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 Warning Letter – “Healthy” products

This is an interesting example of warning letter issued by the FDA. It gives not only some indications about the use of the term “healthy”, but examines also other profiles of non compliance about allergens (“Contains…”).
“The Food and Drug Administration (FDA) reviewed the label for your Dark Chocolate PlumSweets product in July 2014. Based on our review, we have concluded that this product is in violation of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 343) and regulations found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find the Act and FDA regulations through links on FDA’s home page athttp://www.fda.gov.
 
Your Dark Chocolate PlumSweets product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bears a nutrient content claim, but the product does not meet the requirements to make such a claim.
 
Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in the labeling of a food product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act.
 
Specifically, the label of your Dark Chocolate PlumSweets product bears an implied nutrient content claim, because it bears statements suggesting that the product may be useful in maintaining healthy dietary practices and those statements are made in connection with claims or statements about nutrients. Specifically, the label of your Dark Chocolate PlumSweets product bears the claim “deliciously sweet and healthy diced plums…” in connection with the statements “Indulge in the Ultimate Antioxidant treat…” and “Dried Plum Whole Fruit Antioxidants + Decadent Dark Chocolate Goodness = The Ultimate Antioxidant Snack.” In the context of this label, FDA considers the claim “deliciously sweet and healthy diced plums…” to be an implied claim about the food itself. However, this product does not meet the requirements for use of the nutrient content claim “healthy” that are set forth in 21 CFR 101.65(d)(2).
 
In accordance with 21 CFR 101.65(d)(2), you may use the term “healthy” as an implied nutrient content claim on the label or in the labeling of a food provided that the food, among other things, is “low saturated fat” as defined in 21 CFR 101.62(c)(2) (i.e., the food has a saturated fat content of 1 g or less per Reference Amount Customarily Consumed (RACC) and no more than 15 percent of the calories are from saturated fat).
 
According to the Nutrition Facts panel, your product contains 5 g of saturated fat per 40 g serving of the food. This amount exceeds the maximum of 1 g of saturated fat per RACC for the food and the maximum of 15% of calories from saturated fat in the “low saturated fat” definition. Accordingly, your product does not meet the requirements for use of the nutrient content claim “healthy” on a food label [21 CFR 101.65(d)(2)]. Your product is thus misbranded within the meaning of section 403(r)(1)(A) of the Act.
 
The above violations are not meant to be an all-inclusive list of violations that may exist in connection with your products or their labeling. It is your responsibility to ensure that your products comply with the Act and its implementing regulations. You should take prompt action to correct the violations. Failure to promptly correct the violations may result in regulatory action without further notice, including seizure and/or injunction. 
 
In addition, in accordance with section 403(w) of the Act, when a food manufacturer opts to use the word “Contains” followed by the name of the food source from which the major food allergen is derived, this information must be placed immediately after or adjacent to the list of ingredients. The “Contains” statement on your product label is placed at the bottom of the information panel after various printed information such as how to store the product and other non-mandatory labeling information.
 
Please respond to this letter within 15 working days from receipt with the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent similar violations. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction”.
(Source: FDA Website)