Under FSMA, the new rules now read that FDA can “order administrative detention if there is reason to believe that an article of food is adulterated or misbranded.”
FDA is seeking public comment on changes to criteria for detaining food at the point of import.
Enacted in January of this year, the Food Safety Modernization Act (FSMA) changed the administrative detention criteria originally bestowed on FDA by the Bioterrorism Act of 2002, which allowed the agency to “detain any article of food if, during an inspection, examination, or investigation, an FDA officer or qualified employee finds there is credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals.”
Under FSMA, the new rules now read that FDA can “order administrative detention if there is reason to believe that an article of food is adulterated or misbranded.” Read Nutritional Outlook’s in-depth analysis on this change in wording here.
Dietary supplements are regulated as food in the United States. Thus, detention criteria also apply to this segment of the market.
FDA may detain food products for a maximum of 30 calendar days. Appeals can be filed, to which the agency must respond to within five calendar days. For more background on the rules, click here.
The agency has now released draft guidance, asking for public comment on the new detention rules.
Nutritional Outlook thanks Harry Rice, PhD, for the tip.