Wrigley holds off on caffeinated gum as FDA reviews caffeine

Less than a week after the Food and Drug Administration announced that it would investigate the safety of added caffeine in U.S. food and beverage products, Wrigley North America has decided to put its bid to market a caffeinated gum on hold out of respect for the agency's deliberations, the company's president, Casey Keller announced in a statement issued to the Associated Press.

The move appears to be a bow to FDA Deputy Commissioner Michael R. Taylor's public suggestion last week that "together, we should immediately be looking at what voluntary restraint can be used by industry as FDA gets the right regulatory boundaries and conditions in place."

Explaining the company's decision, Keller said, "after discussions with the FDA, we have a greater appreciation for the FDA's concern about the proliferation of caffeine in the nation's food supply."

Taylor had warned that "some in the food industry are on a dubious and potentially dangerous path," and said the agency was prepared to "establish clear boundaries and conditions on caffeine use" in American food and beverages if the scientific evidence suggested there was potential for harm.

American beverage manufacturers especially had hoped to head off such actions. In March, the American Beverage Assn. urged one of its new members, Monster Beverage Corp., to stop selling its Monster Energy drinks as dietary supplements, a position that would in effect allow the company to skirt existing FDA limits on caffeine as a food additive.

The FDA specifically allowed the addition of caffeine in colas in the 1950s, and allows caffeine in sodas at a level of 0.02%, the equivalent of about 50 milligrams in an 8-ounce can of soda. In March, Monster followed the trade group's advice and announced its products' labels would include caffeine content.

But manufacturers of food products have seen more marketing opportunity than cost in adding caffeine. In a bid to win new and largely youthful markets, makers of jelly beans, waffles, marshmallows and sunflower seeds have added caffeine to their products in recent years.

"The proliferations of these products in the marketplace is very distrurbing to us," said Taylor of the FDA in a Q&A released by the agency. "Existing rules never anticipated the current proliferation of caffeinated products," he added.

Neither did they anticipate, as Taylor put it, that "foods that may be inherently attractive and accessible to children" would be used as "vehicles to deliver the stimulant caffeine."

And kids will be a key focus of the FDA's regulatory deliberations, experts say. "Enforcing age restrictions would be challenging," Taylor said last week. At the same time, it might be easier than trying to set lower caffeine limits on foods marketed to or potentially consumed by kids -- a position that the nation's pediatricians in effect have already discouraged.

The American Academy of Pediatrics recently recommended that caffeine and other stimulants (such as the energy drink ingredients guarana and taurine) be avoided altogether by children and adolescents.

"Why would you give a child a substance we know is addictive, that affects the heart, blood pressure, the whole central nervouse system, to growing people?" asked pediatrician Marcie Bethe Schneider, the lead author of the academy's report on sports and energy drinks released last May.

Some regulators have favored approving lower limits on caffeine in products that might be marketed to or consumed by children. But the developing bodies and brains of kids make them different from small adults, said Schneider: It's not clear whether it's safe to treat them like small adults when it comes to caffeine.

In November, the FDA said in a letter that it had received reports of 18 deaths and more than 150 injuries preliminarily linked to energy drinks and products, and that the agency might turn to outside experts to explore the safety of caffeine consumption by children and other vulnerable groups. That was the first indication that the regulatory agency might review rules covering caffeine as a food additive.

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