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posted by martyb on Wednesday April 04 2018, @04:47PM   Printer-friendly
from the B-b-b-but-the-Salmonella-is-natural,-too! dept.

The U.S. Food and Drug Administration (FDA) has issued its first-ever mandatory recall for kratom-containing "food products", because the company selling them did not comply with the agency's request for a voluntary recall:

FDA orders kratom product recall over Salmonella; first such mandatory move in history

Federal drug regulators issued their first-ever mandatory recall Tuesday to a company selling several products containing the herbal supplement kratom and contaminated with Salmonella.

The Food and Drug Administration (FDA) said it issued the order because Triangle Pharmanaturals of Las Vegas refused to cooperate.

The Centers for Disease Control and Prevention said last month that the kratom Salmonella outbreak was linked to 11 hospitalizations among 28 people who caught the strain.

The FDA is advising consumers to discard the products that are part of the mandatory recall, which it says include, but isn't limited to: Raw Form Organics Maeng Da Kratom Emerald Green, Raw Form Organics Maeng Da Kratom Ivory White, and Raw Form Organics Maeng Da Kratom Ruby Red. The company, which promotes itself as a consulting firm, may "manufacture, process, pack and/or hold additional brands of food products containing powdered kratom, FDA says.

Related:
FDA Blocks More Imports of Kratom, Warns Against Use as a Treatment for Opioid Withdrawal
FDA Labels Kratom an Opioid
CDC Warns of Salmonella Infections Linked to Kratom


Original Submission

Related Stories

FDA Blocks More Imports of Kratom, Warns Against Use as a Treatment for Opioid Withdrawal 22 comments

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.

FDA Labels Kratom an Opioid 37 comments

FDA Commissioner Scott Gottlieb has released a new statement denouncing the drug kratom. The statement says that the FDA has learned about new deaths that "involved" kratom use, additional adverse effects associated with its use have been found, and that Public Health Assessment via Structural Evaluation (PHASE) "3-D computer technology" has been used to analyze the chemical compounds in kratom:

Using this computational model, scientists at the FDA first analyzed the chemical structures of the 25 most prevalent compounds in kratom. From this analysis, the agency concluded that all of the compounds share the most structural similarities with controlled opioid analgesics, such as morphine derivatives.

The FDA continues to discourage the use of kratom, which it is calling an opioid.

CDC Warns of Salmonella Infections Linked to Kratom 16 comments

At this time, the CDC recommends that people not consume kratom in any form because it could be contaminated with salmonella:

An outbreak of 28 salmonella infections in 20 states has been linked to kratom products, the US Centers for Disease Control and Prevention said in a statement Tuesday. Though no deaths have been reported, 11 people have been hospitalized.

[...] California had the highest number of salmonella cases (three). North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania and Utah each reported two cases while Alabama, Arizona, Colorado, Florida, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, North Dakota, New York, South Carolina and Tennessee each reported a single case, the CDC found.

Kratom should not be consumed in any form, the CDC said, because the source of salmonella contamination has not been identified.

Also at The Verge, STAT News, and CBS.

Previously: DEA Welcomes Kratom to the Schedule I List Beginning September 30
The Calm Before the Kratom Ban
FDA Blocks More Imports of Kratom, Warns Against Use as a Treatment for Opioid Withdrawal
FDA Labels Kratom an Opioid

Related: Opioid Commission Drops the Ball, Demonizes Cannabis


Original Submission

4/20: The Mary Jane Majority 56 comments

Past articles: 201520162017 👀

U.S. Senate Minority Leader Chuck Schumer (D-NY) has come out in support of federal cannabis decriminalization, just in time for 4/20:

The Minority Leader of the Senate is making it official the day before 4/20: He's down with legal weed. In an exclusive interview with VICE News, Sen. Chuck Schumer (D-NY) confirmed he is putting his name on legislation that he said is aimed at "decriminalizing" marijuana at the federal level. For Schumer, this is a shift. While he has backed medical marijuana and the rights of states to experiment with legal sales of pot, what he is proposing is a seismic shift in federal drug policy.

