Additional Sugar Label Requirements Taste Sour To Supplement Industry

FDA proposes revisions to a 2014 proposed rule due to the 2015 Dietary Guideline Advisory Committee’s report. In a supplemental proposed rule, FDA will establish a daily reference value of 10% of total energy intake from added sugars and require label declarations of the percent daily value for added sugars.

Dietary supplement firms already acting on a 2014 proposed rule by preparing to declare added sugars on product labels will have to find more room to add the daily percentage of total energy intake contained in a product’s added sugars under FDA’s additions to the proposal.

In a supplemental proposed rule published in a July 27 Federal Register notice, FDA said it proposed including on labels the percentage of recommended sugar intake contained in a food or supplement product due to the 2015 Dietary Guideline Advisory Committee’s report. The report includes “evidence suggesting a strong association between a dietary pattern of intake characterized, in part, by a reduced intake of added sugars and a reduced risk of cardiovascular disease,” FDA says.

The report from the DGAC, a panel of nutrition and health experts, who are not employees of government agencies, appointed every five years to make recommendations on federal dietary policy to the Department of Agriculture and the Department of Health and Human Services, suggested Nutrition Facts and Supplement Facts labels include an added sugars declaration and the declaration of a percent daily value for added sugars, FDA’s Center for Food Safety and Applied Nutrition said in the supplemental proposal.

CFSAN said the supplemental proposed rule will establish a daily reference value of 10% of total energy intake from added sugars and require label declarations of the percent daily value for added sugars.

Comments Sought On ‘%DV’ Footnote For Supplements

A separate provision in the supplemental proposal on a label footnote to explain the use of “% Daily Value” reverses FDA’s thinking stated in the original.

While the original proposal required the footnote for Supplement Facts labels and asked for comment on its use in Nutrition Facts, the supplemental proposal requires the footnote for Nutrition Facts and asks for comment on whether it should be used in Supplement Facts.

The supplemental proposal states the footnote text: “* % Daily Value 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 updated proposal also includes an exemption from the footnote requirement that will be applicable to many supplement products. The exemption will be for products that can use these label terms such as “calorie free,” “without calories,” ‘‘trivial source of calories” and “dietary insignificant source of calories.”

CFSAN noted that while the footnote language is similar to the wording of one of the options presented in a study of consumer understanding, the order of the sentences is reversed. Switching the order of the sentences “allows the first sentence to clearly follow the asterisk in the ‘%DV’ column heading that leads to the footnote. Consumers looking to the footnote for additional information linked to the asterisk “may expect to find the sentence that explains percent daily value first, rather than a sentence about calories,” the center stated.

While the requirement likely will not affect typical formulations of supplements in pill and capsule or similar formats, many nutritionals marketed as liquids or as powders for mixing with water or other beverages will be subject to the rule. As with conventional food products, including added sugar helps make a powder or supplement consumed as a beverage more palatable.

Nutritional supplement industry stakeholders are not questioning the science behind the additional requirement in FDA’s supplemental proposed rule, but point out some firms already are spending on preparing changes stated in the original proposed rule published in March 2014. Those and other firms marketing products subject to the sugar provisions would have to make changes stated in both the original and the supplemental proposed rules to be compliant.

“When you have a product like dietary supplements that already have small label space, adding this would be quite a burden for a manufacturer,” said Andrea Wong, the Council for Responsible Nutrition’s VP for scientific and regulatory affairs.

“The whole thing is that it’s another label change,” said Dan Fabricant, CEO of the Natural Products Association.

Fabricant estimated changing labels to comply with the original and supplement proposed rules will be “cost prohibitive” – around $4,000 to $5,000 per product – for many supplement marketers. “It’s still primarily a small business industry and that’s a lot of money to a small business,” he said.

In comments on the original proposed rule, CRN, NPA and other stakeholders asked FDA to allow more than the scheduled two years for compliance after the rule is finalized, scheduled for March 2016.

“We’re going to have to push for more time” in NPA’s comments on the supplemental proposal, Fabricant said. Three years would be more manageable for firms that will need to make the changes, he said.

Wong said CRN will wait for member input before determining the content of its comments on the supplemental proposal, including whether to ask for more time.

Publication of a final rule, however, could be delayed. FDA has received more than 300,000 comments on the original proposed rule and will accept comments on the supplemental rule – docket FDA–2012–N–1210 – through Oct. 12.

