Series Description

The FDA Grand Rounds is webcast every other month to highlight cutting-edge research underway across the agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities.

Lecture Description
This lecture will explain FDA's general approach to safety assessment of food Ingredients and the regulatory pathways for pre-market safety assessment by FDA. Two case studies will be presented (aspartame and BVO) of recent updated assessments and regulatory actions will be highlighted to showcase FDA ongoing post-market review of ingredients on the market.

References

• https://www.fda.gov/food/food-additives-and-gras-ingredients-information-consumers/understanding-how-fda-regulates-food-additives-and-gras-ingredients
• https://www.cfsanappsexternal.fda.gov/scripts/fdcc/?cat=FoodIngredientsPackaging
• https://www.fda.gov/food/cfsan-constituent-updates/fda-proposes-rule-revoke-regulation-allowing-use-brominated-vegetable-oil-bvo-food
• https://www.who.int/news/item/14-07-2023-aspartame-hazard-and-risk-assessment-results-released

Series Objectives

• Discuss the research conducted at the FDA
  
• Explain how FDA science impacts public health

Learning Objectives After completion of this activity, the participant will be able to:

• Describe the safety assessment approach used by FDA to evaluate ingredients for safety.
• List the regulatory approaches for pre-market review and evaluation for all food additives and GRAS uses.
• Discuss FDA findings and actions related to safety and use of BVO and aspartame in food.

Target Audience
This activity is intended for physicians, pharmacists, nurses, and other scientists within the agency and external scientific communities.

Requirements for Receiving CE Credit

Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.

Disclosure

Faculty

• Muldoon Jacobs, Kristi, PhD, Director, Office of Food Additive Safety, FDA - nothing to disclose

Planning Committee

• Dinatale, Miriam, DO, Team Leader, Food and Drug Administration - nothing to disclose
• Pfundt, Tiffany, PharmD, Program Coordinator, FDA/CDER/OTBB - nothing to disclose
• Wheelock, Leslie, RN, MS, Director, OSPD, FDA, OC, OCS, OSPD - nothing to disclose

CE Consultation and Accreditation Team

• Bueide, Rachel E., MPhil, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
• Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
• Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose

Registration Information
Registration is complimentary; therefore refunds are not applicable.