On the heels of Wrigley’s new promotion of its new caffeinated gum called Alert Energy, FDA has announced that it will be investigating the safety of caffeine in food products. The use of caffeine in food products has been a hot topic in the media over the past few weeks. As we previously discussed, there has been a growing push by health experts for regulatory changes related to the use of caffeine in foods and beverages. Meanwhile, companies like Monster Beverage have been making changes related to the marketing and labeling of their caffeinated products.
In its recent announcement, FDA stated that it has concerns regarding the presence of caffeine in a “range of new products, including ones that may be attractive and readily to children and adolescents.” FDA provides examples of new food products with added caffeine, including chewing gum, jelly beans, marshmallows, sunflower seeds, and waffles. It noted that the “proliferation of these products in the marketplace is very disturbing to us.” However, when it comes to taking action on this issue, FDA has not made a clear statement as to how it will proceed. Instead it has stated that it “need[s] to better understand caffeine consumption and use patterns and determine what is a safe level for totally consumption of caffeine” and that the agency “need[s] to address the types of products that are appropriate for the addition of caffeine.” FDA has indicated that it is meeting with food companies to discuss uses of caffeine in food products and the appropriateness of those uses.
FDA notes that it has deemed 400 milligrams per day of caffeine (or approximately four or five cups of coffee) as generally safe for consumption by healthy adults. Substances that are generally recognized as safe or “GRAS” (further explained here) are those that FDA deems generally recognized among qualified experts as having been adequately shown to be safe under the conditions of its intended use. FDA has not set a safe daily level of caffeine consumption for children. Under its current regulatory framework, FDA states that manufacturers can add caffeine to food products as long as the manufacturer determines that the addition meets relevant safety standards and the caffeine is listed on the product label’s ingredient list. Notably, FDA stated in its recent announcement that “[w]hile various uses may meet federal food safety standards, the only time FDA explicitly approved adding caffeine was for colas in the 1950s. Existing rules never anticipated the current proliferation of caffeinated products.”
While it is not clear at this time exactly what FDA intends to do about the growing number of caffeinated products on the market, FDA has stated that it may consider enforcement action against individual products as it deems necessary and appropriate. As the food and beverage industry rapidly grows and expands the novel types and categories of products it offers to consumers, FDA regulation has clearly come up short in keeping pace. Because this caffeine issue has garnered national attention, the food and beverage industry will have to be prepared to quickly adapt to (or potentially fight) any new regulation or policy FDA attempts to implement.
Fuerst, Ittleman, David & Joseph, PL will be closely monitoring FDA’s investigation and actions related to the use of caffeine in food products. For more information, please contact us via e-mail at firstname.lastname@example.org or via telephone at (305) 350-5690.