FDA advisors recommend more study of food dyes


Although there is no clear indication that artificial food dyes cause hyperactivity or other behavioral problems in children, enough uncertainty exists to justify more research, an advisory panel told the Food and Drug Administration on Thursday.

The panel of medical and environmental experts narrowly voted against recommending that more information about dyes be added to food labels. But panelists acknowledged the chemicals can cause problems for some children, including those who already have hyperactivity disorders.

The FDA had asked the panel whether existing research supported the agency’s conclusion that there was no proof food coloring causes hyperactivity among children in the general population.


Critics said the FDA asked the wrong question.

“The question they should have asked is, ‘Is there proof the dyes are safe?’ ” said Michael Jacobson of the Center for Science in the Public Interest, a public advocacy group that petitioned the FDA to ban the dyes.

Examples of foods with artificial coloring include Jell-O, Skittles, M&M’s, Mountain Dew and Fruit Loops, the center said.

“I’m skeptical that FDA will take any action,” Jacobson said after the advisory panel acted. “It’s probably settled for some number of years.”

The FDA is not required to follow the advice of its advisory panels, but it usually does so.

The panelists, meeting in suburban Washington, wrestled with murky data, much of it old, and with the difficulty of gauging the accuracy of research that tried to measure sometimes subtle changes in children’s behavior based on observations of parents and other adults.

“It’s not like measuring blood pressure,” said panelist Lisa Lefferts, an environmental health consultant.


Still, she said, even studies that fall short of conclusive proof don’t exonerate the chemicals. “There’s something going on,” Lefferts said. “Parents know that. But it’s hard to measure.”

Lefferts supported bolstering food labels, which failed on an 8-6 vote.

All but three of the 14 panelists agreed that a causal relationship between dyes and hyperactivity has not been established. All but one voted to recommend more studies on the safety of color additives.

The panel’s discussion frequently turned on whether the standard for action should be scientific certitude, which is clearly lacking, or enough evidence to prompt public health warnings.

Panelist Charles Voorhees, a professor of pediatrics at the University of Cincinnati, said he was struck by the persistent but inconclusive evidence of possible harm.

“After 35 years, [the hypothesis] won’t quite go away,” Voorhees said. “It’s within the latitude of the FDA to express to consumers that there may be a concern.”

Other panelists objected to the suggestion that a warning label could specify possible problems for some children.


“That’s not how a mother or father reads it. They read it as ‘my child,’ ” said A. Wesley Burks, a professor at Duke University Medical Center. “It’s scary more than it’s educational.”

The petition from the Center for Science in the Public Interest to remove the dyes, filed in June 2008, asked the FDA to ban eight of nine approved synthetic food colorings and to put warning labels on food containing the dyes until they could be removed from the market. Dozens of other FDA-approved dyes, made from natural ingredients such as plants, animals and minerals, were not included in the center’s request.

The FDA did not ask its advisory panel about banning the dyes.