Biotrade U-Dream has been caught adding z-drug in their supplement.

Biotrade Canada U-Dream caught by FDA.  They slipped a drug similar to Zopiclone into their product.  I took this for 3 wks and occasionally got 2 to 3hrs sleep.  Yet another withdrawal for me may cost my life.  I was 7 months off drugs.  This company needs to be sued.  Can't trust anyone now.  No more supplements.

Wow this is terrifying! I almost ordered it and glad I didn’t. I wonder what the ingredient is? That is horrible.

 

https://www.fda.gov/drugs/medication-health-fraud/public-notification-u-dream-full-night-contains-hidden-drug-ingredient

https://www.udreamherbal.com/about-us/important-update/

What a joke!  Biotrade statement said a Zopiclone like molecule but not Zopiclone... as though that is reassuring!?  Then they say to abruptly stop using it without even knowing the amount of this substance per pill.  Holy crap!

 

Edit: Removed profanity

I wonder if it’s in one of the herbs?? I smell a lawsuit.

How long did you take them for?

This cannot be real. I mean, how can this happen?? Isn't there any lab which controls the ingredients of a product before it enters the market? Thats how it goes where I live. I mean, do authorities just believe the company that sells the product?? Like checking a list saying "looks good lets put it onto the market"

 

 

That is a scandal. If I had taken it I would sue the company that is for sure. 

I took it 3 wks.  Health Canada not giving me answers.  Say more info will come in months.  Couldn't say how much Zopiclone variant is in each pill.  Told me to contact my health provider about it and how to get off.  Madness!  They should be sued for sure. 

uncomfortablynumb1, Marigold, and others,

 

In the United State, supplements do not go through any regulatory process, check, or review before they enter the market. The FDA does not require any proof of their safety or efficacy. Nor do they check their ingredients. (I've added a link at the bottom to the FDA's own clear statement on this, should you care to skip my remarks and interpretation.)

 

To speak plainly, the FDA specifically states that manufacturers are not required to prove that their products work. They do not require that the manufacturer's claims be truthful or accurate (except in one specific sense that I'll discuss below).

 

In advertising, any false claims are handled by the Federal Trade Commission. I do not think this involves labeling. Just television, radio, etc. advertising. I assume this would result in a fine. Not product recall.

 

Once they are on the market, the FDA does not then check for their safety or efficacy. Instead, they rely on the manufacturer themselves to self-report adverse events that the manufacturer learns of, generally through patient feedback and doctors and other people in the field. I have no idea if manufacturers are required to report this information. Or at what stage the FDA would take action, or if they ever would. Someone here might know of a historical example that would clarify this.

 

I do not know if patient reports that go directly to the FDA are looked into. I highly doubt it. After all, patient reports on prescription meds have been ignored for years, and that falls under the specific purview of the FDA. It is clear that the FDA does not care about this market, except, again, in the way I'll discuss below. Hint. It's probably not about patient safety.

 

I believe the only reason this is coming to light is because U-Dream is a Canadian Company, and their regulatory system caught it in a way that the US system is not designed to investigate. Though I would think even the FDA would be required to take notice if a pharmaceutical drug were being used in a supplement. Whether they would ever know or not is another matter.

 

There are two areas in which the FDA does perform oversight of the supplement market; both of which can be seen as actually working to protect prescription drug companies' sales. 1) They require manufacturers place the word "supplement" on their labeling, and 2) companies are not allowed to make specific claims about a supplement curing or treating a disease. I vaguely remember when this rule went into place and supplement manufacturers had to change their labeling to make their statements more vague; less definitive.

 

So both those rules seem to work to make it clear to customers that supplements are not the same thing as medications. That seems like a smart thing to do, but it also protects the interests of Pharma. So even in the two areas where they do intervene, the FDA's actions are suspect. Also, if they let supplement manufacturers say they treated/cured diseases, they might then be considered "medicines" or "drugs" and so the Food and Drug Administration may then have to police them. Why they don't have to already is bizarre and I'm sure there is some horrible backstory to it. It's all so mendacious and devious.