"Ultimately, it's the right thing to do. Freedom. If smoking marijuana doesn't hurt anybody else, why shouldn't we allow people to do it and not make it criminal?" Schumer said.

The legislation should be available within a week or so, and would remove cannabis (still listed as "Marihuana") from the Drug Enforcement Administration's list of Schedule I substances. States would then be free to regulate or continue to prohibit the plant. Cannabis advertising would be regulated as are alcohol and tobacco advertising. (Also at NPR, CNN, The Washington Post, and CNBC, as well as Reason taking a shot at Schumer for not doing it sooner.)

A majority of Americans support the legalization of cannabis, including, for the first time, a majority (51%) of Republicans, according to Gallup. Nine states and the District of Columbia have legalized cannabis for recreational use. 29 states, D.C., Guam, and Puerto Rico have legalized medical use of cannabis, and another 17 states have legalized the use of cannabidiol (CBD). Cannabis became available for recreational purposes in California on January 1.

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  • (Score: 2) by Osamabobama on Wednesday April 04 2018, @05:48PM (2 children)

    by Osamabobama (5842) on Wednesday April 04 2018, @05:48PM (#662566)

    "It’s shocking the company didn’t cooperate with the FDA’s recall request – if the FDA requests a recall, the company should do it," says Katie Wowak, assistant professor of management in the University of Notre Dame's Mendoza College of Business. "The tangible and intangible repercussions of being forced to issue a mandatory recall could have a devastating long-term impact on the company that may be difficult (if not impossible) to recover from."

    I imagine that a voluntary recall request comes with a lot less paperwork, making it desirable for the FDA staff. Once that proves ineffective, the FDA will have to do more paperwork, perhaps leading them to ensure there is 'a devastating long-term impact,' in order to discourage others.

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    • (Score: 0) by Anonymous Coward on Wednesday April 04 2018, @05:51PM

      by Anonymous Coward on Wednesday April 04 2018, @05:51PM (#662567)

      I tried to go to the triangle pharmnaturals website, and I got some sort of non-eulclidian angle supported browser error. so much for triangles

    • (Score: 0) by Anonymous Coward on Wednesday April 04 2018, @09:22PM

      by Anonymous Coward on Wednesday April 04 2018, @09:22PM (#662639)

      Thanks Osama!

  • (Score: 4, Interesting) by requerdanos on Wednesday April 04 2018, @08:06PM (7 children)

    by requerdanos (5997) Subscriber Badge on Wednesday April 04 2018, @08:06PM (#662616) Journal

    The Food and Drug Administration (FDA) said it issued the order because Triangle Pharmanaturals of Las Vegas refused to cooperate.

    The FDA has engaged in an anti-evidence-based war on Kratom, issuing deceptive press releases and ominous warnings based on zero scientific evidence in an effort to run the Kratom vendors out of business.

    That they would have the gall to accuse a Kratom supplier of "refusing to cooperate" boggles the mind.

    "Hi, I'm going to do everything in my power to kill your livelihood; I am working on it already. By the way, will you cooperate with me?"

    That's a firm no, as it should be. We are being very poorly served by an FDA that seeks to destroy its own credibility and then acts all surprised when they yell "Wolf!" and no one comes running.

    • (Score: 2) by DeathMonkey on Wednesday April 04 2018, @09:20PM (2 children)

      by DeathMonkey (1380) on Wednesday April 04 2018, @09:20PM (#662637) Journal

      I had a lot more sympathy before they hospitalized 11 people.

      • (Score: 3, Insightful) by requerdanos on Wednesday April 04 2018, @09:45PM

        by requerdanos (5997) Subscriber Badge on Wednesday April 04 2018, @09:45PM (#662651) Journal

        more sympathy before they hospitalized 11 people.

        Frankly, so did I. But the world already knows the FDA is acting in bad faith; that's not necessarily true of Triangle Pharma.

        Ordinarily "refusing to cooperate with the FDA" would be an instant sign of bad faith, but in this case, not cooperating with someone who's trying to exterminate you could be good, bad, or indifferent; no way to tell.

