Misunderstanding of Front-Of-Package Nutrition Information on US Food Products.

Front-of-package nutrition symbols (FOPs) are presumably readily noticeable and require minimal prior nutrition knowledge to use. Although there is evidence to support this notion, few studies have focused on Facts Up Front type symbols which are used in the US. Participants with varying levels of prior knowledge were asked to view two products and decide which was more healthful. FOPs on packages were manipulated so that one product was more healthful, allowing us to assess accuracy. Attention to nutrition information was assessed via eye tracking to determine what if any FOP information was used to make their decisions. Results showed that accuracy was below chance on half of the comparisons despite consulting FOPs. Negative correlations between attention to calories, fat, and sodium and accuracy indicated that consumers over-relied on these nutrients. Although relatively little attention was allocated to fiber and sugar, associations between attention and accuracy were positive. Attention to vitamin D showed no association to accuracy, indicating confusion surrounding what constitutes a meaningful change across products. Greater nutrition knowledge was associated with greater accuracy, even when less attention was paid. Individuals, particularly those with less knowledge, are misled by calorie, sodium, and fat information on FOPs.

Relationships among food label use, motivation, and dietary quality.

Nutrition information on packaged foods supplies information that aids consumers in meeting the recommendations put forth in the US Dietary Guidelines for Americans such as reducing intake of solid fats and added sugars. It is important to understand how food label use is related to dietary intake. However, prior work is based only on self-reported use of food labels, making it unclear if subjective assessments are biased toward motivational influences. We assessed food label use using both self-reported and objective measures, the stage of change, and dietary quality in a sample of 392 stratified by income. Self-reported food label use was assessed using a questionnaire. Objective use was assessed using a mock shopping task in which participants viewed food labels and decided which foods to purchase. Eye movements were monitored to assess attention to nutrition information on the food labels. Individuals paid attention to nutrition information when selecting foods to buy. Self-reported and objective measures of label use showed some overlap with each other (r=0.29, p<0.001), and both predicted dietary quality (p<0.001 for both). The stage of change diminished the predictive power of subjective (p<0.09), but not objective (p<0.01), food label use. These data show both self-reported and objective measures of food label use are positively associated with dietary quality. However, self-reported measures appear to capture a greater motivational component of food label use than do more objective measures.

Considerations on an approach for establishing a framework for bioactive food components.

Bioactive food components have shown potential health benefits for more than a decade. Currently there are no recommended levels of intake [i.e., Dietary Reference Intakes (DRIs)] as there are for nutrients and fiber. DRIs for essential nutrients were based on requirements for each specific nutrient to maintain normal physiologic or biochemical function and to prevent signs of deficiency and adverse clinical effects. They were later expanded to include criteria for reducing the risk of chronic degenerative diseases for some nutrients. There are many challenges for establishing recommendations for intakes of nonessential food components. Although some nonessential food components have shown health benefits and are safe, validated biomarkers of disease risk reduction are lacking for many. Biomarkers of intake (exposure) are limited in number, especially because the bioactive compounds responsible for beneficial effects have not yet been identified or are unknown. Furthermore, given this lack of characterization of composition in a variety of foods, it is difficult to ascertain intakes of nonessential food components, especially with the use of food-frequency questionnaires designed for estimating intakes of nutrients. Various intermediary markers that may predict disease outcome have been used as functional criteria in the DRI process. However, few validated surrogate endpoints of chronic disease risk exist. Nonvalidated intermediary biomarkers of risk may possibly predict clinical outcomes, but more research is needed to confirm the associations between cause and effect. One criterion for establishing acceptable intermediary outcome indicators may be the maintenance of normal physiologic function throughout adulthood, which presumably would lead to reduced chronic disease risk. Multiple biomarkers of outcomes that demonstrate the same health benefit may also be helpful. It would be beneficial to continue to refine the process of setting DRIs by convening a workshop on establishing a framework for nonessential food components that would take into consideration intermediary biomarkers indicative of optimal health.

Launching a new food product or dietary supplement in the United States: industrial, regulatory, and nutritional considerations.