 

So basically, no, no one is paying any attention to the manufacturing, selling, ingredients, safety, or efficacy of supplements. It is only after they have entered the market, and then been taken by people, that there is any possibility of feedback that might lead to action. As far as I know, this is incredibly rare. You can easily see how even a "safe" "efficacious" product might have bad batches, or degrade quickly, or change based on new ownership, or be wildly different, depending on which manufacturer you buy from.

 

So when we talk about how supplement X worked/didn't work, it's a statement that has even less of an evidentiary basis as one about a prescription drug.  As bad as the prescription drug and OTC regulatory machine is, the world of supplements is essentially lawless. Generally the risks are lower, I mean, they just aren't as potent as Pharma drugs, but as the U-Dream example points out, risks remain.

 

Greed is greed, it doesn't matter if you have a happy sun on your logo or not.

 

Of course, I'd still rather my doctor had told me to go take some valerian root rather than Klonopin. Supplements cause nowhere near the damage of pharmaceuticals, and many people find them helpful.

 

Here is a link to where the FDA itself spells most of this out. They are perfectly candid about their lack of a real role in the supplement market, though they don't contextualize it in any helpful way.

 

https://www.fda.gov/consumers/consumer-updates/fda-101-dietary-supplements

 

 

Now I don't know what to do.  Thought my sleep was naturally very slowly coming back with the help of time and possibly the herbs in this supplement. I had more 2 or 3hrs sleeps.  Was almost 7 months med free (or so I thought).  Now I am screwed and have to get off U-Dream. 

 

It is outrageous what they have done! Total fraud.  It is like adding Vicodin or codeine to a supplement and calling it natural. 

I've had experience with Zolpidem, another z-drug and for me, it was relatively easy to quit and heal from, nothing like benzo's, so hopefully the same will apply to you. 

This is the perfect example of why benzo people should NOT dabble with supplements. Not enough is known about this stuff, so you take enormous risks trying stuff like this.

Avoid supplements is my advice. Mother Nature created everything you need to be healthier. Use basic common sense.

Nothing better than 8 ounces or orange juice in the morning. Eat a basically decent diet and don't sweat the small stuff. Benzo wd is bad enough, without adding dietary restrictions on top of it!

east

Looking for a short-cut in the healing process is like looking for the fountain of youth. Trust the process.

I've had experience with Zolpidem, another z-drug and for me, it was relatively easy to quit and heal from, nothing like benzo's, so hopefully the same will apply to you.

 

 

Not true for me. Zolpidem and Zopiclone - horrible.

So buddies living in the U.s please do only buy supplements made in Europe. I cannot believe you can just throw a pill on the market and no one controls in a lab if its true what you say about the ingredients !?!?!?!?!

 

 

Here is some recent-ish news concerning the American market. It seems the FDA is at least aware of the problem, and is making some public remarks and promises for future improvements.

 

This is a statement (I guess it's more of a press release) from back in Feb (2019), when then FDA Secretary Scott Gottlieb (now on the board of Pfizer) vowed to begin alerting consumers amid other "modernizing" changes to their oversight of the market; who knows how his successor will approach the matter:

 

https://www.cnbc.com/2019/02/11/fda-plans-to-strengthen-regulation-of-dietary-supplements-create-rapid-response-tool.html

 

This quote seems to best summarize what he is trying to communicate:

 

"These steps include communicating to the public as soon as possible when there is a concern about a dietary supplement on the market, ensuring that our regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation, continuing to work closely with our industry partners, developing new enforcement strategies and continuing to engage in a public dialogue to get valuable feedback from dietary supplement stakeholders."

 

He goes on to describe what each of those steps might entail. Though I found little but superficialities and bland statements of unspecific intentions. Perhaps others more adept at the language of bureaucracy could tease out thing that are more specific. It's not a long document. He promised more details to come in the future. Perhaps they are out there somewhere, should anyone care to dig deeper.

