Regulation and health claims for functional foods

The information provided below is based on a position paper published this month in the Journal of the American Dietetic Association​ (ADA).

To read our article on ‘Functional foods: What they mean around the world’ click here​.To read our article on 'Types of research needed for functional food claims' click here​.To read our article on ‘FDA still reviewing functional food regulatory requirements’ click here​.

Confusing regulation​

In the US, the nation’s Food and Drug Administration (FDA) does not provide a specific definition or regulatory framework for functional foods. As such, their categorization depends on how a manufacturer chooses to market the products.

Functional foods can be regulated as conventional foods, food additives, dietary supplements, drugs, medical foods, or food for special dietary use – depending on the type of health claims being used on the product labels.

In 2006, FDA organized a public hearing to invite comments on how the agency should regulate these claims. As yet, there is no update. (More information here​.)

There are currently three types of claims that can be used on food and dietary supplement labels to communicate health benefits. These are nutrient content claims, structure/function claims and health claims.

Authorized health claims​

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Health claims can be authorized under the Nutrition Labeling and Education Act (NLEA) of 1990. The claims, which are authorized by FDA, must be backed by substantial clinical efficacy and be based on significant scientific agreement to support the purported benefits.

Currently, health claims that meet the significant scientific agreement standard are allowed for 12 diet–disease relationship categories. (More information here.)

FDA can also authorize health claims under the FDA Modernization Act (FDAMA) of 1997. Such claims are based on current, published authoritative statements from “a scientific body of the United States with official responsibility for public health protection or research directly related to human nutrition”​ such as the National Institutes of Health, the National Academy of Sciences, and the Centers for Disease Control and Prevention.

Currently, one nutrient content claim and five health claims have been approved under the FDAMA. (More information here.)

Qualified health claims​

However, claims authorized via the NLEA or FDAMA processes require rigorous and time consuming evidence, based on rigid standards. FDA recognized the need to allow health claims based on less scientific evidence as long as they do not mislead consumers.

As a result, the agency established interim procedures whereby qualified health claims can be used for conventional foods and supplements. (More information here.)

Qualified health claims provide information on a diet-disease relationship, but must contain qualifying language. ADA explains that the body of data required for a qualified health claim does not meet the significant scientific agreement standard; rather it must demonstrate, based on the totality of information available, that the weight of the scientific evidence supports the proposed claim.

Currently qualified health claims are allowed for six disease categories: cancer, cardiovascular disease, cognitive function, diabetes, hypertension, and neural tube defects. (More information here.)

Consumer understanding​

Despite the different level of health claims and scientific substantiation, there is evidence that consumers remain confused regarding different types of claims made on food labels.

A survey conducted by the International Food Information Council (IFIC) in 2004 found that consumers have difficulty distinguishing among different levels of scientific evidence, especially with language-only claims.

The survey also found that consumers rate the scientific evidence and other attributes of a product containing an unqualified claim similar to those products containing a structure-function claim or a dietary guidance statement. (More information here.)