Launching a new food/dietary supplement into the US market can be a confusing process to those unfamiliar with the food industry. Industry capability and product specifications are initial determinants of whether a candidate product can be manufactured in a reproducible manner and whether pilot production can be brought up to the market scale. Regulatory issues determine how a product can be produced and marketed; the primary federal institutions involved in regulations are the US Department of Agriculture, the Food and Drug Administration, and the Federal Trade Commission. A primary distinction is made between food and drugs, and no product may enter the food market if it is in part or whole a drug. Product safety is a major concern, and myriad regulations govern the determination of safety. New foods/dietary supplements are often marketed by health claims or structure/function claims, and there are specific regulations pertaining to claims. Not understanding the regulatory issues involved in developing a new product or failing to comply with associated regulations can have legal and financial repercussions.

Are dietary bioactives ready for recommended intakes?

Research has shown that numerous dietary bioactive components that are not considered essential may still be beneficial to health. The dietary reference intake (DRI) process has been applied to nonessential nutrients, such as fiber, yet the majority of bioactive components await a recommended intake. Despite a plethora of new research over the past several years on the health effects of bioactives, it is possible that the field may never reach a point where the current DRI framework is suitable for these food components. If bioactives are to move toward dietary guidance, they will likely require an alternative path to get there.

Nutrient reference values for bioactives: new approaches needed? A conference report.

Nutrients can be classified as either "essential" or "non-essential," the latter are also termed bioactive substances. Whereas the absence of essential nutrients from the diet results in overt deficiency often times with moderate to severe physiological decrements, the absence of bioactive substances from the diet results in suboptimal health. Nutrient reference values are set by Codex Alimentarius and regulatory bodies in many countries, mostly for essential nutrients with recommended daily intakes. The IOM in the United States has defined a set of four DRIs that, when data are appropriate, include an EAR, a RDA that is derived from the EAR, an AI for nutrients without appropriate data to identify an EAR, and an UL. From the RDA, the United States derives a labeling value called the DV, which applies to older children and most adults. In Codex, the equivalents of the DVs are the NRVs to be used in calculating percentage values on food labels. Nothing in the IOM documents specifies that labeling values can be set only for what have been defined to date as essential nutrients. Indeed, the US Food and Drug Administration sets a labeling value for dietary fiber based on the IOM AI for this ingredient. This conference explores the definitions, concepts, and data on two of the best examples of bioactive substances that, perhaps, should have NRVs: lutein and zeaxanthin, and n-3 long-chain polyunsaturated fatty acids.

How the US Food and Drug Administration evaluates the scientific evidence for health claims.

Health claims describe the relationship between a substance (food or component of food) and a disease or health-related condition. They were first authorized through the Nutrition Labeling and Education Act of 1990. The standard set by the US Congress for the scientific evidence required to authorize a claim was the significant scientific agreement standard. This strong standard was challenged by several manufacturers of dietary supplements. Several court decisions directed the US Food and Drug Administration (FDA) to provide for dietary supplement claims not meeting the significant scientific agreement standard by adding a disclaimer to the claim that would eliminate the claim's potential to be misleading. In December 2002, the FDA announced a major new initiative, "The Consumer Health Information for Better Nutrition Initiative," which, among other things, provided for the use of qualified health claims for both conventional foods and dietary supplements. The process for reviewing the scientific evidence for a claim reaching significant scientific agreement and for those that require qualifying language is the same. In January 2009, the FDA issued a guidance document entitled "Evidence-Based Review System for the Scientific Evaluation of Health Claims." The process used by the FDA to review the scientific evidence for health claims and qualified health claims are described in this article.

Qualified health claims for calcium and colorectal, breast, and prostate cancers: The U.S. Food and Drug Administration's evidence-based review.

In 2003, the United States Food and Drug Administration (FDA) received a health claim petition for calcium supplements and reduced risk of colorectal, breast, and prostate cancers. Health claims characterize the relationship between a substance (food or food component) and disease (e.g., cancer or cardiovascular disease) or health-related condition (e.g., hypertension) and require premarket approval for the labeling of conventional foods and dietary supplements by the FDA. This review describes how the FDA used the evidence-based review system to evaluate the scientific evidence for these proposed health claims. FDA found no credible evidence to support health claims for calcium and a reduced risk of breast and prostate cancers. The agency did find limited evidence for the relationship between calcium intake and colorectal cancer risk.

