How qualified are health claims for food?

How qualified are health claims for food?
Health claims’ efforts to balance free speech with solid evidence could leave you confused.

In 2003, food makers got the green light to slap “heart healthy” labels on a variety of nuts and foods made with them. Now they can do the same for foods and supplements containing omega-3 fatty acids.

Neither of these claims should come as a surprise. We’ve known about the cardiovascular benefits of eating nuts and fish (a prime source of omega-3 fats) for some time. What’s worrisome are a host of other health claims waiting in the wings for FDA approval.

Such claims are one element of an FDA initiative to give consumers better health information about the foods we eat. Part of the plan, such as forcing food makers to list damaging trans fats on food labels, is definitely a step in the right direction. Allowing qualified health claims could be a step or two back.

Grading the evidence
Once upon a time, companies hoping to make a health claim for a particular food or dietary supplement had to document “significant scientific agreement” in support of it. Then, in 1998, a supplement manufacturer hoping to cash in on a health claim for folic acid sued the FDA. It claimed that requiring that kind of evidence interfered with free speech.

The courts agreed, forcing the FDA to set the bar much lower. As of 2004, there are now two types of health claim — unqualified and qualified. To make matters worse, there are several “grades” of qualified claims.

An unqualified health claim is one that still meets the old standard of “significant scientific agreement.” They include claims that a diet low in cholesterol, total fat, and saturated fat can help prevent heart disease, or that soluble fiber from whole oats can do the same. Qualified health claims, such as the ones for nuts and omega-3 fatty acids, come with a disclaimer about the evidence they’re based upon.

The FDA has proposed using a report card to grade health claims (see above). Unqualified claims would get an “A”. For claims given a “B”, the evidence points in the right direction but isn’t conclusive. For a “C” claim, the evidence is limited and inconclusive. A “D” claim is even worse, with little scientific evidence supporting the claim. The agency is also looking at other ways to convey the certainty — or lack of it — of various claims.

Who needs omega-3s?
Where do foods rich in omega-3 fats fit into this scheme? According to the FDA, it’s a qualified health claim that must be worded along the lines of Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.

The American Heart Association takes a more definitive stance (see AHA recommendations below), especially for people with heart disease or high triglycerides, the body’s main fat-carrying particle.