FDA reviewed several studies that included elderly consumers. Recognizing that factors other than type size can also enhance readability and that there are space constraints for labeling on drug packages, the agency chose to require a minimum type size of 6 point along with graphic labeling features. FDA researched this issue very carefully, balancing the need for the required information to fit on various package sizes and the need to ensure that the required information is prominent and readable. FDA considered the comments received on the proposal and reviewed literature studies that demonstrated how important type size is in evaluating readability. Six point type size for the text is a minimum baseline.
Manufacturers can use a larger type size and are encouraged to do so.
Some manufacturers may have to modify the label or package size to accommodate the new format. The agency also notes that the new rule will save consumers approximately 100 million dollars per year in health care costs. While an exemption process is available for unusual circumstances, FDA believes it has developed a rule that takes into account the needs of the variety of marketed OTC drug products and that it will be quite rare for a product to be unable to comply with the various modifications allowed in this regulation. Specifically, the rule provides for modifications of the provisions for packages that require a large amount of drug labeling in a small space. Since most OTC drug product labeling is routinely updated and reprinted every few years, the two-three year implementation period substantially reduces the overall cost impact.