Boost on the ground: Troops love 5-Hour Energy, but experts raise health concerns

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Each week, 9 million plastic vials of 5-Hour Energy disappear from store shelves worldwide — a clear sign that many of us are desperately seeking a quick boost for sleep-deprived days.

The quest for instant energy is particularly intense in the military, where these small shots of caffeine, vitamins and organic and amino acids have proved a particularly popular middle-of-an-op pick-me-up: In 2011, sales topped $9.2 million across the military exchanges — not quite 1 percent of 5-Hour Energy's $1 billion in total sales, but that doesn't include what troops buy in commissaries, where sales reached nearly $1 million in the first seven months of fiscal 2012.

Air Force Staff Sgt. William White could make commercials for the product based on his emails to Military Times. 5-Hour Energy, he says, helps him endure an erratic schedule of 12-hour shifts.

"Being a missile field cop, I can be scheduled to work a day shift and then the day-of ... I get switched to nights," White wrote. "Taking 5-Hour Energy gives me the energy to get through the night, and it does it with less sugar and calorie intake."

But is it safe? And what exactly does a jolt of 5-Hour Energy do to your body?

Air Force researchers including Lt. Col. Michael Lee have launched a two-year study of its effects on blood pressure, heart rate and heart rhythm in 18- to 40-year-olds.

Lee, a pharmacist, said he got the idea after watching troops nail shots to get them through the toils of work and war.

"We have decent knowledge on what caffeine does to blood pressure," explained Lee's fellow researcher, cardiovascular pharmacologist Sachin Shah of the University of the Pacific in Stockton, Calif. "But a lot of energy drinks have other supplements in them. It's with the extra supplements that we don't know what happens to the cardiovascular system."

Loads of caffeine

5-Hour Energy hit the market in 2004 and since has become a multimillion-dollar baby for parent company Living Essentials Inc. Forbes magazine reported in February that the privately held company's 2011 sales accounted for about 90 percent of the U.S. energy-shot market.

But what's not quite as well detailed is why or even how it works. As a dietary supplement, its label lists its ingredients, but the company is not bound to disclose information such as caffeine content or levels of additives such as the amino acid taurine, associated in some studies with improved athletic and cognitive function.

5-Hour Energy is basically a blend of caffeine and massive doses of B vitamins —including more than 200 times the recommended daily amount of vitamin B12— combined with organic and amino acids, which the company says delivers "hours of energy" without the risk of a sugar crash.

Researchers say the caffeine is likely responsible for the punch. According to the 5-Hour Energy label, the amount of caffeine in one "original" 2-ounce shot is equivalent to the amount found in a "cup of the leading premium coffee."

An analysis by ConsumerLab.com, a company that tests health and nutrition products, found that a single 5-Hour Energy shot contains 207 milligrams of caffeine — somewhere between a short and tall Starbucks cup and the caffeine equivalent of drinking a six-pack of Coke in one gulp.

Safety concerns

"Most of the pep results from the amount of caffeine that's in there," said Dr. Tod Cooperman, ConsumerLab.com founder.

But some people — including 5-Hour Energy's makers — say they believe the enormous amount of B vitamins in the small, fruity dram also contributes to the kick.

5-Hour Energy contains particularly high doses of vitamins B6 and B12. Some studies have associated negative health effects with B-vitamin megadoses in some patients.

"We don't comment on third-party tests because testing protocols vary widely," spokeswoman Elaine Lutz said in an email. Nor would Living Essentials disclose results of its own testing.

Experts say large doses of vitamins do not contribute to a feeling of vigor and that the body uses the vitamins it needs and simply excretes the rest.

"There's no evidence whatsoever that massive amounts of vitamins at quantities above the recommended daily allowance accelerate metabolism," said Patricia Deuster, scientific director of the Uniformed Services University Consortium for Health and Military Performance.

But that doesn't mean you won't feel a difference.

In some people, niacin causes vasodilation — an expansion of the blood vessels — called a "niacin flush," producing symptoms ranging from skin redness and tingling to hot flashes.

The label alerts consumers to this physiological reaction: "This is caused by increased blood flow near the skin."

Niacin flush is not harmful. And in fact, niacin doses higher than those found in 5-Hour Energy are commonly prescribed to reduce blood cholesterol. But in military circles, niacin prescriptions are on the Air Force's list of "non-waiverable medications" for flight crews because they can cause dizziness, headaches and shortness of breath.

And in general, all services have restrictions on dietary supplement use, at least for some of their members:

Army: Requires all pilots to report supplement use.

Navy: Divides supplements into categories with differing limitations.

Air Force: Discourages nutritional supplement use for flight crews; all members must get approval from a flight surgeon.

Marine Corps: Requires Marines to report supplement use to doctors, although how well Marines adhere to this is not known.

