News & Insights  |  Media Mentions

Related Professionals

Practice Areas


Patricia O'Connell
Senior Communications Manager

Sonali Gunawardhana Discusses FDA Review of Added Caffeine in Foods, Drinks

Food Chemical News
May 13, 2013

Sonali P. Gunawardhana, an attorney in Wiley Rein’s Food & Drug Law Practice, was interviewed by Food Chemical News for an article about the U.S. Food and Drug Administration’s (FDA) review of caffeine added to some foods and beverages that don’t naturally contain it.

Following the Wrigley Company’s April 29 launch of a new caffeinated chewing gum, the FDA said it is taking a “fresh look” at the potential health impact of “new and easy sources of caffeine” on children and other vulnerable populations.

The FDA’s examination of caffeinated products won’t necessarily lead to imminent regulatory action, said Ms. Gunawardhana, who served as regulatory counsel in the FDA’s Center for Food Safety and Applied Nutrition before joining Wiley Rein last year.

“The FDA always ‘looks into things,’” but that doesn’t always lead to regulatory enforcement, she told Food Chemical News in the May 3 article. The agency typically gives manufacturers the opportunity to make voluntary changes, Ms. Gunawardhana said.

Indeed, Wrigley announced on May 8 that it had decided to pause the production, marketing and sales of the caffeine gum, according to a statement on the FDA website.

It is difficult to determine how much caffeine is too much, Ms. Gunawardhana said. Even if manufacturers try to stay within the limits established by the FDA for beverages like colas, the companies need to understand that the overall amount of caffeine consumed by one person in a single day varies widely, she said.

“The FDA has had a hard time quantifying exactly what is too much and there are so many other possible issues with someone’s general health to directly make a correlation,” Ms. Gunawardhana said. “Thus, the FDA has always pushed that the amounts should be part of the products’ labeling so the consumer can make an educated decision.”

Some companies have begun to voluntarily disclose more about the amount of caffeine in their products, she said. For example, Monster Energy last year began labeling its drinks with the “Nutrition Facts” panel—required by the FDA for conventional foods and drinks—rather than the “Supplements Facts” panel required for dietary supplements. The Nutrition Facts panel provides more information about caffeine content.