WASHINGTON, D.C., July 14, 1997 -- The National Consumers League is a national nonprofit consumer organization that has represented consumers and workers in the marketplace and workplace for almost 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 (OTC), consumers must be provided easy-to-read and understandable information on the drug label. While the League applauds FDA's efforts in this area, we have a few comments on ways to make the label even more consumer-friendly.
I. Consumers Are Assuming Greater Responsibility for Their Own Health
There is evidence that consumers are more health conscious today than ever before --
and the government has responded to consumers' need for more information to help
them make wise health decisions. The new food label is an example of government
response to consumers' desire for information on the nutritional content of food products.
The proposed OTC label is another response to consumers who want to be better
informed about what is in an OTC product, what it is used for, and what are the risks and
benefits of the taking the medication.
Increasingly consumers are practicing self-diagnosis and are self-treating with OTC drug products instead of seeing a physician. Understandable labels will help consumers choose the right medication and avoid harmful mistakes. By reading an OTC label, consumers should be able to determine if this is the appropriate drug for the condition being treated, the benefits of the drug, necessary precautions, and when to consult a pharmacist or other health professional.
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 in assuring consumers receive written information on their prescription medications. It is just as important, if not more important, 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 on how to take the medication safely.
II. More Prescription Drugs Now Available Over the Counter
Consumers are now able to purchase over-the-counter drugs previously only available by
prescription. With nearly 70 prescription products now switched to OTC, consumers are
asking more questions about using these products correctly. To avoid medication errors
when using these drugs, consumers must have clear, concise information readily
available. Information on a drug's active ingredients and purpose is especially important
for consumers using unfamiliar drugs.
III. Comments on Specific Provisions of the Proposed Labeling Rule
The National Consumers League generally supports the FDA's proposed labelling rule,
particularly the requirement that a minimum of 6 point type be used on the label. 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 to be legible. Surveys have shown
that a significant proportion of the adult population is not able to read a smaller size
type, such as 4.5. Even with 6 point type, some elderly consumers and others who have
vision impairment will be unable to read the label.
The League also strongly supports the order of the label information required by the proposed rule, particularly the listing of the drug's active ingredients and purpose first. With the active ingredients first, the consumer is easily able to determine what is in the drug product being purchased and to compare products. In addition, the rule's provision allowing certain terms to be used interchangeably on the label will promote greater comprehension among people with low or moderate literacy skills.
While the League supports the new labelling format, we also believe it could be made even more consumer-friendly with a few additions. Adding at the bottom of the label the sentence "If you have any questions about this medication, consult your pharmacist or other health professional" would direct the consumer to the proper sources for additional verbal guidance on using the OTC products. Although the new label is fairly comprehensive, consumers will still have questions that are best answered face-to-face. 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 purchase.
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. But 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."
Thank you for providing this opportunity for the National Consumers League to present our views on this important rule to the FDA.