Because dietary supplements are monitored by the Food and Drug Administration for safety concerns only after they reach the market, they have become a big concern for the military: An estimated 85 percent of service members report using them, according to a study by the Rand Corp. think tank.

The Defense Department has created the Human Performance Resource Center, run by the Uniformed Services University of the Health Sciences in Bethesda, Md., to serve as a clearinghouse for information on fitness, health and wellness.

Among its latest creations is a website containing a "dietary supplements classification system," a list of dietary supplements and the center's thoughts on their safety: green for those that provide a benefit with a low risk of negative effects; yellow for "use caution"; and red for those that have not been scientifically proven or carry health consequences.

Energy shots fall into the center's red zone.

"The use of these commercial products, especially combined with additional caffeine consumption, has concern for adverse effects due to potentially high caffeine ingestion," the HPRC database states.

But Living Essentials says 5-Hour Energy has an "exemplary safety profile" with the FDA.

"As a dietary supplement that is strictly regulated by the FDA, 5-Hour Energy is subject to adverse event reporting requirements imposed by the FDA," Lutz said.

She added that Living Essentials has conducted its own research on its product, which has faced independent review and found that 5-Hour Energy "is an effective way to achieve a long-lasting feeling of energy without a sudden drop later."

Push for regulation

"Strictly regulated," however, is a matter of perspective: Under the Dietary Supplement Health and Education Act, the FDA's Center for Food Safety and Nutrition monitors after-market safety of supplements, while the Federal Trade Commission regulates their advertising.

Manufacturers are responsible for ensuring that supplements are safe before they reach the market, but they don't actually have to prove it.

In a study published in the July 2011 Journal of Medical Case Reports, a 22-year-old woman developed acute hepatitis after consuming 5-Hour Energy shots — to the tune of 10 a day, far beyond the recommended volume of no more than two a day.

So far, Living Essentials has received no warning letters from the FDA on any safety issues.

However, recent health concerns over supplements have some lawmakers and consumer groups calling for tighter regulation.

In May, the FDA issued a warning for companies to stop adding DMAA — 1,3-dimethylamylamine, also known as methylhexanamine or sometimes "geranium extract" — to fitness supplements because of health concerns.

A safety study is currently underway in the Army examining the health consequences of taking DMAA, which was found in the bodies of two soldiers who suffered heart attacks during physical training last year.

Sen. Dick Durbin, D-Ill., has called for better labeling and tighter regulation of supplements, especially energy drinks, after a young girl in Maryland died of a heart attack after consuming two 24-ounce energy drinks in a single day.

A Durbin spokeswoman said the senator is particularly concerned about energy drinks with high caffeine levels that are marketed to children.

"The distinction between dietary supplements and foods with dietary ingredient additives is not always clear, leaving room for some food and beverage products to be marketed as dietary supplements in order to circumvent the safety standards required for food additives," Durbin wrote in a letter to FDA Commissioner Margaret Hamburg. "I urge the FDA to clarify the definition of conventional foods and its authority to oversee the safety of foods, including energy drinks, containing dietary supplement ingredients."

Dr. Ramin Manshadi, a California-based cardiologist, said more studies and more regulation are definitely needed. As a physician to young student athletes, he believes energy drinks — and shots — negatively affect the cardiovascular system, disrupting the complex electrical system that guides a heart's rhythm.

"The FDA says a 12-ounce drink can't have any more than 71 milligrams of caffeine [added]. Yet because these products are supplements, they can have unregulated amounts. Some have as many as 500 mg of caffeine. At those levels, it's like a drug," Manshadi said.

He said consumers often down energy drinks or shots without considering what else they've ingested that day, including coffee, multivitamins or vitamin-rich food.

"Caffeine toxicity can occur. Problems like palpitations, headaches and insomnia are significant, but high levels of caffeine can interfere with the function of the heart and basically cause the electrical activity in the heart to fail," Manshadi said.

A couple of studies on Air Force and student pilots indicate that energy drinks in general — or at least the caffeine in them — improve cognitive reaction times.

But little is known about their definitive effects on the cardiovascular system. Lee and Shah hope to contribute to the body of scientific literature, with preliminary results by next year.

"The FDA requires new drugs coming on the market to have a thorough QT study," Shah said, referring to studies of the heart's electrical cycle intervals. "The herbal market, the nutraceutical market, are not monitored as closely, so it's very important to investigate these things."

The Defense Department will launch an education campaign this year to warn troops and families about the potential health risks of consuming supplements. Operation Supplement Safety will aim to educate personnel about individual supplements and promote educated decision-making.

Deuster, who helped spearhead the campaign, has some advice when it comes to troops needing a pick-me-up. First, she said, get some sleep — advice that may not seem realistic for many service members. But second and more important, she added: "You want a boost of energy? Stick with chocolate milk and real food."

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