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FDA Seeks Input On Label Clarity

Steve Taormina, Steve Taormina

April 24, 2008

3 Min Read
FDA Seeks Input On Label Clarity

The U.S. Food and Drug Administration has requested emergency funding from the Office of Management and Budget to conduct a survey of 7,000 people to gather empirical data regarding consumers' understanding of labeling on conventional foods and dietary supplements. If approved, the FDA will mail 1,000 questionnaires, conduct 2,000 telephone surveys and 4,000 surveys via the Internet.

The information gathered "can be used to test consumer comprehension and behavioral impact of various label statements and formats," states FDA's Docket No. 02N-0063, published Feb. 21. Claims, disclaimers, warnings, caution statements and notice statements—both existing and proposed by industry and consumers—are all proposed subjects of the study.

Industry leaders question the agency's motives. "We've got to wonder exactly what FDA's agenda is here," said Marc Ullman, FDA and Federal Trade Commission expert and partner at the Ullman, Shapiro, Ullman law firm in New York. "What do they need to understand? What are they looking at?"

To ensure a representative sample, FDA says it will randomly choose individual consumers to represent specified populations. "FDA's general selection method will use stratification, with random sampling within the strata, to achieve representativeness for both overall populations and sensitive subpopulations, such as at-risk individuals or user segments," according to the docket.

"Artfully designed surveys can be put together to come up with almost any result," Ullman said. "So there's some concern, I think, given the track record the agency has in dealing with the supplement industry."

According to the agency, FDA will use the survey information to help its Center for Food Safety and Applied Nutrition make decisions and policies that affect conventional foods and dietary supplements labeling. The docket does not mention anything about bioengineering or genetically modified organisms.

The docket does state, however, that "it is often necessary to test actual or proposed labeling statements in realistic situations with typical consumers to determine what these label statements are communicating to consumers." To achieve this, FDA wrote that one survey methodology would be "shopping mall intercept," although this type of survey is not included in the docket's "Burden of Information Collection" section. An FDA spokeswoman said that it "probably should have" been included.

"I'd like to know a great deal more about the focus of the labeling concern," said Jeffrey Reinhardt, founder and director of People for Pure Foods, a national consumer education organization based in Grand Terrace, Calif. "I would question whether 7,000 surveys is enough," he said.

Ullman added his other concerns: "We want to know if there's going to be transparency in the survey design. We want to know if there's going to be transparency in evaluating the data. We want to know if FDA has checked all current available sources to see if this raw data is out there already, and I submit to you that a lot of it already may be."

He pointed to the Dietary Supplement Education Alliance as one source of information (see

"At a time when the agency is saying [it] really [doesn't] have enough money in the budget to take effective enforcement action against products that are flagrantly, illegally in the marketplace," Ullman said, "should conducting surveys like this really be an agency priority?"

The public comment period was scheduled to close March 25.

Steve Taormina is a freelance writer based in Vancouver, British Columbia.

Natural Foods Merchandiser volume XXIII/number 4/p. 15

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