FDA Completes 2 FSMA-Mandated Tasks

WASHINGTONThe U.S. Food and Drug Administration(FDA) on July 5 completed two critical tasks required by the Food Safety Modernization Act (FSMA)issuing an anti-smuggling food safety strategy and a draft guidance clarifying the agencys expectations on new dietary ingredients.

The anti-smuggling strategy was developed by the Health and Human Services Department (HHS) in conjunction with the Department of Homeland Security (DHS) to identify and prevent smuggled foods from entering the United States and posing a threat to national security and consumer safety.

The Food Safety Modernization Act requires the agency to build a new food safety system," said Deputy Commissioner for Foods Michael R. Taylor. This new system, overall, will better leverage the resources of federal agencies and it will make industry an important partner in safeguarding the health of U.S. consumers."

FDA will work with U.S. Customs and Border Protection (CBP) in DHS to review historical data and better identify products, firms, and countries of origin to establish food smuggling targeting criteria. FDA and CBP also will share information on import shipments and conduct joint examinations, when appropriate, to identify shipments that may contain smuggled food. The agencies will work together to publicize food smuggling enforcement actions to deter others from attempting similar acts.

FDA also issued draft guidance clarifying agency expectations on new dietary ingredients for industry, which is an important preventive control to ensure that consumers are not exposed to unnecessary public health risks from new ingredients with unknown safety profiles.

Dietary supplement manufacturers are required to notify the FDA in advance when they intend to add a new dietary ingredient to their products, except in certain situations when the ingredient has been part of the food supply and has not been chemically altered for use in supplements. The notifications must identify the new dietary ingredient and be accompanied by evidence on its safety. The draft guidance is intended to inform and assist manufacturers, distributors, and others in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient is necessary and in preparing premarket safety notifications.

FDA also announced its authority to suspend the registration of food facilities to prevent the import and export into the United States or other intrastate or interstate distribution of food became effective July 3, 2011. The agency expects individuals responsible for registered food facilities to take steps to produce safe products. If those efforts fail, the facility should file a food report with FDA, voluntarily recall affected products, and take action to keep products from reaching consumers. FDA may suspend the registration of a facility in certain circumstances involving food that has a reasonable probability of causing serious adverse health consequences or death to humans or animals.

The rule also allows FDA to administratively detain food products that it has reason to believe are adulterated or misbranded for up to 30 days, if needed, to ensure they are kept out of the marketplace. Under this rule, these products will not be sold or distributed while the agency determines whether an enforcement action such as seizure or federal injunction against distribution of the product, is warranted.