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.
Mr. Fabricant said that the 13 fatality reports that mentioned 5- Hour Energy had all been submitted to the F.D.A. by Living Essentials. Since late 2008, producers of dietary supplements are required to notify the F.D.A. when they become aware of a death or serious injury that may be related to their product.
Currently, the agency does not publicly disclose adverse event filings about dietary supplements like 5-Hour Energy. Companies that market energy drinks as beverages are not required to make such reports to the agency, though they can do so voluntarily, Mr. Fabricant said.
Along with caffeine, 5-Hour Energy contains other ingredients, including very high levels of certain B vitamins and a substance called taurine.
Reached by telephone, the chief executive of Living Essentials, Manoj Bhargava, declined to discuss the filings and said he believed an article about the reports would cast the company in a negative light.
"I am not interested in making any comment," Mr. Bhargava said.
Subsequently, the company issued a statement that said, among other things, that it took "reports of any potential adverse event tied to our products very seriously," adding that the company complied "with all of our reporting requirements" to the F.D.A.
The company also stated that it marketed 5-Hour Energy to "hardworking adults who need an extra boost of energy." The product's label recommends that it not be used by pregnant women or by children younger than 12.
The number of reports filed with the F.D.A. that mention 5-Hour Energy appears particularly striking. In 2010, for example, the F.D.A. received a total of 17 fatality reports that mentioned a dietary supplement or a weight loss product, two broad categories that cover more than 50,000 products, according to Mr. Fabricant, the F.D.A. official.
He added that it was difficult to put the volume of 5-Hour Energy filings into context because he believed that some supplement manufacturers were probably not following the mandated reporting rules and that consumers and doctors might also be unaware that they can file incident reports with the agency. Last year, the F.D.A. received only 2,000 reports about fatalities or serious injuries that cited dietary supplements and weight loss products, he said.
Another government 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.
Along with Living Essentials, The Times sent queries last week to several producers asking whether they had received reports linking fatalities or serious injuries to their products.
Representatives for two of those companies -- Red Bull and Coca- Cola, which sells NOS and Full Throttle -- said they were unaware of any such reports. A representative for PepsiCo, which makes Amp, also said it was unaware of any such reports.
In addition to Red Bull, NOS, Full Throttle and Amp are also marketed as beverages, rather than as dietary supplements.
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