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FDA Checks Off Two More Tasks Required by FSMA

The U.S. Food and Drug Administration announced Tuesday that it has completed two tasks required by the new Food Safety Modernization Act (FSMA) — an anti-smuggling strategy and draft guidance on new dietary ingredients.


The anti-smuggling strategy was cooperatively developed by the Department of Health and Human Services (HHS) and the Department of Homeland Security (DHS) to help spot and prevent smuggled foods from entering the United States.

Smuggled foods could pose a threat to national security and consumer safety.

FDA and the U.S. Customs and Border Protection will work together  to review historical data and better identify products, firms, and countries of origin to establish food smuggling targeting criteria; share information on import shipments and conduct joint inspections, when appropriate; and, whenever possible publicize enforcement actions to deter food smuggling.

The FDA also issued draft industry guidance on new dietary ingredients 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 before they add a new dietary ingredient to their products, except in certain situations when the ingredient has been part of the food supply, and present evidence on its safety.

Under the FSMA, the FDA is required to meet various deadlines for certain tasks as it builds a new food safety system based on prevention. The law required the agency to complete the anti-smuggling strategy and the dietary ingredients guidance on or before July 3, 2011, or within 180 days of the signing of FSMA into law.

Among other developments related to FSMA implementation, the FDA also announced that the agency’s 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 on July 3.


In a news release, the FDA stated that it 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.

Additionally, the rule, issued in May, has gone into effect that allows the 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.

For more information:

o Federal Register Notice for New Dietary Ingredient Notifications and Related Issues 


o Federal Register Notice for Interim Final Rule on Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption 

o FDA Food Safety Modernization Act (FSMA) 

o Consumer Update:  FDA Meeting FSMA Food Safety Goals 

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