Regulation and the U.S.–China Dynamic

Another looming issue is that of food additives, a challenge illustrated by the melamine issue of 2006-2007. FDA approval is required for food additives. Even though many additives are generally recognized as safe, like sugar and spices, or are previously approved, some exporters fail to recognize that the standard applies to them. Some do not understand the stringency of the standard. A tough approval standard requires demonstrating with reasonable certainty that the additive presents no harm to consumers. More sophisticated scientific standards are making these approvals harder to obtain, and consumer attitudes also play a greater role than ever before. Consumer petitions or preferences, such as eating more foods that contain a certain additive, may lead the FDA to reconsider its prior approval of a specific additive.

Regulatory Integration

Even though U.S. regulatory requirements are often confusing, Chinese food supply companies must meet U.S. sanitation and safety standards if they want to expand their presence in the American market. The International Conference on Harmonisation of compliance standards, which focuses on the United States, Japan, and the European Union, is conducting outreach to producers in countries such as China, India, and Brazil to foster greater integration of regulatory standards among countries. In addition, the presence of FDA food experts in China will help transform the China-U.S. food system into an integrated whole.

As China and other countries begin integrating their food regulatory standards with those of the United States, the FDA is unlikely to accept as definitive the agency decisions of other countries. Even though the FDA is pursuing the use of third-party certification, which could include the Chinese government as a certifier for safety and manufacturing compliance overseas, it is much more likely that the FDA will cooperate with, and rely upon, other countries’ agencies in formulating its own decisions. Either way, food safety is the primary concern. The FDA’s regulation of the entire chain—from production to distribution to consumption—is one that food producers from China and every other country must accommodate in order to be a player in the U.S. market. ■

Hargan, a former deputy secretary for the U.S. Department of Health and Human Services and a regulatory policy officer, is currently a partner with McDermott Will & Emery. Reach him at [email protected] or (312) 984-0385. Qian is a founding partner of MWE China Law Offices, a Shanghai-based joint venture with global law firm McDermott Will & Emery. Reach him at [email protected] or +86 21 6105 0500.