Unlocking International Markets

U.S. FDA compliance, marketing clearance, and being in general good standing with the Agency is oftentimes the secret sauce to international markets. Foreign governments and foreign purchasers are keen to understand whether and to what extent exported goods comply first with U.S. regulatory requirements, marking a glittery stamp of approval.

To help in this effort, businesses can seek FDA export certificates, which are official documents issued by U.S. FDA to facilitate the export of FDA-regulated products. These certificates serve as formal affirmations that a product complies with U.S. regulations and can be legally marketed in the U.S. or, in certain cases, meet specific requirements for export.

Serving as a passport to global trade, the issuance of FDA export certificates can (1) facilitate international trade as many foreign governments require FDA export certificates to verify that U.S. products comply with local regulations and standards, (2) ensure product safety and compliance as these certificates provide assurance that the products being exported meet the stringent safety and quality standards enforced by the FDA, and (3) support U.S. businesses by providing a mechanism for verifying compliance to expand their markets and compete globally.

For example, in many cases, foreign governments are seeking official assurance that products exported from the U.S. to their countries can be lawfully marketed in the U.S. or meet specific U.S. regulations, such as current good manufacturing practice (cGMP) regulations. A foreign government may also require export certification as part of the registration or import process into that country. It is also important to note that the exporter is responsible for ensuring the exported product meets the compliance requirements of the foreign country.

Additionally, while FDA issues several types of export certificates, not all certificate types are issued for every FDA-regulated product. Export certifications include the Certificate of Free Sale, Certificate to Foreign Government, Certificates of Exportability, Certificates of Pharmaceutical Product and more. These certificates are applicable to various industries (e.g. foods, medical devices, drugs) and to certain operations (e.g. operations/products that are compliant with U.S. law, vs. not compliant with U.S. law, but may be legally exported).

In other cases, FDA may develop specific criteria for product exports. For instance, FDA recently announced new Food Safety and Standards Authority of India (FSSAI) requirements for dairy products for human consumption exported to India. As of September 1, 2023, FSSAI is requiring establishments that import dairy products into India to appear on FSSAI’s lists of approved establishments eligible to export such products. FSSAI has stated that it will include establishments on these lists that comply with applicable food safety requirements by the competent authority of the exporting country. As the U.S. competent authority, FDA provides export certification for dairy products manufactured in establishments that are included in the Export Listing Module (ELM). This certification helps facilitate U.S. exports and permits U.S. establishments to be included on FSSAI’s approved establishments lists. In the case of dairy exports to India, U.S. establishments can qualify for the FSSAI list if they comply with relevant FDA requirements for the products intended for export. FDA advises that the Agency will transmit an initial list of approved establishments to FSSAI by September 1, 2024, but that any firms seeking addition to the list, should request to do so by August 23, 2024. FDA will provide updates to these lists quarterly.

Accordingly, FDA export certificates and/or compliance with specific export criteria help play a crucial role in facilitating the global distribution of U.S. products by ensuring they meet both domestic and international regulatory standards. By understanding the various types of certificates and their purposes, businesses can effectively navigate the complexities of international trade and expand their market reach, and be… certifiably export-ready.

For more information on FDA export certificates, new dairy export requirements, or FDA’s Export Listing Module, please contact us at info@garg-law.com.