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This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENT "HIGH POTENCY," "BALANCED" CLAIMS should not be considered health claims, the Nonprescription Drug Manufacturers Association asserted in Aug. 17 comments on FDA's June 18 proposed rule implementing the nutrient content claim provisions of the Nutrition Labeling & Education Act. "These and other formulation descriptors, which properly and truthfully describe the nature and type of the product, are not health claims," NDMA maintained. Responding to FDA's request for comments on whether the terms "high potency," "high absorption" and "balanced" characterize the level of nutrients in a dietary supplement product and should be defined under NLEA, NDMA said that "high potency" and "balanced" are "terms that have been used for many years and consumers have come to understand that products so described have at least the [Recommended Daily Allowance] of the primary nutrients in the formulations." NDMA did not comment on the term "high absorption." NDMA suggested that FDA has "set a precedent for excluding such terms from description regulations." For example, the association pointed out that in the tentative final monograph for internal analgesics, "FDA concluded that the terms 'extra- strength,' 'maximum strength,' 'extra-pain relief'" are "outside the scope of the OTC review" and "will not be included in labeling required by the mongraph, but may be used elsewhere in labeling." In separate Aug. 17 comments to FDA, the Council for Responsible Nutrition disagreed with NDMA that "high potency" should not be defined under NLEA. CRN noted that "high potency characterizes the level of nutrients in a food, and therefore, falls within the category of claims that NLEA requires FDA to define." CRN requested additional time, however, to comment on the definition of "high potency" because the council has been "unable to determine the appropriate use of the term for all classes of products" in the "short time available" for commenting on the NLEA proposals. In the interim, CRN suggested, FDA should allow manufacturers to continue using the term "as it is currently being used" since "high potency" has "been used for years without apparent evidence of consumer misunderstanding." CRN agreed with NDMA that "balanced" does not require definition under NLEA. "High absorption" also does not require definition, CRN said, because it does not refer to the level of nutrients in a product. The National Nutritional Foods Association asserted in separate Aug. 17 comments that none of the three terms in question is a nutrient content claim. NDMA also contended that FDA's proposal to allow nutrients without established Recommended Daily Intake levels to be listed on the label but not within the "Nutrition Facts" box will lead to consumer confusion "about the importance of these nutrients." NDMA pointed out that nutrients including vitamin K, selenium, manganese, chromium and molybdenum do not have established RDIs. The "listing of such 'non-RDI' essential nutrients as single molecular entities within the nutrient facts box" will communicate to consumers the importance of these elements, NDMA argued. "Their placement outside the box, however, would falsely denote lesser importance." In its proposal, FDA ruled that only RDI nutrients existing in a dietary supplement in higher than "insignificant amounts" should be listed in the Nutrition Facts box. CRN concurred with NDMA that the label listing of nutrients in dietary supplements should not be limited to vitamins and minerals for which there is an established RDI. CRN also disagreed with FDA's proposal to "prohibit claims giving prominence to, or emphasizing ingredients other than, vitamins and minerals." These "prohibitions result in the withholding of information that is relevant to consumers," the dietary supplement trade group said, concluding that "often, the principal reason for the purchase of these products is not their vitamin and mineral content, but the other ingredients." A similar opinion was offered by the U.S. Pharmacopoeia in July 28 comments to FDA. USP recommended that the agency allow on dietary supplement nutrition labels a separate listing of "other ingredients" -- or "nutrients that are [not] the sources of vitamins and minerals" -- under the "Nutrition Facts" box ("The Tan Sheet" Aug. 16, p. 7). CRN also criticized FDA's proposal to "permit 'free,' 'low' and 'reduced' claims for calories, fat and cholesterol on dietary supplements." CRN suggested that such terms should only be authorized for supplements that are a "significant source of calories, such as protein supplements." It is "nonsensical to permit dietary supplements that are not a significant source of calories to make a claim about reduced amounts of calories, fat and cholesterol contained therein," CRN stated.

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