Enter the US Food and Health Market with FDA Certification

What is FDA approval and who needs to obtain it?

The FDA (Food and Drug Administration) is the official regulatory agency in the United States that oversees the safety and regulation of food, drugs, cosmetics, medical devices, and certain chemical products concerning human health. While FDA approval is not always a legal requirement for offering products in the US market, it is mandatory for high-risk product groups and acts as a trust-enhancing factor for low-risk groups. Especially for medical devices, prescription drugs, and certain dietary supplements, obtaining FDA approval is compulsory.

Manufacturers operating in sectors such as food, beverages, cosmetics, dietary supplements, veterinary products, and certain packaging materials must register with the FDA during export processes and declare their relevant products. Additionally, production facilities are expected to meet specific hygiene, labeling, and traceability standards. FDA approval or registration indicates that the product is manufactured according to legal requirements and can be marketed in the US, ensuring both regulatory compliance and enhanced brand value.

FDA requirements for food and cosmetic products

Manufacturers wishing to sell food and cosmetic products in the US market must comply with specific rules set by the FDA. Key criteria for food products include content safety, hygienic production, accurate labeling, and allergen notifications. The reliability of product ingredients and accuracy of stated nutritional values are carefully checked. Production facilities must also be registered with the FDA system and operate under Good Manufacturing Practices (GMP).

For cosmetic products, the FDA ensures that the product is harmless and that ingredient contents comply with legal limits. The approval process for cosmetics is more flexible than for drugs, but label information, usage instructions, and ingredient lists must be prepared with absolute transparency. Certain ingredients such as color additives may require prior approval. Both food and cosmetic products undergo strict inspections related to packaging safety and truthful content information during marketing and distribution.

Pre-inspections to be conducted at the facility

To comply with FDA regulations, it is crucial to evaluate production facilities according to certain criteria before manufacturing. These pre-inspections aim to ensure compliance with both local legislation and international requirements. Especially in sectors such as food, cosmetics, and pharmaceuticals, facilities should conduct internal controls in advance on hygiene conditions, cross-contamination prevention, personnel hygiene, material flow, and traceability.

The physical layout of production lines, cleaning protocols, warehouse management, and waste disposal systems must comply with certain standards. Furthermore, risk-based measures should be taken throughout all processes inside the facility, from personnel access to raw material input. Critical Control Points (CCPs) must be identified and special record systems should be established for these areas. These inspections not only guarantee production quality but also prepare the facility for FDA audits.

FDA registration and label accuracy

Before beginning product sales in the US market, manufacturers and facilities must officially register in the FDA system. The registration process may vary according to product category, but throughout the process, facility information, product classification, communication channels, and U.S. Agent details must be accurately submitted. Providing misleading or incomplete information can cause serious consequences, potentially halting all export operations.

Labels must contain all FDA-required information completely and accurately. For food products, mandatory details include ingredient lists, allergen warnings, net quantity, nutrition facts, and distributor information. For cosmetics, the order of ingredients, warning statements, and usage instructions must be carefully prepared. Label information is critical both for legal compliance and consumer trust. Every claim on the product must correspond exactly to FDA records and product content.

Compliance documents for export

Manufacturers who want to export to the US market must prepare various documents depending on the product category. These documents are prepared for presentation in customs processes and FDA inspections. The most common documents for food and cosmetic products include FDA registration approval, product content declarations, label samples, production procedures, analysis certificates, and transportation compliance documents. Documents proving product safety for human health must always be accessible.

Additionally, the Prior Notice process must be completed on time to avoid the product entering the import evaluation phase or being held at customs. This involves entering product information, transport mode, buyer and sender details into the FDA system. Errors in this process can lead to product delays or returns at the port. Updated, transparent, and systematic documentation directly affects sustainability in the US market.

FDA application with KIOSCERT

The FDA application process requires careful preparation and detailed documentation. Organizations must provide complete information regarding product description, manufacturing location, label contents, and registration system data. FDA places higher sensitivity on data accuracy for high-risk product groups. Misclassifications, incomplete content declarations, or outdated registration information can result in negative application outcomes.

Preparation plans for the audit process

FDA audits are comprehensive and detailed processes that can be conducted announced or unannounced. These audits review not only physical premises but also production records, hygiene protocols, employee training, internal control reports, and label samples. Preparation should be ongoing, not one-time. Organizations must always be ready for possible audits.

During preparation, all facility areas should be checked, production lines and warehouse layouts reviewed, and all records completely archived. Roles of responsible personnel must be clearly defined and emergency scenarios rehearsed to enable quick responses to audit teams. The most common non-compliance issues in FDA audits usually include label discrepancies, record deficiencies, and insufficient cleaning protocols. Addressing these risks in advance ensures successful audit completion.