US FDA Compliance & Market Entry
Dietary supplements, cosmetics, foods and OTC products for the US market — facility registration, labelling, claims and import readiness done before your first shipment, not after your first refusal.
Where this usually starts
- You are launching on Amazon US or D2C and need labels, claims and registrations that hold up.
- Your facility exports to the US and needs FDA registration with a US Agent.
- A shipment was refused or flagged and you need the root cause fixed, not just the symptom.
What we handle
Facility registration & US Agent
FDA food-facility registration for supplement and food manufacturers, with US Agent coordination for foreign sites.
Supplement labels & claims
Supplement Facts panels, structure/function claims with the required disclaimer, and the line you must not cross into disease claims.
MoCRA for cosmetics
Facility registration, product listing and safety substantiation under the Modernization of Cosmetics Regulation Act.
Ingredient review
Dietary-ingredient status checks — including whether a botanical needs a New Dietary Ingredient notification.
Importer setup & FSVP
Foreign Supplier Verification Program obligations for your US importer, structured and documented.
Import alerts & refusals
Prior notice, detention responses and corrective packages when shipments hit trouble.
How the engagement runs
Classify
Supplement, food, cosmetic or drug — the category decides every requirement that follows.
Register
Facility registrations, listings and agent arrangements in the right sequence.
Label & claim
Compliant artwork and marketing claims for packs, listings and ads.
Ship & maintain
Import readiness, renewals and ongoing compliance as the range grows.
What you receive
Questions founders ask us
Does the FDA approve dietary supplements before sale?
No — there is no pre-market approval for supplements. The obligation is on you: registered facility, compliant ingredients, truthful claims and correct labels. That is exactly why marketplaces and importers check your paperwork instead.
What is MoCRA and does my cosmetic brand need it?
MoCRA is the biggest change to US cosmetics regulation in decades: facility registration, product listing and safety substantiation are now mandatory for most brands selling in the US, including foreign manufacturers.
What claims can I make on a supplement?
Structure/function claims ("supports immunity") with the FDA disclaimer are permitted if substantiated; disease claims ("treats diabetes") make your product an unapproved drug. We review packs and listings so growth marketing stays on the right side of that line.
Trusted by brands we are proud to work with
From heritage Ayurveda houses to global FMCG leaders, teams rely on AIDNI to move products through regulation and into market.
Planning a US launch or already shipping?
Tell us the product category and how you plan to sell. We will map the registrations, labels and claims work your launch needs.
AIDNI Business Consultancy
Ahmedabad · Dubai · Global Network
+91 98981 AIDNI (24364)
·
www.aidni.me