We’ve all seen the tiny red and yellow bottles in the supermarket. Most of us have seen the TV commercials too: 5-Hour Energy bills itself as an afternoon pick-me-up for flagging office workers, and as time-efficient replacement for a late commuter’s morning coffee.
According to an investigation by the New York Times, however, information compiled by the federal government raises important questions about the safety of 5-Hour Energy and similar products. “Since 2009, 5-Hour Energy has been mentioned in some 90 filings with the FDA, including more than 30 that involved serious or life-threatening injuries like heart attacks, convulsions and, in one case, a spontaneous abortion” the newspaper reports.
The paper notes that the mention of a product in an FDA filing does not necessarily mean that the product is connected with a particular incident – only that a connection is possible or suspected. Still, the Times reports that 13 fatality reports mention 5-Hour Energy and that the government, as a result, is concerned. The Times adds that the regulatory world concerning energy drinks is often confusing because some are treated as beverages while others (including 5-Hour Energy) are classified as dietary supplements. Each category has different rules regarding both labeling and whether and how adverse events need to be reported to the government. The article quotes an FDA official saying that the reports are prompting a closer examination by the Agency.