Health Canada has licensed more than a dozen caffeine-laden “energy shot” drinks in the past month, at a time when the Food and Drug Administration is investigating reports linking one of the best-known brands to deaths in the United States.
Energy shots typically come in fist-sized bottles that contain as much as 200 milligrams of caffeine – about half of the maximum amount Health Canada says is safe to consume in a day. They are marketed as a natural way to stay alert and are often featured near the cash register at gas stations and convenience stores.
As the popularity of both energy shots and the larger-sized energy drinks grows, governments are grappling with how to regulate their sale. Some experts worry about news reports that teenagers are mixing alcohol with the larger-sized drinks, such as Red Bull, and fear those who use the smaller shots may not be aware of how much caffeine they are consuming at once.
The FDA says it is looking into reports that 13 people have died over the past four years after drinking 5-Hour Energy, a popular brand of energy shot that is also sold in Canada, while Health Canada records show that seven serious reactions were reported as possibly linked to 5-Hour Energy shots in recent years. (Both the FDA and Health Canada note that adverse-reaction reports point only to a suspected link and are not conclusive).
Living Essentials LLC, the company that distributes 5-Hour Energy, has said it takes the reports seriously and is unaware of any deaths proven to have been caused by its products.
Health Canada announced in the fall of 2011 that it would place a 180-mg cap on caffeine levels for single-serving portions of the larger-volume energy drinks, changes that began to come into effect last month. The department also said it would regulate energy drinks as foods and establish new labelling rules. The smaller energy shots were unaffected by the changes and continue to be regulated as “natural health products.”
About 20 energy shots were licensed by Health Canada during the past month alone, according to the department’s records, with most of the newly approved shots containing between 100 and 200 mg of caffeine.
A majority of the companies that were granted licenses had previously been allowed to sell their products in Canada using an “exemption number,” a temporary measure brought in to allow items regulated as natural-health products to stay on the shelves while Health Canada completed a full review. Monday marked the end of the temporary system that allowed the exemption numbers to be granted.
Health Minister Leona Aglukkaq’s office referred questions about the licensing rules for energy shots to the department.
A spokeswoman for Health Canada said all natural-health products are evaluated on a case-by-case basis. “As a result of its review, Health Canada may request a company to make changes to their product in order to receive an NPN [Natural Product Number]. For changes that do not pose a risk to Canadians, a transition phase for products on the market may be permitted, while companies update product formulations and/or labels,” Blossom Leung wrote in an e-mailed response.
Bottles of 5-Hour Energy sold in Ottawa stores currently contain 190 mg of caffeine, according to their labels, while the extra-strength versions contain 220 mg. The licence granted by Health Canada in January indicates the higher-strength shot will be limited to 200 mg in the future.
Health Canada could not say whether 5-Hour Energy had been asked to reduce its caffeine levels to obtain its licence, and a spokeswoman for Living Essentials would only say that the company complies with all government regulations “wherever our product is marketed and sold.”
Montreal-based RAGE Beverages Inc. said it was asked to include additional warnings on its labels before being issued a licence, including a note that its energy shots are not recommended for children or pregnant or breastfeeding women, founder and president Michel Myara said.
But the department made no comment on the amount of caffeine the shots contained, he said, even when the company increased the dosage. “Regarding the caffeine level, we have voluntarily increased it from 150 mg to 180 mg, without any objection” from Health Canada, Mr. Myara wrote in an e-mail.