Export Certificates

Interested in exporting foods, drugs, cosmetics, or dietary supplements from the United States to other countries?

Let R. FLORA & ASSOCIATES, INC. help you obtain Export Certificates for the products you want to export. You don’t need the hassle. We will interface with the regulatory agencies for you. We will provide you with a simple list of information that we need. Once you provide it, we do the rest, and, we will keep you informed until you receive your documents.

Firms exporting products from the U.S. are often asked by foreign customers or foreign governments to supply a certification relating to products subject to the Federal Food, Drug, and Cosmetic Act (the Act) and other acts FDA administers. Certification is the process by which a formal or official attestation is made concerning the regulatory status of a product, or the system by which a commodity is manufactured. Requests for certification have variously asked for verification that the products being exported:

(1) are freely marketed in the U.S.;

(2) are in compliance with U.S. laws and regulations;

(3) are in compliance with the importing country's requirements;

(4) meet certain national or international standards, such as quality standards; or

(5) do not contain specific contaminants. This certification process may include issuance of a certificate to accompany the exported product.

FDA has historically issued a number of different types of certificates, e.g., "Certificates of Free Sale," "Certificates for Export," "Certificates of Exportability," "Certificates to Foreign Governments," "Certificates of Pharmaceutical Products," and the "European Union (EU) Health Certificate for Fishery Products."

FDA's long-term goal is to reduce or eliminate export certificates by finding other means to assure other countries of the acceptability of FDA regulated products. However, the agency recognizes the current importance of providing export certificates. For commodities regulated by FDA under authority of the Federal Food, Drug, and Cosmetic Act, or other acts FDA administers, FDA is the U.S. agency with regulatory oversight of the certification process. Under the FDA Export Reform and Enhancement Act of 1996, FDA is required to issue certificates for drugs and biologics, animal drugs, and devices that meet the applicable requirements of the Act within 20 days of receipt of a request for such a certificate. A fee of up to $175 may be charged for each certificate issued. While FDA is not required to issue certificates for foods and cosmetics, the agency intends to continue to provide this service with the anticipation of achieving full cost recovery by charging the requestor a fee based on the actual expense incurred. In addition to issuing export certificates for products that are approved, licensed, or otherwise in compliance with the applicable requirements of the Act, the FDA will also issue export certificates for products that meet the requirements of Sections 801(e) or 802 of the Act but that may not otherwise be marketed, sold, offered for sale, or distributed in interstate commerce. Various states and other government entities have similar certification programs.

We can cut through the red tape and help you get the certification you need. We will contact the agency, fill out the paperwork, and do the follow-up. You only need to provide the information we request. We’ll do the rest.

The states have export certificate programs as well.