For better or worse, many of us live on caffeine. We consume coffee as if it were the cornerstone of a balanced diet. And if it’s not coffee, it’s often can after can of diet soda. But in the last few years, caffeinated products have expanded from these time-honored sources to a vast array of energy drinks and caffeinated snacks. Unlike the naturally-occurring caffeine in coffee (or tea), many of these new caffeinated products get their energy boost through caffeine additives. Caffeine is generally recognized as safe (GRAS) for use in cola-type beverages up to a level of 0.02 percent or 200 parts per million. This means that manufacturers do not need the Food and Drug Administration’s (FDA’s) approval to use caffeine additives in soda, as long as the amount of caffeine is within these established limits. Though regulatory agencies such as FDA or the Federal Trade Commission have acted in the past to address health concerns related to the use of caffeine additives in particular products, such as caffeinated alcoholic beverages, energy drinks, or inhalers, this piecemeal approach to caffeine additives may be changing, especially where children are concerned.

On April 29, 2013, FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor issued this brief statement:  

The only time that FDA explicitly approved the added use of caffeine in a food was for cola and that was in the 1950s. Today, the environment has changed. Children and adolescents may be exposed to caffeine beyond those foods in which caffeine is naturally found and beyond anything FDA envisioned when it made the determination regarding caffeine in cola. For that reason, FDA is taking a fresh look at the potential impact that the totality of new and easy sources of caffeine may have on the health of children and adolescents, and if necessary, will take appropriate action.

Deputy Commissioner Taylor was responding to a new product launched by Mars Inc.’s Wrigley brand -- a caffeinated gum called Alert Energy. Each Alert Energy package claims that the caffeine in one piece of gum is the equivalent of half-a-cup of coffee, giving each eight-piece pack the potency of four cups of coffee. While the use of caffeine additives in a wide range of products is not new, the introduction of caffeinated gum may represent the tipping point when the proliferation and ubiquity of caffeinated products, from jelly beans to potato chips to trail mix, has simply overwhelmed the long-standing regulatory status quo. 

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Though Wrigley’s Alert Energy website states that the gum is “[n]ot recommended for children or persons sensitive to caffeine,” Deputy Commissioner Taylor expressed concerns about “the totality of new and easy sources of caffeine . . . .” Interpreting exactly what his statement means or exactly what FDA will do next requires reading some tea leaves. Broadly speaking, however, Deputy Commissioner Taylor’s statement suggests that before changing its overall regulatory strategy or enforcement priorities, FDA will undertake a comprehensive review of categories of commonly caffeinated foods to determine the cumulative potential effects of these products. On May 3, FDA announced it will undertake this review, considering factors like consumption levels, rates and, patterns among specific populations, particularly children and adolescents.  The review will likely consider other information such as the available scientific data on toxicity, behavioral effects, and other health effects across the specific categories of foods with caffeine additives.

It is unclear at this point what, if any, “appropriate action” FDA may take if it makes adverse findings regarding the health effects of caffeine additives on children. FDA could, for example, impose more stringent requirements on the marketing and sale of products containing caffeine additives. FDA may also increase enforcement activity against particular products that raise health concerns related to caffeine additives. This Blog will continue to monitor the FDA’s progress and provide updates on developments as they occur.

Update (5/9/2013): Following discussions with FDA, Wrigley announced on May 8 that it would voluntarily and temporarily suspend the production and sale of Alert Energy gum. Wrigley explained that this decision was designed to give the FDA space to develop a new regulatory framework for caffeine additives. The President of Wrigley North America, Casey Keller, stated, “There is a need for changes in the regulatory framework to better guide the consumer and the industry about the appropriate level and use of caffeinated products.” Deputy Commissioner Taylor lauded Wrigley’s decision, which he believed “demonstrates real leadership and commitment to public health.” He expressed hope that others would follow Wrigley’s lead.