      • (Score: 3, Interesting) by pipedwho on Wednesday April 04 2018, @10:39PM

        by pipedwho (2032) on Wednesday April 04 2018, @10:39PM (#662667)

        The summary of the 'evidence' provided in the various articles that came out about this didn't support the conclusion. The result was buried so deep in the noise, that you could draw any conclusion you want from that level of confidence. This is not even P hacking. This is completely ignoring the whole concept of P.

        Millions of people are hospitalised over the same time period for various cases of food poisoning. Yet, somehow, they establish that 11 of them were due to Kratom (in any form - including processed tablets), and then for some reason decide that these 11 deserve a recall of a product that may be some small coincidence be the cause. With such a small sample group from potentially 10s of thousands of people consuming the product, they conclude that the Kratom was definitely the cause, ignoring the far more likely causes. At the same time ignoring that lettuce and other fresh fruit and vegetables are harvested and prepared in pretty much exactly the same way. It's like putting a recall on all heads of lettuce, because someone bought a contaminated lettuce from their local grocer (assuming the contamination actually came from the grower and didn't arise through exposure by the end customer).

        Then the internet echo chamber makes out like 11 people were directly affected without any of the other (non)supporting 'facts'. And true to the internet echo chamber, it is echoed in the parent post like it was established fact.

        So, no, your loss of sympathy bares no basis in anything but personal perception.

    • (Score: 5, Interesting) by Hyperturtle on Wednesday April 04 2018, @09:40PM (3 children)

      by Hyperturtle (2824) on Wednesday April 04 2018, @09:40PM (#662646)

      And look what the lack of cooperation has lead us to.

      It may very well be that the product had samonella in it. Ground flour can, eggs can, bagged spinach, raw milk... many more products have sickened people and even killed them as a result of improper storage of a perishable food or non-existant safety processes.

      Those things are not going to get banned for it -- but just watch, this is just the first shot.

      Jeff Sessions has said that people should just tough out addiction withdrawal. Clearly they are too much of a wuss to deal with the consquences of their doctors prescribing opioids and then refusing to refill the prescriptions now that they created a bunch of addicts. (After all, the pill mill guys are getting put into jail). The tactic is working; they can now do the same thing with the Kratom.

      Then the two only legal (prescription only) alternatives will save the day so that the pharma companies can both create and solve the problem profitably. This natural plant stuff is not part of that profit motive and needs to be suppressed--just like those pill mill doctors that drew too much attention to the problem with their greed. (That greed was supposed to be from the top down.)

      I assume it'll get banned and the people that used it before opiates were even a problem (it never was marketed for opiate withdrawal relief until recently) will have stocked up. The people that technically need it will be too weak to do more than write more stern letters.

      Too bad it doesn't get anyone high; they could tie it to gangs or illegal immigrants and declare a war against it. Instead, they have to treat it like some sort of product.

      Anyway, I'd assume bacteria can grow in it. It's a plant powder; it's not sand or something inert. Few precautions are taken with it and it's on the shelf for who knows how long, shipped in whatever way, and left to bake in the sun or freeze in a cargo hold with no special requirements. Leave it to rot and it will. Kept sealed and dry, it'll last like any other plant powder... a long time, but if you ignore your kitchen stored bleached enriched white flour, and just have sitting around unused for a long time, something will probably start growing in it. Any seller of this stuff needs a better defense than "these pills, don't ingest them because lol" to at least cover themselves.

      Even some made-up expiration dates or some sort of bland statement that says this contains what we claim--but might have something else because its a natural product. Do not ingest at your own risk. It won't offer much of a defense, but right now, it is hard to claim that its not ingestable when sold in pill form, and when that pill form has preventable and detectable bacteria in it, you can bet the FDA will get involved once it turns into a PR spectacle that can serve as a means to help push a related agenda.

      Does anyone remember L-Tryptophan being banned in the USA? Something about.. bacteria growth in it? How familiar!

