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

¹ From the Center for Food Safety and Applied Nutrition, Food and Drug Administration, CFSAN-ONPLDS, College Park MD.

² Presented at the ASNS/ASCN Public Information Committee Symposium "Dietary Reference Intakes (DRIs) for Food Labeling," held in San Diego, CA, 4 April 2005.

³ Address reprint requests to B Schneeman, Center for Food Safety and Applied Nutrition, Food and Drug Administration, CFSAN-ONPLDS, HFS-800, 5100 Paint Branch Parkway, College Park, MD. E-mail: bschneem{at}cfsan.fda.gov.

ABSTRACT

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.

Key Words: Food and Drug Administration • Dietary Reference Intakes • Recommended Dietary Allowance • 21 CFR • Nutrition Labeling and Education Act

INTRODUCTION

In 1990 the Nutrition Labeling and Education Act was signed into law (public law 101-535). This amendment to the Federal Food, Drug, and Cosmetic Act, which added sections 403(q) and 403(r) to the Act, led to significant changes in food labeling and resulted in major revisions to nutrient labeling. Through rule-making, the Food and Drug Administration (FDA) promulgates regulations that specify the requirements for nutrition labeling as well as the criteria for nutrient content and health claims (1). More than one decade after the implementation of the nutrition labeling regulations, the FDA is in the process of considering whether emerging public health issues as well as new scientific information should result in revisions to nutrition labeling.

A PUBLIC HEALTH ISSUE OF CONCERN

An example of a public health issue that the FDA is concerned with is the growing problem of obesity in the United States. In 2003 the FDA Commissioner convened a task force to identify steps to be taken (within FDA's mandate) to help address this problem. A report, titled Calories Count, was released in March 2004. It made several recommendations, including several in important areas related to nutrition labeling on food products (2).

These recommendations included enforcement action on inaccurate serving size information on packaged foods. Inaccurate serving size information makes it difficult for consumers to compare products. In addition, the FDA issued a letter to manufacturers reminding them of ways, within the current regulations, in which they can provide more information to consumers about the calorie content of foods, especially products that can be consumed in a single eating occasion. For example, products can carry dual columns to indicate the nutrient content per serving and that per package; for certain products that contain <200% of the reference amount customarily consumed, the nutrient content per package can be listed in the Nutrition Facts panel.

The task force made recommendations and raised questions about changes to nutrition labeling that might help consumers make more informed choices regarding serving sizes and caloric content of foods. For example, changes to the font size and typeface might make the calorie information more prominent on the label. Another area identified by the task force was serving size information on packaged foods and consumer understanding of how this information is used in making decisions about food choice and portion size. The amendments to the Food, Drug, and Cosmetic Act that established nutrition labeling require that servings on most foods regulated by the FDA reflect the amounts customarily consumed and be expressed in household measures appropriate for the food.

In establishing the reference amounts customarily consumed, the FDA relied on data from the 1977–1978 and 1987–1988 Nationwide Food Consumption Surveys conducted by the US Department of Agriculture. The task force raised questions about 1) information on serving sizes for products that can reasonably be consumed in one occasion, 2) whether the reference amounts customarily consumed need to be updated, and 3) whether to provide a way to compare calories in smaller portions of identical foods. The agency published advanced notices of proposed rule-making on April 4, 2005, to gather information about the display of calorie and serving size information on the nutrition label (3, 4).

DRIs AND THE DIETARY GUIDELINES 2005

In considering any updates to the nutrition label, the agency needs to consider the recent reports from the Institute of Medicine of the National Academy of Sciences (NAS) on the Dietary Reference Intakes (DRIs) as well as the Dietary Guidelines for Americans 2005. The DRI reports include 6 publications that present the most recent science on establishing recommended intake levels for nutrients. They also include publications on the use of DRIs in planning diets and in nutrition labeling and fortification (5-11).

In 1993, when the FDA published its regulations to implement the Nutrition Labeling and Education Act, it established 2 sets of reference values: the Reference Daily Intakes (RDIs) and the Daily Reference Values (DRVs), which are used to set the label reference values known as the Daily Values (DVs) (1). In most cases, the RDIs are based on the Recommended Dietary Allowances (RDAs) published by the NAS in 1968. For most nutrients, the RDI is the highest RDA from among the values for adults and children aged 4 y (excluding the values for pregnant and lactating women).

Six additional nutrients were included in 1995. These were based on the 1989 RDA publication from the NAS (12). The DRVs used to establish the DVs are derived from the Diet and Health report of the NAS (1989) and the Surgeon General's Report on Nutrition and Health (1988). They are based on a 2000-kcal diet (13, 14). The 1990 and 1995 Dietary Guidelines for Americans relied on these 2 reports as well in their recommendations, but the most recent version of the Dietary Guidelines refers primarily to the DRI reports (15). In addition, the Dietary Guidelines 2005 identifies particular nutrients of concern for the American public. These should be considered in reviewing current label information on nutrients. The consumer education part of the Dietary Guidelines has highlighted the importance of the Nutrition Facts panel in helping Americans select a healthful diet.

