Natural Products Insider

NOV-DEC 2016

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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naturalproductsinsider . com 5 In the News In the wake of pressure from Congress and the American public, DEA is at least temporarily reversing its decision to outlaw the botanical known as kratom. In October, DEA withdrew its Aug. 31, 2016, notice of intent to temporarily place the main constituents of kratom—the plant formally known as Mitragyna speciosa— into schedule I under the Controlled Substances Act (CSA). But kratom's future remains uncertain. DEA is soliciting comments from the public until Dec. 1, 2016, regarding the scheduling of mitragynine and 7-hydroxymitragynine under the CSA. The agency said it is expecting to receive from FDA a scheduling recommendation for the two substances, as well as a medical and scientifi c evaluation. DEA has requested FDA expedite its scheduling recommendation and evaluation. "With respect to mitragynine and 7-hydroxymitragynine, DEA will consider all public comments received under the above procedures, as well as FDA's scientifi c and medical evaluation and scheduling recommendation for these substances," DEA said in a document published in October in the Federal Register. "Once DEA has received and considered all of this information, DEA will decide whether to proceed with permanent scheduling of mitragynine and 7-hydroxymitragynine, or both permanent and temporary scheduling of these substances." The main constituents of kratom remain noncontrolled substances under federal law, DEA said. The American Kratom Association welcomed the development. "We dedicated all our resources to a team of nationally recognized experts and enlisted a formidable grassroots army to get here today," Susan Ash, founder and director of the American Kratom Association, said in an emailed statement. "We're thankful to the DEA for listening to us, the many members of Congress and the research scientists who expressed the opposition that led to a withdrawal of the emergency attempt to make kratom a schedule I controlled substance." John Hudak, who studies drug policy at the Brookings Institution, described DEA's most recent move as "shocking" in The Washington Post. "The DEA is not one to second-guess itself, no matter what the facts are," he told the newspaper. Plenty of DEA critics second-guessed the agency's notice of intent, rejecting claims that kratom has no accepted medical use and high potential for abuse. "We believe kratom should not be scheduled in any way, and available to responsible adults," Ash of the American Kratom Association said. "Since it's been consumed safely for decades in the United States and worldwide for millennia, there is no impetus to make it a controlled substance." Kratom, a petition to the White House asserted, "has been shown numerous times in reports from users to help recovering opiate addicts [sic], treat pain, combat depression and anxiety, and much more." The petition garnered more than 142,000 signatures. "Congress granted emergency scheduling authority to the DEA based on the need for law enforcement interdiction of new and previously unknown illegal synthetic street drugs that result in injuries and death," declared a letter to DEA Acting Administrator Charles Rosenberg, which the Post reported was signed by a bipartisan group of nine U.S. senators. "The use of this emergency authority for a natural substance is unprecedented, so it is important to determine whether the circumstances here necessitate a jump to Schedule I." Industry lawyers viewed DEA's notice of intent as virtually eliminating kratom's potential future as a lawful dietary supplement in the United States. "It is now or never for the kratom industry," attorney Marc Ullman told INSIDER after DEA's notice of intent was published, meaning kratom proponents would need to prove the botanical can be safe and has medical benefi ts. "The kratom trade has always touted the botanical as 'good for you,' but I have not seen a serious effort to rebut the concerns on kratom that have been percolating for some time," added Ullman, of counsel to the law fi rm Rivkin Radler LLP. Kratom is popularly used in the United States to address chronic pain, as well as to lessen the withdrawal symptoms when kicking an opioid addiction. The botanical is also popular with bodybuilders and athletes. Despite the herb's anecdotal benefi ts, DEA noted information from the Centers for Disease Control and Prevention (CDC), published literature, poison control centers and medical examiners indicated use of kratom (containing the two primary active compounds) has resulted in serious adverse events, including deaths. FDA, which assisted with DEA's efforts to schedule kratom and regulates supplements, has previously cautioned the botanical has the potential for abuse and is a risk to public health. In an import alert, FDA said it has no evidence that kratom was marketed as a dietary ingredient before Oct. 15, 1994. Therefore, it cannot be sold in the United States as a dietary supplement without a new dietary ingredient notifi cation (NDIN). Under the 1994 Dietary Supplement Health and Education Act (DSHEA), such a notifi cation must demonstrate that kratom, when used under the recommended conditions or suggested in the labeling of the product, "Will reasonably be expected to be safe." At the time DEA announced its notice of intent to outlaw the main constituents in kratom, FDA confi rmed receiving only one NDIN on kratom. But the notice was incomplete, failing to satisfy federal regulations. And in a three-page letter of objection, FDA noted there was no history of use or other evidence supplied to meet the safety burden required by DSHEA. DEA Backpedals on Plan to Outlaw Botanical Kratom by Josh Long

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