CRN, LEDERLE SEEK ONE-YEAR DELAY IN NLEA LABELING REQUIREMENTS

CRN, LEDERLE SEEK ONE-YEAR DELAY IN NLEA LABELING REQUIREMENTS to June 30, 1995, citing "the undue economic hardship to the dietary supplement industry of having to comply with the proposed June 30, 1994 effective date." In separate Dec. 10 comments, the Council for Responsible Nutrition and Lederle asked FDA to delay the effective date of the nutrition labeling and nutrient content claim provisions of the Nutrition Labeling & Education Act under an "economic hardship" provision in the act. The agency expects to issue final NLEA regs for dietary supplements by Dec. 31. If issued on Dec. 31, the dietary supplement regs will become effective by July 1994. In arguing for an extension of the effective date, CRN maintained that "FDA has substantially underestimated the relabeling costs the industry will incur." In its June 18 NLEA proposal for supplements, the agency estimated the cost of relabeling dietary supplement packaging at $ 20 mil., or roughly .55% of the total annual U.S. sales of dietary supplements ($ 3.7 bil.), according to CRN. However, the trade association insisted, "the total relabeling cost [for the dietary supplement industry] will exceed $ 100 mil., or 2.7% of industry sales." CRN noted that FDA granted the food industry a one-year extension of the effective date for nutritional labeling based on a finding of undue hardship. The agency determined that it would have cost the food industry $ 1.5 bil. to relabel its products within a six-month period, a figure CRN said represents .4% of the food industry's total sales. In contrast, "the cost of relabeling for the dietary supplement industry, as a percent of revenues, is substantially greater," CRN maintained. During a Dec. 7 meeting between Center for Food Safety and Applied Nutrition Director Fred Shank, other FDAers, CRN President J. B. Cordaro and representatives from supplement companies including Nature's Bounty, Perrigo, Pharmavite and Leiner, CRN noted that the four firms "reported that they alone had 19,000 labels -- 4,000 more than FDA estimated for the entire industry -- that would have to be changed." The four companies also argued that it would cost them "between 2% to 4% of their annual revenues to make the required label changes within a six-month period," CRN said. CRN pointed out that "these four companies are among the largest companies in the industry" and the "cost impact of relabeling is disproportionally larger for smaller companies." CRN suggested that "these estimates probably understate the full cost impact of a six-month effective date." Addressing another industry concern, Lederle told FDA that "given the number of ingredients in a product such as" Lederle's Centrum, "we have estimated that the agency's proposed labeling format will render it virtually impossible to fit all of the proposed required information on our smallest (30-count) package size and still be readable." In addition to the 30-count Centrum package, Lederle said it manufactures and markets 30 other package styles that will be affected by the NLEA regs. Lederle added that overall, the products it markets "require changes to 31 labels, 17 cartons and eight stretch cards," which all must be "completely revised and redesigned." The firm concluded that the NLEA regs "and the labeling changes they will mandate are far more complex than any changes we have ever undertaken." CRN added in its letter that "costs aside, many of our member companies tell us they simply cannot meet a six-month period compliance. The larger private label manufacturers, which have up to 7,000 different labels that will need to be changed, have indicated they absolutely cannot do it in less than 15 months." Lederle noted that "an extremely simple package design change can take over 10 months to implement from inception to retail shipping date." CRN also voiced objections to specific labeling requirements under NLEA, including the type size required. Under the proposed regs, labels of less than 40 square inches would be required to use a six-point type. With many dietary supplement labels being "substantially smaller than this," CRN said, "there simply is not enough room on a label of this size to include all of the required information in a six-point type." CRN asked FDA instead to allow labels of less than 20 square inches to use 4.5-point type and labels of less than 12 square inches to use I/32-inch type. CRN added that these type sizes adhere to the voluntary OTC drug labeling program adopted by the Nonprescription Drug Manufacturers Association. Commenting on the proposed requirement that the name of each nutrient be immediately followed by the quantitative amount by weight of the nutrient, CRN instead urged that "FDA permit this information to be presented in a separate column, as it now generally is." Regarding the requirement that all ingredients be listed on a label, CRN asked that manufacturers be allowed to "identify the source of individual nutrients in the Nutrition Facts box and limit the ingredient list to those additional ingredients (such as excipients and fillers) that are not the source of the nutrients." This set-up would be "more readable and understandable," CRN asserted, and would be helpful to consumers who "have strong preferences regarding the source of some nutrients." CRN also reiterated support for inclusion of all nutrients -- not only those with a Recommended Daily Intake, as proposed by FDA -- in the Nutrition Facts box, and requested that U.S. Pharmacopeial designations be permitted "to encourage the use of USP quality ingredients and the adoption of USP quality standards."