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.

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FDA registration and US market compliance at LumaNutra

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.

Related services

NPN application and Health Canada licensing

We prepare and file your Natural Product Number application. 100% first-time approval on every Class I and Class II NPN we've filed. Most consultants won't share their number.

Compliant bilingual product labels

Canadian law requires English and French on every label. We design labels that meet both Health Canada and FDA rules so you can sell on both sides of the border with one SKU.

Export supplements

Manufacture Made-in-USA or Made-in-Canada supplements and ship them to China cross-border e-commerce, the Gulf, or Latin America with the documentation pack importers ask for. Certificate of Free Sale, GMP attestation, ISO 17025 COAs, Halal/Kosher coordination. In-country regulatory registration stays with your importer or local agent.

Related reading

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Health Canada NHP Compliance Guide for Supplement Brands

Canada's NHP framework is among North America's strictest. What supplement brands need to know about NPN, site licensing, bilingual labels, and cross-border.

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How to Launch a Supplement in Canada: 2026 NPN Guide

Launch a supplement in Canada: NPN application steps, GMP manufacturing partners, bilingual labeling, Health Canada timelines, and realistic starter budgets.

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5 Expensive Mistakes First-Time Supplement Brands Make (2026)

The 5 most expensive mistakes first-time supplement brand founders make in Canada and the USA, and how to sidestep each one before signing the first check.

Where we manufacture

Our GMP-certified partner facilities run in six regions across Canada and the United States. Each region page covers the local network, dosage forms, and regulatory ground.

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Tell us about your project and we'll put together a plan and quote tailored to your product, timeline, and budget.

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