- June 9, 2021
On June 9, 2021 the Food and Drug Administration (FDA) is conducting a public workshop entitled “The Nonprescription Drug Facts Label in a Changing Consumer Marketplace 2021.” The purpose of the public workshop is to evaluate the data and information currently available on consumer comprehension of the nonprescription Drug Facts Label (DFL) and to bring together stakeholders from the FDA, academia, and industry to discuss areas where improvements could be made to the format and content of the DFL. The DFL is intended to enable consumers to appropriately self-select and use nonprescription drug products safely and effectively. The FDA is seeking ways to optimize the DFL for consumer use so that it is robust, user-friendly, compatible with traditional text/paper-based presentation, and adaptable for use with new technologies.
ABOUT THE PUBLIC WORKSHOP:
The workshop will include presentations and panel discussions on various topics related to DFL comprehension and opportunities for improvement, including:
- Overview of the current regulatory background.
- Evaluation of successful elements of the DFL and those that can be improved.
- Discussion of consumer behavior studies related to DFL comprehension and adherence.
- Barriers the general population encounters in readability and comprehension of nonprescription drug product labeling.
- Individual consumer characteristics that impact DFL comprehension such as health literacy and specific patient populations.
- Trends in packaging that impact DFL effectiveness.
- Overcoming communication barriers through innovations to the DFL and developing DFL content for the digital space.
In addition to providing input at the public meeting, stakeholders are invited to provide their perspectives on the discussion topics through the public docket.
- The docket closes on August 10, 2021. FDA invites stakeholders to submit research, data, or information relevant to the public workshop topics to the public docket.
EVENT POINT OF CONTACT:
If further information is needed, please contact the OND Public Meeting Support Team at ONDPublicMTGSupport@fda.hhs.gov
|DFL WORKSHOP Speaker Biosummaries||pdf (724.96 KB)|
|Nonprescription Drug Facts Label Workshop Agenda||pdf (107.55 KB)|
|20210609 DFL Presentation Aker||pdf (2.62 MB)|
|20210609 DFL Presentation Bix Becker||pdf (4.27 MB)|
|20210609 DFL Presentation Brach||pdf (786.62 KB)|
|20210609 DFL Presentation Brass||pdf (688.21 KB)|
|20210609 DFL Presentation Catlin||pdf (813.12 KB)|
|20210609 DFL Presentation Kochanowski||pdf (2.20 MB)|
|20210609 DFL Presentation Konya||pdf (1.30 MB)|
|20210609 DFL Presentation Lorick||pdf (1.12 MB)|
|20210609 DFL Presentation Pike-McCrudden||pdf (1.06 MB)|
|20210609 DFL Presentation Richardson||pdf (1.68 MB)|
|20210609 DFL Presentation Scroggs||pdf (481.42 KB)|
|20210609 DFL Presentation Spinner||pdf (970.31 KB)|
|20210609 DFL Presentation Wolf||pdf (1.87 MB)|
|DFL Workshop Transcript||pdf (18.80 MB)|