Federal officials' Jan. 6 seizure of $400,000 worth of dietary supplements containing the botanical kratom not only signals FDA's concerns about the risk of abuse of the ingredient, but also could be a tip of the agency's cap to a US senator calling for tighter regulation of the supplement industry.

The seizure, which followed a Jan. 2 New York Times article on the addictive quality of kratom that has been criticized by experts, targeted some 90,000 bottles of RelaKzpro brand products marketed by Dordoniz Natural Products LLC, of South Beloit, Ill.

"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, FDA's associate commissioner for regulatory affairs, in the agency's statement.

FDA says the Department of Justice filed a complaint in the US District Court for the Northern District of Illinois alleging supplements containing kratom are adulterated because it is a new dietary ingredient for which information is inadequate to provide reasonable assurance it does not present a significant or unreasonable risk of illness or injury.

Kratom (mitragyna speciosa korth), indigenous to Southeast Asia, has been in FDA's crosshairs for several years, and in February 2014 the agency issued an import alert allowing detention without physical examination of bulk kratom or supplements containing the ingredient ([A#05140324007]).

The agency had said kratom increasingly was reaching the US in shipments of supplements and bulk ingredients in capsules, whole leaves, processed leaves, leaf resins and other forms. Although FDA cautioned manufacturers about kratom’s safety as a dietary ingredient in 2013, industry stakeholders said the agency should clarify whether the botanical is a legitimate supplement ingredient Also see "Kratom Action Presents Regulatory Puzzle For FDA" - Pink Sheet, 4 October, 2013..

Since kratom is categorized as a botanical but is considered an NDI, it could be cleared for use in supplements if a firm submits a notification to FDA with evidence supporting its safe use. Notifications to FDA are required at least 75 days before an NDI-containing product is marketed, but firms are not required to wait for the agency's response on an ingredient before launching the products.

The Drug Enforcement Administration includes kratom on its list of drugs and chemicals of concern, though it does not list it as a controlled ingredient.

Getting Durbin's Attention

The seizure of kratom from a firm in a city northwest of Chicago likely will be noticed by a member of Illinois' congressional delegation, Sen. Dick Durbin, a Democrat who is a steadfast critic of the supplement industry and plans to introduce legislation for tighter regulation ([A#05160104003]).

While kratom is available from many businesses, both online and in stores, the seizure at Dordoniz Natural in South Beloit is more likely to attract Durbin's attention as a sign of FDA's enforcement under the current regulatory framework than an agency action against a firm marketing the ingredient in another state.

An attorney who represents supplement firms, speaking generally about FDA and DoJ enforcement in the space, noted that federal agencies also could decide against investigating a firm in a certain area of the country in order to align with the interests of a member of Congress.

"If the impetus for the Illinois action is the US senator, as you suggest, it would certainly not be the first time politics drove an enforcement action," said the attorney on background in an email. "The reverse also can happen (i.e., an enforcement action is dropped due to congressional scrutiny). This would especially hold true if the US attorney in Illinois personally knows the senator or would like to stay in his good graces.",

The World Coalition for Botanical Development issued a statement Jan. 6, ahead of the announced seizure, criticizing a New York Times article that stated the product, which often is used to treat substance addiction, can become addictive as well.

Ryan Estevez, a psychiatrist and psycho-pharmacologist who advises the coalition, said the contention that kratom can be “just as addictive” as narcotics is false.

“In recent years, kratom has been widely misrepresented as dangerous and without medical value. These disturbing labels overlook the fact that valuable remedies and dietary supplements derived from kratom benefit lives. Kratom, in fact, is not a drug at all: It is a plant derivative no more dangerous than a cup of coffee,” Estevez said.

More troubling than the news reports are the “subsequent careless and knee-jerk response by many legislators and policy makers to ban kratom,” he added.

FDA said it will continue to exercise its "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.”

FDA has authority to detain any food or supplement product it has reason to believe is adulterated or misbranded and to keep the products off the market for a maximum of 30 days while it determines whether to take further enforcement action.

FDA Kicks Off Kratom Enforcement With $400,000 Seizure In Illinois

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