 

As with all things involving the FDA, it's anyone's guess how much of this is reality and how much is talk. And also, how much of the reality will actually benefit consumers.

 

Here is a more recent article from Pew (Nov 2019), that emphasizes the limited role the FDA plays:

 

https://www.pewtrusts.org/en/research-and-analysis/articles/2019/11/08/stronger-dietary-supplement-oversight-still-needed-to-protect-consumers

 

One alarming quote that speaks directly to the issue the OP raised:

 

"For example, one study attributes over 23,000 emergency room visits each year to adverse events related to supplements. Another published last year found that many of these products contain some of the potent active pharmaceutical ingredients found in prescription drugs, which could cause serious adverse health effects from accidental misuse, overuse, or interaction with other medications, underlying health conditions, or other pharmaceuticals within the supplement."

 

Though one major chain, CVS, at least claims (according to the article) to be doing something about one element of this:

 

"For example, CVS Pharmacy—the largest retail pharmacy chain in the U.S.—launched an effort earlier this year that requires third-party testing of all supplements sold in-store and online, to determine whether products contain the ingredients as labeled and are not contaminated with heavy metals or other toxins. So far, 7 percent of products have failed the testing, resulting in either an update to the supplement facts panel on the packaging or removal from company shelves."

 

So that is interesting. Again, I imagine there is a whole history here. Apparently the FDA was given the "ability" by congress to regulate this market decades ago. So it is perhaps simply a matter of interest, willingness, resources, COIs, and the typical inertia that has kept them from doing so.

 

 

 

I should have "invented" a magic pill and put it on the American market. I would be rich now, wouldn't I? Of course I would not have added a z-drug. I am not evil.

Numb I am so sorry. The good thing is their level of ingredient cannot possibly as high as actual z drugs. Esp if you only got 2-3 hours of sleep while taking it. So it might be equivalent to taking valerian root or ibuprofen or another otc supplement that affects gaba.

The only reason I started taking the U-Dream a Canadian product (and I took the lite version- opening the pill and taking some out -eventually taking 1/2 or less) was because it had been licensed by Canada  Health which does regulate and test --I assumed they never wouldn't have licensed it without testing- The president of Bio-Trade called me (I have talked to them and the US distributor since I started taking- I really didn't want to get burned again) and he sounded truly perplexed- Suggesting that the substance might be from naturally occurring chemical combining of some of the herbs- or from the Chinese herbs that were imported- Of course I wanted to believe him but don't have trust in anyone peddling anything any more- Meanwhile their website has disappeared- no longer any way to contact anyone- 

Let's post if any of us get more information- I'd really like to know how much was found-was it a trace or much more than that.

 

Good luck to all of us as we attempt another test of our strength- Thank you Pamster for the positive response -you know how important it is for us to hear 🙏

The president sounds like a con artist or possibly not too smart.  Combining herbs may have miraculously created zopiclone 22?  That sounds like the most plausible answer? Give me a break!  Shutting down their website also seems a little fishy. 

 

Stopping this gave me pacing type anxiety and crawling under my skin.  Didn't have this before.  Guess it is akathisia possibly.  Probably best to contact lawyers and see if they are following this.  They really should not get away with this. It is unbelievable! 

Have a feeling there will be an uproar over Health Canada’s initial approval and how it passed the licensing testing.

 

The only reason I started taking the U-Dream a Canadian product (and I took the lite version- opening the pill and taking some out -eventually taking 1/2 or less) was because it had been licensed by Canada  Health which does regulate and test --I assumed they never wouldn't have licensed it without testing- The president of Bio-Trade called me (I have talked to them and the US distributor since I started taking- I really didn't want to get burned again) and he sounded truly perplexed- Suggesting that the substance might be from naturally occurring chemical combining of some of the herbs- or from the Chinese herbs that were imported- Of course I wanted to believe him but don't have trust in anyone peddling anything any more- Meanwhile their website has disappeared- no longer any way to contact anyone- 

Let's post if any of us get more information- I'd really like to know how much was found-was it a trace or much more than that.

