FDA amends its procedures for dairy, infant formula firms exporting to China

The U.S. Food and Drug Administration (FDA) is announcing changes to its export listing procedures for dairy and infant formula firms seeking to export their products to China. In the Economic and Trade Agreement Between the Government of the United States and the Government of the People’s Republic of China (Economic and Trade Agreement) signed Jan. 15, 2020, China agreed to recognize the U.S. dairy-safety system as providing at least the same level of protection as China’s dairy-safety system.

As a result of the Economic and Trade Agreement, facilities seeking to be listed as eligible to export dairy and infant formula products to China should no longer provide to the FDA, and the FDA will no longer provide to China, confirmation that a third-party auditor has found the firm to be in compliance with the relevant standards, laws, and regulations of China for dairy and infant formula firms. On June 24, in an action taken as the result of the Economic and Trade Agreement, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service, in charge of facilitating the efficient marketing of milk and dairy products worldwide, announced that it would eliminate plant audits for dairy and infant formula firms seeking to export to China as of July 1, 2020.

The FDA reminds firms intending to export dairy and infant formula products to China that it will include firms on export lists only if the firm is in substantial compliance with applicable FDA regulations. Firms may apply to be included on these lists via the FDA’s Export Listing Module (ELM). This process applies to all ELM applications received for these export lists on or after July 1, 2020.