F.D.A. Posts Injury Data for 3 Drinks

BARRY MEIER
November 15, 2012
The New York Times

As its policy on highly caffeinated energy drinks is scrutinized, the Food and Drug Administration publicly released records on Thursday about fatality and injury filings that mentioned the possible involvement of three top-selling products.

The Web posting of the records by the agency included 13 previously undisclosed injury filings that mentioned Rockstar Energy. The F.D.A. also released filings related to 5-Hour Energy, a popular energy shot, and Monster Energy, another popular brand.

The agency’s action comes a day after The New York Times reported that the agency had received more than 90 filings about 5-Hour Energy, including reports that cited its possible involvement in 13 fatalities. In late October, the F.D.A. confirmed that it had received five fatality reports that cited Monster Energy.

The filing of an incident report with the F.D.A. does not mean that a product was responsible for a death or an injury or contributed to it in any way. The makers of 5-Hour Energy and Monster Energy have insisted their products are safe and unrelated to the problems reported to the F.D.A.

Officials of Rockstar Energy Drink, which is based in Las Vegas, did not return calls on Thursday seeking comment

The release of the filings may represent a turnabout in agency policy. While units within the F.D.A. that oversee prescription drugs and medical devices make so-called adverse event reports about those products available to the public through Web sites or other means, the unit that oversees dietary supplements routinely does not do so.

Shelly Burgess, an agency spokeswoman, said the agency had decided to release the records “in an effort to be transparent.” She added that the filing of a report did not show a product was at fault.

“If we find a relationship between consumption of the product and harm, F.D.A. will take appropriate action to reduce or eliminate the risk,” Ms. Burgess said.

Meanwhile, two senators, Richard Durbin of Illinois and Richard Blumenthal of Connecticut, sent a letter on Thursday to the F.D.A. commissioner, Dr. Margaret A. Hamburg, seeking a meeting to discuss energy drinks. Mr. Durbin and Mr. Blumenthal are Democrats.

Both lawmakers have pressed the agency to tighten regulations 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 healthy adults can safely consume 400 milligrams or more of caffeine daily, or about as much caffeine as in several 8-ounce cups of coffee or in two 16-ounce cans of many energy drinks.

There is scant data, however, about whether such levels are safe for young teenagers to whom energy drinks are frequently marketed. Along with caffeine, energy drinks typically contain other ingredients like high levels of certain B vitamins and a substance called taurine, which exists inside the body.

The records released on Thursday by the F.D.A. cover a period from 2004 to last month. But the vast majority of filings are from the last four years; beginning in late 2008, makers of dietary supplements were required to notify the F.D.A. of a report of a fatality or injury that might have been associated with their products.

The three products involved in the release — Rockstar Energy, 5-Hour Energy and Monster Energy — are all marketed as dietary supplements. Other energy drinks like Red Bull, NOS and AMP are marketed by their producers as beverages. There is not a mandatory reporting requirement for beverages, though makers can do so voluntarily.

In releasing the filings, the F.D.A. said it thought that even with the mandatory reporting requirement for dietary supplements, “only a small fraction of adverse events associated with any product is reported.”

Last year, the F.D.A. received about 2,000 such reports about dietary supplements and weight-loss products, two broad categories that include more than 50,000 products.

Officials of the F.D.A. dietary supplement unit have said they were working on ways to make reports of adverse events public, but they have not set a timetable to do so. The records related to Monster Energy and 5-hour Energy came to light because they were released by the F.D.A. under the Freedom of Information Act.

Over all, sales of energy drinks in the United States grew an estimated 16 percent last year to $8.9 billion, a record level, according to Beverage Digest, a trade publication.

A report last year by the federal Substance Abuse and Mental Health Services Administration found that the annual number of emergency room visits in this country linked to energy drinks rose to more than 12,000 in 2009, the latest year for which data was available. The figure represents a tenfold jump from the number of such visits reported in 2005.