Defining Boundaries for Caffeine in Today’s Marketplace

We all know that healthy adults have consumed caffeine in coffee, tea, and chocolate for centuries. Caffeine has also been added to certain soft drinks for many years. These uses of caffeine are considered by most people to be safe, but the availability of caffeine in these products has been accompanied by a sense of boundaries and some health-related advice: Coffee has traditionally been thought of as a drink for adults; pregnant women have been advised to limit caffeine intake; and parents have monitored young children’s consumption of caffeinated soda.

In addition, most of these traditional products have not typically been marketed for their stimulant properties, though it’s no secret that caffeine, whether naturally present or added, is a remarkably effective central nervous system stimulant. And today’s marketers have caught on to this fact in a big way. Caffeinated “energy” drinks hit the shelves over a decade ago, and, more recently, we have seen caffeine added to nontraditional products like waffles and syrup to snack foods, candy, chewing gum, and a variety of beverages—all marketed to provide “energy” through the presence of widely varying levels of added caffeine.

By breaking far outside the traditional boundaries surrounding caffeine as a component of the food supply, these products pose challenging public health and regulatory questions. They stem from the fact that these products are being marketed explicitly for their stimulant properties, are prone to being consumed under a range of new and different conditions, and are providing caffeine in forms that are attractive and accessible to children and adolescents.

From a public health standpoint, does it matter that a cold energy drink might be chugged by young athletes before or after they engage in high stress activity? Does it matter that caffeine in chewing gum is absorbed directly through the oral cavity? How will the availability of caffeine from a much wider range of products affect total intake? Will new sources substitute for traditional ones or be additive? How will children and adolescents be affected?

The regulatory questions are equally challenging. The legal framework for substances like caffeine is complicated, but one thing is clear: Companies adding caffeine to foods and beverages have an obligation to ensure there is a sound scientific basis for concluding that their uses are safe. FDA’s job is to be sure they have met that obligation. To ensure safety, FDA has the authority to place limits on the amount of caffeine that is added to food, if the science warrants such a step. Working within our statutory and public health mandate, we will take whatever actions are needed in the interest of protecting the health of consumers.

But an understanding of the relevant science surrounding caffeine comes first and that’s why FDA turned to the Institute of Medicine (IOM), the arm of the National Academy of Sciences charged with providing the federal government with science-based input on health issues. At FDA’s request, the IOM convened a two-day workshop this past August on the potential health hazards of caffeine consumption. We received valuable scientific input and heard diverse perspectives from a wide range of researchers, clinicians, and stakeholders. Caffeine is a widely studied substance, but we learned there are few simple answers to some of the questions raised by its new uses, and there are gaps in the data on some of the questions we are asking. Our commitment is to incorporate what we learned at the workshop into our ongoing scientific assessment and to consider the regulatory needs and options on that basis.

In the interest of everyone, and drawing on the perspectives of such groups as the American Academy of Pediatrics and the American Medical Association, we think there needs to be a scientifically grounded and common sense approach to the addition of caffeine to the food supply. We applaud the restraint many food companies are exercising as we figure this out, and we will rely on collaboration with the scientific community, consumers, and the food and beverage industry to shape that approach in the context of today’s new uses of caffeine.

Michael R. Taylor is Deputy Commissioner for Foods and Veterinary Medicine, U.S. Food and Drug Administration. For inquiries, email Danielle Schor at [email protected]