On February 4, 2013, the FDA announced the final rule amending the criteria for administrative detention to prevent potentially unsafe food from reaching the marketplace. This change follows the changes to the Federal Food, Drug, and Cosmetic Act under the Food Safety Modernization Act. The final rule adopts the same policy that was implemented by the interim final rule without any change. The interim final rule was published in May 2011. This rule became effective in July 2011. The interim final rule amended the criteria for ordering administrative detention. This rule permits the FDA to administratively detain food it believes is adulterated or misbranded.
Prior to the enactment of the Food Safety Modernization Act, the FDA was able to detain a food product only when it had credible evidence that a food product presented a threat of serious adverse health consequences or death to humans or animals. The final rule loosens the parameters of the previous regulation and allows the FDA to detain food that it believes is adulterated or misbranded. The agency can keep the products out of the marketplace for a maximum of 30 days while the agency determines whether it will be taking further enforcement action. Further enforcement action may include the seizure of the goods. This new rule could cause difficulties in the importation of your product. Please contact me now so that I may inform you what your options are to avoid any potential issues that may arise due to the enactment of this regulation.