
“We have identified kratom as a botanical substance that could pose a risk to public health and have the potential for abuse,” said Melinda Plaisier, associate commissioner for regulatory affairs for the agency. “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.”
The FDA’s action arrives as the latest in a series of measures it has taken against dietary supplements containing kratom, stemming from concerns regarding the toxicity of the botanical in internal organ systems. In February, 2014 the agency issued an import alert allowing the FDA to detain any kratom coming in from overseas. Later that year U.S. Marshals executed a seizure of more than 25,000 pounds (worth upwards of $5 million) of raw kratom material Rosefield Management, Inc. in Van Nuys, Calif.
Last month, Vivazen, a product similar in nature to RelaKzpro, reformulated its shot-format pain relief supplement to be kratom-free in response to the FDA’s sustained pressure. Vivazen’s website states its new version is now manufactured under conditions that are in compliance with the FDA’s Current Good Manufacturing Practices.