The U.S. Food and Drug Administration announced today that it issued warning letters to eight retailers for selling unauthorized tobacco products, including nicotine pouches and dissolvable tobacco products. The tobacco products cited in the warning letters look like candy, breath strips, and cough drops. https://lnkd.in/e8G9UcQg Products that imitate these everyday items pose dual concerns: They can accidentally be ingested by young children and may appeal to children looking to disguise the nature of the products from parents, teachers, or other adults. These warning letters are part of FDA’s efforts to remove unauthorized tobacco products from the market, particularly those that may appeal to children.
About us
The Food and Drug Administration is an agency within the Department of Health and Human Services. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.
- Website
-
http://www.fda.gov/
External link for FDA
- Industry
- Government Administration
- Company size
- 10,001+ employees
- Headquarters
- Silver Spring, MD
- Type
- Government Agency
- Specialties
- Food, Drugs, Medical Devices, Vaccines Blood and Biologics, Animal and Veterinary, Cosmetics, Radiation-Emitting Products, Tobacco Products, Regulatory Research, and Toxicological Regulatory Research
Locations
-
Primary
Get directions
10903 New Hampshire Ave
Silver Spring, MD 20993, US
Employees at FDA
Updates
-
On #ClinicalTrialsDay, we celebrate everyone involved in clinical trials. This includes individuals who participate in research, run clinical trials, and review data. In recognition of this day, CDER’s Center for Clinical Trial Innovation (C3TI) shares a personal reflection from an FDA Clinical Reviewer and C3TI Champion on the importance of innovating clinical trials. https://lnkd.in/gB_uy_XK This reflection describes the challenges of clinical trial enrollment and the need for streamlining recruitment efforts to pave the way for more efficient, and hopefully faster, evidence generation that may lead to new therapeutic options. Now in its third year, C3TI continues to evolve to support innovation in clinical trials. Please visit our webpage to learn more: https://lnkd.in/gwmKUxsj Subscribe to our newsletter to stay up to date on advances in clinical research: https://lnkd.in/eauuDa8g
-
-
⏱️REdI 2026 is here! Don't miss your chance to learn from FDA experts in all three medical product centers. Gain essential regulatory knowledge in drugs, devices, and biologics. 🗓️ Register and join today 👉 https://lnkd.in/e8B-DJFe
-
-
⏱️REdI 2026 is approaching! Don't miss your chance to learn from FDA experts in all three medical product centers. Gain essential regulatory knowledge in drugs, devices, and biologics. 🗓️ Save the date and register today 👉 https://lnkd.in/e8B-DJFe
-
-
Today, the FDA issued an EUA for an over-the-counter injectable drug for New World screwworm infestations in dairy cattle, horses, swine, sheep, and deer. https://lnkd.in/e6M7ARij
-
-
⏱️REdI 2026 is approaching! Don't miss your chance to learn from FDA experts in all three medical product centers. Gain essential regulatory knowledge in drugs, devices, and biologics. 🗓️ Save the date and register today 👉 https://lnkd.in/e8B-DJFe
-
-
Developing patient-centric oral formulations? This virtual workshop is for you! Learn about regulatory strategies for specialized dosage forms, pediatric formulation development, swallowability considerations, innovative physiologically based pharmacokinetic (PBPK) modeling approaches, and more at our FDA AGDD workshop. Reserve your spot. Join us on June 11, 2026, via Adobe Connect. https://lnkd.in/eUCVrB3Y
-
-
On May 15, 2026, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (T-DXd, Enhertu, Daiichi Sankyo, Inc.) for two separate indications in adults with HER2-positive early-stage breast cancer. The first indication is for T-DXd followed by a taxane, trastuzumab, and pertuzumab (THP), for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test. The second indication is for T-DXd for the adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant treatment with trastuzumab (with or without pertuzumab) and taxane-based treatment. https://lnkd.in/ehTzcGGu FDA also approved two companion diagnostic devices, the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody and the VENTANA HER2 Dual ISH DNA Probe Cocktail, both for identifying HER2-positive (IHC3+ or ISH+) patients for treatment with T-DXd, consistent with the approved drug labeling. The prescribing information includes warnings and precautions for neutropenia and left ventricular dysfunction. Learn more in the FDA-approved prescribing information at: https://lnkd.in/emUfeBq
-
-
Last chance to register for the June 23 Patient Listening Session on CAR T Cell Therapy! ⬇️
The FDA wants to hear from you! If you or a child you care for received CAR T cell therapy, we invite you to share your experience post-treatment long term follow up studies directly with the FDA staff. • What: FDA Patient Listening Session on CAR T Cell Therapy • When: June 23, 2026 ➡️ What happens at a Listening Session? A small group of people who receive CAR T cell therapy or care for a child who received CAR T cell therapy will share their firsthand experiences with FDA staff. We want to understand: • The burden, barriers and challenges of adhering to long term follow up studies after receiving an FDA-approved CAR T cell therapy. • Any unique burdens, barriers and challenges for pediatric and young adult patients including those in college who may be returning home only during college breaks. • For patients who develop a new cancer after CAR T cell therapy, the burdens, barriers, and challenges of receiving a workup after the secondary malignancy is found, including biopsies and appropriate testing for their tumor specimen. ➡️ Who can participate? Patients (adult or young adult) and caregivers of pediatric patients who received an FDA-approved CAR T cell therapy. Participants will be selected based on various factors including age and geographic location to ensure a variety of perspectives. ➡️ How to participate: Space is very limited. If you're interested in participating, please complete this brief interest survey by May 18, 2026: https://lnkd.in/eMXQ7xE6 Your voice matters. Help the FDA better understand what it's like to be in a CAR T cell therapy follow up study. #FDA #PatientListeningSession #CARTCellTherapy
-
-
Food safety is a shared responsibility, and collaboration across government, industry, and academia is essential to protecting public health. Human Foods Program Acting Deputy Commissioner Donald A. Prater was proud to participate in the 2026 Food Safety Summit, joining leaders from across the food ecosystem to discuss prevention-focused strategies, modernization efforts, supply chain oversight, and emerging food safety challenges. These conversations help strengthen our nation’s food safety system and support consumer confidence. Learn more about the FDA Human Foods Program’s collaborative efforts here: https://lnkd.in/eXvZJxMr
-