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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
(Score: 5, Interesting) by Hyperturtle on Wednesday April 04 2018, @09:40PM (3 children)
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)
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
That may be part of the FDA's motive here, but it's not one that they stated in this case [fda.gov]:
.
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.
[SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
(Score: 1, Interesting) by Anonymous Coward on Thursday April 05 2018, @09:49AM
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.