 

Good luck to all of us as we attempt another test of our strength- Thank you Pamster for the positive response -you know how important it is for us to hear 🙏

 

Chinese herbs have created zolpiclone? Does he think consumers are idiots?? Is he an idiot? or just very clever?? I DID NOT KNOW ANYTHING - the best explanation, oh no, wait isn't it "I don't remember!"??

Why did you want to believe him?? cause he sounded perplex? Do not let them trick you.

And now all contact options are closed down. Haha. Seems someone is leaving the country.

In your shoes I would not only talk with my own layer and not with those who have made the problem.So sorry it happened to you.

It is criminal.  His plausible explanation is indicative of his stupidity or of his sneakiness.  This is much worse than companies ripping people off.  When they disregard customers' health for their greed, this is the worst offense.

 

I have never sued anyone in my life and I am not that type of person.  But this is different.  The store should never have sold me the last package on Dec 7th because U-Dream was already flagged by FDA and was under investigation.   

It is criminal.  His plausible explanation is indicative of his stupidity or of his sneakiness.  This is much worse than companies ripping people off.  When they disregard customers' health for their greed, this is the worst offense.

 

I have never sued anyone in my life and I am not that type of person.  But this is different.  The store should never have sold me the last package on Dec 7th because U-Dream was already flagged by FDA and was under investigation. 

 

 

The good thing is when this happens in a country like canada, as far as I know, you can sue both. The company producing the med AND the shop selling it to you. Maybe even the FDA on top, cause they did not make the job. I would search for other people who took the product and sue them together - this is an easy case and can only be won. I know you will need money to sue them at first, but if you cannot afford it I woulds go on gofundme.com and ask others for help. I mean it just cannot be NOT brought to court.

 

... and I do not believe that the man on the phone did not know. I also wonder why a boss of a company talks on the phone with customers, by the way. Overall the picture I get from this company is not good.

If he called an individual costumer, in the middle of a PR crisis, he is either the most conscientious, concerned corporate leader, and he honestly feels horrible, and really somehow a mistake was made that he had no control over (I can think of absurd ways [products made in same factory, rogue lunatic employee, industrial sabotage by a competitor, enormous mistake at the testing facility] but they are all quite fanciful and sound like the plots of boring movies that would never get pick up).

 

Or, he is the least-risk averse CEO/President of all time. Who would call an individual customer to explain their business practices? Why? He would have 30 lawyers staple-gunning him to his boardroom chair before they allowed him to do that. You don't go on the record when your company has (by all appearances) been caught illegally drugging their customers. That is the kind of behavior you expect out of people who are out of control; or narcs, who think they can get away with anything, explain away everything. And then to just pack up shop?

 

It's really incredibly bewildering.

 

Thanks for sharing that experience.

If he called an individual costumer, in the middle of a PR crisis, he is either the most conscientious, concerned corporate leader, and he honestly feels horrible, and really somehow a mistake was made that he had no control over (I can think of absurd ways [products made in same factory, rogue lunatic employee, industrial sabotage by a competitor, enormous mistake at the testing facility] but they are all quite fanciful and sound like the plots of boring movies that would never get pick up).

 

Or, he is the least-risk averse CEO/President of all time. Who would call an individual customer to explain their business practices? Why? He would have 30 lawyers staple-gunning him to his boardroom chair before they allowed him to do that. You don't go on the record when your company has (by all appearances) been caught illegally drugging their customers. That is the kind of behavior you expect out of people who are out of control; or narcs, who think they can get away with anything, explain away everything. And then to just pack up shop?

 

It's really incredibly bewildering.

 

Thanks for sharing that experience.

 

I highly doubt that he is the CEO at all. I think it was an employer who claimed to be the CEO and someone who thought he was very smart has decided to do that. Very clever. Not. But... I know a president who calls himself all the time .. just because he thinks he does not have to follow any protocol.... so maybe the man is a narcisst and thinks him calling is the best that can happen to a customer. A customer who is now going through withdrawal thanks to him and his product. It's disgusting.