OTC LABEL "CONSUMER FRIENDLY" LANGUAGE BEING PURSUED BY NDMA

OTC LABEL "CONSUMER FRIENDLY" LANGUAGE BEING PURSUED BY NDMA as part of the association's ongoing label readability campaign, Nonprescription Drug Manufacturers Association Technical Affairs Director William Bradley told a July 13 session of the Drug Information Association annual meeting in Chicago. Bradley noted that NDMA plans to "aggressively pursue" more "consumer friendly terms" in over-the-counter drug labeling "in the second phase of our [label] readability program." The first phase of the NDMA campaign covered technical factors including print type size and spacing. Bradley observed that FDA's proposal allowing the interchangeability of certain terms in OTC labeling "opens the door to the possibility that more consumer friendly terms may be allowed in labeling." In April, FDA solicited suggestions for terms included in various OTC monographs that may be used interchangeably, such as "doctor" and "physician." In response, NDMA offered five interchangeable terms to be considered by FDA, including "chronic/persistent" and "clean/cleanse" ("The Tan Sheet" June 14, p. 14). NDMA has not yet determined what actions it will take in encouraging terminology that is more understandable to consumers. Bradley informed the DIA audience that label readability guidelines for the OTC industry, devised as part of the first prong of NDMA's label readability initiative, have been extended "beyond NDMA membership to include private label brands and other products." To that end, Bradley said NDMA has been presenting the guidelines at meetings of the Private Label Manufacturers Association, the Regulatory Affairs Professionals Society and the food and drug section of the American Society for Quality Control since 1991. "PLMA is distributing copies of the the NDMA guidelines to its members who manufacture OTC products," Bradley said. More recently, NDMA has held discussions on label readability with the National Association of Chain Drug Stores, which is "developing a plan to market the [NDMA] guidelines to its members who sell private label [OTC] products," and with the Food Marketing Institute. FMI has urged its members to comply with the NDMA guidelines, Bradley noted. The readability guidelines advise manufacturers to use a label type size of "at least 4.5 points" and emphasize the importance of contrast between print and background. The guidelines also encourage sufficient spacing between letters, lines and paragraphs; discourage use of hyphens; and suggest boldface, color highlights and boxing as other options to enhance label readability. Bradley noted that NDMA is "presently rewording the print size" recommendations in the guidelines to clarify that the minimum type size of 4.5 points is intended only for small packages with an extraordinarily large amount of copy. The revised guidelines will recommend that the minimum type size for most OTC labels should be around six points. Bradley said that the revision is being undertaken to "avoid confusion by those outside the industry" who complained that the minimum type size suggested by the trade association was too small. According to NDMA, type size for most OTC product labels is an average of 6.85 points, the median type size is 7 points and the mode type size is 8 points. As part of the label readability initiative, NDMA is disseminating a brochure in cooperation with the National Council on the Aging entitled "Modern Medicines for Mature Americans." Intended to improve OTC label readability among the elderly, the brochure "tells the readers to always read package labels in a properly lighted room, to wear their glasses or contact lenses when reading labels," to "ask for help in reading labels if they can't read them," and to read larger sized packages in the store even if "they want to purchase a small size," Bradley said. Prior to developing the brochure, NDMA found that "much of the difficulty encountered by the elderly in reading [product labels] is due to poor lighting." Specific sections in the brochure include "Rx and OTC: Both are serious medicines," "Read the Label," "Label Readability: Things you should know" and "Tips for Responsible Self-Care." Modern Medicines for Mature Americans is being distributed by NDMA to its members, pharmacy groups, federal and state government officials, and through individual requests. NCOA is disseminating the brochure mainly through senior citizen centers and homes for the elderly. NDMA said that 150,000 copies of the brochure have been printed and estimated that 75,000-100,000 will go out within the next year. Approximately 20,000 of the brochures will be included in an information packet being mailed in October by the National Council on Patient Information and Education. The packet, which is part of NCPIE's eighth annual "Talk About Prescriptions" month campaign, will reach officials from state and county agencies associated with the U.S. Administration on Aging. The information then will be disseminated to organizations for the elderly. Bradley concluded his presentation at DIA by noting that NDMA is "concerned" that "environmental concerns actually are going to conflict with readability because" of the demand for "smaller packages or less packaging," such as marketing a bottle without an outside carton. NDMA said it is monitoring the issue of environmental requirements and its effects on label readability.