As a result of the initiative on obesity as well as the review of the DRI reports and the Dietary Guidelines 2005, the Center for Food Safety and Applied Nutrition at the FDA has identified several priorities that could result in changes to the nutrition label on products. The agency is also considering modifications to regulations through the petition process. It does so in response to new laws or as a result of court case decisions. In all cases, the process—which is referred to as "notice-and-comment" rule-making—involves several opportunities for comments on the agency's proposals. The input of qualified scientists is especially important to ensure that sound scientific decisions are made during the process.

THE PROCESS OF CHANGE

The first step in this process is most likely the publication of an "Advanced Notice of Proposed Rule-Making" (ANPRM) in the Federal Register. An ANPRM identifies an area of interest for the agency, either for revision of existing regulations or for development of new regulations. It is designed to seek relevant information. Typically, the agency publishes several questions in an ANPRM. These indicate the type of additional information that is needed to develop a proposal or evaluate whether a proposal is appropriate. The ANPRM contains information on how to reply to the notice and contact information for obtaining further information. In conjunction with the publishing of an ANPRM, a docket is opened to allow submission of public comment; comments can be submitted electronically or as written documents.

Generally, the information submitted becomes public. A docket may be opened for 30, 60, or 90 d. In some cases, the agency may decide to reopen a comment period if it becomes aware of the need for a longer comment period or of information that would be useful to have as a part of the public comment period. The comments submitted are used by the agency as part of its decision-making process on the appropriate course of action. This course of action could include a range of options from doing nothing to developing a proposed rule.

A PROPOSED RULE

A proposed rule can be used to modify existing regulations or to introduce new regulations into Title 21 of the Code of Federal Regulations (21 CFR). The 21 CFR is the document that contains all of the regulations that the FDA enforces. Development of a proposed rule requires several types of expertise to analyze not only nutrition issues, but also the legal authority and regulatory impact of the regulation. Increasingly, consumer research is an important component of the development of regulations affecting the label; this is because of the intent to convey information that is truthful and not misleading. An important issue often overlooked by research scientists is the Constitutional First Amendment implications of a regulation. Because a regulation may prohibit certain types of speech or compel it, the rule must be analyzed to determine whether the requirements related to commercial speech are appropriate.

A proposed rule is laid out in the following sections: Background, Petitions and Grounds, Legal Authority, The Proposal, Preliminary Regulatory Impact Analysis, Regulatory Flexibility Analysis, Unfunded Mandates, Executive order 13132: Federalism, Environmental Impact, Paperwork Reduction Act of 1995, Comments, References, and proposed Codified Language. Within the proposal, options for the regulatory approach are outlined, and the economic analysis considers the costs and benefits of the various options. Clearly, it is important to select an option that maximizes benefits relative to costs.

Before it can be published, a proposed rule (as well as an ANPRM) must be reviewed by the Office of General Counsel at the FDA, the Commissioner's Office, the Department of Health and Human Services, and the Office of Management and Budget. Each group has its own unique focus and raises comments and questions that are addressed by the agency. Once it has gone through all of these steps successfully, a proposed rule is published in the Federal Register, and a docket for comments is opened. A proposed rule outlines the agency's thinking in terms of modifications or additions to the CFR.

The comments submitted to the docket are analyzed to determine whether and how the agency should make adjustments to its proposed rule before issuing a final rule. To publish a final rule, the agency needs to go through a government review process similar to the one for the proposed rule. In addition to the sections described for the proposed rule, the agency must include an analysis of the comments received and the agency response to the comments. It must also determine dates for implementation of the rule and the final language for inclusion in the CFR.

THE PRIORITY OF SCIENCE

Because scientific findings are important to decision-making in the agency, scientists can make a significant contribution to the rule-making process. The agency looks closely at current science in published peer-reviewed articles and reports from authoritative groups such as the NAS. Scientists help to provide scientific information by publishing original, peer-reviewed research relevant to the decision-making process and participating in the NAS process. In some cases, the FDA may convene a meeting of its scientific advisory committee, invite experts to public meetings, or invite experts to serve as consultants. In such cases, the agency will typically have specific questions on the scientific issues related to a rule that it is seeking help in addressing.

Once it has the best scientific advice, the agency can determine the most appropriate regulatory action. In some cases, scientists may be invited by industry or certain advocacy groups to submit comments on a particular document or proposal. These comments have value to the agency if they provide an independent evaluation of the proposal and identify relevant literature or other resources that are useful in the evaluation. As with any publication or presentation made by scientists, it is important to reveal any potential conflicts of interest (eg, honoraria or grant funding) as a part of the comments.

CONCLUSION

In summary, this article gives a brief overview of the process used by the FDA to change the CFR to allow changes in nutrition labeling that reflect current science and address public health issues. Although the process seems long and at times bureaucratic, it is designed to meet the expectations of the Administrative Procedures Act and ensure adequate public input.

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