Energy shot cited in 13 death reports to FDA
Since 2009, 5-Hour Energy has been mentioned in about 90 filings with the FDA.
By Barry Meier THE NEW YORK TIMES
Federal officials have received reports of 13 deaths over the past four years that cited the possible involvement of 5-Hour Energy, a highly caffeinated energy shot, according to Food and Drug Administration records and an interview with an agency official.
The disclosure of the reports is the second time in recent weeks that FDA filings citing energy drinks and deaths have emerged. Last month, the agency acknowledged that it had received five fatality filings mentioning Monster Energy, another popular drink.
- Since 2009, 5-Hour Energy has been mentioned in about 90 filings with the FDA, including more than 30 that involved serious or life-threatening injuries such as heart attacks, convulsions and, in one case, a spontaneous abortion, a summary of FDA records reviewed by The New York Times showed.
The filing of an incident report with the FDA does not mean that a product was responsible for a death or an injury. Such reports can be difficult to investigate.
The distributor of 5-Hour Energy, Living Essentials of Farmington Hills, Mich., did not respond to written questions about the filings, and its top executive declined to be interviewed.
However, in a statement, Living Essentials said that the product was safe when used as directed and that it was “unaware of any deaths proven to be caused by the consumption of 5-Hour Energy.”
Since the public disclosure of reports about Monster Energy, its producer, Monster Beverage of Corona, Calif., repeatedly has said that its products are safe, adding that they were not the cause of any of the health problems reported to the FDA.
Unlike Red Bull, Monster Energy and some other energy drinks that look like beverages, 5-Hour Energy is sold in a 2-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.
An 8-ounce cup of coffee can contain from 100 to 150 milligrams of caffeine.
The FDA has stated that it does not have sufficient scientific evidence to justify changing how it regulates caffeine or other ingredients in energy products. The issue of how to do so is complicated by the fact that some high-caffeine drinks, such as Red Bull, are sold under agency rules governing beverages, while others, such as 5-Hour Energy and Monster Energy, are marketed as dietary supplements. The categories have differing requirements.
In an interview yesterday, Daniel Fabricant, the director of the agency’s division of dietary-supplement programs, said the agency was looking into the death reports that cited 5-Hour Energy. He said that while medical information in such reports could rule out a link with the product, other reports could contain insufficient information to determine what role, if any, a supplement might have played.
Fabricant said that the 13 fatality reports that mentioned 5-Hour Energy had all been submitted to the FDA by Living Essentials. Since late 2008, producers of dietary supplements are required to notify the FDA when they become aware of a death or serious injury that might be related to their product.
Now just two days later, another article with further problems cited:
More energy-drink problems noted
Senators press FDA for action to limit caffeine
By Anna Edney BLOOMBERG NEWS
WASHINGTON — Rock-star Inc.’s energy drinks, distributed in most of the United States by PepsiCo, were named in 13 adverse-event reports dating to 2006, the Food and Drug Administration says.
No deaths were cited.
The events in some cases involved increased heart rate, abdominal pain and nausea, and included four hospitalizations, according to a list posted this week on the FDA’s website. The incidents are reported voluntarily and are deemed allegations with no conclusion drawn until investigations are completed.
Living Essentials’ 5-Hour Energy was cited in 92 reports, including 33 hospitalizations and 13 deaths, according to the data covering Jan. 1, 2004, to Oct. 23, 2012.
Monster Beverage Corp. products were in 40 reports, with 20 hospital stays and five deaths. The FDA hasn’t yet made public reports for other drinks such as Red Bull and PepsiCo’s AMP Energy.
“It takes time to go through these reports and get the information ready and redacted,” FDA spokeswoman Shelly Burgess said.
- Energy drinks are the target of some lawmakers, including Sen. Dick Durbin, D-Ill. He is seeking to impose caffeine limits on the beverages after emergency-room visits involving such drinks jumped 10-fold from 2005 through 2009.
Monster and competitors such as Red Bull aren’t bound by the FDA guidelines for caffeine in sodas because energy drinks often are sold as dietary supplements. Soda typically can have as much as 71 milligrams of caffeine per 12 ounces for the FDA to consider it safe. The FDA might require companies to prove caffeine levels are safe if they exceed the guideline.
Caffeine in energy drinks often ranges from 160 milligrams to 500 milligrams a serving, the FDA said in an August letter responding to Durbin’s call for greater regulation of the industry.
- Durbin and Sen. Richard Blumenthal, D-Conn., sent a letter yesterday to FDA Commissioner Margaret Hamburg asking for a meeting to discuss the safety of energy drinks.
(Thank goodness for these two senators who seem to have more common sense than the FDA’s Margaret Hamburg whose job it is to serve the public and protect us all from the claims and shenanigans of “creative” yet obviously potentially harmful products. In this case, the harm done is in evidence. How many more deaths, hospitalization and years must she have in order to take action? Jan)