FDA Issues First New Rules under the Food Safety Modernization Act
The U.S. Food and Drug Administration (FDA) today issued the first rules under the FDA Food Safety Modernization Act (FSMA). As we previously reported, President Obama signed the FSMA in January of this year to help ensure the safety and security of foods in the United States. The first rule gives the FDA the ability to administratively detain food for up to 30 days. The second rule requires that food importers declare whether the food products, including food for animals, have been denied entry into any other country. The final rules will become effective July 3, 2011. Interested persons may submit comments by August 3, 2011.
The first interim final rule issued under the FSMA gives the FDA the ability to administratively detain food the Agency believes has been produced under insanitary or unsafe conditions. Once the rule becomes final, the FDA will be able to detain food products that it has reason to believe are adulterated or misbranded for up to 30 days. The products will be kept out of the marketplace while the FDA determines whether an enforcement action, such as seizure or federal injunction against the distribution of the product in commerce, is necessary.
Previously, the FDA only had the authority to detain food products when it had credible evidence that a food product presented was contaminated or mislabeled in such a way that it presented a threat of serious adverse health consequences or death to humans or animals. In order to pursue enforcement, the FDA would often work with state agencies to embargo a food product under the states legal authority until federal enforcement action could be initiated in federal court.
Under the second interim final rule, anyone importing food into the United States will be required to inform the FDA if any country has refused entry to the same product, including food for animals in addition to any other information already required. The new requirements in this notice allow the FDA the ability to better identify imported food shipments that may pose safety and security risks to consumers in the United States. This new reporting requirement will be administered through the FDAs prior notice system for incoming shipments of imported food established under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
In a press release issued by the FDA, FDA Deputy Commissioner for Foods Mike Taylor said, “[t]he new information on imports can help the FDA make better informed decisions in managing the potential risks of imported food entering the United States.” According to Taylor, “[t]hese rules will be followed later this year and next year by a series of proposed rules for both domestic and imported food that will help the FDA continue building the new food safety system called for by Congress.”
Fuerst Ittleman will continue to monitor new rules issued by the FDA under the FSMA. For more information regarding the new rules, please contact us at firstname.lastname@example.org or (305) 350-5690.