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This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENT NUTRITION LABEL PRINT-SIZE FLEXIBILITY REQUESTED by the Nonprescription Drug Manufacturers Association, the Council for Responsible Nutrition and Mead Johnson Nutritionals in comments on FDA's June 18 proposed rule implementing the nutrition labeling provisions of the Nutrition Labeling & Education Act for dietary supplements. CRN reported that an analysis of 500 vitamin and mineral supplement labels found that all were smaller than 40 square inches and 72% were in the range of 10 to 15 square inches. FDA is proposing to require type size no smaller than eight points in the labeling of dietary supplements "unless the package has a total surface area available to bear labeling of 40 square inches or less," CRN noted. "Even the small six-point type size is too large for many dietary products," the association said. CRN urged FDA "to recognize the essentiality of permitting a smaller type size for the labeling of dietary supplements with small labels and a large number of dietary ingredients." The association said that individual members also will be submitting comments on type size for dietary supplement labels. Mead Johnson Nutritionals maintained that "most if not all dietary supplements . . . for pediatric use have bottle labels with a surface area smaller than 12 square inches." Because it is "important for the consumer to have nutrition information on the bottle label after the retail package has been discarded," Mead Johnson recommended that a four-point type style "would be satisfactory" if FDA were to allow other modifications in the nutrition label requirements, including elimination of the bar line at the bottom of the required "Nutrition Facts" box. Acknowledging that six-point type is easier for most consumers to read, NDMA suggested that such a requirement may be impractical given that multivitamin products "have too many ingredients to comply with this proposal." Instead, NDMA recommended that the type size be at least 4.5 points "if black on white or similar high-contrast dark on light print" is used in a label. However, NDMA advised that if the "copy is reversed, the type size should be . . . about six points." NDMA's voluntary label readability guidelines contain similar recommendations. NDMA agreed with FDA that "dietary supplements should be subject to the same regulations as foods to the greatest extent possible." However, maintaining consistent formats between foods and dietary supplements has "practical consequences," NDMA asserted. Not only is the space for labeling on dietary supplement packaging smaller, on average, than for foods, NDMA pointed out, but additional information is included in supplement packaging that is not necessary on conventional foods. This includes directions for use, lot number, expiration date, warnings, statements indicating tamper-resistant features and storage information to protect potency. Therefore, NDMA suggested, the "entire labeling, as opposed to the primary container, should be used to relay all of the necessary nutrient information to consumers." NDMA offered this as an alternative that "would allow display of all information listed in the agency's proposal in a manner which can be easily read by all consumers." For example, NDMA suggested listing ingredients on point-of-purchase packaging only. Most of the comments submitted to date ask FDA to extend the six-month implementation date in the nutrition label proposed regulation in order to give industry more time to meet the new labeling requirements. Both CRN and NDMA are requesting one-year extensions beyond the current June 1994 deadline. CRN estimated the cost to the dietary supplement industry of coming into compliance with the labeling provisions within six months of issuance of a final rule at about $ 70 mil. The association maintained that FDA's estimate of the $ 20 mil. cost to industry is inaccurate. However, FDA's estimate of $ 6 mil. in industry savings if a six-month extension is granted and $ 9 mil. in savings from a one-year delay "warrants" an extension, CRN asserted.

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