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FDA targets kratom alternative in import alert

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A new dietary ingredient (NDI) called Sakae NAA—considered an alternative to kratom—is now the subject of an FDA import alert.

Xi'an Le Sen Bio-technology Co. Ltd. and its NDI are subject to detention without physical examination under Import Alert 54-18, which was updated July 9.

“As with the other ingredients listed under Import Alert 54-18, the FDA has determined that Sakae NAA 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,” Lindsay Haake, an FDA spokeswoman, said in an email.

Like kratom, Sakae NAA is native to Southeast Asia. The herb grows in Cambodia, Laos, Myanmar, Thailand and Vietnam, can be found in wetlands and jungles along the riverbanks, and its leaves were traditionally chewed like kratom and other ancient herbs, according to the website of Oasis Kratom, a Nevada-based retailer and wholesaler of kratom powder.

A separate FDA import alert that’s been in effect for several years pertains to kratom.

Mac Haddow, senior fellow on public policy with the American Kratom Association, said Sakae NAA is a kratom alternative used in Thailand, largely due to a kratom ban in that country since 1943. However, he said the government in Thailand has decriminalized the use of kratom, and it’s his understanding the country is in the final stages of a lengthy process to allow for the growing of kratom plants for the purpose of exports.

Haddow said he does not know who sells Sakae NAA or produces finished products containing the ingredient.

Xi'an Le Sen Bio-technology could not be reached for comment, and an employee of the company contacted through LinkedIn did not immediately respond to a request.

“The entry came to attention of import investigators as part of their routine follow-up on shipments that flag as a result of screening criteria,” Haake, the FDA spokeswoman, said. “There are many ingredients that could potentially meet the standard for this [import alert]. In this case, the review indicated that the entry contained an NDI.”

Two other Chinese firms, and an NDI known as higenamine, also are subject to Import Alert 54-18. Pieter Cohen, M.D., an associate professor of medicine at Harvard Medical School, told Natural Products Insider that higenamine exerts additional stress on the human heart, and it’s unknown at what quantity the ingredient causes such stress when consumed in oral form.

Higenamine also is on an FDA “Dietary Supplement Ingredient Advisory List” of substances that do not appear to be lawfully marketed in dietary supplements. Sakae NAA does not appear on the advisory list, although that could change. An FDA official recently said the agency plans to work on the list this year.

FDA has not received an NDI notification for either Sakae NAA or higenamine to demonstrate the safety of either ingredient in supplements, based on recent FDA public filings. Due to a confidentiality clause in the law, the agency can neither confirm nor deny whether any such notifications have been received until at least 90 days after their receipt.

Cara Welch, FDA's acting director of the Office of Dietary Supplement Programs (ODSP), recently commented on Import Alert 54-18. 

“Not all ingredients of concern to our program will be applicable for this import alert," Welch said during the Dietary Supplements Regulatory Summit, a collaboration between five trade associations and hosted this year by the Natural Products Association (NPA). "For example, they have to be NDIs, but for those that are, this is an opportunity to catch shipments as they’re coming into the country. Based on the interest this import alert has garnered over the past couple of months, I know this is a desire shared with many in the industry.”




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