Under the direction of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized nearly 90,000 bottles of RelaKzpro, a dietary supplement containing kratom, from a manufacturer in Illinois. Kratom is a botanical substance that FDA has identified as a potential risk for public health and substance abuse. The agency issued an Import Alert for the substance in February 2014. FDA administratively detained the RelaKzpro supplements early in 2016, and the products were seized shortly after.
“The FDA will continue to exercise our full authority under law to take action on these new dietary ingredients, especially if they ignore the notification requirements, as part of our commitment to protecting the health of the American people,” said Melinda Plaisier, FDA Associate Commissioner for Regulatory Affairs.
FDA was granted administrative detention authority in 2002 by a provision of the Bioterrorism Act. The provision allowed FDA to detain any food, beverage, or supplements found during an inspection, examination, or investigation that was likely to pose a threat of serious adverse health consequences or death to humans or animals. In 2011, the Food Safety Modernization Act (FSMA) expanded FDA’s administrative detention authority to allow FDA to detain any food, beverage, or supplement believed to be adulterated or misbranded.
Food products may not be moved while under an FDA detention order. FDA may detain a product for up to 20 days (up to 30 if additional time is required to institute a seizure or injunction action) while the agency determines and executes regulatory action.
It’s prudent to ensure your products are FDA compliant before distributing them in the USA in order to avoid costly detentions. Registrar Corp’s Regulatory Specialists can review food, beverage, and supplement labeling and ingredients for FDA compliance. Clients receive a detailed report (typically 40 to 50 pages) explaining how FDA labeling and ingredient regulations apply to the particular product, along with a print ready graphic file that incorporates our suggested changes.
For questions about or assistance with FDA detentions or labeling regulations, contact +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.