Food and Drug Administration's Suggested Consumer Research Ideas

Citation:

William B. Schultz (1996) ,"Food and Drug Administration's Suggested Consumer Research Ideas", in NA - Advances in Consumer Research Volume 23, eds. Kim P. Corfman and John G. Lynch Jr., Provo, UT : Association for Consumer Research, Pages: 316.

Advances in Consumer Research Volume 23, 1996      Page 316

FOOD AND DRUG ADMINISTRATION'S SUGGESTED CONSUMER RESEARCH IDEAS

William B. Schultz, Food and Drug Administration

Senior staff at the Food and Drug Administration (FDA) were asked, "In what areas would consumer research be helpful, especially where rulemaking is concerned?" The suggestions that were raised in response to this question fall into a few categories: patient information, food/drug labeling and tobacco. The following is a broad overview of the ideas that were suggested, along with the names of contact people who would be able to provide more detailed information:

1. Patient Information:

The FDA has proposed a program called Medication Guides, a voluntary initiative that would encourage pharmacists to distribute information (a patient information leaflet) about a drug at the time that the patient receives the medication. There are issues that need to be researched regarding this area, including:

! Who is the "average" consumer;

! What sort of format is the best to convey important information to the consumer;

! Which information is absorbed and which is ignored, why, and how can more information be absorbed; and

! If a patient reads information, i.e. dosage instructions and warnings, does having knowledge affect patient behavior (for example, will giving patients the information have the desired effect of improving patient compliance and ability to avoid adverse reactions)?

2. Labels:

Another common theme for consumer research would involve labelsCboth for food and over-the-counter (OTC) drugs. The FDA has recently implemented the Nutrition Labeling and Education Act, which requires nutrition information on packaged foods. The FDA hopes to assess how consumers use these new "Nutrition Facts" labels. Similarly, FDA is currently developing a labeling initiative for OTC drugs. Also, many cosmetics have labeling that people should read before use. Issues surrounding these intiatives include:

! Comprehension of the labelsCFDA has heard complaints from groups such as senior citizens who find the new food label difficult to understand, particularly the "serving size" area, and how it relates to the entire package. What can be done to make this information clearer to all readers;

! Use of sunscreenCthere is a rising incidence of skin cancer in the United States; is this due to lack of education about the dangers of being in the sun, or due to failure to use sunscreen/cosmetics with a high enough SPF;

! How often consumers actually read nutrition labels;

! Does having nutrition information affect consumer behavior, i.e. diet or product selection;

! Could a label on OTC drugs increase patient awareness;

! Would improved or revised OTC labeling affect consumer product selection; and

! Will improving OTC drug labeling result in improvements in product use (e.g. avoiding adverse reactions)?

3. Tobacco:

Last August, the FDA published a proposed regulation restricting the access of tobacco for minors. A large part of this regulation dealt with the effect of advertising on underage use of tobacco. A great deal of consumer research was used to support the proposed rule. Some areas where additional consumer research on tobacco may be useful to the agency include:

! How can one best gauge the effect of an educational campaign against tobacco use on underage smoking;

! What would comprise an effective educational campaign;

! What is the best design for anti-smoking messages for youths/teens; and

! How successful would "tombstone" (black-and-white, text- only) advertising be in reducing teen tobacco use?

The above suggestions provide broad ideas. For more detailed discussions regarding these topics, please contact Paul Coppinger in the Office of Planning and Evaluation at (301)443-4230, or one of the following contact people:

Tobacco-related issues: Judy Wilkenfeld, Office of Policy, (301) 827-3350

Patient Information: Lou Morris, Center for Drug Evaluation and Research, (301) 827-2828

Food Labeling: Alan Levy, Center for Food Safety and Nutrition (301) 205-9448

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