Health Canada and Regulatory Creep...

Friday, October 26, 2007 at 09:17PM
in General Health

As our Canadian customers of Total Balance know we had to reformulate this product a few years ago to conform to Health Canada’s regulations by replacing the L-Carnitine with other nutrients that would give a similar action.

Everything was going smoothly until recently when several customers had shipments of the Canadian version of Total Balance stopped at the border. The reason given by Health Canada this time is that they have decided that DMAE and Gotu Kola extract should be considered a schedule F drug. Because Total Balance contains a small amount of each of these nutrients the total product would now be disallowed for Canadian residents.

OK…back to the ‘drawing board’. We had to ‘fix’ the problem as we have many Canadian customers who depend upon their regular supply of Total Balance. So, we had Prof. Dr. Munem work on the formula and adjust the ingredients so we could remove these two substances and replace them with others that would ensure maximum efficacy would be maintained.

This was successfully done and new version produced and new labels printed. Well, no sooner than we had done this we have some more shipments held up at the border. This time…it’s lithium! Health Canada have decided this substance should also be a prescription drug even though we only use a minute amount as a co-factor (0.06mgs per 6 tablets)

In all other jurisdictions that I know of including Europe lithium is allowed in a supplement in small doses such as we use. Ironically, Health Canada recognizes the benefits of lithium in that they will actually subsidize prescription lithium at several thousand times the dose? Hard to understand their rationale isn’t it?

If you are a Canadian customer and reading this, you can rest assured that we will fix this problem. We hope to get to the bottom of what the new rules within the next day or two. Unfortunately we cannot find any details on their website and we cannot get a response to our queries. We have now enlisted the help of the New Zealand Embassy in Canada and they will try and get the details for us.

However, it looks like we will have to produce a new batch of Canadian Total Balance without the lithium to get over the problem. We will do this quickly so there will be very little delay.

I raise this issue as Canadians and indeed other nationalities should be aware of ‘regulatory creep’ which is taking place in some jurisdictions regarding natural health products.

Reader Comments (6)

Hi. As a new Canadian customer I am dissapointed with all the hoop jumping you have to go through to create your "Canadian product". As someone new to your product, I have initial concerns. Would the replacement products be suitable alternatives to your original ingredients, or am I receiving a slightly inferior product to that of the international product.


Thanks.


Jeff C

October 31, 2007 | Jeff Caldwell

Hi Jeff,

No need to worry. The Canadian version is not inferior in any way, we just have to use different ingredients to acheive the same end result. As a matter of fact when we release our 6th generation Total Balance next year which we are working on now we will not need to have a special Canadian version as all the ingredients are acceptable to to Health Canada.

And...it will be considerably more potent than all current versions of Total Balance. We are really excited about it, but it is taking a lot of organizing. We have completed the development of the formula and are now working on sourcing some of the ingredients that are new.

In the meantime you can rest easy with the current versions.

October 31, 2007 | Warren Matthews

Warren
I just about had enough of this so call Canadian Health department. Not only are they incompetents, they are paid under the table to protect the chemical industries. Those morons are trying to eliminate all natural ingredients including good old horse manure. I kid you not they are against anything that can't be patent for control and profit. The system is corrupted beyond repair -

November 7, 2007 | Yvan

Hi Ivan,

It's not isolated to Canada.

Big Pharma wish to control everything and with CODEX they hope to get their way.
What we need is more awareness, people like yourself to spread the word that, The Big Drugs companies are solely out to make profits.at the expense of our health, very few of their products actually cure anyone.
The whole system is corrupt and flawed and I am amazed no one has taken them on for what they really are, Parasites

The bottom line for the Parasites is PROFITS.

People have to do more to stop them and expose them for the Con merchants they are.

Together we can do it.

Bruce

November 7, 2007 | Bruce Jackson

Bruce, Ivan and others

Count on me to spread the word (here in Greece) as I try in every occassion and meetings I have with my friends and other people, to tell them ( wake them up actually) about the benefits of going "the natural way" of living.
Big Pharma got another blow from Bayer's latest drug scandal.Their drug was withdrawn from the market due to "side effects" (i.e deaths).
"Health Canada" congratulations!!! You protect Canadians well by forbiting 0.06 mgs of Lithium from Warren's supplements.

November 8, 2007 | Christos

What really irks me is that in Canada we can get supplementary health benefits through our employer plans in order to cover prescription medications, but my doctor can't write me a prescription for Total Balance because it's not a drug. It's absurd and getting worse.

November 9, 2007 | Rick