Freight booked, entry filed, product received into the U.S. inventory position and available to sell.
Who this is for
You have a finished product manufactured to GMP standard, you intend to sell it in U.S. physical retail, and you are willing to change artwork and claims language to do it.
Your formula contains an ingredient with no lawful pathway in the United States, or the claims on pack are the reason the brand sells at home and you aren't prepared to change them. We will tell you that at the assessment stage rather than after you've paid for a program.
Go deeper
Registration, labeling, claims and imports for brands entering the United States.
Read the guide →The sequence from first decision to first purchase order, and what it costs at each stage.
Read the guide →Twenty questions. Your score, your readiness band, and your three biggest gaps named.
Start the assessment →In their words
“They fully assisted us with FDA compliance for our products and even had their graphics team make all necessary label changes for us. It was very clear that we made the right decision to partner with them from the start.”John KimCEO, Elementelle
Questions
U.S. Market Assessment
Send us your product and your numbers. We'll come back with a written assessment of what entering U.S. retail would require and what it would realistically return.
