The National Consumers League is a national nonprofit consumer organization that has represented consumers and workers in the marketplace and workplace for nearly 100 years. Assuring that consumers can purchase safe and effective medication is of primary concern to our organization.

The National Consumers League supports FDA's proposed labeling requirements for over-the-counter (OTC) drug products. As consumers assume greater responsibility for their own health, and as more drugs become available over-the-counter, consumers must be provided with easy-to-read and understandable information on the drug label. While the League applauds FDA's efforts in this area, we have some comments on ways to make labels even more consumer-friendly.

There is an increasing need for consumers to have easily readable and understandable information about OTC drugs. Information on active ingredients, warnings, contraindications, directions, purposes, and other information, must be legible and accessible as OTC drug products are now widely available and used without medical supervision, and as more potent drugs have been switched from prescription to OTC status. Furthermore, consumers are becoming more actively involved in their own health care, and are practicing self-diagnosis and self-medication with OTC drug products. Thus, it is extremely important that OTC drug products be clearly and uniformly labeled to ensure their safe and effective use by consumers.

The new label not only responds to consumers taking greater responsibility for their health, but also complements the ongoing work of the Department of Health and Human Services (HHS) in assuring consumers receive written information on their prescription medications. It is just as important, if not more so, for consumers to receive comprehensible written information about OTC drugs. The information presented on the label of an OTC drug is most likely the only information a consumer will receive regarding proper use of the medication and any safety warnings.

The National Consumers League generally supports the FDA's proposed labeling rule, particularly supporting seven important aspects of FDA's proposal:

• The requirement that a minimum of 6 point type be used on the label. NCL also supports the FDA guidelines concerning leading and kerning of type face. In order for the information appearing on the new OTC drug label to be of any use to the consumer, it must be in large enough type size, with adequate spacing, to be legible. Studies have shown that a significant proportion of the adult population, particularly those 65 and over, is not able to read a small and compressed type setting and size¹. The United States population continues to age, and the elderly represent a very large percentage of those taking prescription and OTC medications. Further, visual acuity declines with advancing age, thus, it is imperative that OTC drug labels be clear and easy to read. As one study stated, "because many elderly individuals cannot accurately read the labeling on OTC labels, and because the elderly tend to use more medications, we can assume that they are at a higher risk of having adverse side effects due to improper usage of these [OTC] medications."²

• The NCL also strongly supports the FDA's proposed rule regarding the ordering of the label information, particularly the listing of the drug's active ingredients and purpose first. With this information, the consumer is more easily able to determine what is in the drug product, what it is intended to treat, and to compare products.

• NCL also supports the rule's provision allowing certain terms to be used interchangeably on the label, as this should promote greater comprehension among people with low or moderate literacy skills.

• The League further supports the rule's provision calling for uniformity of labels for all OTC drug products.

• NCL supports FDA's proposal to preempt different and additional state labeling requirements. There should be one nationally uniform system of OTC drug product labeling.

• The League supports the FDA's decision to conduct research focusing on consumer reading and comprehension of information from the revised format, compared to existing labeling, particularly for people at low or moderate literacy levels. The League also supports FDA's efforts to conduct research on consumer judgments about OTC drug products and the overall effects on consumer behavior, as well as public health impacts, of the imposed OTC drug labeling.

• The League supports the use of alternative packaging designs to increase available labeling space. The League also supports the FDA's belief that the available surface area of the labeling on a number of products could be increased without changing the size of the current container or package. The League further suggests that applicants, manufacturers, packers, or distributors make more efficient use of the surface area of labeling to better present the necessary and required information. This too, will allow labeling to accommodate the increase to 6-point type without having to increase package or container size.

The above-mentioned provisions will greatly enhance consumers' knowledge about the safe and effective uses of OTC's as well as allow consumers more ability to make the appropriate choices regarding cost, purpose, and other factors.

While the NCL supports the new labeling format, we also believe it could be made even more consumer-friendly with some important additions. Adding the sentence, "If you have any questions about this medication, consult a pharmacist or other health professional," at the bottom of the label would direct consumers to the proper sources for additional verbal guidance on using the OTC products. Although the new label is quite comprehensive, consumers may still have questions that are best answered by a health care professional--either face-to-face, or by phone. Consumers should be specifically encouraged to consult a pharmacist because they are trained to counsel and give advice on OTC products and are usually immediately accessible to the consumer at the point of sale.

The new label format should also include in the accidental overdose or ingestion warning the recommendation to contact a "poison control center." FDA proposes to delete the recommendation because poison control centers do not exist in every state. However, for consumers who do have access to poison control centers, they should be instructed to utilize this valuable resource. The label should state that in case of accidental overdose or ingestion, "get medical help right away or contact a poison control center."

Having discussed the OTC labeling issue with the Nonprescription Drug Manufacturers Association (NDMA), NCL, while agreeing for the most part with NDMA, has some reservations about specific points of their position.

Warning Consolidation: NCL believes that there should be no elimination of separate "specialty" warning sections. This section would draw attention to specific warnings that people may need to know about in order to avoid injury or illness. While the general warning section will suffice for the general population without special needs or conditions, those people who have certain conditions (i.e., pregnant women or those with diabetes), may need to pay special attention to "specialty' warnings that, if ignored, could cause adverse reactions from use of these OTC drug products.

Provisions for Brand names and Product Attributes on the Information Panel: While NCL agrees that product attributes aid in proper understanding and use of the product, we do not feel that it is necessary to include them on the information panel, especially if doing so eliminates space for other, and more important information (i.e., active ingredients, warnings, directions). Attribute information can be easily displayed on the Principal Design Panel and does not need to be included on the information panel. Furthermore, we are opposed to providing reserved space on the information panel for brand names and attributes. Placing brand names on the information panel serves no other purpose but additional advertising/marketing and product reinforcement. It does not add to the necessary information that consumers need to make the proper choices for OTC drug products. Instead, it detracts from the space on the information panel, which is already at a premium. Again, there is ample space on the remainder of the packaging to display brand names and attributes without having to be on the information panel

Thank you for this opportunity for the National Consumers League to comment on FDA's proposed regulations on Over-The-Counter Drugs and Proposed Labeling Requirements. NCL strongly supports the FDA's efforts to make OTC drug labeling even more consumer-friendly, and we look forward to working with the Agency to ensure that its final rule is a consumer-friendly as possible.

Respectfully submitted,

LINDA F. GOLODNER
President

² Ibid.