FDA estimates it will receive 856 adverse events reports (AERs) for dietary supplements during the first year of required reporting—about 100 fewer than it first estimated—based on the 214 mandatory accounts it received during the first quarter of 2008 (January 1 to April 15). Last year, FDA acknowledged receipt of 482,154 AERs for prescription drugs. The Dietary Supplement and Non-Prescription Drug Consumer Protection Act required supplement manufacturers to begin collecting AERs in December of 2007.

According to a Federal Register notice published on September 15: “For the first quarter of 2008 (January 1 to April 15), FDA has received 214 mandatory reports of serious adverse events related to dietary supplements.” The agency did not identify the supplements linked to the adverse events.

The notice further states: “FDA revises our annual burden estimate from 960 mandatory reports to 856 mandatory reports of serious adverse events related to dietary supplements.”

A serious adverse event is one that results in death, a life-threatening experience, inpatient hospitalization, significant disability or incapacity, or congenital anomaly or birth defect, or one that requires medical intervention to prevent one of the outcomes. But an AER does not necessarily indicate a supplement caused the negative health outcome.

Loren Israelsen, executive director of the United Natural Products Alliance (UNPA), Salt Lake City, UT, said that while this reporting system is new, he and others are encouraging FDA to provide more specificity regarding an adverse event’s level of seriousness and, to the extent possible, the cause.

He expressed concern about the “collective effect of stimulants” in particular. “Say you have someone who drinks a cup of coffee and a Red Bull, then takes a couple of pills before they go to the gym. And then they start to get heart palpitations and end up in the emergency room. The question is, ‘how do you unravel the causal effect?’”

FDA needs to provide more details on these events in order to better serve the public, he continued. “We think it is incumbent that FDA do so in order for industry to evaluate genuine serious adverse event reports, to address either quality failures or supply chain management issues.”

He likened the current system to reporting automobile accidents without distinguishing between fatalities and bumper on bumper collisions. “One thing we really must have is stratification of what these reports represent.”

Mr. Israelsen added that without more precision from FDA, the media would continue to latch on to AER figures that don’t necessarily represent the whole story. He also called the following comments from Senator Dick Durbin (D-IL), which appeared in a September USA Today article, “distressing”: “Five years ago, the dietary supplement industry claimed that they had no reports of health problems—zero—related to their products,” the senator reportedly said in e-mail to the newspaper. “Thanks, in part, to our legislation, today we know that there are 100s of serious problems each year, many involving hospitalization and death.”

Mr. Israelsen commented: “I am unaware that anybody said that there were no health problems or AERs for dietary supplements. I intend to ask Senator Durbin’s office just who said this.”