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.

Technorati tags: Optimum Health Care Sleep Easy, Optimum Health Care SleePlus TCM, BYL SleePlus, Health Canada, clonazepam, Optimum Health Care, BYL Pharmaceuticals, Vancouver, British Columbia, Canada, Traditional Chinese Medicine, TCM, Tongliang Zhuo, Yanxiao Zhang, FDA

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.