Science and Law
16th November 2012

FDA Crashing 5-hour Energy Dietary Supplement?

This week the New York Times reported they learned in an interview with an FDA official that FDA has been investigating the “possible” involvement of the dietary supplement 5-hour ENERGY in the deaths of 13 individuals over the last four years.

FDA Crashing 5-hour Energy Dietary Supplement?
This week the New York Times reported they learned in an interview with an FDA official that FDA has been investigating the “possible” involvement of the dietary supplement 5-hour ENERGY in the deaths of 13 individuals over the last four years.

Considering the huge potential downside to the maker and distributor of 5-hour ENERGY (Innovation Ventures/Living Essentials) based on mere “possibility” (i.e. speculation), it was somewhat surprising that these premature statements were made. Importantly, other known or unknown variables may have contributed to the unfortunate deaths of the 13 individuals noted in the release. This is because the filing of an FDA incident report does not mean that the product was responsible or contributed to the death or injury in any way, and further, none of the deaths appear to have been conclusively shown to be caused by this dietary supplement.

 

According to the Committee on Military Nutrition Research of the Institute of Medicine’s (IOM) Food and Nutrition Board, variables such as smoking, age, and prior caffeine use can have a significant effect on an individual’s caffeine sensitivity. Serving levels greater than 250-300 mg/d have been associated with adverse health effects such as tachyarrhythmias and sleep disturbances. However, the Mayo Clinic considers consumption of 200-300 mg/d, which they equate to 2-4 cups of coffee per day, to be moderate intake (Mayo Clinic Staff [Mayo Clinic website] 2011). Mayo defines heavy caffeine use as 500-600 mg/d and associates that amount with possibly causing insomnia, nervousness, restlessness, irritability, stomach upset , fast heartbeat, and muscle tremors.

According to the Times report, the level of caffeine in a shot of 5-hour ENERGY was determined by Consumer Reports to be in the range of 215 mg. For comparison, a “tall” size (12 fl oz or 354 ml) brewed Starbucks coffee contains about 200 – 240 mg of caffeine. Thus, the caffeine level in a shot of 5-hour ENERGY does not seem incredulous,  and most individuals I know drink at least two tall Starbucks coffees per day.

In addition to caffeine, 5-hour ENERGY contains B vitamins and numerous other ingredients. However, the effect of any individual ingredient or combined interaction of these ingredients is difficult to evaluate unless controlled studies are conducted, which are not likely to be conducted.

Overall, caffeinated energy drinks have come under scrutiny lately, including Monster Energy. According to various sources, this product category remains popular and is growing. Whether it crashes or not remains to be seen.

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