Vitamin, Mineral ULs In Food, Supplement Labeling Unnecessary – CRN

Tolerable upper intake levels (UL) for vitamins and minerals generally should not be used in food and dietary supplement labeling, according to Council for Responsible Nutrition VP-Scientific & Regulatory Affairs Annette Dickinson, PhD.

"The UL should not be routinely listed on product labels, since it is likely to be confusing to consumers," Dickinson's written comments say. "The UL is by definition a safe level of intake," the CRN rep adds, stating "if it is mentioned at all in labeling, there should be no implication that it is an unsafe level."

Dickinson's written comments were presented at an Institute of Medicine Food & Nutrition Board meeting held to solicit information on how the board's recently released Dietary Reference Intakes for vitamins and minerals should be incorporated into food and supplement labeling.

"If there were to be any mention of the UL in product labeling, it should be only when the recommended intake of a particular nutrient is high, and it should appear only as a footnote, not in the nutrient table and not in a separate column," Dickinson maintains.

Examples for which providing information about the UL might make sense include foods and supplements containing vitamins A or D, she states.

Written comments submitted by Consumer Healthcare Products Association VP-Nutritional Sciences Leila Saldanha, PhD, recommend UL values be considered in product labeling "only for those nutrients where there is an overlap between the children's UL and the adult" Recommended Dietary Allowance/Adequate Intake levels.

Saldanha notes the five nutrients for which this occurs are zinc, vitamin A, folic acid, niacin and magnesium.

The CHPA exec also maintains that manufacturers should have the option of using voluntary label statements when ULs and RDAs do not paint a complete picture. She cites the common labeling statement "If you are pregnant or nursing a baby, ask a health professional" as an example.

Taking a more conservative view, Center for Science in the Public Interest Director of Nutrition Bonnie Liebman asserts in written comments that "consumers need to know that high levels of certain nutrients can cause harm, and that those levels vary from one nutrient to another."

Although she agrees "requiring ULs to appear on all food and supplement labels would create too much clutter," Liebman suggests they be required in the labeling of supplements other than multivitamins, because "people could more easily take excessive levels of single-nutrient supplements."

Use of ULs in food and supplement labeling was one of several topics discussed during the May 23 meeting, which was convened by FNB's Committee on Use of Dietary Reference Intakes in Nutrition Labeling.

The committee, which was formed in October 2001, has been charged with conducting a study to "assess the objectives, rationale and recommendations for the methodology to select reference values for labeling the nutritive value of foods based on the" DRIs.

The study will identify "general guiding principles for use in setting reference values for nutrients on the food label, recognizing that there may be modifications of the approach based on special situations or physiological needs related to each nutrient."

The majority of food and supplement products currently on the market cite RDAs established in 1968, even though IoM has since updated many of its intake recommendations. The institute's most recent report, which was on micronutrients, was released in early 2001 (¹ (Also see "More Chromium Research Needed To Set RDA, FNB Report Concludes" - Pink Sheet, 15 Jan, 2001.), pp. 4-7).

Although IoM's recommendations have no binding impact on nutrition labeling, FDA could use the findings to issue new guidance on label reference values and food fortification levels.

The agency is one of the project's sponsors, along with the U.S. Department of Agriculture and Health Canada. A final report is anticipated by October 2003.

In addition to the appropriate use of ULs, the FNB committee will consider how reference values for nutrients should be set and whether product labels should offer separate values for specific populations.

Dickinson and Saldanha both agree that for most nutrients, the Reference Daily Intake should be based on the highest RDA or AI available, which is the approach currently used in product labeling.

Both maintain using the Estimated Average Requirement (EAR) would be inappropriate; Dickinson's written remarks note the value is "not intended as [a] target for individual nutrient intake."

Liebman says the committee should support a daily value that "protects the most vulnerable segments of the population." Because most people are at risk for not getting enough micronutrients, she agrees choosing the highest RDA is beneficial. However, she cautions that FNB should take into account whether that value could, in turn, harm certain segments of the population.

Although Dickinson advocates an overall RDI for each nutrient, she adds "there should also be RDIs that can be used for other population groups as appropriate," such as specific RDIs for infants, children ages four to 12, pregnant women and adults over 70.

Manufacturers that formulate products to meet a specific population's nutrient needs could then use the respective reference values when labeling that product.

For nutrients that have significantly different RDAs for men and women, such as iron, companies should have the option of a separate RDI for both groups, Dickinson adds. "Special consideration" also should be given to reference values for nutrients with a relatively narrow range of safe intakes, such as vitamin A, the CRN rep's comments state.

National Food Processors Association Senior Director of Food Labeling & Standards Regina Hildwine cautions that changes in labeling reference values will affect many nutrient content claims and could cause some products to become ineligible to carry the claims they currently bear.

For example, her written comments note "a food that is now a 'good source' of a nutrient could become 'high' in that nutrient if the daily value is lowered...[and] a food that is now a 'good source' may become ineligible...for any nutrient content claim at all."

Hildwine also stresses the cost of changing food labeling. She estimates the food industry spent $1.28 bil. to change labeling in 1992 to comply with the Nutrition Labeling & Education Act. "No doubt the costs would be higher today," she adds.

Saldanha advises the committee to be "cognizant of the limited amount of space available for the 'Supplement Facts' box on dietary supplement labels by limiting the amount of mandatory information required." She notes supplement manufacturers would need at least two years to implement any labeling change.