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 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. 


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. 

Hybrid Public Workshop

Location: FDA Great Room, Building 31, 10903 New Hampshire Ave., Silver Spring, MD 20993
Date: October 30, 2023

Session 1: Formulation Considerations for Solid Oral Candy-Like Dosage Forms (Recording

Welcome & Opening Remarks 


Theresa Michele, Office of Nonprescription Drugs, FDA    
8:45 a.m. - 9:05 a.m. 

Overview of USP Monographs

Natalia Davydova, United States Pharmacopeia (USP)

 Presentation (PDF)  
9:05 a.m. - 9:25 a.m. 

Drug Product Palatability

David Tisi, Senopsys

 Presentation (PDF)  
9:25 a.m. - 9:45 a.m

3D Printing Technologies for Oral Drug Deliver

Xiaoling Li, Thomas J Long School of Pharmacy, University of the Pacific

 Presentation (PDF) 
9:45 a.m. - 10:30 a.m. 

PANEL 1: Formulation Considerations for Solid Oral Candy-Like Dosage Forms

Moderator: Danae Christodoulou, Office of Pharmaceutical Quality, FDA

Panelists: Natalia Davydova, Jeffrey Worthington (Senopsys), Xiaoling Li,
Swapan De (Office of Pharmaceutical Quality, FDA)




Session 2: Exploring the Impact of Candy-Like Characteristics on Medication Adherence in Pediatric and Geriatric Populations (Recording)

10:40 a.m. - 11:00 a.m. 

Impact of Candy-Like Characteristics on Medication Adherence in Pediatric Populations

Rachel Meyers, Ernest Mario School of Pharmacy, Rutgers University

 Presentation (PDF)  

11:00 a.m. - 11:20 a.m. 

International Perspectives: Appropriate Pharmaceutical Design of Oral Medicines in Pediatric and Geriatric Populations

Catherine Tuleu, University College London School of Pharmacy

 Presentation (PDF)  

11:20 a.m. - 11:40 a.m. 

Use of Sedative Gummy Bears Compared to Oral Syrups in Pediatric Dental Patients

Judith Chin, Department of Pediatric Dentistry Nova Southeastern College of Dental Medicine

 Presentation (PDF)  

11:40 a.m. - 12:25 a.m. 

PANEL 2: Exploring Candy Market Trends and Implications for Medication Adherence in Pediatric and Geriatric Populations

Moderator: Gilbert Burckart, Office of Clinical Pharmacology, Pediatrics, FDA

Panelists: Rachel Meyers, Catherine Tuleu, Judith Chin

12:25 p.m. - 1:30 p.m. 



Session 3: Assessment of Accidental Pediatric Exposure to Candy-like Nonprescription Medications and Potential Overdose Mitigation Strategies (Recording)

 1:30 p.m. - 1:50 p.m. 

A Case Study of Unintended Consequences: Children and “Candy”

Aspirin in Twentieth Century America
Cynthia Connolly, University of Pennsylvania, School of Nursing

Presentation (PDF) 
1:50 p.m. - 2:10 p.m. 

Preventing Pediatric Medication Overdose: Strategies, Challenges, and Innovations

Jennifer Lind and Maribeth Sivilus, The Prevention of Overdoses and Treatment Errors in Children Taskforce (PROTECT) Initiative and Centers for Disease Control and Prevention (CDC)

Presentation (PDF) 
2:10 p.m. - 2:30 p.m. 

Poison Control Guidelines for Overdoses

Christopher Hoyte, Rocky Mountain Poison and Drug Safety (RMPDS)

Presentation (PDF) 
2:30 p.m. - 2:50 p.m. 

Pediatric Ingestions of Gummy-Formulated Medications

Suzanne Doyon, Connecticut Poison Control Center, UConn Health

Presentation (PDF) 
2:50 p.m. - 3:00 p.m.  Break  Break 
3:00 p.m. - 3:50 p.m. 

PANEL 3: Assessment of Accidental Pediatric Exposure to Candy-like Nonprescription Medications and Potential Overdose Mitigation Strategies

Moderator: Kristine Parbuoni, University of Maryland, School of Pharmacy

Panelists: Cynthia Connolly, Jennifer Lind, Maribeth Sivilus, Christopher Hoyte, Suzanne Doyon

3:50 p.m. - 4:00 p.m. 

Closing Remarks and Next Steps

Theresa Michele, Office of Nonprescription Drugs, FDA