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The two consumer studies pertained to proposed changes to the format of the Nutrition Facts label and to consumers’ interpretations of information on the Nutrition Facts label. Collectively, with respect to the proposed rule, the supplemental proposal, and the related Federal Register documents, we received nearly 300,000 comments from consumers, foreign governments, industry, trade associations, professional societies, academia, health professionals, and other government agencies. However, other comments opposed the exemptions because, according to comments, products that have little or no impact on calorie intake still may contain substantial amounts of nutrients such as vitamins and minerals.

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  • With that said, there are key differences between dietary supplements and medical foods.
  • According to the comments, not declaring n-3 polyunsaturated fatty acids may confuse consumers who are not aware of differences among individual polyunsaturated fatty acids with respect to their ability to reduce heart disease risk.
  • In reference to the Te Morenga et al. paper, the comments said that there was no effect of sugar and measures of weight found in children based on the reviews of randomized controlled trials and only a minor effect was found in cohort studies with intake of sugar-sweetened beverages but no other sugar-containing foods.
  • Some comments said that the evidence related to healthy dietary patterns characterized, in part, by lower intakes of sugar-sweetened foods and beverages is not strong and questioned whether we relied on the DGAC’s analysis and conclusion rather than doing our own analysis of the studies.

However, several comments addressed this issue, particularly with regards to the use of the proposed linear format on small and very small food packages. After reviewing the comments on the proposed rule, we tentatively concluded that we did not intend to further consider the alternative format for the Nutrition Facts label . Most comments agreed with our tentative conclusion, and other comments raised questions that we may consider if we decide to conduct further research on this issue in the future. A review of the-cbd-store the results of FDA’s consumer research, which we made available in reopening of the comment period as to specific documents , did not provide information to change our tentative conclusion, so we are not giving further consideration to the alternative format as part of this rulemaking. Our preexisting regulations, at § 101.9, require that the Nutrition Facts heading be set in a type size larger than all other print size in the nutrition label (§ 101.9) but does not require that this heading be set apart from the rest of the label with a horizontal hairline rule, which is a thin line. Horizontal lines are used throughout the Nutrition Facts label as a key graphic element to divide space, direct the eye, and give the label a unique and identifiable look.

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Several comments supported the mandatory declaration of total fat on the Nutrition Facts label. The comments suggested that retaining the declaration of total fat also would help consumers who are trying to consume foods with a lower calorie density because foods higher in fat have a higher caloric density. (Caloric density is the amount of calories per unit of food weight.) Some comments provided evidence to show that consumption of a lower-fat, lower-calorie diet promotes weight loss, weight maintenance, and the reduction in risk of diabetes.

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A few comments agreed with our conclusion that there is inadequate justification in consensus reports to use a tiered approach. The comments noted that a tiered approach would be an unprecedented process and inconsistent to the approach used for other nutrients, such as saturated fat and cholesterol, to limit in the diet. Another comment noted that a tiered approach may not help consumers adjust their taste preferences for sodium (Ref. 176). Our preexisting regulations, at § 101.9, set the DRV for protein at 50 grams, and this represents 10 percent of the 2,000 reference calorie intake level.

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We disagree with how Madden (Ref. 41) assessed nutrient intake for EPA and DHA because the IOM did not set an AI or EAR for EPA and DHA. The IOM only noted that EPA and DHA contribute approximately 10 percent of the total n-3 polyunsaturated fat intake (Ref. 29). There is no quantitative intake recommendation (i.e., EAR) available for assessing inadequate intake in populations. Furthermore, there are a number of nutrients for which there is suboptimal intake which was considered as part of the factors for mandatory or voluntary declaration.

If a dietary fiber is the subject of an authorized health claim, we would consider the relationship between the fiber and the chronic disease risk or health-related condition, to provide a beneficial physiological benefit to health. In fact, we proposed, and include in this final rule, two dietary fibers in the definition of dietary fiber that are the subject of an authorized health claim. Prospectively, if we issue a final rule authorizing a health claim for a dietary fiber, we intend to modify the dietary fiber definition accordingly. In the preamble to the supplemental proposed rule , we noted that the 2015 DGAC based its recommendation that Americans limit their added sugars intake to no more than 10 percent of total energy intake, in part, on current consumption data.

A font size at least two points greater shall be used for “Calories” and the heading “Calories” and the actual number of calories per serving shall be highlighted in bold or extra bold type. Type size no smaller than 6 point may be used for column headings (e.g., “Amount Per Serving” and “% Daily Value”) and for footnotes (e.g., “Percent Daily Values are based on a 2,000 calorie diet). The sample label shown in paragraph of this section illustrates one method of nutrition labeling a proprietary blend of dietary ingredients. Beta-carotene may be declared as the percent of vitamin A that is present as beta-carotene, except that the declaration is required when a claim is made about beta-carotene.

The comment noted that the results for older adults and teenage girls were a little higher, but similar regardless of the approach. The comment recommended that we continue to promote vitamin B12 intake in at-risk subpopulation groups and to continue monitoring population intake. We disagree that the same rounding increments should be used for quantitative amounts of all vitamins and minerals. Some nutrients, such as potassium, have a relatively large RDI value while others, such as thiamin, have a relatively small RDI value (1.2 mg). The declaration of those nutrients with relatively smaller RDI values requires greater specificity than those with relatively larger RDI values. Furthermore, for some nutrients with relatively larger RDI values, it may not be possible, given current analytical methods, to determine the amount of the nutrient with precision when very small quantities are present (e.g., at a level of less than 1 mg).