Health Committee on June 8th, 2010

[Dr. Samuel Godefroy]

My colleague Chris Turner would probably be the better one to answer this question. There is a protocol that needs to be followed in order to consider the adverse reports. There is actually a stringent requirement about the way this information is collected and then subsequently assessed.

[Patrick Brown, Conservative, Barrie, ON]

Is there any information, or are there any medical records, or is it just a report?

Maybe Ms. Boudreau can answer that.

[Michelle Boudreau]

Yes, I'll try my best. Certainly, as Dr. Godefroy mentioned, Dr. Turner would probably give you a more complete answer. We can supply things in writing as well, if you'd like.

Part of the assessment is to go beyond the report. Certainly when the marketed health products directorate looks at a spontaneous report or a case report, there are a lot of questions asked around that.

You referred to medical records and whether there were there tests done. That is all part of the assessment: what exactly was consumed, other medications or other products that may have been consumed around the same time, and the proximity of when the product might have been consumed compared with when the reaction may have occurred.

All those precise questions, in accordance with guidelines from WHO and some very specific standard operating procedures within MHPD, are done in order to complete a proper assessment.

[Patrick Brown, Conservative, Barrie, ON]

So Health Canada does have access to medical records when they look at the adverse reports...?

[Michelle Boudreau]

I think it's fair to say to a certain extent.

Maybe Dr. Turner will just nod his head here, but--

[Dr. Chris Turner]

Not medical records.

[Michelle Boudreau]

Not records per se, but the information we might ask directly of the person who reported the adverse reaction.

[Patrick Brown, Conservative, Barrie, ON]

If you don't have access to medical records, would you have access to lab tests?

[Michelle Boudreau]

We have access to the lab tests that may have been done on a person who reports. If the individuals themselves report, or if a physician reports, then at times that information will be available. It certainly would be requested if there were any lab tests or other things done at the time.

[Patrick Brown, Conservative, Barrie, ON]

The next question I have is for Mr. Kadi.

It was mentioned before, I think in Ms. Duncan's question, about mixing caffeine and taurine. I thought I read somewhere that the EU looked at the safety of taurine. Maybe you could comment a little about the safety of taurine. I understand that taurine comes from meat.

If we're concerned about mixing caffeine and taurine, wouldn't anyone who goes to Tim Hortons to have one of their sausage breakfast sandwiches and a coffee be mixing caffeine and taurine?

[Andreas Kadi]

Yes, they would be mixing them. I think it would be an interesting mix for breakfast.

As you say, taurine is a substance that occurs in the food we eat, so you will find it in meat products like beef and chicken. You will find it in larger quantities in seafood. It is what nutritionists call a non-essential amino acid. It is also a substance found in the human body. A person weighting 60 to 70 kilograms will have about 60 to 70 grams of taurine in their body, so this is not a substance that is new to the organism or to the diet.

I may take the opportunity to shed light on a question Mrs. Duncan asked about safe levels of taurine. This is what the European Food Safety Authority looked at in the 2009 opinion. As I mentioned in my opening statement, the safety assessment of energy drinks in Europe has a 10-year history. The European Food Safety Authority asked several questions and asked for studies, which were provided, so they could come up with a final conclusion.

For taurine they established what is called a “no observed adverse effect level” of 1,000 milligrams per kilogram of body weight per day. They said that this was respectively 120-fold higher than the estimated mean and 43-fold higher than the estimated 95th percentile exposure to taurine from energy drinks when calculated for a 60-kilogram person.

If I do a rough calculation and divide this by two, you may be in the area of children, so you have a factor of 60, or about 21 respectively, when you look at the very high uses. But of course we do not expect children to be high users of energy drinks, so this is just hypothetically for consideration.

[Patrick Brown, Conservative, Barrie, ON]

How many milligrams of taurine are in a Red Bull?

[Andreas Kadi]

A can of Red Bull contains 1 gram or 1,000 milligrams.

[Patrick Brown, Conservative, Barrie, ON]

And in Europe it was 1,000?

[Andreas Kadi]

Yes, and that is per kilogram of body weight to no observed effect level. So if you did a scientific calculation--not a fully justified calculation, but at least to get the magnitude--this would correspond to 120 cans of Red Bull per day, which of course nobody would seriously consume.

[Patrick Brown, Conservative, Barrie, ON]

Obviously it doesn't appear that there's a concern there. I know that on a can of Red Bull it says that the recommended dose is two per day. But the Health Canada figures—

[The Vice-Chair, Liberal, Joyce Murray]

It will have to be a very quick question, Mr. Brown.

[Patrick Brown, Conservative, Barrie, ON]

--show 400 milligrams a day. So technically, following the Health Canada's levels, you could have five a day, but you recommend two. Why have you taken a more conservative approach?

[Andreas Kadi]

As was mentioned by Health Canada, there's range of sources for caffeine intake. The main source is coffee. Then you have tea and other products contributing to the daily caffeine intake. So advising consumers to not have more than two cans, which is 160 milligrams, is a reasonable approach to allow for other sources of caffeine in the diet.

[Patrick Brown, Conservative, Barrie, ON]

Thank you.

[Andreas Kadi]

On the interaction of caffeine and taurine, I owe you an answer in a nutshell. The European Food Safety Authority has looked at that, and I recall one sentence from the summary report, to answer your question. They said that “...it was unlikely that d-glucuronolactone would have any interaction with caffeine, taurine, alcohol or the effects of exercise”. So they looked at potential interactions with all the substances, plus alcohol and physical exercise.

[Patrick Brown, Conservative, Barrie, ON]

Thank you.

[The Vice-Chair, Liberal, Joyce Murray]

Thank you.

Dr. Fry.

[Hedy Fry, Liberal, Vancouver Centre, BC]

Thank you very much.

First I want to say, Mr. Shepherd, please accept my condolences on what has happened to your child.

I want to ask a couple of questions.

If Red Bull is not supposed to be good for children, and you say that children should not take it, why is it that Red Bull, up until adverse reporting occurred, had been marketing to children? That's the first question I need to ask.

Secondly, if Red Bull or very highly caffeinated energy drinks are not supposed to be used with alcohol, surely when a product is marketed with vodka in most bars you should know that this is marketing with alcohol. Due diligence would ensure that it should be said very clearly to people who buy Red Bull for use in a bar that they should not mix it with alcohol. Has either of those things happened?

Also, we talk about labelling and everyone says what the labelling is, but what if labelling is not clear? If a child cannot read a label that says they should not be taking this, or if an adult cannot read a label that says they should not be taking this when they've had five cups of coffee because of the cumulative effect of caffeine, why is that labelling not absolutely clear?

Because I have to tell you, Red Bull is marketed a lot. And I think the issue of exercise is an important one when combined with it, and yet whenever you go to any parade, any athletic event, there is Red Bull, marketing to everyone.

I think the issue of the precautionary principle is extremely important, so I'm going to ask this question of Health Canada. As a result of some of this, given that children are using this product freely, given that it is being sold with alcohol, given that it is being marketed to children who are not told they shouldn't take it, have you begun or do you intend to start adverse reporting mechanisms?

[Dr. Samuel Godefroy]

Again, this question is about Red Bull and energy drinks, so I'm going to ask my colleague, Michelle Boudreau, the director general of the natural health products directorate, to answer your question.