Does The FDA Operate Internationally?

Did you know that approximately 10 to 15 percent of the U.S. food supply comes to this country internationally? That includes 53 percent of fresh fruit and 29 percent of vegetables. In addition, about 35 percent of medical devices used in the U.S. is produced in another country.

With these types of numbers, the FDA (U.S. Food and Drug Administration) which operates mainly in the 50 states and surrounding territories faces unique challenges in determining if these foods and products that are being manufactured and distributed overseas meet FDA’s standards. In addition to manufacturing and distribution, many foods and products can be improperly formulated, packaged and even counterfeited.

To help combat these very important potential problems, the FDA collaborates and shares information with regulatory agencies in other countries through various international partnerships and agreements.

These collaborations aim to enhance the safety and quality of food, drugs, cosmetics, and medical devices globally. Additionally, the FDA also oversees the import and export of regulated products to ensure compliance with U.S. regulations. They have done this in a variety of ways including:

• Conducting foreign inspections
• Collaborating with foreign regulators and stakeholders
• Educating foreign countries about FDA requirements
• Develop and enforce new regulatory tools. 
• Increase transparency and accountability in the supply chain

FDA’s Office of Regulatory Affairs conducts inspections and reviews imported products for entry with the United States. The Office of Global Policy and Strategy then serves as a bridge for FDA coordination and information sharing as a well as a point of access to multilateral organizations like the World Health Organization (WHO).

Should you have a food or product you are looking to bring to market both domestically or internationally, the team at FDA Specialist can provide you with a variety of reviews and reporting to make sure you are FDA compliant. From label and regulatory reviews to registration and submissions, FDA Specialist has FDA consultants and experts with years of experience in all the major spaces of FDA regulation covering foods, medical devices, pharmaceuticals, cosmetics and other products regulated by the FDA. Having this broad array of experts allows us to provide the most effective solutions for our clients.

For more information call 562-882-4981 or visit https://fdaspecialist.com/.