by "themanwithsauce - has as many vehicles as job titles" (themanwithsauce)
Published 08/18/2017 at 11:18
by "themanwithsauce - has as many vehicles as job titles" (themanwithsauce)
Published 08/18/2017 at 11:18
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STARS: 11
A “homeopathic” company got busted for having high variances in their manufacturing process. In essence, some tablets would have the correct level of nothing, while others would have something resembling a dose. The supposed inert they were using? Deadly nightshade. The product? Infant teething tablets.
It’s probably a good thing the FDA can’t deploy armed forces. The company that did this, homeolab, would probably be a smoldering crater right now if they could. Although if you are essentially selling a pill for babies that contains fucking DEADLY NIGHTSHADE and you have no control over your manufacturing process.....You deserve it. Criminal charges should come from this. Children have died and will continue to die because these companies are run by hacks and people think homeopathy is some legit medicine. Meanwhile they have zero control or care over their manufacturing processes and show a complete disregard for science and medicine.
Link to their letter to Homeolab here.
Two highlights from the letter here. Both show how the company is trying to weasel out of any responsibility for their processes. ANd I guarantee you plenty of other “homeopathic” remedies are made by other companies that do the same exact thing.
1) Note that when a manufacturer employs a contract facility for part of drug manufacturing (including processing, packing, holding, or testing), the manufacturer’s quality unit is responsible for approving or rejecting drug products manufactured by the contract facility, (b)(4). See 21 CFR 200.10(b) and 211.22(a). Furthermore, it is important to note that quality agreements cannot be used to delegate statutory or regulatory responsibilities to comply with CGMP. Refer also to the FDA 2016 guidance for industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements
2) In your response you state, “Homeolab is NOT a manufacturer. Homeolab is a private label distributor, which has no manufacturing capabilities.” In your response you also state, “Homeocan is by agreement a contract manufacturer for Homeolab.” Homeolab USA Inc. and Homeocan Inc. share the same address, facility, and personnel, including the chief executive officer and the head of quality. Your head of quality signs email correspondence with “Homeocan Inc./Homeolab USA” as your firm’s identity. Homeolab (part of the parent company, Homeocan Inc.) is a registered manufacturer with the FDA. According to your Duties and Responsibilities document, Homeolab is responsible for “GMP Compliance with regulatory bodies” and “Approval of Batch for Distribution.” In terms of drug manufacturing, Homeolab USA Inc. and Homeocan Inc. have no significant separation, so we are treating Homeolab/Homeocan as a single entity.
Here’s a tip - don’t do either of those things! Oh and they tried blocking the inspectors form taking pictures. Another tip - REALLY DON’T DO THAT!
"WilliamsSW" (williamssw)
08/18/2017 at 11:27, STARS: 7
Maybe we should feed these people a strict diet of their own products.
"ttyymmnn" (ttyymmnn)
08/18/2017 at 11:29, STARS: 12
But wouldn’t it be better for business if we removed the regulations? The industry will police itself.
"benjrblant" (benjblant)
08/18/2017 at 11:30, STARS: 5
Yes, thanks FDA for banning questionable additives such as Red #40, Yellow #5, Yellow #6, rBGH, potassium bromate, BHA and BHT among many other food additives which are illegal in most of the EU because of their health side effects.
oh wait.
"Highlander-Datsuns are Forever" (jamesbowland)
08/18/2017 at 11:31, STARS: 2
Jeabuz, we gave our children these...
"Bman76 (hates WS6 hoods, is on his phone and has 4 burners now)" (bman76-4)
08/18/2017 at 11:32, STARS: 3
I’d give the FDA and EPA way more enforcement power. Let them tear down all the sketchy shit out there.
"CB" (jrcb)
08/18/2017 at 11:44, STARS: 2
I think the FDA is the one government agency I wouldn’t mind being armed.
"Daily Drives a Dragon - One Last Lap" (ddadragon)
08/18/2017 at 11:49, STARS: 5
“Natural Relief”
Well yeah because you can’t feel anything when you’re dead.
