Following revelations in the New York Times that leading energy shot company 5-Hour Energy had been mentioned in reports to the Food and Drug Administration as potentially playing a role in up to 13 deaths, the FDA also released a list showing that Rockstar Energy had been mentioned in 13 more reports of “extreme adverse reactions.”
All of the reports had been submitted to the agency under a statute that companies self-report those kinds of incidents. Monster has been facing enhanced public scrutiny since the filing of a lawsuit revealed that the FDA had reports on five deaths since 2009 in which that energy drink may have been involved.
But 5-Hour is disputing that its product played a role in any fatality, saying that it was nevertheless required to tell the FDA about the deaths — and that it had fulfilled its statutory duties by doing so.
“Living Essentials, LLC is unaware of any deaths proven to have been caused by the consumption of 5-Hour energy,” said company spokesman Elaine Lutz in a release to the media. “It is important to note that submitting a serious adverse event report to the FDA, according the agency itself, is not construed by FDA as an admission that the dietary supplement was involved, caused or contributed to the adverse event being reported, or that any person included in the report caused or contributed to the event.”
A list of the reports indicating the dates, symptoms, and outcomes has been made available on the FDA web site for a period from June, 2005 to as late as this fall was posted on the FDA web site Friday morning. Overall, a total of 40 reports have been filed concerning Monster and 92 were filed concerning 5-Hour Energy; an additional 13 have been filed mentioning Rockstar Energy as well, FDA postings indicated this morning.
Like Monster and many other – but not all – energy drinks and shots, 5-Hour Energy is marketed as a dietary supplement. Under terms of a law passed in 2006, sellers of dietary supplements and weight loss products are required to provide a way on their packaging for consumers to report extreme adverse reactions to the companies, and the companies are required to pass those reports along to the FDA within 15 days of receiving them. The companies are also required to submit follow-up reports disclosing any new information received within one year of the initial report. The agency also set up a reporting system for the general public.
Regulatory attorneys who spoke with BevNET made it clear that if a company that is reporting an extreme adverse reaction – basically, an extreme physical illness, injury or death that may have involved the product – that reporting does not mean that the product itself caused the reaction, only that the company is following the requirements of the statute.
“The fact that there were serious adverse events reported doesn’t mean they were necessarily responsible,” said Justin Prochnow, an FDA expert at Greenberg, Traurig LLC. “They certainly could have been, but responsibility is not the threshold. You’re required to make the report to the agency whether [the product] is actually tied to the extreme adverse reaction or not.”
The FDA uses the reports as a basis for follow-up investigation, according to Tamara Ward, a public affairs officer with the FDA.
“The FDA considers an adverse event report as a sign of a possible problem and is therefore seeking any additional available data such as: to solicit more information from those who submitted reports, to analyze any new reports of adverse events, and to apply epidemiological tools to assess the data and determine whether there are any safety concerns,” Ward told BevNET.
The incident reports posted Friday by the FDA shed little light on the circumstances regarding any of the adverse reactions. For several, under the “Symptoms” classification and the outcome classification, the only description is one word: “Death.” Other incident reports describe symptoms like “vomiting, crying, anxiety” with an outcome of “visited a health care provider, visited an ER.”
Regulatory attorneys agree that maintaining public safety is important, but undue scrutiny of products as a result of the mandatory reporting system can hurt industry, said Mark Gardner, a lawyer with Minnesota law firm DuVal & Associates who specializes in FDA work.
“It’s terrible when someone is injured,” Gardner said. “But the broader policy question is should we over-react to a rare event and propose laws and regulations which will over-regulate the 99.9999% of products and companies where serious events do not occur?”
Vexing industry even further is the notion that they companies that have reacted according to statute are the ones receiving negative publicity. FDA officials have indicated that, unlike the energy drink companies who have been the focus of media inquiry, many supplement manufacturers weren’t submitting reports as required. Additionally, consumers and doctors may not have realized they could file reports with the companies. Complicating matters even further, multiple reports may have been submitted by different parties all dealing with the same incident.
Gerry David, CEO of Celsius Holdings, Inc., an energy drink and “fat burning” weight loss supplement told BevNET that his company had only had to file one adverse event report to the FDA in seven years.
“This event occurred over a year ago and was related to an upset stomach and was circumstantial,” David said. “We have sold millions of cans of Celsius and consider this event an anomaly.”
Just how anomalous the rest of the events are may lie somewhere in the full text of the reports, which have not yet been made available.
