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FDA issues guidance on labeling claims

By staff reporter , 12-Feb-2007

The US Food and Drug Administration (FDA) has issued a guidance letter to remind food and beverage manufacturers of the different types of labeling claims available for use, and to clarify the agency's regulation of these.

The claims that currently appear on conventional food labels include nutrient content claims, dietary guidance, structure/function claims and health claims. Published last month on FDA's website, the Letter Regarding Food Labeling is designed to provide an indication of the regulatory body's thinking on the topic. It does not exclude alternative approaches, if these are approved in the necessary manner, said FDA. According to the agency, nutrient content claims describe the level of a nutrient in a food using terms such as free, high and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced and lite. Nutrient content claims, which help ensure the consistent and meaningful use of such terms, usually only apply to those nutrients or substances that have an established Daily Value (DV). FDA defines the term Healthy as an implied nutrient content claim that characterizes a food that has 'healthy' levels of total fat, saturated fat, cholesterol, other nutrients and sodium. FDA determines which nutrient content claims may be used on a label by two means: either the agency issues a regulation authorizing a claim after reviewing scientific evidence submitted in a nutrient content claim petition; or FDA prohibits or modifies a nutrient content claim within 120 days after it has received a nutrient content claim notification. Dietary guidance statements focus on general dietary patterns, practices and recommendations that promote health. Typically 'dietary guidance' statements refer to a category of foods and not a specific substance or ingredient. An example of a dietary guidance statement is: "Carrots are good for your health." Dietary guidance statements can be made without FDA review or authorization before use but the statements must be truthful and non-misleading. Health claims describe the relationship between a food or ingredient and a disease or health-related condition. These statements are limited to claims about disease risk reduction, and cannot be claims about the cure. An example of a health claim is "Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors." FDA regulates health claims in one of three ways: it issues a regulation authorizing a health claim that meets the significant scientific agreement standard set forth in the 1990 Nutrition Labeling and Education Act; it prohibits or modifies a health claim within 120 days after it has received a health claim notification; or it issues a letter of enforcement discretion for qualified health claims pursuant to the 2003 FDA Consumer Health Information for Better Nutrition Initiative. Structure/function claims describe the role of substances intended to affect the normal structure or function in humans, for example, "calcium builds strong bones." In addition, this type of claim may characterize the means by which substances act to maintain such structure or function, for example, "fiber maintains bowel regularity", or they may describe general well-being from consumption of a nutrient or dietary ingredient. They may also describe a benefit related to a nutrient deficiency disease (like Vitamin C and scurvy), as long as the statement also tells how widespread such disease is in the US. Such claims, which may not link the relationship to a disease or health-related condition, can be made without FDA review or authorization before use, but they must be truthful and not misleading and the claims must derive from the nutritional value of the product, said the agency. "Because accurate food labeling information can assist consumers in making healthy nutritional choices, FDA recommends that manufacturers and distributors continue to include appropriate claims on their food products and that they ensure that these claims are consistent with FDA's current laws and regulations," wrote the agency. "In addition, all manufacturers and distributors are reminded to review your Internet sites and to make sure that the information presented on those sites is also consistent with FDA's current laws and regulations," it added. To view the Letter Regarding Food Labeling click here .

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