FDA revises proposed Nutrition Facts label rule to include a daily value for added sugars

The U.S. Food and Drug Administration today proposed including the percent daily value (%DV) for added sugars on the Nutrition Facts label of packaged foods, giving consumers additional information for added sugars similar to information they have seen for decades with respect to nutrients such as sodium and certain fats. The percent daily value indicates how much a nutrient in a serving of food contributes to a daily diet and would help consumers make informed choices for themselves and their families. The percent daily value would be based on the recommendation that the daily intake of calories from added sugars not exceed 10 percent of total calories.

The proposed rule is a supplement to the March 3, 2014 proposed rule on updating the Nutrition Facts label, under which the FDA proposed that food companies include added sugars on the Nutrition Facts label. The proposed rule did not include the declaration of the percent daily value for added sugars.

The 2015 Dietary Guidelines Advisory Committee (DGAC) recently summarized scientific data related to added sugars. The FDA considered the scientific evidence that the DGAC used, which showed that it is difficult to meet nutrient needs while staying within calorie requirements if one exceeds 10 percent of total calories from added sugar, and has determined that this information supports this daily value for added sugars. The DGAC also recommended that Americans limit their added sugars intake to less than 10 percent of total calories; this and other recommendations from the DGAC, which is an independent advisory committee, will be considered in the development of the final 2015 Dietary Guidelines.

The FDA’s initial proposal to include the amount of added sugars on the Nutrition Facts label is now further supported by newly reviewed studies suggesting healthy dietary patterns, including lower amounts of sugar-sweetened foods and beverages, are strongly associated with a reduced risk of cardiovascular disease. When sugars are added to foods and beverages to sweeten them, they add calories without providing additional nutrients.

“The FDA has a responsibility to give consumers the information they need to make informed dietary decisions for themselves and their families,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition. “For the past decade, consumers have been advised to reduce their intake of added sugars, and the proposed percent daily value for added sugars on the Nutrition Facts label is intended to help consumers follow that advice.”

The current label requires the percent daily value be listed for total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, calcium and iron.

The FDA is also proposing to change the current footnote on the Nutrition Facts label to help consumers understand the percent daily value concept. The proposed statement on the label would be shorter than the current footnote to allow for more space on the label, stating:

*The percent daily value (%DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.

The FDA is seeking public comment on the proposal for 75 days. The agency continues to review comments received on the 2014 proposed rule and is reopening the comment period on its March 2014 proposal for 60 days to invite public comment on two consumer studies related to label formats. The agency will consider comments on the original and this supplemental proposed rule before issuing a final rule. The proposed rule on serving size requirements, also issued in March 2014, is not affected by the supplemental proposed rule on the Nutrition Facts label released today.

In addition, the FDA is also releasing results of its consumer studies on the declaration of added sugars and the footnote and on the label format. As part of the March 3, 2014 proposed rule, FDA proposed updating the format of the Nutrition Facts panel and continues to consider the comments received on this proposal as it develops the final rule. Based on comments received to the proposed rule and the consumer studies’ results, the FDA does not intend to pursue the alternative graphic format for the Nutrition Facts label at this time.

FDA ruling on Trans-Fats

FDA released its’ final determination that Partially Hydrogenated Oils (PHOs) are not Generally Recognized as Safe (GRAS). The determination is based on extensive research into the effects of PHOs, as well as input from stakeholders during the public comment period.

PHOs are the primary dietary source of artificial trans fat in processed foods. In FDA view, removing PHOs from processed foods could prevent thousands of heart attacks and deaths each year.

Implementation

FDA has set a compliance period of three years. This will allow food companies to either reformulate products without PHOs and/or petition the FDA to permit specific uses of PHOs. Many companies have already been working to remove PHOs from processed foods and the FDA anticipates that many may eliminate them ahead of the three-year compliance date.

It’s important to note that trans fat will not be completely gone from foods because it occurs naturally in small amounts in meat and dairy products, and is present at very low levels in other edible oils.

The FDA encourages consumers seeking to reduce trans fat intake to check a food’s ingredient list to determine whether or not it contains partially hydrogenated oil.

Background

In January 2006, FDA required the food industry to declare the amount of trans fat in food on the Nutrition Facts label. FDA data indicate that many processed foods have been reformulated to reduce the amount of trans fat since the requirement was instituted, but a substantial number of products still contain PHOs.

One of FDA’s core regulatory functions is ensuring that food, including all substances added to food, is safe. In November 2013, FDA made a preliminary determination that PHOs are not “generally recognized as safe” (GRAS) for use in food. FDA opened a 60-day public comment period on this measure to solicit data and information on a number of issues, including:

1. Whether FDA should finalize its tentative determination that PHOs are no longer GRAS;
2. How long it would take producers to reformulate food products to eliminate PHOs.

The comment period was then extended an additional 60 days and closed March 8, 2014.

The final determination was released June 16, 2015. This determination is based on extensive research into the effects of PHOs, as well as input from all stakeholders received during the public comment period (see Final Determination Regarding Partially Hydrogenated Oils, June 2015).

To learn more about trans fat, see also the FDA Trans Fat page.

EU Situation

In EU art. 30.7 of the FIC Regulation (“Food Information to Consumers” Reg. (EU) n. 1169/2011) says that “by 13 December 2014, the Commission, taking into account scientific evidence and experience acquired in Member States, shall submit a report on the presence of trans fats in foods and in the overall diet of the Union population. The aim of the report shall be to assess the impact of appropriate means that could enable consumers to make healthier food and overall dietary choices or that could promote the provision of healthier food options to consumers, including, among others, the provision of information on trans fats to consumers or restrictions on their use. The Commission shall accompany this report with a legislative proposal, if appropriate.”

Today the report has not been submitted yet and the Commission has been deeply criticized, especially from consumers associations for the unexpected delay. As a matter of fact in this situation is not even possible to declare voluntary the trans fat value in the EU format of the nutrition declaration (while in USA is mandatory from 2006).

Here below, you can find the definition of Trans fatty acids (TFA) and the advice given by EFSA in a 2010 Scientific Opinion:

“Trans fatty acids are not synthesised by the human body and are not required in the diet. Therefore, no Population Reference Intake, Average Requirement, or Adequate Intake is set. Consumption of diets containing trans-monounsaturated fatty acids, like diets containing mixtures of saturated fatty acids, increases blood total and LDL cholesterol concentrations in a dose-dependent manner, compared with consumption of diets containing cis-monounsaturated fatty acids or cispolyunsaturated fatty acids. Consumption of diets containing trans-monounsaturated fatty acids also results in reduced blood HDL cholesterol concentrations and increases the total cholesterol to HDL cholesterol ratio. The available evidence indicates that trans fatty acids from ruminant sources have adverse effects on blood lipids and lipoproteins similar to those from industrial sources when consumed in equal amounts. Prospective cohort studies show a consistent relationship between higher intakes of trans fatty acids and increased risk of coronary heart disease. The available evidence is insufficient to establish whether there is a difference between ruminant and industrial trans fatty acids consumed in equivalent amounts on the risk of coronary heart disease. Dietary trans fatty acids are provided by several fats and oils that are also important sources of essential fatty acids and other nutrients. Thus, there is a limit to which the intake of trans fatty acids can be lowered without compromising adequacy of intake of essential nutrients. Therefore, the Panel concludes that trans fatty acids intake should be as low as is possible within the context of a nutritionally adequate diet. Limiting the intake of trans fatty acids should be considered when establishing nutrient goals and recommendations.”