Claims that Matter: Health Claims with Significant Scientific Agreement and Qualified Health Claims on Food Packaging

by Charles Platkin, PhD

“Granted, sometimes confusion occurs, but the original intention was really to limit manufacturers from making claims that weren’t valid,” says Catherine M. Champagne, Ph.D., R.D., a nutrition professor at Pennington Biomedical Research Center.

But while the food label is supposedly a vehicle to educate consumers to make better choices, unfortunately, “The rules for what may appear on the label [or packaging] are influenced by food industry petitions and responses, court decisions and the philosophy and politics of the party in power,” says Luise Light, M.S., Ed.D., author of What to Eat: The Ten Things You Really Need to Know to Eat Well and Be Healthy (McGraw-Hill, 2006).

Here is a rundown on what you should know about two types of health claims:

Authorized (aka Significant Scientific Agreement) Health Claims

(View a summary of the claims at )

What they mean:
This is the gold standard. Authorized health claims characterize a relationship between a substance (a specific food component or a specific food) and a disease (such as lung cancer or heart disease) or a health-related condition (such as high blood pressure), and are supported by scientific evidence. They are sometimes called unqualified health claims because they meet the “significant scientific agreement” standard and do not require a qualifying statement to explain the state of the science. There are 12 authorized health claims for use in foods.

An authorized health claim must withstand the greatest scientific scrutiny before it is approved, says Lona Sandon, M.Ed., R.D., a spokesperson for the American Dietetic Association.

These claims can also be made as an “authoritative statement” from a scientific body of the U.S. government (e.g., the National Institutes of Health) or the National Academy of Sciences. There are currently two claims based on authoritative statements: one relating whole-grain foods to a decreased risk of heart disease and certain cancers and the other involving potassium levels and high blood pressure and stroke.

What makes something an authorized health claim?
The standard of scientific validity for an authorized health claim includes two components. No. 1, the totality of the publicly available evidence must support the substance/disease relationship that is the subject of the claim, and No. 2, there must be significant scientific agreement among qualified experts that the relationship is valid.

Why they matter:
Of all the claims, these might help us the most, especially if we are trying to live healthy lives. “The public deserves health information based on fact, not fiction or opinion. Health claims are designed to protect the consumer from false or misleading marketing information about food,” says Sandon.

How can you know it’s an authorized health claim?
The statement will include words such as “may” or “might” reduce risk but does not specify a degree of risk. The statement must also imply that disease is based on several factors, not just one nutrient alone, says Sandon.

Examples: “Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors,” and, “Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease.”

How can a claim be misleading or confusing?
Often people think a product may prevent certain diseases, but we need to remember that disease conditions are often complex, and a multitude of factors may be involved, says Champagne. To some, health claims may come across as a guarantee of health. They may think that by choosing a specific food, they will not get heart disease. It is not a guarantee, says Sandon.

What’s the most important, relevant health claim — basically the one you should know?
That fruits, vegetables and whole-grain products containing fiber, particularly soluble fiber, lower the risk of coronary heart disease.

Example of a model claim according to the FDA: “Diets low in saturated fat and cholesterol and rich in fruits, vegetables and grain products that contain some types of dietary fiber, particularly soluble fiber, may reduce the risk of heart disease, a disease associated with many factors.”

Qualified Health Claims

What they mean:
Qualified health claims are supported by scientific evidence, but do not meet the significant scientific agreement standard required for the FDA to approve an authoritative claim. As a result, to ensure that they are not false or misleading to consumers, claims must be accompanied by disclaimers or other qualifying language to accurately communicate the level of scientific evidence supporting them.

Why they matter:
If you’re trying to prevent or treat a specific disease, they help create awareness and help the consumer cut through other sources of information, says Lauren Swann, M.S., R.D., L.D.N., a food consultant with Concept Nutrition, in Bensalem, Pa.

How can you recognize a “qualified health claim” on a food label?
Look for a qualifying statement, such as “supportive but not conclusive,” or “very limited and preliminary scientific research,” or “scientific evidence suggests but does not prove” or “limited scientific evidence.”

Example: Walnuts and coronary heart disease: “Supportive but not conclusive research shows that eating 1.5 ounces per day of walnuts, as part of a low saturated fat and low cholesterol diet and not resulting in increased caloric intake, may reduce the risk of coronary heart disease. See nutrition information for fat [and calorie] content.”

How can the claims be misleading or confusing?
“It is confusing to the consumer to add information to a label that clearly states not all health and research professionals agree on the statement. The consumer is then left not knowing who or what to believe,” says Sandon.

What’s the most important, relevant qualified health claim?
“The one relating to omega-3 fatty acids and reduced risk of coronary heart disease,” says Champagne.

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