Comply with FDA labeling requirements and export or import to the United States without complications

At CORE Consulting, we help you create and review your product labels to ensure full compliance with FDA guidelines and other regulatory agencies such as the TTB, USDA, MoCRA, and AAFCO—preventing rejections, fines, and customs holds.

Why is it important to comply with FDA labeling requirements?

Your label is the first barrier between your product and the U.S. market.

Complying with FDA labeling requirements is essential to ensure your products can enter and remain in the U.S. market without obstacles. Proper labeling not only guarantees legal compliance, but also builds consumer trust, ensures product traceability, and protects your brand’s reputation.

At CORE, we help you adapt your labeling to FDA regulation and other authorities such as the TTB, USDA, MoCRA, and AAFCO, avoiding errors that can lead to detentions, fines, or rejections at customs.

General FDA labeling requirements applicable to all industries

Whether you export food, dietary supplements, cosmetics, drugs, textiles, or animal food, the FDA requires essential labeling elements to enter the U.S. market. Complying with these requirements helps prevent rejections, penalties, and delays, ensuring your product reaches its destination in full compliance.

Make sure your label meets these requirements before exporting.

Product name (Statement of Identity)

The name must accurately describe the type and nature of the product, avoiding misleading or incomplete terms.

Manufacturer or importer information

Must include the legal name, full address, and country of origin. This information enables traceability and regulatory compliance.

Refining

For food or cosmetic products, all ingredients must be listed in descending order by weight, and major FDA-recognized allergens must be clearly identified.

Information panel (Nutrition, Supplement, or Drug Facts)

Each product category must use the appropriate information panel:

Nutrition facts: food and beverages
Supplement facts: dietary supplements
Drug Facts: over-the-counter (OTC) drugs

Language and legibility

All information must be presented in English, using clear typography, adequate contrast, and legible font size.

Country of origin

Mandatory for all imported products. It must be clearly stated, for example: “Made in Mexico” or “Product of Spain.”

Lot identification and traceability

The lot number or production code allows product traceability in case of recalls or quality control and is an essential FDA and multi-agency requirement.

Cada tipo de producto tiene su propia regulación. Conoce qué exige cada agencia para garantizar el cumplimiento total de tu etiqueta

Specific labeling requirements by U.S. regulatory agency

In addition to the FDA, different U.S. federal agencies regulate labeling depending on the product type: USDA, TTB, MoCRA, and AAFCO. Complying with their guidelines ensures your product can be marketed without the risk of rejection or penalties. At CORE, we help you identify the applicable regulations and prepare 100% compliant labels.

Animal-Derived and Agricultural Foods

USDA

Applies to: meat, poultry, eggs, and dairy products

Request USDA

USDA inspection seal

Approved establishment number

Type of Inspection (Federal or State)

Origin declaration and net weight

Mandatory “Safe handling Statement” for raw products

Alcoholic Beverages

TTB

Applies to: wine, beer, and spirits

Request TTB

Formula and Label approval (COLA)

Alcohol content statement

Responsible consumption warnings

Name and address of manufacturer or bottler

Country of origin, container size, and TTB seal

Cosmetics

MoCRA

Applies to: makeup, creams, perfumes, and hair products

Request MoCRA

FDA Facility Registration (MoCRA)

Official product listing

Complete ingredient list in descending order

Net weight and manufacturer or distributor name

Warnings and directions for use

Animal food

AAFCO

Applies to: pet food, livestock feed, and veterinary supplements

Request AAFCO

Guaranteed Analysis (protein, fat, fiber, moisture)

AAFCO-Approved Ingredients

Intended animal species

Manufacturer name and net weight

Country of origin

Dietary supplements

FDA

Applies to: dietary and nutritional supplements

Request FDA

“Supplement Facts” Panel

Active and inactive ingredients

Recommended dosage and directions for use

Standard DSHEA Disclaimer: “This product is not intended to diagnose, treat, cure, or prevent any disease.”

Over-the-Counter (OTC) Drugs

FDA

Applies to: OTC medications

Request FDA

“Drug Facts” Panel

Active and inactive ingredients

Indications, warnings, and directions for use

Lot number

Expiration date

Benefits of complying with FDA labeling requirements

Compliance with FDA labeling requirements allows your product to enter and remain in the U.S. market without setbacks. A properly designed and validated label conveys trust, transparency, and quality—three key factors that enhance your export opportunities and strengthen your reputation with clients, distributors, and importers.

Avoid customs holds

Reduce risks and delays by meeting all FDA requirements before shipment.

Protect your reputation and avoid fines

A compliant label demonstrates responsibility and commitment to consumer safety.

Facilitate entry into the U.S. market

Regulatory compliance opens doors to new distribution channels and sales opportunities in the United States.

Build trust

A clear, FDA-compliant presentation communicates credibility and professionalism.

Ready to validate your product label with the FDA?

Take the next step and ensure your label meets every requirement before exporting or importing into the U.S. market.

We guide you step by step—from label review to validation with the FDA and complementary agencies such as TTB, USDA, MoCRA, and AAFCO.

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.