CFSAN says comments will be considered only on these issues:

• information from the 2015 DGAC report and the science it states regarding added sugars
• proposal to establish a DRV for added sugars and to require the declaration of the percent DV for added sugars on Nutrition and Supplement Facts labels
• using the term ‘‘Total Sugars’’ instead of ‘‘Sugars’’ on labels
• proposed text for footnotes to be used on Nutrition Facts and whether to make changes to a Supplement Facts footnote
• exemptions from the footnote requirement
• whether there should be a footnote on labels of food represented for infants 7 months through 1 year old, or for children 1 through 3 years old, and, if so, what that footnote should say.

In addition to the added sugar statement, the 2014 proposed rule included revised daily values for calcium and dietary fiber, but allows voluntary listing for vitamins A and C to make space on labels for the addition of potassium and vitamin D amounts to the labeling (Also see "In Brief: Nutrition Facts Update, Valeant Sales" - Pink Sheet, 3 Mar, 2014.).

Science Supports Added Sugars DRV

FDA has re-opened the rulemaking docket to receive comments on the original proposed rule through Sept. 25 on consumer studies added to the record: an eye-tracking experimental study on consumer responses to modifications to Nutrition Facts labels outlined in a June 2015 proposed rulemaking, and an experimental study of proposed changes to Nutrition Facts label formats.

FDA said in the original proposed rule that it planned to conduct those studies on consumer understanding of the declaration of added sugars on the Nutrition Facts label and of a daily value footnote.

With the consumer study results pending, information from the Dietary Guidelines Advisory Committee’s report became available and the agency looked again at establishing a daily recommended value and requiring the declaration of a percent DV for added sugars on the Nutrition Facts and Supplement Facts labels. CFSAN noted that the 2015 DGAC’s final report is not yet published.

However, FDA clarifies it is not proposing a daily reference value for total sugars or to require the mandatory declaration of a percent DV from added sugars “because there is no quantitative intake level or other reference amount for which there is sufficient scientific evidence upon which” it could base a proposal.

Current science supports a DRV for added sugars, though. FDA proposes establishing a DRV for added sugars “because science underlying the 2015 DGAC report provided a scientific basis for a reference amount for added sugars upon which we can propose a DRV (a recommended maximum of 10 percent of total energy intake),” according to the supplemental proposal.

Food and drug law attorney Riette van Laack says although FDA referenced the then-pending DGAC report in the original proposal, basing the change on it is surprising.

“I think it’s unusual because they have proposed a supplemental proposed rule on dietary guidelines that are not final yet,” said van Laack, a director at Hyman, Phelps & McNamara LLC in Washington.

The supplemental proposed rule also surprises by establishing a DRV for total energy intake from added sugars and requiring label declarations of the percent DV for added sugars without setting a DRV for total sugars.

“They’re still kind of wishy-washy about it,” van Laack said.

HHS and USDA are considering the DGAC report and public and agency comments and are expected to publish the 2015 guidelines in the fall. CRN in 2014 submitted comments recommending that the U.S. dietary guidelines for the first time endorse regular use of vitamins and dietary supplements to maintain a healthy diet (Also see "Dietary Guidelines Should Endorse Regular Vitamin Use – CRN" - Pink Sheet, 12 Sep, 2014.).

‘Total + Added’ Format Clearest

The supplemental proposal explains that participants in FDA’s added sugars experiment viewed Nutrition Facts labels in one of three formats:

• “Added Sugars” Format, where an added sugars declaration was indented below a “Sugars” declaration;

• “Total Sugars + Added Sugars” Format, where an added sugars declaration was indented below a “Total Sugars” declaration;

• Control format, where participants viewed the current Nutrition Facts label throughout the study.

Participants were asked about their ability to accurately recognize and compare nutrients on the Nutrition Facts label and their judgments about a product’s overall healthfulness and relative nutrient levels. They were not given the proposed definition of added sugars or provided with ingredient lists for the products tested.

The study found that with the “Total Sugars + Added Sugars” format, the majority correctly reported the added sugars amount and accurately identified which products had less added sugars.

Although the majority of the respondents correctly identified the total amount of sugars in a serving of food in each label that included an added sugars declaration, the “Added Sugars” Format results show a number of participants were confused about the distinction between sugars and added sugars, regardless of whether added sugars declarations appeared on the Nutrition Facts label.

Participants viewing Nutrition Facts labels without added sugars declarations could not accurately determine the amount of added sugars in the products; the majority reported the total sugars amount was the amount of added sugars.

Additionally, “many participants who viewed Nutrition Facts labels without added sugars declarations assumed that the more nutritious products in the study had less added sugars,” FDA stated.

The supplemental proposed rule also notes research data, including the intake of solid fats and added sugars is high across all age groups and genders of U.S. consumers, with nearly 90% of the general population “exceeding the recommended daily limits,” and added sugars intake remains high at 13.4% of total calories daily among all people ages 1 year and older.