“Once more unto the breach…”
FDA has released 21 reports filed since 2004 citing leading energy drink Red Bull in adverse events up to and including hospitalizations for everything from fatigue (the irony is lost on no one) and pancreatitis to irregular heart beat and vomiting.
This announcement comes on the heels of reports linking Monster and 5-Hour Energy to the deaths of some 18 consumers. Senator Richard Durbin wasted no time in admonishing the FDA for the third time this year to crack down on what he claims is an unregulated market. The Senator speaks specifically of energy drinks being marketed to children, lacking adequate labeling and being marketed as supplements rather than foods/beverages.
Interestingly the New York Times reported on November 16 that while companies that market their products as supplements—such as Monster, 5-Hour Energy, and Rockstar—must notify FDA of adverse events (death or injury) linked to their products, companies marketing their products as beverages do not. So it would seem that at least in terms of reporting the FDA places more stringent regulations on supplements. But we would be remiss if we didn’t also mention DSHEA, GMP compliance and NDI notifications.
Yet it seems clear that some action needs to be taken to protect consumers and perhaps even to keep these manufacturers out of hot water. The same New York Times article also reported that some 13,000 emergency room visits in 2009 cited energy drinks as a possible cause.
Bottom line: This issue clearly isn’t going away and at the very least caffeine content labeling must be on the table.
How might this turbulent category shift in 2013? Leave your thoughts in the comments below.