FDA registration and US market compliance
Selling supplements in the US means registering your facility, filing structure/function claims correctly, and getting labels right. We handle all of it.
The US supplement market is worth over $50 billion annually, and entering it means complying with FDA regulations that are different from Health Canada's framework. We handle the full US market compliance process so you can sell with confidence.
FDA compliance for dietary supplements includes facility registration (every manufacturing facility must be registered with the FDA), proper Supplement Facts panel formatting under 21 CFR Part 101, structure/function claims that don't cross into drug claim territory, and New Dietary Ingredient (NDI) notifications for ingredients not marketed before 1994.
We also set up your adverse event reporting (AER) procedures. A requirement that many brands overlook until they get a warning letter. Our label compliance review catches the formatting errors, claim violations, and missing disclaimers that trigger FDA enforcement actions.
What's Included
Facility registration and NDI notification support
Label compliance review against 21 CFR Part 101
Adverse event reporting (AER) setup and procedures
Why Brands Choose This Service
Full FDA compliance package
Facility registration, label review, claims compliance, and NDI notifications handled under one service. No gaps in your regulatory coverage.
Label compliance review
We review your Supplement Facts panel, claims, and disclaimers against 21 CFR Part 101. Catching errors before the FDA does saves you from warning letters.
Adverse event reporting setup
We build your AER procedures and train your team on serious adverse event reporting requirements. A legal requirement many brands miss.
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