Benefits of FDA compliance

Meeting FDA regulatory requirements allows you to position your dietary supplements in one of the world’s most demanding markets while strengthening trust with your commercial partners.

Avoid customs holds, penalties, and fines
Build trust and traceability with U.S. importers
Strengthen your international brand reputation
Increase competitiveness against other supplement brands

What happens if your dietary supplement does not comply with FDA regulations?

A registration error or incorrect label can cost you more than time—it can result in product detention, financial penalties, and loss of commercial credibility. FDA compliance is not optional; it is the foundation for secure and sustainable access to the U.S. market.

Avoid sanctions and customs delays—let’s discuss your project.

Essential FDA requirements to export dietary supplements to the USA

Complying with FDA regulations is a fundamental step to ensure your dietary supplements can enter and remain in the U.S. market without disruptions. Below are the essential requirements every company must meet before exporting or importing:

DUNS Number

The DUNS (Data Universal Numbering System) number is a global identification code that validates your company’s legal existence and physical location.
This number is mandatory for registering your manufacturing facility with the FDA and serves as an official reference across all regulatory compliance processes.
Without an active DUNS number, your FDA registration cannot be validated.

FFRN Registration

Any facility that manufactures, processes, packs, or stores dietary supplements intended for the U.S. market must have a valid FFRN.
This registration is completed directly through the FDA platform and must be renewed every two years during the official renewal window (typically October–December).
An active FFRN is essential to keep your products authorized and traceable by the FDA.

FDA U.S. Agent

If your company is located outside the United States, you must designate an FDA-authorized U.S. Agent.
This agent acts as the legal intermediary between your company and the FDA, receiving official notifications, inspection requests, and regulatory communications.
A reliable U.S. Agent accelerates processes and ensures timely responses during audits or regulatory reviews.

FDA-Compliant Labeling for Dietary Supplements

Labeling is your product’s first point of contact with the U.S. market.

FDA-compliant labeling is one of the most critical and decisive steps when exporting dietary supplements to the United States.

A single labeling error may lead to customs detention, fines, or even a sales ban.

Proper FDA labeling not only protects your product but also builds credibility and trust with distributors and consumers.

“Supplement Facts” panel with the amount of each active ingredient per serving
Complete list of inactive ingredients in descending order by weight
Usage warnings, restrictions, or potential risks
Contact information of the manufacturer, packer, or distributor
Refuerza la seguridad, trazabilidad y confianza de tus productos

Strengthen product safety, traceability, and market trust

FDA compliance goes beyond registration and labeling. These additional processes ensure your dietary supplements are safe, verifiable, and competitive in the U.S. market:

FSVP Plan

Verify that your products and suppliers meet FDA food safety standards

Request FSVP support
Certificado sanitario

Certifies the safety of your supplements for unrestricted export

Start certification
Approved ingredients review

Ensure your ingredients are permitted and not classified as unauthorized NDIs (New Dietary Ingredients)

Review ingredients
Adverse event reporting

Meet traceability requirements by responsibly reporting side effects

Start event reporting

Comply with All FDA Requirements to Commercialize in the United States. Let’s talk about your project and ensure full regulatory compliance.

Over a decade supporting global brands

FDA and international regulatory compliance experts

At CORE, we guide companies through the entire FDA compliance process—from registration and labeling to health certificates and regulatory strategies. We provide end-to-end solutions to ensure your safe and compliant entry into the U.S. market.

Trust FDA compliance specialists.

Secure FDA compliance before your next export

Every month, hundreds of shipments are detained due to labeling errors or FDA non-compliance. Don’t let your product be one of them—verify your documentation and ingredients before exporting.

Utilizamos cookies para personalizar contenido y anuncios, ofrecer funciones de análisis y mejorar el tráfico de nuestro sitio. Compartimos información sobre su uso con nuestros socios de publicidad y análisis, quienes pueden combinarla con otros datos que les haya proporcionado. Al hacer clic en "Aceptar", acepta el almacenamiento de cookies en su dispositivo para mejorar la navegación, analizar el uso del sitio y apoyar nuestros esfuerzos de marketing. Consulte nuestra Política de Privacidad para más información.