"and 100 more" (nth256)
08/18/2017 at 11:52, STARS: 3
Not defending the shady company for using shady business practices...
Also, not claiming that homeopathic remedies are all legit...
But therapeutic doses of Belladonna (the active ingredient in Hyland’s teething tabs) have been used for literally thousands of years for various ailments. I’m not up-to-speed on my herbology, otherwise I’d list off what it can be used to treat.
Bad people ruin good things. Herbology was the first medical practice, and it still finds use today.
All things are poison, and nothing is without poison, the dosage alone makes it so a thing is not a poison.
—Paracelsus
"LastFirstMI is my name" (donstone13)
08/18/2017 at 11:54, STARS: 1
There are two possibilities for unregulated “homeopathic” or “all natural” therapies. They either do nothing, or they do something (and anything that does something can have side effects). There is literally no therapy that has a beneficial effect with no risk of side effects. Anyone that says otherwise is selling you something.
"shop-teacher" (shop-teacher)
08/18/2017 at 11:55, STARS: 2
Yep. We gave them to our first kid. This had come to light by the time we had our second. I would hunt them all down like rabid dogs if my kid had died from them.
"RallyWrench" (rndlitebmw)
08/18/2017 at 12:05, STARS: 1
I’m ok with smoldering craters.
"RallyWrench" (rndlitebmw)
08/18/2017 at 12:07, STARS: 4
"Smallbear wants a modern Syclone, local Maple Leafs spammer" (smallbear94)
08/18/2017 at 12:09, STARS: 0
Almost all meds are poison. Poison that can be given in nonlethal doses. Natural ones are no different. For example Arnica is an effective natural painkiller. Guess what? It’s also a deadly poison. Oregano can effectively address a ton of common shit... infections, immune boost, colds etc... but take too much and it’ll shred you from the inside out.
So there’s nothing really odd about finding that ingredient in there... but damn that needs to be regulated.
"Textured Soy Protein" (texturedsoyprotein)
08/18/2017 at 12:13, STARS: 0
I’m confused, is Hyland’s and Homeolab the same company? My wife sometimes takes Hyland’s Calms Forte as a mild sleeping pill. It has chamomile extract and (now that I’ve looked up the other ingredients) a bunch of random minerals and other crap that probably do nothing.
Right now she’s got some other random brand of supplement that has chamomile and other random crap in it that I picked up at the grocery store.
Now that I think about it, I need to get her some plain old chamomile capsules. I personally quit taking any random concoctions of ingredients for my fitness-related supplements, in favor of single ingredients taken for specific purposes. No sense in giving my wife other random crap along with the chamomile.
"duurtlang" (duurtlang)
08/18/2017 at 12:29, STARS: 3
therapeutic doses
Which is the opposite of homeopathic. Homeopathy is about an infinite dilution of a substance. A substance is so far diluted there’s usually not a single molecule left. It’s about the ‘memory’ of water (which has never been shown to exist) and is thus a placebo. If someone finds an homeopathic treatment to work it’s either due to a placebo effect or due to another effect not directly related to homeopathy, like for example the moisturizing effects of a ‘homeopathic’ ointment.
Homeopathy is NOT about being ‘natural’ or using herbs or other ancient remedies, which can have an actual effect. Homeopathy = infinite dilution.
"duurtlang" (duurtlang)
08/18/2017 at 12:39, STARS: 2
Being homeopathic, it actually is odd finding that ingredient. A purely homeopathic ‘medicine’ can only harm you if you drown or suffocate from it as it has no working substance as it has been diluted infinitely. The pills will simply contain sugar and/or other filler materials that shouldn’t be hurtful (or beneficial).
"Smallbear wants a modern Syclone, local Maple Leafs spammer" (smallbear94)
08/18/2017 at 12:45, STARS: 0
Yeah... fair point. Though some work purely on the alcohol that supposedly has stuff dissolved in it. Cold remedies and the like. You’d get almost the same effect out of drinking vodka, except that you lose the placebo effect.