      It increases the level of Serotonin (5-HTP is the legal alternative to it). There was indeed a bad batch in Japan that ended up with toxins introduced (bacterial waste, I think). That was all controllable via different manufacturing methods, but that's not what was done. Instead, it was banned, instead of just slapping that source with fines or banning them.

      3 days later, Prozac came out. The first wonder drug drug selective serotonin uptake inhibitor. It was prescription only, and was quite the marketed success. With no actual alternatives out (having been banned and 5-HTP not having been developed yet), anyone wanting to try the cheaper natural method wasn't able to find it anymore, and it was pretty cheap prior to becoming unavailable.

      It could be said that anything "natural" that works and isn't patented medicine gets banned because it prevents some large business from profiting from their expensive synthetic alternative. I am not that much of a conspiracy theorist, but it does seem that once the masses learn of something interesting, it's only a matter of time before there is a sweeping gesture to control or constrain it. This applies to lots of things besides just natural stuff like this, it also applies to any disrupted status quo. Look at what has happened to the internet and digital currencies.

      So yeah, back to requerdanos point, I can see why the seller wouldn't want to cooperate, but their more selfish survival action is going to create more problems for their 'cause' than if they had simply cooperated.

      • (Score: 2, Disagree) by qzm on Thursday April 05 2018, @04:53AM (2 children)

        by qzm (3260) on Thursday April 05 2018, @04:53AM (#662780)

        Wow, quite some skin in this game havnt you..
        Let me give you a little perspective perhaps.

        Of course, the FACT that people are taking Kratom WITH opiates (often illegally sourced..) as a 'lifestyle'm thinking this makes them immune to addiction couldnt be the reason.
        The FACT that sellers are claiming medical effects without the required evidence couldnt be the reason.

        Face it, Kratom is NOT a good thing for society as a whole, and they are quite sensibly using this as a short term ban-hammer until they get the required legal proceedings in place to properly control it.

        ANYTHING supporting the burgeoning illegal market in opiates, targeted directly at the young and middle class, is a bad thing, and Kratom falls directly into that category.

        So yes, it is a pity for people who DO have enough self control to manage these things sensible that this is how things need to be, but that is a small minority.
        As usual, something that should be perfectly ok is ruined by the idiots.

        • (Score: 3, Interesting) by takyon on Thursday April 05 2018, @09:46AM

          by takyon (881) <takyonNO@SPAMsoylentnews.org> on Thursday April 05 2018, @09:46AM (#662842) Journal

          Of course, the FACT that people are taking Kratom WITH opiates (often illegally sourced..) as a 'lifestyle'm thinking this makes them immune to addiction couldnt be the reason.
          The FACT that sellers are claiming medical effects without the required evidence couldnt be the reason.

          That may be part of the FDA's motive here, but it's not one that they stated in this case [fda.gov]:

          We continue to have serious concerns about the safety of any kratom-containing product and we are pursuing these concerns separately. But the action today is based on the risks posed by the contamination of this particular product with a potentially dangerous pathogen

          .

          Face it, Kratom is NOT a good thing for society as a whole, and they are quite sensibly using this as a short term ban-hammer until they get the required legal proceedings in place to properly control it.

          Your opinion, not FACT.

          It would be better to legalize/decriminalize all drugs, but allow the FDA to continue pursuing voluntary/mandatory recalls due to specific contamination concerns.

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        • (Score: 1, Interesting) by Anonymous Coward on Thursday April 05 2018, @09:49AM

          by Anonymous Coward on Thursday April 05 2018, @09:49AM (#662843)

          Face it, Kratom is NOT a good thing for society as a whole

          Irrelevant, unless you are supporting the concept of humans-owning-humans, aka slavery, to declare fiat prohibitions on things you don't want other humans possessing or using.

          Painkillers are a blessing from heaven. I want to have painkillers IMMEDIATELY available should I suddenly find myself in serious pain. I am forbidden at gunpoint from possessing such items as morphine and other opium products by USian agents, and so I researched natural painkillers and found that the leaves of the kratom tree can be used for just such a purpose. I've tested them, they work, and I've bought myself an emergency supply.

          If you try to forcibly take my painkillers away from me, I will kill you. Deal with it.

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