Earlier this week we posted about the halo effect of health claims, enticing consumers to believe a food may be more nutritious than it really is. Today we will take a closer look at the different types of health claims, their history, and the cooperation between the food industry and the FDA to allow more claims on packaged foods.

Background

The Nutrition Labeling and Education Act of 1990 (NLEA) was designed to give consumers nutrition information about the foods they eat. This includes the ingredient list and nutrition information panel we are all familiar with. Some players in the food industry were not very happy to disclose so much information, especially levels of “bad” nutrients. As a means to sweeten the deal, they demanded (through vigorous lobbying), and received permission to provide “additional health information” to consumers. In more formal terms, the FDA was given the power to allow manufacturers to place “health claims” on foods. Note: health claims cover dietary supplements as well, but we’ll focus on food in this post.

What is a health claim?

The FDA defines a health claim as any information on the food package that expressly or by implication claims that a relationship exists between the presence or level of a substance in the food and a disease or health-related condition. A health claims can talk about disease risk reduction, not about diagnosis, cure, or treatment of a disease. Health claims are required to be reviewed and evaluated by FDA prior to use. Health claims are directed to the general population or subgroups (e.g., the elderly, pregnant women).

There are two types of health claims: authorized and qualified.

Authorized health claims (sometimes called Full or SSA health claims) are ones that are based on significant scientific agreement (SSA). This means that there need to be many independent research results, with very significant results, agreed upon by large majority of the scientific community before a claim becomes authorized. An example of an authorized health claim, is: “Three grams of soluble fiber from oatmeal daily in a diet low in saturated fat and cholesterol may reduce the risk of heart disease. This cereal has 2 grams per serving.”

Qualified health claims are scientifically weaker than authorized health claims, and therefore are required to appear with a disclaimer (a qualifier) so as not to mislead consumers. Many consumers would beg to differ, but we’ll get to that in a minute.

The first appearance of qualified health claims was in the late nineties in dietary supplements, as a result of a legal battle between the FDA and their manufacturers. In 2003, through the Consumer Health Information for Better Nutrition Initiative, qualified health claims were allowed on foods as well. A petition process was put in place, and manufacturers can now file for more claims.

There are 3 levels of qualified health claims:

1. Strongest: “Although there is scientific evidence supporting the claim, the evidence is not conclusive.”
2. Medium: “Some scientific evidence suggests …However, FDA has determined that this evidence is limited and not conclusive.”
3. Weakest: “Very limited and preliminary scientific research suggests…. FDA concludes that there is little scientific evidence supporting this claim.”

Here’s an example of a weak claim. In 2006, a petition was filed for a “Corn Oil / Reduced Risk of Heart Disease” claim by the makers of Mazola. The petition asked for permission to claim:

“Scientific evidence establishes that including corn oil-containing foods in your diet may reduce your risk of heart disease. To achieve such benefits, include slightly less than 1 tablespoon (12 grams) of corn oil per day in your diet while not increasing calories, saturated fat or cholesterol. One serving of this product contains x grams of corn oil. Although there is scientific evidence supporting the claim, the evidence is not conclusive.”

They asked for the strongest claim. The FDA examined the research behind the claim, and earlier this year allowed the following weakest claim (obviously much more qualified than the original wording):

“Very limited and preliminary scientific evidence suggests that eating about 1 tablespoon (16 grams) of corn oil daily may reduce the risk of heart disease due to the unsaturated fat content in corn oil. FDA concludes that there is little scientific evidence supporting this claim. To achieve this possible benefit, corn oil is to replace a similar amount of saturated fat and not increase the total number of calories you eat in a day. One serving of this product contains [x] grams of corn oil.”

In either case, that’s a lot of reading for a busy dad trying to finish up the grocery shopping on a hectic weekday evening. That’s why the claim will be presented in such a way to get the “right message” through. Perhaps:

“Very limited and preliminary scientific evidence suggests that

eating about 1 tablespoon (16 grams) of corn oil daily may reduce the risk of heart disease

due to the unsaturated fat content in corn oil. FDA concludes that there is little scientific evidence supporting this claim. To achieve this possible benefit, corn oil is to replace a similar amount of saturated fat and not increase the total number of calories you eat in a day. One serving of this product contains [x] grams of corn oil.”

Some nutrition professionals say that qualified health claims have turned the FDA into a pawn in the hands of the food industry, allowing ridiculous claims to confuse consumers into buying the wrong kinds of foods.

Additional Types of Claims

Nutrition Content Claims (NCC) on a food products characterize the level of a nutrient in the food (e.g., “low fat,” “high in oat bran,” or “contains 100 calories”). These are a means to translate numbers into words to better convey the level of a specific nutrient in a food product. Manufacturers often present NCCs, as there are simple straightforward rules regarding their use.

Structure/Function Claims relate to dietary supplements. The Dietary Supplement Health and Education Act of 1994 (DSHEA) states that a dietary supplement may bear certain statements on its label or in its labeling if the claim meets certain requirements

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