Adherence and label literacy: Changing US diets leads to updates in Supplements Facts label

24 Jul 2019 --- Due to changes in the US diet and updates in nutrition science, the US Food and Drug Administration (FDA) has mandated new label requirements for foods and dietary supplements. These include amendments on how folate acid is measured and how added sugars are presented. The changes offer “a tremendous opportunity” for responsible supplement manufacturers and suppliers to promote transparency, Brian Wommack, Senior Vice President, Communications, Council for Responsible Nutrition (CRN), tells NutritionInsight.

The nutrition label for a dietary supplement is called a “Supplement Facts” panel and it differs from the “Nutrition Facts” label used for foods in a number of ways. These include that one may list the source of a dietary ingredient in the “Supplement Facts” panel for dietary supplements and list dietary ingredients without RDIs or DRVs. Also, the part of the plant from which a dietary ingredient is derived for dietary supplements must be included.

The label changes range from measuring folic acid in micrograms of dietary folate equivalents (DFEs) to including added sugar and its percentage of daily value. The updates were presented by Paula Trumbo, Ph.D., Independent Consultant, EAS Consulting Group, and former Acting Director, Nutrition Programs Staff, Office of Nutrition and Food Labeling, CFSAN, at last week’s Dietary Supplement Caucus (DSC) briefing. 

The nearly 40 attendees viewed examples of efforts to educate consumers on the label changes, including Label Wise, an initiative aimed at educating consumers of the upcoming changes to the supplement facts label. When talking to either constituents or consumers in general, attendees were encouraged to utilize the toolkit of materials available on the Label Wise website. 

Diving into the label updates
“New percent Daily Values (DVs) for certain nutrients will be updated to reflect the latest in nutrition science and changes in American diets. Some units of measure will also change. For example, for vitamins A, D and E, the measure will change from amounts in International Units (IU), to the more common measure of milligrams (mg) and micrograms (mcg),” Wommack explains.

Based on a new understanding of requirements and American dietary habits, the list of nutrients considered under-consumed by Americans has also been updated. For instance, calcium, potassium, dietary fiber and vitamin D are all now considered nutrients of public health concern and will be required on labels. Potassium and vitamin D are new to the list. Vitamins A and C are no longer mandatory on the label, as they have dropped off of the list of under-consumed nutrients.

For the dietary supplement industry, changing label requirements is an important regulatory action that needs to be adhered to; a lack of compliance can result in FDA enforcement action.

Companies who do not comply with the label regulation will have their food product misbranded, Wommack explains. “FDA examines Nutrition and Supplement Facts labels during routine GMP inspections, as well as part of efforts to monitor the market (including online websites), and take enforcement action, such as with form 483 inspectional observations, or warning letters,”    

The changes also apply to non-US companies hoping to sell human food products in the US market. 

Nutrition Facts label
On May 27, 2016, the FDA published final rules on the new Nutrition Facts label for packaged foods to reflect new scientific information, including the link between diet and chronic diseases such as obesity and heart disease. 

The new label will make it easier for consumers to make better-informed food choices. The new label is already appearing on packages even before it is required to be used. Manufacturers with US$10 million or more in annual sales must switch to the new label by January 1, 2020; manufacturers with less than US$10 million in annual food sales have until January 1, 2021 to comply. Manufacturers of single-ingredient sugars such as honey and maple syrup and certain cranberry products have until July 1, 2021 to make the changes.

According to a study published in Circulation, the added sugar component of the label could prevent or postpone nearly 1 million cases of cardiometabolic disease, including heart disease, stroke and Type 2 diabetes, over a 20 year period. The study highlights how the new label could be a cost-effective way to generate important health gains and cost-savings. 

A key component of the new label will be how dietary fiber is listed. In June 2018, the FDA greenlighted a list of specific fibers which could be classified as “dietary fibers” on the upcoming label, marking the end of two years of uncertainty for manufacturers.  

By Laxmi Haigh