The US Food and Drug Administration has announced that it is investigating 13 deaths possibly linked to 5-Hour Energy, a so-called "energy shot" supplement, and is advising consumers to talk to their doctors before using any energy drinks.
The agency said it had received 92 reports that cite illnesses, hospitalisations and deaths after consumption of 5-Hour Energy, a highly caffeinated drink sold in small bottles.
Agency officials said the reports to the FDA from consumers, doctors and others don't necessarily prove that the drinks caused the deaths or injuries, but said they are investigating each one. In a statement, FDA officials said they would take action if they can link the deaths to consumption of the energy drink. Such action could include forcing the company to take the drinks, often found at convenience store checkout counters, off the market.
FDA spokeswoman Shelly Burgess said the agency was warning consumers that these "energy shots" or "energy drinks" are not alternatives to rest or sleep. "If someone is thinking about taking one of these products, they should consult with their health care provider to ensure that there are no underlying or undiagnosed medical conditions that could worsen as a result of using them," Burgess said.
The FDA released details of the investigation on the internet on Thursday. The web posting of the records by the agency also included 13 previously undisclosed injury filings that mentioned Rockstar Energy, another caffeine-loaded drink.
The FDA doesn't individually regulate caffeinated drinks or supplements such as the energy shots but can take action if they are proven to do harm. Makers of caffeinated alcoholic drinks took those products off the market in 2010 after the FDA sent the companies warning letters saying that combinations of caffeine and alcohol in the drinks was a public health concern and could lead to alcohol poisoning, car accidents and assaults.
The small size of 5-Hour Energy can also be dangerous to consumers with underlying conditions because it's easier to take several of them or mix them with alcohol. Though it is liquid, the 5-Hour Energy "shot" is marketed not as a drink but as a dietary supplement. FDA regulations require supplement manufacturers themselves to be responsible for products' safety.
A spokeswoman for the company that makes the product, Michigan-based Living Essentials, says 5-Hour Energy is a "compact-sized energy shot intended for busy adults - it is not an energy drink, nor marketed as a beverage."
The FDA last month said it had received reports that cited the highly caffeinated Monster Energy Drink in five deaths and one non-fatal heart attack.
Meanwhile, two Democratic US senators, Richard Durbin of Illinois and Richard Blumenthal of Connecticut, sent a letter to the FDA commissioner, Dr Margaret Hamburg, seeking a meeting to discuss energy drinks.
Both lawmakers have pressed the agency to tighten regulation of energy drinks, but it has said that it has not yet seen sufficient evidence to do so.
"There has been alarming evidence that energy drinks pose a potential threat to the public's health," the two senators wrote.
Many medical experts say that healthy adults can safely consume 400 milligrams or more of caffeine daily.
Additional reporting by The New York Times