Monster Beverage Corp. will change labeling on its cans so that its energy drinks will no longer be considered dietary supplements. This move requires different labeling rules under Food and Drug Administration guidelines, including the notable addition of the drink’s caffeine content.
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Monster’s CEO told the industry tracker Beverage Digest that the cans will now list “Nutrition Facts” rather than “Supplement Facts.”
The change reflects the intensifying scrutiny energy drinks have come under over the past year, with lawmakers calling on the FDA to look into the safety of the caffeine levels and other ingredients used in the drinks. It also highlights the confusion consumers may encounter when it comes to the labeling of energy drinks.
Currently, companies having the discretion to categorize them as either dietary supplements or traditional drinks. For example, while Monster is categorized as a dietary supplement, the No. 2 energy drink Red Bull is categorized as a traditional beverage.
Generally speaking, companies have more leeway in the ingredients they can add to dietary supplements. When products considered to be food or drinks, companies can only use ingredients that are approved food additives or that are “generally recognized as safe,” said Elizabeth Campbell, a senior adviser at EAS Consulting Group, which specializes in FDA regulatory matters.
A December 2012 study by Consumer Reports highlighted this label confusion. Researchers tested caffeine contents in 16 energy drinks — some of which had caffeine amounts on their labels — and found wide variation in the ranges of caffeine contents found.
“Consumer and scientific groups have for years urged the Food and Drug Administration to make companies disclose caffeine levels, but the agency says it lacks the authority,” the magazine concluded.
That report found Monster had more than 270 milligrams of caffeine in a 24-ounce can. At the time, Monster said that the company does not post caffeine amounts because “there is no legal or commercial business requirement to do so, and also because our products are completely safe, and the actual numbers are not meaningful to most consumers.”
Among the issues lawmakers have raised over energy drinks is that they sometimes contain little-known ingredients, such as the taurine used in some Monster drinks. Campbell, who previously worked at the FDA for 35 years, said taurine is not approved for use in food and is not listed in the database of notifications for “generally recognized as safe” ingredients. Companies are responsible for submitting their own research to show an ingredient is “generally recognized as safe.”
A spokesman for Monster Beverage was not able to confirm the report in Beverage Digest or whether the Corona, Calif. company would remove any ingredients as a result of any possible labeling changes.
Meanwhile the FDA is still working on final rules for what qualifies as a beverage versus a dietary supplement. But the agency had issued guidance in 2009 noting that dietary supplements were being marketed in ways that suggested they were regular drinks. It also noted that products that use terms such as “drink”, “juice” and “beverage” suggest they’re conventional foods, rather than supplements.
Notably, companies that make dietary supplements are required to report incidents of adverse effects to the FDA while food makers are not. A spokeswoman for the FDA did not immediately know how many, if any, reports of adverse effects Monster had made to the agency.
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However, it is known that the FDA in October 2012 investigated at least five deaths and one heart attack linked to Monster Energy Drinks dating back to 2004. The FDA’s announcement followed the filing of a wrongful death suit of 14-year-old Anais Fournier, who died of a cardiac arrhythmia due to caffeine toxicity after drinking two 24-ounce Monster drinks in 24 hours. Fournier also had a preexisting medical condition that may have weekend her blood vessels.
In November 2012, the FDA said it was also investigating another popular energy drink called 5-hour Energy, after it was linked to 92 side effect reports including 33 hospitalizations and 13 deaths.
A study released Feb. 1 in Pediatrics In Review emphasized that energy drinks can cause insomnia, rapid heartbeat, high blood pressure, anxiety and obesity among other issues which can be exacerbated by alcohol.
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