FDA OTC labeling "statement of identity" survey to involve 216 participants.

OTC COMBO ACTIVE INGREDIENTS LISTING ON PRINCIPAL DISPLAY PANEL TO BE EVALUATED in a consumer comprehension labeling study planned by FDA. The purpose of the study, which addresses the "statement of identity" on OTC drug product labels, "is to investigate consumers' perceptions, processing and evaluation of the placement of active ingredient information on the front and/or back portion of the product package," FDA says in an Aug. 6 "supporting statement" on the proposed research.

The agency previously announced plans to conduct the consumer study, along with a survey to assess consumer understanding of an alcohol warning on analgesics, in the May 23 Federal Register ("The Tan Sheet" June 2, p. 8). Comments on the studies are being accepted until Sept. 30. FDA is planning a total of four studies on consumer comprehension of OTC labels. The two other studies combined are expected to involve over 2,000 subjects ("The Tan Sheet" May 26, p. 4).

The active ingredient in "single ingredient" OTCs is usually listed on the principal display panel, along with the brand name and general pharmacological category of the drug, FDA notes. However, for combinations, "only the general pharmacological category or intended action of the active ingredient mixture (in terms meaningful to the layman) are displayed in conjunction with the most prominent listing of the brand name."

In its Feb. 27 proposed rule on standardized OTC labeling, FDA does not call for changes to the principal display panel ("The Tan Sheet" March 3, pp. 1-9). However, "some have argued" that active ingredients should be listed on the principal display panel of OTC combination products "so that consumers would have ready access to that information at the time of purchase," FDA notes. "This would prompt or more readily permit consumers to make product decisions on the basis of product ingredients," the agency explains.

"Others have argued that such information is readily available for consumers who simply examine the back panel," FDA continues, "and that listing all of the [active ingredients] for combination OTC products would distract from the overall communication of product identity, make the package unattractive or lessen the communication of other information listed" on the principal display panel. Mock labels used in the study will simulate that of analgesics and cough/cold products, which are two OTC drug classes that include multiple active ingredient products, the agency notes.

Two "placements" for the active ingredients will be evaluated. For both, the brand name and pharmacological activity name will appear on the principle display panel, and the active ingredients list will be placed on the back panel. In the second "placement," the active ingredients will be listed on both the front and back panel. Approximately 216 participants will be recruited for the mall intercept study. Participants will be over 18 and able to read English.

Participants will be asked to compare three package designs within each drug class. Any reference to ease of reading, consumer friendliness, "neatness" or other evaluation of the package will be recorded. Participants also will be asked to describe the "advantage or benefit" of each product as a means of assessing the degree to which the number or placement of active ingredients influence product perception, FDA says.

FDA postulates that consumers may process active ingredient label information on the principal display panel using two basic decision-making processes. On one hand, the agency says, consumers may include the ingredient information as part of a systematic decision process. "Here, consumers integrate the [active ingredient] information along with other information about the product in an effortful and careful process," the agency explains. "For example, they may seek to determine if the ingredients listed are appropriate for the conditions they seek to treat." On the other hand, consumers may use active ingredients "as a `signal' that is processed more superficially as part of a `judgment heuristic' that forms the basis for a purchase decision," according to the agency.

"Judgment heuristics allow individuals to make simple, quick decisions requiring little effort" and where information is "unsystematically analyzed," FDA explains. For example, the agency says, "instead of carefully considering the effect of" the individual active ingredients on their symptoms, consumers "would rely on the `signal value'" of the active ingredient list to "form impressions and make decisions (e.g., the more [active ingredients] the more potent the medicine, the more value for their money)." Thus, while listing the active ingredients on the principal display panel "may allow the consumer to make systematic comparisons, it may also increase the use of [active ingredients] as a cue for heuristic decision-making."