WASHINGTON—As the nation’s food regulatory agency considers a sweeping overhaul of food and supplement labels, trade organizations representing the dietary supplement industry weighed in last week with observations by the deadline for submitting public comments: Aug. 1.
Earlier this year, FDA proposed updating the two-decade-old Nutrition Facts label in an effort to more accurately represent what Americans are eating and highlight parts of the label that address public health ailments such as obesity and heart disease.
FDA also proposed updates to the Supplement Facts label as part of a comprehensive rulemaking that regulators hope will encourage Americans to eat—and motivate food manufacturers to produce—healthier products. Chronic diseases such as heart attack and stroke rank as the leading cause of death in the United States, and a poor diet including excessive calories is widely known to contribute to such ailments.
“A primary change that we are proposing to the format of the Nutrition Facts and Supplement Facts labels is to increase the prominence of the ‘Calories,’ numeric value of calories, ‘Servings per container,’ and numeric value of servings per container declarations," FDA explained in the proposed regulation published in the Federal Register. “Research suggests that these proposed changes may increase consumers' attention to the information, and in certain situations, help consumers to accurately identify the number of calories in a product."
Critics of the current Nutrition Facts label, which was created in 1993, have pointed out that some information is unnecessary, hard to read and difficult to understand. A side-by-side comparison of the current label and the proposed one emphasizes that calories and servings per container would be displayed more prominently through larger fonts.
On the Supplement Facts label, FDA has not proposed making the serving size or servings per container information more noticeable or prominent. FDA explained it’s more important for consumers to know the quantity of the product to take, such as the number of tablets and packets, than the number of servings that are contained in the package. However, the agency has proposed requiring a more prominent display of calories on the Supplement Facts label.
“We are concerned that a small number of dietary supplement products, especially those in liquid form, could contribute a significant amount of calories and other macronutrients to the diet when consumed regularly," the agency explained.
Following passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), FDA established labeling requirements for supplements. The Supplement Facts label was first incorporated into federal regulations in 1997, then amended a year later and in 2003, said Justin Prochnow, a Denver-based food and supplement lawyer with Greenberg Traurig LLP.
In seven pages of comments filed last week with FDA, the Natural Products Association (NPA) said it mostly supported the FDA’s proposed changes to the food and supplement labels, though it raised some concerns and questions. For instance, the trade group asked the agency to share its research demonstrating that declaring added sugars on a label will result in food companies reducing the amount of added sugars in products. NPA also wondered how updating the reference value for sodium to 2,300 milligrams from 2,400 mg would result in consumers eating less sodium.
The Council for Responsible Nutrition (CRN) also commented on the proposed changes. Among its observations in 29 pages of comments, CRN raised concerns about a proposal to reduce the Recommended Daily Intake of vitamin B12 from 6 mcg to 2.4 mcg. FDA’s proposal is consistent with the standard established by the Institute of Medicine in 2000.
“CRN is concerned that decreased vitamin B12 fortification would lower the amount of crystalline vitamin B12 in the food and dietary supplement supply, making it more difficult for those at risk for deficiency to achieve adequacy for this nutrient," CRN explained.
The Nutrition Facts label has basically stayed the same for 20 years. The only exception was a requirement that took effect in 2006, requiring that trans fat be declared on the label.
Earlier this year, Michael Taylor, FDA's deputy commissioner for foods, told journalists that more than half of Americans use the Nutrition Facts panel. According to food and beverage market research from the NPD Group, consumers read food labels when they first appeared but stopped doing so as time wore on. FDA, however, has cited surveys showing increasing reliance on the label.
The conventional food and dietary supplement industries will have ample time to comply with the new rules once they are completed. FDA’s proposed changes, even if finalized, won’t take effect for two years, Prochnow pointed out. An FDA spokesperson said the agency cannot provide a timeline for finalizing the regulations.
FDA’s proposed changes on the Nutrition Facts label will affect disclosures that pertain to certain vitamins. For instance, FDA currently requires the mandatory disclosure of percent Daily Values for vitamins A and C, calcium and iron. It is proposing to require such declarations for vitamin D and potassium while making the declaration of vitamins A and C optional. But unlike the Nutrition Facts label in which certain vitamins must be disclosed even if the content is zero, the Supplement Facts panel doesn’t require such disclosure if the ingredient is not contained in the product, Prochnow explained.
To understand key differences between the Nutrition Facts and Supplement Facts labels, check out this FDA resource guide on nutrition labeling.