Unapproved habit-forming Chinese sleep aids containing clonazepam being recalled
Health Canada has pulled a set of sleep aids off the market because they contain a habit-forming ingredient, clonazepam, that is not listed on the labelling. These products have not even been submitted for approval by Health Canada.
The Health Canada advisory does not mention the ties to China, though. So I'll describe them.
Health Canada has issued an advisory against the use of Optimum Health Care Sleep Easy, sold also under the names Optimum Health Care SleePlus TCM and BYL SleePlus:
Health Canada is advising consumers not to use the sleep supplement product Optimum Health Care Sleep Easy, because it contains the undeclared drug clonazepam, which can be habit forming when used for as little as a few months. Consumers who may still have this product in their homes are advised to consult with a health care professional before they stop taking the pills, because of the risk of serious withdrawal symptoms.
Optimum Health Care Sleep Easy has a different name but has the same formulation as Optimum Health Care SleePlus TCM and BYL SleePlus, which were the subject of a Health Canada public advisory issued on June 14, 2007. All of these products are promoted as sleeping aids and are not authorized for sale in Canada.
Clonazepam belongs in the class of drugs known as benzodiazepines, which should only be prescribed by a health care professional.
The side-effects associated with the use of products containing clonazepam vary according to the individual and can include dizziness, drowsiness, confusion, depression, loss of memory and hallucinations.
Optimum Health Care Sleep Easy was sold to patients by Optimum Health Care, a clinic in Vancouver. The product is being recalled; however consumers may still have the product in their homes.
"TCM" stands for Traditional Chinese Medicine.
Cross-referencing the phone number for Optimum Health Care and found this listing for the TCM Association of British Columbia:
Dr. Tongliang Zhuo
#305-2150 W. Broadway
Vancouver, BC.
TeL:604-739-2388
So Optimum Health Care is really a dispensary for traditional Chinese medications prescribed by Doctor Zhuo.
And the sleep potions? Labeled in Chinese:
Optimum Health Care SleePlus TCM was labeled in Chinese and sold to patients through a clinic in Vancouver, while BYL SleePlus was distributed to retail stores by BYL Pharmaceuticals also in Vancouver.
Both establishments will recall the products.
The fact there is a Chinese link to one of these products is likely to raise a few eyebrows amidst recent controversy surrounding imports from the country.
Highly publicized contamination scares involving imports from China have been leading some suppliers to take extra precaution in testing their ingredients so as to calm manufacturers and distributors.
A recent spate of contamination incidents involving products ranging from pet food to toothpaste has drawn attention to the Chinese supply chain and regulations.
BYL Pharmaceuticals is run by Yanxiao Zhang, and this is not the first time I've found a problem with the labelling of their products. The FDA turned back a shipment of some sort of male enhancement product this past April:
BYL Pharmaceuticals Ltd
Vancouver CA-BC, CA V6P6G5
54FCE99 V 53 MALE ENHANCER CAPSULES
26-APR-2007
DIETARYLBL
NUTRIT LBL
The two reasons are both related to misbranding:
Reason: DIETARYLBL
Section: 403(s)(2)(B), 801(a)(3), misbranded
Charge: The label/labeling of the dietary supplement fails to identify the product by using the term "dietary supplement".Reason: NUTRIT LBL
Section: 403(q); 801(a)(3); Misbranding
Charge: The article appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
So no nutrition information, and apparently labeled as a dietary supplement instead of a male performance enhancer, if I'm reading this correctly.
In any case, the sleep aid being pulled in Canada had no DIN number at all, indicating it had not been submitted to Health Canada for evaluation.
Makes you wonder what else is on shelves out there.
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Comments
Jean (Le Wretch) Chretien embraced this "Trade".
It must be bonafide if the Liberals endorse it, NO?
Posted by: ZiLLa at July 21, 2007 10:17 PM
'Had not been submitted to Health Canada for evaluation'? Am I reading this properly? Does this mean that Health Canada does NOT inspect all drugs imported into the country unless they are asked to? Does this not seem a bit ridiculous? What fox is in charge of this henhouse?
Posted by: George at July 22, 2007 05:41 AM
It's not clear this stuff was imported. It might have been made here for the local TCM market.
Posted by: Steve Janke at July 22, 2007 06:59 AM
You are right Steve. BUT--any drug on the market should be either tested reputably or must state it has not been tested for human use. This is getting ridiculous. We pay billions every year to have HC, CFIA and how many other government departments keep us 'safe' from just such an occurance, but no one is accountable, the buck stops with no one and we keep paying and dying.
The fact that the product is not authorized for sale in Canada, is sold by a 'clinic' 'doctor' is suspect. What didn't the regulators find odd about this situation?
Posted by: George at July 22, 2007 07:48 AM
...i'm still awaiting the breaking news that Fruit of the Loom shorts made in China were spiked with saltpeter.
Posted by: tomax7 at July 22, 2007 01:28 PM
tomax7: It's no joke, could be part of their plan, if they can't poison us slowly they can curb the urge, which might effect reproduction. They certainly are up to no good. They have a plan, we don't. Boobs like Chretien and Mo Stlong are part of their plan, they "tleat" them well, give them "foltune" cookie without dung. Gotta keep them healthy for the economy.
Posted by: Libby at July 22, 2007 06:32 PM
I was looking at labels for vitamins and herbal extracts sold at Shopper's Drug Mart, and I came across one that contained "rice flour" as one of the ingredients. My immediate thought was that the rice flour came from China and was contaminated in some way.
Really we don't know what we are ingesting nowadays, and what lurks on the plastic toys our children play with and most likely made in China.
The Chinese will exploit us in any and every way they can to enrich themselves as quickly as possible. Our world is rapidly deteriorating because our political and business leaders are inviting the Chinese commies to join the global market, and then investing in Chinese companies to rake in huge profits.
We know that powercorp-CITIC and CSL are deep into Chinese economy, and will not hesitate to expoit Canadians for their Chinese interests .. like sending Canadian taxpayer's money to China to buy useless Kyoto Carbon Credits !!
Posted by: Sandra at July 22, 2007 08:32 PM
Steve, do you still have that "This product is certified not to contain goods from China" image kicking around? Mind if I link to it?
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