The lot of product, branded as RelaKzpro, is worth more than $400,000, according to FDA. Dordoniz Natural Products, the company that was holding the product at its South Beloit, IL facility, is incorporated in Delaware and has only been in existence since September of 2015.
FDA issued an import alert on kratom in February, 2014. This allows allows US officials to detain imported dietary supplements and bulk dietary ingredients that are, or contain, kratom without physical examination. Despite this hurdle, some companies and individuals continue to run the risk of seizure, perhaps hoping they can slide in under the radar.
“It is one of these situations in which historically the agency has made these pronouncements, and then sometimes the agency does something about it quickly, and sometimes it takes FDA a long time to do something about it,” said Marc Ullman, of council with the law firm Rivkin Radler LLC.
Kratom as an NDI
The agency has administratively detained RelaKzpro alleging, among other things, that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury; therefore, dietary supplements containing kratom are adulterated under the FD&C Act. This de facto makes any product containing kratom to be adulterated under the act.
Mitragyna speciosa, commonly known as kratom, is a botanical substance that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. Serious concerns exist regarding the toxicity of kratom in multiple organ systems. According to FDA, consumption of kratom can lead to a number of health impacts, including, among others, respiratory depression, vomiting, nervousness, weight loss and constipation. Kratom has been indicated to have both narcotic and stimulant-like effects and withdrawal symptoms may include hostility, aggression, excessive tearing, aching of muscles and bones and jerky limb movements.
“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, the FDA’s associate commissioner for regulatory affairs. “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.”
Kratom contains two alkaloids, mitragynine and 7-hydroxymitragynine, that have analgesic and potentially psychedelic properties. It has been suggested that if a way were found to remove these that much of FDA’s concern about the ingredient would disappear. Ullman said that could form part of an effort to legitimize the ingredient. Kratom, he said, could be argued to have been present in the food supply prior to the DSHEA grandfather date in the form of tea consumed in areas in Southeast Asia where the plant is native. In Ullman’s view, 'being present in the food supply as an article of food’ applies the world over, and not just the US market.
“If kratom has historically been used to make tea and you have a water-based kratom extract and you are not looking to target any of the constituents for special concentration, then you might have a case. Or you could argue you have a plant grown under conditions that discourage the presence of whatever opiods might be in the plant,” he said.
Daniel Fabricant, PhD, executive director and CEO of the Natural Products Association, said that while efforts continue on the state level by groups like Botanical Legal Defense to protect the legality of kratom in those markets (the group helped defeat a Florida bill that would have outlawed the ingredient), on the federal level the botanical continues to exist under a cloud.
“FDA did not issue a ban as it did for ephedra. But the import ban on kratom is pretty clear. With that said, while it is not ‘banned’ it certainly isn’t legal. We don’t have a position on kratom per se; our position is that companies ought to abide by the law,” he said.
UNPA applauds action
The United Natural Products Alliance has adopted a policy in which members agree not to sell products containing kratom as a condition of membership. UNPA president Loren Israelsen said that FDA’s action proves that regulators are awake at the switch.
“When UNPA learned that FDA issued an import alert for kratom, we promptly established a no sale of kratom as a condition of membership. This was done after reviewing the safety and potential for abuse associated with it,” Israelsen said.
“FDA’s recent seizure of a large inventory of kratom is welcome.This affirms that FDA is serious about following up on its stated regulatory policies and sends a message to kratom traffickers that they may be next. If we are to ever convince critics that this is a regulated industry, actions such as this one will help us do so,” he said.