Today, the U.S. Food and Drug Administration (FDA) has received 92 reports citing illnesses, hospitalizations and deaths following the consumption of a product called 5-Hour Energy since 2009, including more than 30 reports involving serious or life-threatening injuries, such as heart attacks, convulsions and, in one case, spontaneous abortion, as reported by the New York Times following FDA records review.
The New York Times reported that federal officials have received evidence of 13 deaths over the last four years, citing the possible involvement of 5-Hour Energy, a highly caffeinated-energy “shot,” according to FDA recommendations, as well as an interview with an agency official.
The report’s disclosure marks the second time in recent weeks that FDA filings cited energy drinks linked to consumer deaths. As we reported to you last month, the agency acknowledged it had received five fatality filings, which mentioned another popular energy drink, Monster Energy.
These popular energy drinks are popular for the jolt people get when trying to stay awake. They contain caffeine, which is a stimulant, but regulations do not require the manufacturers to list the amount of caffeine in each drink.
U.S. Consumer Reports conducted an investigation regarding the actual caffeine levels in these energy drinks. Only 5 cans listed the caffeine content, 11 products did not specify the caffeine content at all, since dietary supplements are not required to list them on the labels. The studies found the actual caffeine content was 20 percent higher than the companies listed on the label.
While 5-Hour Energy does not disclose the exact amount of caffeine contained in each energy “shot,” the company has stated that each shot has “about as much” caffeine as a cup of premium coffee. It is not to be interpreted that caffeine alone can kill you, it becomes a serious problem if a person has an underlying health condition, especially a child or young adult, when excessive amounts of caffeine can play a critical role in increasing the risk of danger. Medical research suggests it takes as much as 10,000 milligrams of caffeine to kill as person, although there is not a lot of study on the subject.
Some lawmakers are calling on the FDA to increase regulation of the products and the practices of some of the energy drink producers and are being investigated by the New York State attorney general.
Unlike Red Bull, Monster Energy and some other energy drinks that look like beverages, 5-Hour Energy is sold in a two-ounce bottle referred to as a “shot.” The company does not disclose the amount of caffeine in each bottle, but a recent article published by Consumer Reports placed that level at about 215 milligrams. Also, the mere size of the 5-Hour Energy drink is a problem. The size is small, making it easier to consume more than one of these “shots.” But it is so powerful, making it even more dangerous.
The problem is that some companies classify their energy drinks as beverages while others classify them as dietary supplements. The regulations are very different. The FDA has stated that it does not have sufficient scientific evidence to justify changing how they regulate caffeine or the other ingredients found in energy products. Drinks such as Red Bull are sold under agency rules governing beverages, while 5-Hour Energy and Monster Energy, are marketed as dietary supplements.
In an interview Wednesday, Daniel Fabricant, director of the agency’s division of dietary supplement programs, said that of the 13 fatality reports that mentioned 5-Hour Energy drinks, all 13 deaths had been reported to the FDA by the distributor of 5-Hour Energy, Living Essential. Since late 2008, producers of dietary supplements are required to notify the FDA when they become aware of a death or serious injury, which may have been related to their product.
However, presently, the FDA does not disclose adverse event filings regarding dietary supplements like 5-Hour Energy. Companies that market energy drinks as “beverages” are not required to make such reports to the agency, but may voluntarily do so, Mr. Fabricant stated.
If the FDA does not make these filings public, how will consumers be made aware of the serious risks involved? If the companies are not required to list the amount of caffeine in each drink, or the risks of the other ingredients contained in the drinks, how will anyone know just how dangerous these drinks are?
In addition to high levels of caffeine, and extremely high sugar content, 5-Hour Energy contains other ingredients, such as very high levels of some B-vitamins, as well as a substance called taurine, an amino acid. The daily dose of taurine should be between 100-500 mg. One can of an energy drink has 1,000 mg of synthetically produced Taurine. Too much taurine can have a drug-like effect on the body and cause damage.
Last month, we reported to you about the tragedy that occurred in December 2011 when 14-year-old Anais Fournier consumed two 24-ounce cans of Monster Energy within a 24-hour period. The 480 milligrams of caffeine contained in the drinks (as much as drinking 14 sodas), exacerbated an underlying heart condition and after spending six days in a coma, she was pronounced brain dead. (The underlying condition, mitral valve prolapse, never required any restriction of activities or caffeine consumption by her doctors).
The victim’s mother filed a wrongful death lawsuit against the beverage company for failure to warn about the product’s dangers, as well as filing a Freedom of Information Request with the FDA. The inquiry revealed that five other people had also reported deaths linked to Monster Energy drinks since 2004.
A spokeswoman for Monster Energy drinks, Judy Lin Sfetcu, said that its’ products were safe and not the cause of the teenager’s death. She also said that they were “unaware of any fatality anywhere that has been caused by its drinks.”
According to an article in Pediatrics, almost half of the 5,448 cases reported with caffeine overdoses in 2007 were in people under the age of 19.
So many high school and college kids purchase these energy drinks or “shots” and mix them with alcohol, increasing the risk of death.
Makers of caffeinated alcoholic drinks took their products off the market in 2010 after the FDA sent warning letters to those companies stating that combinations of caffeine and alcohol in the drinks was a public health concern and could lead to alcohol poisoning, car accidents and assaults.
Another federal agency, the Substance Abuse and Mental Health Services Administration, reported late last year that more than 13,000 emergency room visits in 2009 were associated with energy drinks alone. This is a dramatic surge in recent years of young adult visits to the emergency room.
The FDA should have the authority to regulate these dangerous energy drinks. It does not make sense that some energy drinks are classified as beverages, while others fall under the dietary supplement category and are not subject to any regulations. There have been too many unnecessary deaths and serious incidents associated with these energy drinks.
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