F.D.A. threatens to pull the plug on products with added caffeine
May 23, 2013
by Keith Nunes
Many food products promoting the func-tional benefit of a boost of energy have three things in common: Catchy names like Perky Jerky, Wired Waffles, Cracker Jack’d and Alert Energy; added caffeine; and the attention of the Food and Drug Administration. The last, and most recent, similarity may pose a challenge for food and beverage manufacturers interested in participating in the market for energy products.
The growth and profitability of the energy beverage category has not been lost on food manufacturers. In an effort to capture a share of the category, many companies have introduced functional products that have an energy benefit. On April 29 the Wm. Wrigley Jr. Co., a business unit of Mars, Inc., introduced Alert Energy, a gum featuring 40 mg of added caffeine. Shortly after the introduction, the F.D.A. announced it would be taking a closer look at how new sources of caffeine — which include foods and beverages — may affect children’s health.
“The only time that F.D.A. explicitly approved the added use of caffeine in a food was for cola, and that was in the 1950s,” said Michael R. Taylor, the F.D.A.’s deputy commissioner for foods and veterinary medicine. “Today, the environment has changed. Children and adolescents may be exposed to caffeine beyond these foods in which caffeine is naturally found and beyond anything F.D.A. envisioned when it made the determination regarding caffeine in cola.
“For that reason, F.D.A. 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.”
Shortly after the F.D.A.’s announcement, Wrigley said it was halting the production and marketing of Alert Energy.
“When Wrigley laun-ched Alert Energy Caffeine Gum, we took great strides to ensure that the product was formulated, distributed and marketed in a safe and responsible way to consumers 25 years old and over,” said Casey Keller, president of Wrigley North America. “We exceeded all regulatory requirements on labeling and disclosure because we believe consumers should be informed about the amount of caffeine they are consuming in their food and beverage products so they can make smart choices.
“After discussions with the F.D.A., we have a greater appreciation for its concern about the proliferation of caffeine in the nation’s food supply. There is a need for changes in the regulatory framework to better guide the consumers and the industry about the appropriate level and use of caffeinated products. In an effort to support this process, and out of respect for the F.D.A., we have paused the production, sales and marketing of Alert. This will give the F.D.A. time to develop a new regulatory framework for the addition of caffeine to food and drinks.”
The F.D.A. has said 400 mg of caffeine per day, which is the equivalent of four cups to five cups of coffee, is an amount not generally associated with dangerous negative effects. The agency has not established a recommended safe amount for children.
Mr. Taylor said the American Academy of Pediatrics discourages the consumption of caffeine and other stimulants by children and adolescents.
“We need to continue to look at what are acceptable levels,” Mr. Taylor said. “We’re particularly concerned about children and adolescents and the responsibility F.D.A. and the food industry have to protect public health and respect social norms that suggest we shouldn’t be marketing stimulants, such as caffeine, to our children.”
A letter sent to the F.D.A. on March 19 and signed by 18 doctors who represent a variety of disciplines within the medical establishment urged the agency to apply existing Generally Recognized As Safe standards for soft drinks, energy drinks and other beverages in which caffeine is an additive.
“We conclude that there is neither sufficient evidence of safety nor a consensus of scientific opinion to conclude that the high levels of added caffeine in energy drinks are safe under the conditions of their intended use, as required by the F.D.A.’s Generally Recognized As Safe (GRAS) standards for food additives,” the letter said. “To the contrary, the best available scientific evidence demonstrates a robust correlation between the caffeine levels in energy drinks and adverse health and safety consequences, particularly among children, adolescents and young adults.”
The letter from the doctors pointed to a 2010 F.D.A. study that showed 65% of energy drink users are of the ages 13 to 35. According to a study published in the March 2011 issue of Pediatrics, 30% to 50% of energy drinks are consumed by adolescents and young adults.
Mr. Taylor called the development and enforcement of age restrictions impractical and added, “For me, the more fundamental questions are whether it is appropriate to use foods that may be inherently attractive and accessible to children as the vehicles to deliver the stimulant caffeine, and whether we should place limits on the amount of caffeine in certain products.”
There is precedent for the F.D.A. to take action regarding the addition of caffeine to food and beverage products. In 2010, the agency brought about the withdrawal of caffeinated alcoholic beverages, because studies indicated the consumption of caffeine and alcohol may lead to dangerous situations due to the fact caffeine may mask the sensation of intoxication.
Mr. Taylor did not rule out the F.D.A. taking some sort of regulatory action.
“If necessary, and if the science indicates that it is warranted, we are prepared to go through the regulatory process to establish clear boundaries and conditions on caffeine use,” he said. “We are also prepared to consider enforcement action against individual products as appropriate.
“However, we hope this can be a turning point for all to prevent the irresponsible addition of caffeine to food and beverages. Together, we should be immediately looking at what voluntary restraint can be used by industry as F.D.A. gets the right regulatory boundaries and conditions in place. I’m hopeful that industry will step up.”
Roger Sullivan, a principal with Wired Wyatt’s L.L.C., Marysville, Wash., the manufacturer of Wired Waffles and Wired Wyatt’s Caffeinated Maple Syrup, recommends consumer education and labeling initiatives to address some of the F.D.A.’s concerns.
“In order to address this properly, consumers need to be educated and informed of how much caffeine they are indeed consuming,” he said. “At the heart of these issues are the labeling practices of manufacturers. A look at the side of most caffeinated products or energy drinks and the consumer will not find the exact amount of caffeine in the product. While they may see the total amount of ‘proprietary blend,’ they cannot see how much of that blend is actually made up of caffeine. Most consumers also do not really understand how much caffeine is in a 16-oz cup of their favorite brew.
“At Wired Wyatt’s our Wired Waffles and our Caffeinated Maple Syrup have the quantity of caffeine on the label clearly marked. As a pioneer in the caffeinated snack industry we advocate this open labeling. The consumers have a right to know exactly what they are consuming.
“We also take a stand against these products being so readily available to children. If a product is being marketed as an energy supplement then steps should be taken to assure these are not ending up in the hands of children. Many of these products are intended for athletes and all are intended to be consumed by responsible adults.”