December 9, 2024

Dear Colleague, 

The FDA works to safeguard the public against potential health risks, ensures the safety and efficacy of medical products, and the safety of our nation’s food supply and cosmetics. The Public Engagement Staff is responsible for engaging, educating and communicating with external partners including patients, caregivers, health care providers, consumers, academia and trade associations on the agency’s policy priorities. We also recognize the invaluable work of our external partners in achieving these goals. Your partnership, knowledge and engagement in the public health space are appreciated. 

Sincerely,

The Public Engagement Staff
Public Engagement Staff | FDA

Updates

• December 6, 2024 – Outbreak Investigation of Salmonella: Cucumbers (November 2024)
• December 6, 2024 - FDA Roundup
• December 5, 2024 - What Is the FDA Doing to Reduce the Diabetes and Obesity Epidemics in America and Take on the Greed of the Food and Beverage Industry?
• December 5, 2024 – Working with States, FDA Warns More than 100 Retailers for Illegal Sale of Youth Appealing E-Cigarettes, Including Geek Bar
• December 4, 2024 – FDA grants accelerated approval to zenocutuzumabzbco for non-small cell lung cancer and pancreatic adenocarcinoma
• December 3, 2024 - USDA-FDA Seek Information About Food Date Labeling, Aim is to Provide Further Clarity, Transparency and Cost Savings for U.S. Consumers
• December 3, 2024 – FDA Issues Warming About Certain Supplements Substituted with Toxic Yellow Oleander (January 2024)
• December 3, 2024 - Outbreak Investigation of E. coli O157:H7: Onions (October 2024)
• December 3, 2024 - FDA Roundup
• December 2, 2024 – FDA Issues 2024 Voluntary National Retail Food Regulatory Program Standards

Spotlight!

FDA’s New Chapter | FDA In Your Day Ep. 17

Recently, the FDA completed one of its largest transformations, impacting almost every part of the agency. This installment of FDA In Your Day highlights two of the many examples of the important work the FDA is doing every day to keep us safe!

Consumer Updates

Keep Your Dogs and Cats Safe From Holiday Hazards

Happy holidays? Not if your pet gets sick. The Food and Drug Administration’s Center for Veterinary Medicine discusses some unhealthy holiday temptations and how to keep your pets safe.

FDA Voices

Youth Tobacco Product Use Continues to Decline as FDA Actions Build Momentum

By: Dr. Brian King, Director of FDA’s Center for Tobacco Products

As Director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), I often reflect on conversations with the public, including the people behind tobacco product use statistics. This type of reflection started in the early days of my career when I answered calls for a tobacco quit line. On a daily basis, I spoke with people who had a desire to quit smoking. Each had a different reason for wanting to quit: living to meet their grandchildren, walking their child down the wedding aisle, or taking a dream vacation with their spouse. While their reasons varied, they had heartbreaking similarities – a deep desire to be there for their families and to celebrate life’s precious moments with the ones they love.

Guidance Documents

Draft Guidance for Industry: Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions

CVM GFI #49 Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine Mastitis

Accelerated Approval – Expedited Program for Serious Conditions

Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry

View all Official FDA Guidance Documents and other Regulatory Guidance

You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.

ICYMI!

Primary Care Providers Can Prescribe with Confidence

An estimated 5.7 million people over the age of 12 have an opioid use disorder (OUD) in the United States. Based on that prevalence, if you are a primary care provider it is very likely that you already provide medical care to people who also have OUD.

Webinars and Virtual Workshops

NIH-FDA Nutrition Regulatory Science Workshop

December 17 - 18, 2024; 1 - 2 p.m. ET

The U.S. continues to face high rates of morbidity and mortality from diet-related diseases. The U.S. Food and Drug Administration (FDA) uses evidence-based approaches to help advance nutrition and support healthier dietary patterns in the U.S. However, critical research gaps and limited awareness of research resources related to nutrition regulatory science remain. The National Institutes of Health (NIH) has invested in a wide range of nutrition-related initiatives, research resources, and infrastructure that could be leveraged and augmented to further inform FDA efforts and benefit public health.

Webinar on Allergen Labeling for Retail Food Stores and Food Service Establishments

December 18, 2024; 2:00 - 2:45 p.m. ET

Labeling errors associated with undeclared allergens are one of the leading causes of food recalls in the U.S. Therefore, it is important for industry, including retail food stores and food service establishments, to follow FDA’s food allergen labeling requirements. This webinar is intended to help industry better understand and comply with these requirements.

View Upcoming FDA Meetings, Conferences and Workshops

Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts

About Us

The Public Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, patients and patient advocacy organizations, consumer groups, trade associations, think tanks and academia, and other interested parties, in order to better inform our policy making process, identify policy hurdles or misconceptions, and create strategic collaborations. For more information, please contact us at: PublicEngagement@fda.hhs.gov. For patient specific inquiries, please contact us at: Patients Ask FDA.