(STR Trade Report)
The Food and Drug Administration has adopted without change a May 2011 interim final rule concerning administrative detentions of potentially adulterated or misbranded human or animal food. As specified by the Food Safety Modernization Act, this rule allows the FDA to order administrative detention of any article of food that is found during an inspection, examination or investigation if it has reason to believe that the article of food is adulterated or misbranded. Previously the FDA was only able to order such detentions if it found credible evidence or information indicating that the article of food presented a threat of serious adverse health consequences or death to humans or animals.
The FDA believes this authority will further help it to prevent potentially harmful food from reaching U.S. consumers. The agency noted in the interim final rule that it had never administratively detained an article of food despite having the authority to do so but that under the new criteria it is more likely to use administrative detention in situations where it might previously not have; e.g., where the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
In response to comments on the interim final rule the FDA has provided the following information.
• Decisions on whether the FDA has “reason to believe that an article of human or animal food is adulterated or misbranded” are fact-specific and will therefore be made on a case-by-case basis.
• The FDA will continue to use its advisory action tools, such as warning letters and untitled letters, to achieve voluntary compliance and voluntary corrective action to address adulteration or misbranding violations, as appropriate.
• Given the procedural and substantive differences between administrative detention and detention that occurs during import admissibility review, confusion between the two is unlikely; however, when the FDA gives written notice in either circumstance it will make clear which type of detention is involved.
• The FDA intends to issue notice of termination of administrative detention on the same day the decision is made whenever practicable. If the FDA fails to issue a termination notice and the detention period expires (a maximum of 30 days from the date the detention was ordered) the detention is deemed to be terminated.
• The responsibility for paying the storage costs of administratively detained food is a matter to be resolved between the private parties involved. An owner, operator or agent in charge of the place where the food is located can request modification of a detention order to allow the food to be moved or destroyed if they do not want to store it.