Navigating the Health Claims Landscape

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By Kimberly J. Decker, Contributing Editor

Health claims have made headlines lately—and not always for the right reasons. First there was last summer’s Federal Trade Commission action against the Kellogg Company, resulting in a settlement barring the manufacturer from making cognitive health claims for its Frosted Mini-Wheats cereal. Later, the Center for Science in the Public Interest (CSPI) petitioned FDA to prohibit qualified health and structure/function claims for foods. This March, FDA sent letters to 17 manufacturers, including Dreyer’s, Nestlé and POM Wonderful, warning them that labeling on 22 of their products violated the Federal Food, Drug, and Cosmetic Act. And barely two months later, the Institutes of Medicine (IOM) issued a report calling into question the scientific rigor with which FDA evaluates biomarker evidence in health-claim proposals.

Surely, this isn’t the press that FDA, manufacturers or Congress had in mind when the Nutrition Labeling and Education Act of 1990 (NLEA) included provisions for food companies to provide “additional health information” to consumers by way of health claims on packages. But, since the act’s passage, health claims have been both a blessing and a curse, giving manufacturers an opportunity to celebrate their products’ health-giving potential, and making them a popular target for skeptics. When navigating this regulatory and public-relations minefield, it’s best to arm yourself with a clear understanding of the laws, as well as a healthy dose of discretion.

Politics and sausage

“Manufacturers develop products with the intent of fulfilling a need that they believe the public has, and that need covers a lot of things—certainly taste, availability and pricing, but also certainly nutrition,” says Allan I. Zackler, Zackler & Associates, Oakland, CA. An attorney with more than three decades’ experience in consumer products/food regulatory and marketing law, he’s seen nutrition trends and regulatory moods come and go. In his view, the pendulum analogy is an apt fit.

“There really have been swings from a lot of regulation to less,” Zackler says. “When problems come up, there’ll be more regulation, sometimes related to the administration in office. Other times, manufacturers themselves will seek to come up with something that’s acceptable to consumers and fulfills their needs; they’ll start pushing the envelope, and it gets pushed back by groups such as CSPI. A regulatory process then comes into play.”

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