Zion Herbals

Marketer of Botanical Kratom Made Drug Claims, Justice Department Says

October 3, 2014 By Josh Long
WASHINGTON—Dried Herbal Leaf. Mitragyna Speciosa. Made in Indonesia. Not for Human Consumption. That is essentially the label on 577 cartons of a botanical named kratom that U.S. Marshals have seized in California.

The 25,000 pounds of raw kratom material, FDA recently announced, is worth more than USD $5 million.

The botanical is used for “potpourri, incense and teas,” Mark Rose, the owner of the kratom importer, said in an affidavit, according to documents filed in federal district court. And the kratom label stated, “Not for Human Consumtion [sic]”, the documents said. But the importer, Rosefield Management, Inc. in Van Nuys, California, distributed the kratom under the direction of a company making claims the botanical can treat diseases, the U.S. Justice Department alleged in a complaint filed over the summer.

Wholesale Shamanic Herbs states on its website that kratom “is often used as a substitute for opium when opium is unavailable,” and the website said a 1994 study indicated “many people had used it to get off of morphine or heroine,” according to the complaint. Such claims render kratom a drug under the Federal Food, Drug, and Cosmetic Act (FD&C), the Justice Department said.

Last month, U.S. District Judge Percy Anderson gave authorities permission to seize the kratom after finding found probable cause that the botanical was an unapproved new drug. The Justice Department said an unapproved new drug is subject to seizure, forfeiture and condemnation.

In a brief phone interview Friday, Rose said he does not plan to fight FDA in court.

“I believe once the FDA has deemed something as an unregistered drug like that, it’s going to be an uphill battle to get their position changed and it’s going to be an expensive battle,” said the importer, who noted his company handled fulfilment and had no customer base.

Rose said it is his understanding FDA has not filed any criminal prosecutions against importers of kratom. The agency on Friday did not immediately confirm that statement.

Kratom is a new dietary ingredient (NDI) containing alkaloids that can cause pharmacological effects similar to morphine and other opiates. The herb can produce such adverse health effects as hallucinations, sleeplessness and tremors, according to FDA. The Drug Enforcement Administration (DEA) recognizes no legitimate medical use for kratom, which is in the same family tree as coffee and contains more than 25 alkaloids.

American consumers of kratom deny that it is harmful to them and have touted its benefits. Kratom helps to alleviate pain, relax and treats other conditions, including restless leg syndrome, consumers told Natural Products INSIDER earlier this year. Board members of the non-profit Botanical Legal Defense denied kratom makes a person hallucinate and said research does not support claims that kratom causes other adverse effects such as nervousness.

The seized kratom came from C.V. Bali Herbal of Indonesia. The company’s products are subject to detention without physical inspection under an import alert that FDA issued on Feb. 28.

A month before the import alert, U.S. Customs and Border Protection notified FDA that it had identified a shipment of kratom declared as herbal incense, according to court documents. On March 6, FDA investigators discovered Rosefield was holding 550 cartons of kratom from a Jan. 20, 2014 shipment and 27 cartons from a Dec. 29, 2013 shipment, the court documents noted.

FDA said it has noticed an increase in the number of shipments of dietary supplements containing kratom, which is known by several other names including Mitragyna speciosa, mitragynine extract and biak-biak. FDA takes the position that kratom does not have a history showing that it will reasonably be expected to be safe as a dietary ingredient.

“In fact, the scientific literature disclosed serious concerns regarding the toxicity of kratom in multiple organ systems,” FDA said in a June 16, 2014 import alert. “Consumption of kratom can lead to a number of health impacts, including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal signs and symptoms.”

In March 2014, at least one company that was selling kratom as a dietary supplement recalled the product. SNI National announced the voluntary recall of its products from all distributors and retail locations. At the time, the company was unaware of any complaints or adverse health effects associated with the sale of the products.

The Council for Responsible Nutrition (CRN), a Washington, D.C.-based trade organization representing the dietary supplement industry, hasn’t taken an official position on kratom.

“We look to the agency (FDA) on this. The agency seems to feel pretty strongly there are safety concerns” related to kratom, CRN president and CEO Steve Mister said.

Mister, an attorney who previously practiced law with a Washington, D.C. law firm, said he is not aware of any lawsuits that have been filed against companies for marketing kratom as a dietary supplement. In the recent complaint, he said, it is clear the drug claims triggered the seizure of kratom. The question of whether kratom was marketed as a dietary supplement was not raised in the lawsuit.

The complaint was filed on Aug. 27 in the U.S. District Court for the Central District of California, Western Division, CV-14-6729.
-Natural Products Insider

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