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Exclusive: Health Canada panel takes aim at energy drinks
Its always about the children....
Exclusive: Health Canada panel takes aim at energy drinks
OTTAWA Energy drinks such as Red Bull, Rockstar and Monster should be renamed "stimulant drug containing drinks" and only be sold under the direct supervision of a pharmacist, an expert panel for Health Canada has concluded.
The panel's report, obtained by Postmedia News using access to information legislation, says stricter control of energy drinks is important in order to address consumer confusion, especially among young people who can now purchase the caffeinated beverages at convenience stores alongside sports drinks, juices and pop.
"This would more formally signal to the general public that these are drug products, not foods," the report, dated November 2010, states.
Unlike sports drinks, which contain electrolytes, energy drinks, formulated for adults but popular among teenagers, are boosted with caffeine to levels far higher than those in a can of cola.
The elevated caffeine content in the drinks, which are currently regulated as natural health products, allows companies to make a health claim that Red Bull and other similar drinks provide an energy boost.
The panel's drastic recommendations, presented to the government nearly a year ago, pose a dilemma for Health Minister Leona Aglukkaq, who has mused about tightening controls on energy drinks. The expert panel's suggestions are already running into fierce opposition from the beverage industry.
If the recommendations were adopted, Canada would set an international precedent for regulating energy drinks, which Aglukkaq would have to defend on the world stage.
Although available without a prescription, drugs classified as Schedule III under the National Association of Pharmacy Regulatory Authorities this is what the panel proposes for energy drinks are sold on shelves of a pharmacy "operated under the direct supervision of the pharmacist." They do not have to be behind the counter, however. The panel described energy drinks as "drug delivery systems in a beverage format."
Energy drink labels should also be revamped because "'energy' drinks is a marketing term and should not be used," according to the expert panel. The panel was comprised of Canadian specialists in cardiology, pediatrics, pharmacology and kinesiology who conferred with a doctor specializing in pharmacovigilance at the World Health Organization and three experts at the European Food Safety Authority before formulating its recommendations.
In addition to recommending the term "stimulant drug containing drinks" on the front panel of the product, the report says Health Canada needs to take the lead internationally by requiring warnings labels on cans stating that serious adverse events including death have been seen with these products, possibly due to cardiac events.
Steve Outhouse, a spokesman for Aglukkaq, said the report remains under consideration as the department works on a plan to deal with the fastest-growing category in the beverage industry. Seven million units of energy drinks are sold per month in Canada.
"We're looking to come forward with our plan, and we are looking at this as one part of the information that we're evaluating. The plan, when it does come forward, is going to put the health and safety of Canadians first. We want to make sure that people have accurate information so they can make good decisions about health,"Outhouse said Tuesday.
If the advice of its expert panel is accepted, Canada would set a global precedent for its tough stand on energy drinks.
The Canadian Beverage Association, representing many energy drinks brands, says this would be a big mistake, claiming the panel had invalid data and information to craft its recommendations.
Based on the panel's definition of drinks containing stimulants, all forms of coffee would fall into the same category, the association says.
"We violently dispute these recommendations," the group's president, Justin Sherwood, said after reviewing the report. "It's a completely unrealistic and flawed assessment if the matter is caffeine, which it is."
For example, a tall cup of brewed coffee at Starbucks contains more caffeine (260 mg.) than the caffeine in a standard can of Red Bull (80 mg.) or the AMP Alert energy drink (158 mg.). A can of cola contains 44.94 mg. of caffeine.
"The coffee shops are going to have to start hiring pharmacists," quipped Sherwood.
The panel, while acknowledging substantive safety data for these drinks are lacking, especially for adolescents, reviewed information about 61 adverse drug reactions related to "energy" drinks reported to Health Canada. Of the 32 serious reports, the report notes that 15 involved the cardiovascular system and seven of the 32 occurred in adolescences.
Following World Health Organization standards about causality, four serious adverse reactions were graded as probably related to the beverage and eight as possibly related. The panel also notes that three other reports, including two deaths, could not be assessed due to incomplete information.
"Even if the risk (probability of occurrence) of serious adverse events is expected to be very low, cases of serious adverse events have occurred. Therefore, due to the high volume of use, the risk of adverse events is considered to be a public health issue as these stimulant drug containing drinks are not being medically prescribed for a health indication. In the absence of real therapeutic and medically indicated benefits, the panel considers that the risks associated with the use of these drugs outweigh the benefits," the report states.
But the industry group said the panel received summaries of adverse reaction reports from Health Canada, rather than raw data. The department also expanded its interpretation of "serious adverse event" rather than adhering to its definition in Canada's natural health products regulations, the group says.
Energy drinks, currently regulated as natural health products, should be classified as foods, as is the case in other countries, said Sherwood.
Since 2004, when Health Canada made the decision to classify these caffeinated drinks as natural health products rather than as a food or drug, the department has issued nine licences for energy drinks, representing 18 products. Another 157 products, such as Rip It Energy Fuel, Monster Nitrous Killer-B and N.O.-Xplode Igniter Shot, are also permitted to be sold as natural health products while Health Canada considers their licence applications.
The expert panel was chaired by Dr. Noni MacDonald, a professor of pediatrics at Dalhousie University in Halifax.
Other panel members included: Dr. Robert Hamilton, the head of electrophysiology in the division of cardiology at Toronto's Hospital for Sick Children; Dr. Jane Shearer, a professor of kinesiology at the University of Calgary; Yola Moride, professor of pharmacy at the University of Montreal; and Patricia Malloy, a clinical nurse specialist at the Hospital for Sick Children.
The panel consulted Dr. Richard Hill, manager of pharmacovigilance service at the WHO, and Hugues Kenigswald, Majlinda Lahaniatis and Tobin Robinson at the European Food Safety Authority.
Before convening an expert panel on energy drinks, Health Canada had considered taking some drastic measures, with an eye to curbing the use of energy drinks among teens and children, but stopped short of implementing any of them as it considered feedback from its expert panel.
These included stop-sale orders and possible product recalls, according to internal records released to Postmedia News earlier this year under access to information legislation.
The records, from 2010, also indicate that Health Canada had also planned to announce new cautionary labeling rules by March 2010, requiring energy drink makers to add a risk statement on cans: "Irregular heart rate or rhythm have been known to occur, in which case discontinue use and consult a health care practitioner." (Companies are already required to state on cans sold in Canada that the drink is not recommended for children, pregnant or breastfeeding women and caffeine-sensitive persons and that it is not to be mixed with alcohol.)
The labelling proposal, considered alternately as "high priority" and "extremely high priority" in internal correspondence, stalled after the industry group questioned the scientific basis for the cardiac statement.
Its always about the children....
