Natural Foods Merchandiser

FDA Permits Qualified Health Claims on Nut Labels

For the first time, the U.S. Food and Drug Administration has recognized a qualified health claim made by a conventional food.

In a surprise move in July the FDA granted permission for peanuts, almonds, hazelnuts, pecans, pistachios and walnuts to carry a label touting their heart-healthy effects. "Scientific evidence suggests but does not prove that eating 1.5 ounces of most nuts, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease," the label will read, along with an advisory to consult the nutrition label for further information. About a third of a cup, or a small handful, constitutes 1.5 ounces of most nuts.

Studies performed on each of these types of nuts have shown that people who eat 1 to 2 ounces of them five or more times per week can lower their risk of heart disease by 20 percent or more.

Later in July, the FDA also approved a "dietary guidance" label for fruits and vegetables that it devised in cooperation with the National Cancer Institute. Because they don't pertain to specific nutrients, the labels are not considered to assert health claims. The labels will inform consumers that "Diets rich in fruits and vegetables may reduce the risk of some types of cancer and other chronic diseases."

Previously, the FDA had said it would begin on Sept. 1 to accept applications from food manufacturers seeking to make qualified claims.

But FDA Commissioner Mark McClellan has made it clear that providing Americans with better health information is a top priority. "Helping consumers improve their nutrition is an increasingly urgent part of our mission at FDA," he said in a July 1 speech at the Harvard School of Public Health.

On July 10, the FDA announced it would institute a "grading" system for health claims, giving an A rating to unqualified, or scientifically proven claims, and B, C or D ratings to "qualified" claims with lesser levels of scientific rigor behind their assertions. The nuts' claim is considered qualified.

Until now the FDA has only permitted A-level claims on packaging, such as the one stating that oatmeal's fiber is heart-healthy. "There are only a few claims allowed on product labels about health consequences, even though we know that dietary choices have enormous health consequences," McClellan said in his July 1 speech.

"Many of the health claims about such dietary choices as abundant consumption of fruits and vegetables, and substitution in favor of unsaturated fats ... are in the category of considerable good evidence but not definitive evidence," McClellan said at Harvard, adding, "I think many Americans would appreciate being more aware of it with proper qualifications."

McClellan says grading health claims will help consumers sift through the glut of information about various foods.

Some groups, though, oppose the change in labeling. "It has the potential to be misleading because it's information underload," said Lawrence Lindner, executive editor of the Tufts University Health & Nutrition Letter. "It's impossible to explain how to fit one single food in the context of a total diet on a food label."

"Many, many people are not in a position to add calories to their diet."
Lindner is also concerned that people will misinterpret the information and add the food to their diets without making caloric adjustments. "It's easy for people to assume, 'OK, I'll just add nuts to my diet. Many, many people are not in a position to add calories to their diet."

Representatives of the various nut industries maintain, however, that weight-conscious consumers should substitute nuts for saturated fats they would normally consume. Researchers at Purdue University found that people who snacked on peanuts made spontaneous adjustments in the rest of their diet and didn't add any extra calories by eating the peanuts.

Lindner's not convinced. "What's done in a controlled study is very different from what happens out there in the real world. If you're sitting with a can of nuts in front of the TV, it's not so easy to control your portion size." But, says Peanut Institute spokeswoman Kristen Ciuba, portion control is possible. "The industry has been pretty good to respond in getting the [1-ounce] portion-controlled packets out."

Lindner thinks Americans need a paradigm shift in their diet and would like to see consumers educated through a more comprehensive approach than what food labels can offer. "Our single biggest [dietary] problem in this country is overnutrition. To have food labels saying, 'Eat me, I'm healthy,'" is counterproductive, he said.

But nuts are likely to be the first of many conventional foods approved for labels promoting their health benefits. The FDA is expected to consider claims that eating salmon and other foods rich in omega-3 fatty acids reduces the risk of heart disease; and that products made with vegetable oil rather than solid or trans fats are more heart-healthy. Other, more controversial claims that may also be considered include lycopene's effect on prostate cancer and fiber's effect on colon cancer.

Natural Foods Merchandiser volume XXIV/number 9/p. 14

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