Actually really pisses me off though when people use homeopathics as an excuse to write off natural meds. THEY AIN’T THE SAME THING PEOPLE.
"themanwithsauce - has as many vehicles as job titles" (themanwithsauce)
08/18/2017 at 12:53, STARS: 0
Hylands is not the same, but they also got chewed out by the FDA and decided to stop making the teething tablets.
"themanwithsauce - has as many vehicles as job titles" (themanwithsauce)
08/18/2017 at 12:55, STARS: 1
I don’t doubt for a second that the atropine in nightshade can be used for medicinal purposes. But if you manufacture a drug and can’t consistently produce the same dose again and again, you need to stop trying to make it...
"WiscoProud" (wiscoproud)
08/18/2017 at 13:00, STARS: 1
Once I read up on what homeopathic dilution was, I completely rejected everything they offer. Its a ridiculous concept that’s used to sell sugar water to fools.
"themanwithsauce - has as many vehicles as job titles" (themanwithsauce)
08/18/2017 at 13:01, STARS: 2
I’m reminded of the time the FDA held off on approving thalidomide despite it being the big craze in europe at the time.
Look up thalidomide babies. The FDA didn’t necessarily know for sure that that would happen, or why it was happening, but they knew that they didn’t know. Now we know that one enantiomer of thalidomide works as intended, but the other enantiomer causes severe birth defects. When synthesized in a lab, most chemists purify it to just the enantiomer we want. When made on a mass scale, it comes out as a 50/50 mix and is toxic to the unborn child.
No one is perfect, we just try the best we can. And some of those things are banned just because of outcry, not based on published, repeated findings.
"WiscoProud" (wiscoproud)
08/18/2017 at 13:02, STARS: 0
I do the same for supplements. I take specific things from reputable sources. Sure it means I take a half dozen things in the morning, but I can tell you what each one of them is.
"Chariotoflove" (chariotoflove)
08/18/2017 at 14:36, STARS: 0
So is digitalis, right?
"Chariotoflove" (chariotoflove)
08/18/2017 at 14:39, STARS: 1
I love the FDA. People get all crazed when the FDA won’t approve use of something that other countries or the EU is doing. Then, they’re unnecessarily keeping us from great advances in medicine because they’re so backward.
Other times, law suits come out over dangerous side effects of FDA approved drugs, and then everyone condemns them for not be careful enough and safeguarding us. Damned if they do...
I thank God we have the FDA.
"gmporschenut also a fan of hondas" (gmporschenut)
08/18/2017 at 21:56, STARS: 0
The FDA doesn’t get the credit it deserves. If you want to read some sketchy shit read product complaint investigations from foreign doctors. medical products unsanitized and reused... etc.
“Here’s a tip - don’t do either of those things! Oh and they tried blocking the inspectors form taking pictures. Another tip - REALLY DON’T DO THAT!”
Oh and their criminal investigations group are full federal agents and they’re packing.
https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048380.htm
"themanwithsauce - has as many vehicles as job titles" (themanwithsauce)
08/18/2017 at 22:01, STARS: 0
FOxglove might contain something that could be used medicinally. But to my understanding, most of the components have too narrow of a range of dosing to be used successfully as a medicine. And I certainly would NOT want a homeopathic company making the medicine based off foxglove, given how badly they fuck up medicines based off of nightshade.
"Dusty Ventures" (dustyventures)
08/18/2017 at 22:12, STARS: 0
So what you’re saying is... life is pain, Princess?
"LastFirstMI is my name" (donstone13)
08/18/2017 at 22:13, STARS: 0
Inconceivable
"Chariotoflove" (chariotoflove)
08/18/2017 at 22:33, STARS: 0
Oh, it’s used, mostly for heart failure (e.g: digoxin). But yeah, anyone who sells something with foxglove over the counter should be charged with attempted murder.