September 25, 2023
We appreciate the opportunity to comment on the Food and Drug Administration (FDA) draft guidance for industry concerning questions and answers about Dietary Guidance Statements in food labeling.
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
We support the use of Dietary Guidance Statements to improve dietary patterns, reduce the burden of nutrition-related chronic diseases, and advance health equity. Dietary Guidance Statements provide important nutrition information to consumers, and are especially important to consumers with poor nutritional habits. They also encourage industry to reformulate products to improve nutritional standards.
We recommend the following to improve this guidance:
- Revise the recommendation that manufacturers may use Dietary Guidance Statements on products that exceed recommended limits on saturated fat, sodium, or added sugar.
Manufacturers should not be allowed to use Dietary Guidance Statements on products that exceed recommended limits on saturated fat, sodium, or added sugar, even with an added disclosure statement explaining the nutrient levels the product may exceed. This would be confusing and potentially misleading to many consumers. If the FDA insists on this confusing strategy, the agency should clearly describe which recommended nutrient level is exceeded, and should be designed to grab the attention of consumers, similar to that of a black box warning on medical products.
- Provide an explicit definition that includes examples of a “consensus report.”
In this draft guidance, FDA defines a “consensus report” as: “A report that represents the consensus produced by a group of qualified experts whose bias and conflicts of interest have been minimized and that are convened to study a specific issue. The consensus report conveys agreed-upon recommendations that reflect widely accepted, objective views of current scientific evidence.” This definition does not specify what FDA considers a “minimized” conflict of interest. This definition needs to be explicit to ensure that inappropriate sources are not included and that Dietary Guidance Statements do not conflict with recommendations in the Dietary Guidelines for Americans released every five years by HHS.
We recommend that FDA provide a list of which published reports from U.S. Federal government agencies, U.S. scientific bodies, or U.S. health organizations outside the Federal government are appropriate to serve as the basis for Dietary Guidance Statements. The list should be updated at least every five years, and be in agreement with the release of updated Dietary Guidelines for Americans.
- Amend the use of Dietary Guidance Statements related to juice and reduce misleading claims about fruit drinks.
The FDA guidance recommended that products should contain at least ½ cup equivalent of fruit per Reference Amount Customarily Consumed (RACC), which can also be ½ cup of fruit juice per RACC. However, a Dietary Guidance Statement on a product that contains fruit only in the form of juice would be misleading to consumers, because the Dietary Guidelines for Americans place an emphasis on the importance of whole fruits. FDA should amend the guidance to clarify that Dietary Guidance Statements involving fruit should emphasize the benefits of whole fruit over fruit juice, as well as the benefits of fruit juice compared to fruit drinks.
- Amend the use of Guidance Statements regarding whole grains.
Consumers are often misled by claims of products that “contain whole grains” despite whole grains constituting a small amount or small proportion of the total grains. The Dietary Guidelines for Americans recommend a diet including “grains, at least half of which are whole grain.” As an example guidance statement, the FDA provides a label saying, “Make half your grains whole grain.” This should be amended to recommend that “at least half” your grains should be whole grain. Additionally, for products that contain high amounts of grain, the FDA should recommend at least 50% of the total grains be whole grains.
- FDA should provide guidelines for Dietary Guidance Statements on alcohol.
Evidence regarding the harmful effects of alcohol, including moderate amounts of alcohol, is well documented and we therefore urge that the Dietary Guidance Statement should include that information. That would require amending the definition of Dietary Guidance Statements to include those that “represent or suggest that a food or food group may or may not contribute to or help maintain a nutritious dietary pattern. ” Dietary Guidance Statements regarding alcohol should emphasize the recommended limits as well as established evidence about the impact of alcohol consumption on health.