SENATORS ARE TOLD FDA REFORM IS VITAL

JOYCE BARRETT

WASHINGTON (FNS) -- Reform of the Food and Drug Administration is needed to ensure nationally uniform standards and a science-based regulatory system, a representative of the Grocery Manufacturers of America and the National Food Processors Association recently told a Senate panel.

Al Clausi, a consultant on food research and development, told the Senate Labor and Human Resources Committee April 11 that changes should be made in the FDA food-additive approval process, as well as in the Delaney Clause and on what is permitted in health claims.

Clausi made the industry's case to Capitol Hill a day after nine industry leaders wrote to Sen. James Jeffords (R-Vt.), chairman of the Labor and Human Resouces Committee, about the need for FDA change this year. Specifically, the group said the Delaney Clause should be altered to modify the zero-risk standard so that it is based on a reasonable certainty of no harm. The group also asked for changes to the food-additive approval process and the health-claims approval process.

In his testimony, Clausi said that FDA's delay in making decisions on food-additive petitions for new food ingredients has stifled product development.

"The end result is that there has been a huge backlog of new product approvals, which has denied consumers access to more nutritious and convenient alternatives," he said.

Because it takes up to seven years for a food-additive petition to be approved, Clausi said companies no longer want to submit petitions.

On the Delaney Clause, Clausi said the current standard -- which bars use of additives unless there is a zero carcinogenic risk -- is outdated and unscientific because scientific methodology can detect the most minute risk levels. It should be replaced with a more reasonable level of "no harm or no significant risk," he said.

Clausi also complained about the increased prevalence of state standards on safety and warning labels. The standards are difficult to deal with since most food and FDA-regulated products are marketed and sold nationally.

"When these bills require warnings that are determined [to be] unnecessary by federal agencies distribution is disrupted, consumers are misled and public health is potentially jeopardized," he said. "Consumers would simply not know who to believe."

On labeling, Clausi charged that the FDA's approval process for new health claims are "laborious and terribly slow.

"At a minimum there should be a common-sense time frame for action by FDA on petitions regarding the health benefits or nutrient composition of foods," he said.

Clausi noted that a content claim such as "high in soluble fiber" can only be made on a food after the FDA has developed a daily value amount for a nutrient.