from the kratom-latte dept.
The FDA has issued a public health advisory warning of deaths related to kratom (Mitragyna speciosa) and warning against using it to treat opioid withdrawal symptoms. The DEA attempted to temporarily regulate kratom as a schedule I drug in 2016, but stopped short of doing so after a public backlash. From FDA Commissioner Scott Gottlieb's statement on the advisory:
It's very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms. The FDA is devoted to expanding the development and use of medical therapy to assist in the treatment of opioid use disorder. However, an important part of our commitment to this effort means making sure patients have access to treatments that are proven to be safe and effective. There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder. Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product's dangers, potential side effects or interactions with other drugs.
There's clear data on the increasing harms associated with kratom. Calls to U.S. poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year. The FDA is aware of reports of 36 deaths associated with the use of kratom-containing products. There have been reports of kratom being laced with other opioids like hydrocodone. The use of kratom is also associated with serious side effects like seizures, liver damage and withdrawal symptoms.
Given all these considerations, we must ask ourselves whether the use of kratom – for recreation, pain or other reasons – could expand the opioid epidemic. Alternatively, if proponents are right and kratom can be used to help treat opioid addiction, patients deserve to have clear, reliable evidence of these benefits.
I understand that there's a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders. But the FDA has a science-based obligation that supersedes popular trends and relies on evidence. The FDA has a well-developed process for evaluating botanical drug products where parties seek to make therapeutic claims and is committed to facilitating development of botanical products than can help improve people's health. We have issued guidance on the proper development of botanical drug products. The agency also has a team of medical reviewers in the FDA's Center for Drug Evaluation and Research that's dedicated to the proper development of drug applications for botanicals. To date, no marketer has sought to properly develop a drug that includes kratom.
[...] As a physician and FDA Commissioner, I stand committed to doing my part to prevent illegal substances that pose a threat to public health from taking their grip on Americans. While we remain open to the potential medicinal uses of kratom, those uses must be backed by sound-science and weighed appropriately against the potential for abuse. They must be put through a proper evaluative process that involves the DEA and the FDA. To those who believe in the proposed medicinal uses of kratom, I encourage you to conduct the research that will help us better understand kratom's risk and benefit profile, so that well studied and potentially beneficial products can be considered. In the meantime, based on the weight of the evidence, the FDA will continue to take action on these products in order to protect public health.
The FDA Commissioner may want your help to study kratom, but you'll find it hard to do so as imports of the substance are being seized:
The FDA has exercised jurisdiction over kratom as an unapproved drug, and has also taken action against kratom-containing dietary supplements. To fulfill our public health obligations, we have identified kratom products on two import alerts and we are working to actively prevent shipments of kratom from entering the U.S. At international mail facilities, the FDA has detained hundreds of shipments of kratom. We've used our authority to conduct seizures and to oversee the voluntary destruction of kratom products. We're also working with our federal partners to address the risks posed by these imports. In response to a request from the Drug Enforcement Administration (DEA), the FDA has conducted a comprehensive scientific and medical evaluation of two compounds found in kratom. Kratom is already a controlled substance in 16 countries, including two of its native countries of origin, Thailand and Malaysia, as well as Australia, Sweden and Germany. Kratom is also banned in several states, specifically Alabama, Arkansas, Indiana, Tennessee and Wisconsin and several others have pending legislation to ban it.
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Kratom, an herbal drug made of ground-up tree leaves, is "temporarily" joining other natural substances such as cannabis, psilocybin, and peyote on the schedule I list of the Controlled Substances Act. The active ingredients in kratom, the indole alkaloids mitragynine and 7-hydroxymitragynine, are both being added to the list for up to three years, after which they can be added permanently.
Prior to this move, the U.S. has already been seizing shipments of kratom:
In 2014, the FDA issued an import alert that allowed US Customs agents to detain kratom without a physical examination. "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. According to the DEA, between February 2014 and July 2016, nearly 247,000 pounds of kratom were seized.
Advocates say that kratom is a natural treatment for opioid addiction, an application that the Drug Enforcement Agency dismisses. Meanwhile, the heroin/opioid epidemic continues with "unprecedented" events like the recent 174 heroin overdoses in just six days in Cincinnati, Ohio.
Check out the implosion of this kratom subreddit, which is attempting to get 100,000 signatures on the White House petition site:
APATHY WILL GET US NOWHERE. IF THERE WAS EVER A TIME FOR US TO BAND TOGETHER, ITS NOW. stand with me brothers and sisters. hope is not lost.
The blowback against the U.S. Drug Enforcement Administration's decision to ban kratom has caught the attention of a bipartisan group of legislators, but a DEA spokesman has said that "It's not a matter of if. It's simply a matter of when" the DEA bans kratom:
A bipartisan group of nine senators is calling on the Drug Enforcement Administration to delay its "unprecedented" decision to ban kratom, a plant that researchers say holds great potential for mitigating the effects of the opioid epidemic. [...] The Senate letter, spearheaded by Orrin G. Hatch (R-Utah) says: "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. 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.
"Given the long reported history of Kratom use," the letter continues, "coupled with the public's sentiment that it is a safe alternative to prescription opioids, we believe using the regular review process would provide for a much-needed discussion among all stakeholders." [...] The DEA cites 600-plus poison-control center calls involving kratom between 2010 and 2015 in its justification for banning the plant, and notes that 15 deaths were linked to the use of the plant between 2014 and 2016. In an interview with The Washington Post, a DEA spokesman later clarified that all but one of those fatalities involved the use of other substances. Earlier this week 51 U.S. representatives similarly called on the DEA and the White House to reconsider or at least delay the ban, which was slated to go into effect as early as Friday. In an interview, DEA spokesman Russell Baer confirmed that the ban was not yet in place. "We have not yet determined a date when we will publish that final order" putting the ban into effect, he said.
There may be a public comment period before the ban takes effect, and the White House is now obligated to respond to the petition about kratom, which has reached over 140,000 signatures.
Previously: DEA Welcomes Kratom to the Schedule I List Beginning September 30
Heroin, Fentanyl? Meh: Carfentanil is the Latest Killer Opioid
Alcohol Industry Bankrolls Fight Against Legal Pot in Battle of the Buzz [Updated]
The FDA is proposing a new, risk-based enforcement approach to homeopathic drug products (alternative medicine):
To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA's existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.
Under the law, homeopathic drug products are subject to the same requirements related to approval, adulteration and misbranding as any other drug product. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the agency's enforcement policies since 1988.
"In recent years, we've seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren't adequately tested or disclosed to patients," said FDA Commissioner Scott Gottlieb, M.D. "Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm."
FDA draft guidance (8 pages).
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