May 12, 2025

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.  Your partnership, knowledge and engagement in the public health space are appreciated. 

Sincerely,

The Public Engagement Staff
Public Engagement Staff | FDA

Updates

• May 9, 2025 - FDA and NIH Announce Innovative Joint Nutrition Regulatory Science Program
• May 9, 2025 - FDA Approves Three Food Colors from Natural Sources
• May 8, 2025 - FDA Grants Accelerated Approval to the Combination of Avutometinib and Defactinib for KRAS-Mutated Recurrent Low-Grade Serous Ovarian Cancer
• May 8, 2025 - FDA Alerts Industry and Consumers about Palm Leaf Dinnerware
• May 8, 2025 - FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline
• May 8, 2025 - Front-of-Package Nutrition Labeling Comment Period Extension
• May 7, 2025 - FDA Advises Consumers, Tattoo Artists, and Retailers to Avoid Using or Selling Certain Sacred Tattoo Ink Products Contaminated with Microorganisms
• May 6, 2025 - FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities
• May 6, 2025 - CORE 2023 Annual Report - Investigations of Foodborne Outbreaks and Adverse Events in FDA-Regulated Foods

MedWatch: The FDA Safety Information and Adverse Event Reporting Program

The FDA’s medical product safety reporting program for health professionals, patients and consumers.  MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products.  The most recent alerts/recalls are:

• Raven Black and Sunny Daze Tattoo Ink Products by Sacred Tattoo Ink: Alert - Avoid Using or Selling Certain Products Contaminated with Microorganisms
• Endurance Boost with Horny Goat Weed Capsules by EnShiShiXiangNiShangMaoYouXianGongSi
• New “Gas Station Heroin” Tianeptine Product Trend
• Male Ultra, Malextra, Electro Buzz, Ultra Armor and Male Ultra Pro by Health Fixer

Consumer Updates

National Women's Health Week (NWHW) May 11-17, 2025

Join FDA Office of Women’s Health (OWH) in celebrating National Women’s Health Week (NWHW) May 11-17, 2025.  NWHW is an annual weeklong observance designed to encourage all women to prioritize their health.  The FDA OWH theme for this year is “Know Your Pelvic Floor.”  Pelvic floor health is an important part of a woman’s overall well-being.  Approximately 1 in 4 women will experience a pelvic floor disorder (PFD).  FDA OWH encourages all women to learn more about their pelvic floor—including the risk factors and symptoms of different types of pelvic floor disorders, treatment options and proactive steps to take to strengthen and support their pelvic floor.

Tianeptine Products Linked to Serious Harm, Overdoses, Death

People seeking to treat their ailments sometimes mistake a product as being safe because it’s easily available, whether online or even at gas stations.  But availability is no indication of effectiveness or safety.  This is especially true of tianeptine products, which have been associated with serious health risks and even death.  Tianeptine, a drug, is not approved by the U.S. Food and Drug Administration for any medical use.

Guidance Documents

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!

FDA Direct with Dr. Martin Makary, FDA Commissioner

Webinars and Virtual Workshops

Meeting of the Oncologic Drugs Advisory Committee

Tue, May 20, 2025; 8:00 a.m. - 5:00 p.m. ET
Wed, May 21, 2025; 8:00 a.m. - 5:00 p.m. ET

Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science.

OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration

Tue, May 20, 2025; 1:00 - 2:00 p.m. ET

This webinar will provide an overview of the Over-the-Counter Drug User Fee Program (OMUFA) and describe the key elements of the program as it relates to OMUFA user fees.

Primary Mitochondrial Diseases Virtual Public Workshop

Thu, May 22, 2025; 10:00 a.m. - 4:00 p.m. ET

The Reagan-Udall Foundation for the FDA, in collaboration with the Food and Drug Administration, will host a virtual public workshop on "Primary Mitochondrial Diseases."  This workshop will explore opportunities to optimize therapeutic development addressing primary mitochondrial diseases and best practices in designing and interpreting clinical studies that can produce meaningful data to accelerate drug development for these rare diseases.

Vaccines and Related Biological Products Advisory Committee Meeting Announcement

Thu, May 22, 2025; 8:30 a.m. - 4:30 p.m. ET

On May 22, 2025, the committee will meet in open session to discuss and make recommendations on the selection of the 2025-2026 Formula for COVID-19 vaccines for use in the United States.

Fiscal Year 2025 Generic Drug Science and Research Initiatives Public Workshop

Tue, June 03, 2025; 8:00 a.m. - 5:30 p.m. ET
Wed, June 04, 2025; 9:00 a.m. - 4:30 p.m. ET

The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives.

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.