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This article was originally published in The Tan Sheet

Executive Summary

SUGAR-FREE CLAIMS FOR VITAMIN PRODUCTS WOULD BE ALLOWED BY FDA under a June 18 proposed rule for nutrient content claims that implements the Nutrition Labeling & Education Act for dietary supplements. FDA stated in the nutrient claim reg that most sugar- related claims in product labeling are applicable to dietary supplements "because of consumer interest in the sugar content of food" and because "sugars are added to dietary supplements." Such claims include "sugar free" and synonyms for "sugar free" such as "no sugar," and "no added sugar." FDA decided, however, that the term "unsweetened" is not applicable to dietary supplements and, as FDA decided for foods, that "reduced sugar" or "less sugar" is not permissible. In addition, FDA is proposing to allow sugar claims in children's vitamins, including supplements marketed to infants and toddlers. The proposal departs from an agency determination in the Jan. 6 NLEA implementing regs for conventional foods. In those regs, FDA concluded that, except for statements about the percentage of the Recommended Daily Intake (RDI), "nutrient content claims may not be made on food intended specifically for use by infants and children less than two years of age," according to the June 18 notice. Explaining its rationale for allowing nutrient content claims for sugar, FDA noted: "While the amounts of other nutrients of public health importance in dietary supplements, such as sodium, may be quite small or nonexistent, the amount of sugars in dietary supplements in chewable form represents a potentially contributing factor to dental caries." In a separate, same-day reg implementing nutrition labeling provisions of NLEA for dietary supplements, FDA proposed that the nutrition label contain "information on sugar content when sugars are present in the dietary supplement in more than insignificant amounts, or when a claim is made," the notice says. Analytical values for sugar content that are less than .5 g are to be declared as zero on the nutrition label, FDA proposed. The June 18 nutrient content proposal essentially includes "dietary supplements of vitamins, minerals, herbs or other similar nutritional substances under the coverage of the general principles for nutrient content claims," provides for the use of "expressed and implied nutrient content claims on labels" of dietary supplements, and provides for petitions for dietary supplement nutrient content claims, FDA explained. As part of devising final NLEA regs for dietary supplements, FDA called for public comments on various supplement claims in the proposed rule. For example, because FDA "has no evidence that salt is used in the formulation of dietary supplements," the agency said it cannot make a final decision on whether to allow "unsalted" or "salt free" claims for supplements. Thus, the agency is soliciting "any data on the presence of salt in dietary supplements." FDA concluded in the proposal, however, that salt- related claims are not applicable to dietary supplements for the time being. The agency also invited the submission of comments and "relevant data" on the applicability of fat claims, such as "fat free," "low fat" and "reduced fat" to supplements. Although "fat content is typically insignificant or nonexistent in dietary supplements and" fat-related claims "are unlikely" in those products, FDA said, "there may be products for which these claims would appropriately apply." For instance, "some fish liver oils may qualify for a 'low fat' claim depending on the labeled serving size," the agency suggested. FDA also called for examples of "statements that facilitate avoidance" for dietary supplements, such as the statement "lactose free" for foods. FDA asked for comments on whether terms such as "high potency" and "high absorption" in dietary supplements have "established meanings," and if so, " whether they characterize the level of the nutrients in the food." "If comments demonstrate that there are accepted definitions used in the dietary supplement industry for these terms that characterize the level of nutrients, and that these definitions will assist consumers in maintaining healthy dietary practices, FDA will proceed with further rulemaking to adopt those definitions or to propose new ones," the agency said. FDA added that terms such as "high potency," "high absorption" and "balanced" on dietary supplement labels "seem to imply that the dietary supplement will contribute to good health." In addition, FDA also invited comments on "whether there is a need to allow nutrient content claims for nutrients without RDIs" such as vitamin K, selenium, manganese, fluoride, chromium, molybdenum and chloride. "If there is," the agency continued, "comments should address how such claims can be defined in the absence of" an RDI for the nutrient. In the proposal, FDA limited the proposed definitions for nutrient content claims to nutrients for which there are RDIs or DRVs. The agency also proposed that "statements about ingredients that are not vitamins or minerals," such as "more fiber," "good source of fiber" and "high protein," may not be made on dietary supplements. In the proposal, FDA "tentatively concluded" that most nutrient content claims authorized for foods under the Jan. 6 NLEA final regs "are directly applicable to dietary supplements." Having like claims for both dietary supplements and conventional foods would "be helpful to continue to minimize inconsistencies in nutrient content claims between dietary supplements and foods," FDA maintained, adding that "consumers would be confused if they were confronted with a situation in which nutrient content claims were allowed for nutrients when they are present at a certain level in foods" but not when they are present at the same level for dietary supplements. Among provisions that are similarly applied to dietary supplements as they are to conventional foods are: reformulation requirements for 'low' and 'free' claims; labeling mechanics; statements about the amount or percentage of a nutrient; relative claims such as 'light' and 'reduced'; and nutrition labeling. For some nutrient claims, such as "light" and "reduced calories," FDA pointed out that they would have "limited applicability to dietary supplements," but did not disallow them.

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