The U.S. Food and Drug Administration's evidence-based review for qualified health claims: tomatoes, lycopene, and cancer.

Several studies have reported an inverse association between tomato and/or lycopene intake and the risk of some types of cancer. In 2004, the U.S. Food and Drug Administration (FDA) received two petitions for qualified health claims regarding tomatoes, lycopene, and the risk reduction for some forms of cancer. Health claims that characterize the relationship between a food or food component and a disease or health-related condition require premarket approval by FDA to be included on the labels of conventional foods and dietary supplements. Here we describe FDA's review of the scientific data for tomato and/or lycopene intake with respect to risk reduction for certain forms of cancer. The FDA found no credible evidence to support an association between lycopene intake and a reduced risk of prostate, lung, colorectal, gastric, breast, ovarian, endometrial, or pancreatic cancer. The FDA also found no credible evidence for an association between tomato consumption and a reduced risk of lung, colorectal, breast, cervical, or endometrial cancer. The FDA found very limited evidence to support an association between tomato consumption and reduced risks of prostate, ovarian, gastric, and pancreatic cancers.

Supplemental calcium and risk reduction of hypertension, pregnancy-induced hypertension, and preeclampsia: an evidence-based review by the US Food and Drug Administration.

The labeling of health claims that meet the significant scientific agreement (SSA) standard (authorized health claims) and qualified health claims on conventional foods and dietary supplements requires premarket approval by the US Food and Drug Administration (FDA). FDA conducts an evidence-based review to determine whether there is sufficient evidence to support an authorized or qualified health claim. An evidence-based review was conducted on the human intervention and observational studies evaluating the role of supplemental calcium in reducing the risk of hypertension, pregnancy-induced hypertension, and preeclampsia. This review provides FDA's evaluation of the current scientific evidence on the role of supplemental calcium in reducing the risk of these three end points. Based on this evidence-based review, the agency concluded that the relationship between calcium and risk of hypertension is inconsistent and inconclusive, and the relationship between calcium and risk of pregnancy-induced hypertension and preeclampsia is highly unlikely.

Lutein and zeaxanthin intakes and risk of age-related macular degeneration and cataracts: an evaluation using the Food and Drug Administration's evidence-based review system for health claims.

The labeling of health claims that meet the significant scientific agreement standard and of qualified health claims on conventional foods and dietary supplements requires premarket approval by the Food and Drug Administration (FDA). The FDA conducts an evidence-based review to ascertain whether sufficient evidence exists to support a significant scientific agreement standard or a qualified health claim. The FDA recently reviewed intervention and observational studies that evaluated the role of lutein and zeaxanthin in reducing the risk of age-related macular degeneration and cataracts. On the basis of this evidence-based review, the FDA concluded that no credible evidence exists for a health claim about the intake of lutein or zeaxanthin (or both) and the risk of age-related macular degeneration or cataracts.

Chromium picolinate intake and risk of type 2 diabetes: an evidence-based review by the United States Food and Drug Administration.

The labeling of both health claims that meet significant scientific agreement (SSA) and qualified health claims on conventional foods and dietary supplements requires pre-market approval by the US Food and Drug Administration (FDA). Approval by the FDA involves, in part, a thorough review of the scientific evidence to support an SSA or a qualified health claim. This article discusses FDA's evidence-based review of the scientific evidence on the role of chromium picolinate supplements in reducing the risk of type 2 diabetes. Based on this evidence-based review, FDA issued a letter of enforcement discretion for one qualified health claim on chromium picolinate and risk of insulin resistance, a surrogate endpoint for type 2 diabetes. The agency concluded that the relationship between chromium picolinate intake and insulin resistance is highly uncertain.

The regulatory process to revise nutrient labeling relative to the Dietary Reference Intakes.

The Nutrition Labeling and Education Act of 1990--an amendment to the Federal Food, Drug, and Cosmetic Act--paved the way for significant changes in the labeling of foods, nutrient content, and health claims. This article gives an overview of the regulatory process used by the US Food and Drug Administration to revise the food label relative to the Dietary Reference Intakes and in ways that reflect new scientific knowledge and public health issues.