Defining “Candy-Like” Nonprescription Drug Products

The Food and Drug Administration will be hosting the following public workshop entitled “Defining Candy-Like Nonprescription Drug Products.”  The purpose of the public workshop is to bring together stakeholders from FDA, academia, and industry to discuss areas where improvements could be made to further define formulation and labeling requirements for drug products that may be considered “candy-like.”

The public workshop was held on October 30, 2023, planned from 8:30 AM to 4:00 PM Eastern Time. 

Registration is free and based on space availability, with priority given to early registrants.  Persons interested in attending this public workshop must register by October 23, 2023, 5:00 PM. Eastern Time.  Early registration is recommended due to limited seating; therefore, FDA may limit the number of participants from each organization.  Registrants will receive confirmation when they have been accepted.  If you need special accommodations due to a disability, please contact ONDPublicMTGSupport@fda.hhs.gov no later than October 9, 2023.  This public workshop will also be via Zoom. A link will be provided via email to registered participants.  

The public workshop will be held at the FDA White Oak Campus Great Room and online. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. 

Background

On Friday, March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law to include statutory provisions that reform and modernize the way over-the-counter (OTC) monograph drugs are regulated in the United States.  Under this OTC monograph reform legislation, referred to as the OTC Monograph User Fee Act (OMUFA), key changes to the OTC monograph process include a manufacturer’s ability to make minor dosage form changes without FDA issuing regulatory action if the product meets a number of legally defined requirements.  

In addition to the changes outlined under OMUFA, confectionary-based dosage forms are becoming more prevalent in the nonprescription space as manufactures seek to appeal to consumers and make drugs more palatable. However, these products are easily confused with candy and non-drug products, resulting in misuse and inadvertent overdose, particularly among young children. In anticipation of potential nonprescription drug dosage form innovation, FDA is seeking ways to further define features of drug products that could be considered “candy-like.”

Topics for Discussion at the Public Workshop

The workshop will include presentations and panel discussions on various topics related to solid oral “candy-like” dosage forms, including the following:

• formulation considerations for developing palatable drug products,

• implications of candy-like characteristics on medication adherence in pediatric and geriatric populations, 

• assessment of accidental pediatric exposure to candy-like medications, 

• and strategies to prevent medication overdose of “candy-like” medications.