FDA

To increase transparency, today, FDA unveiled the Chemical Contaminants Transparency Tool, an online searchable database providing a consolidated list of contaminant levels that are used to evaluate potential health risks of contaminants in human foods. Prior to development of the consolidated list, some levels could be found only in specific guidance documents. The CCT Tool provides contaminant levels in one location for ease of searching. https://lnkd.in/eKN99rG8

Today, FDA announced the over-the-counter (OTC) Monograph Drug User Fee Program (OMUFA) facility fee rates for fiscal year 2025 in a Federal Register notice (FRN). This FRN publishes annual OMUFA fees and includes information about fee calculations, due dates, and payment procedures. Learn more: FRN ➡️ https://lnkd.in/eqagFDeB FDA’s OMUFA webpage ➡️ https://lnkd.in/eCUeY2dJ

Today, under the leadership of U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., the FDA is taking steps to enhance its efforts to ensure the ongoing quality, safety, nutritional adequacy, and resilience of the domestic infant formula supply. https://lnkd.in/eUW-a2pb The FDA is announcing a set of actions and initiatives focused on infant formula, such as beginning the nutrient review process and increasing testing for heavy metals and other contaminants. The agency is also encouraging companies to develop new infant formulas and clarify opportunities to help inform consumers about formula ingredients. These enhanced FDA commitments are focused on making sure a strong supply of the sole source of nutrition for formula-fed babies and children remains available for one of our nation’s most vulnerable populations.

The FDA has added hemodialysis bloodlines (product code FJK) to the Medical Device Shortages List. The agency has also determined that the shortages of blood culture media bottles (product code MDB) and Container, I.V. (product code KPE) are resolved and have been removed them from the MDSL. Find out more: https://lnkd.in/e73XMJTG

Today we are releasing interim results of FDA’s ongoing sampling of 60-day aged raw milk cheese. Of those 110 samples collected to date, 96 were negative by PCR (meaning that H5N1 was not detected in the analyzed samples), and 14 are still in progress. Final results are expected later this spring. In addition, we’re previewing research results from an FDA-funded Cornell study suggesting the 60-day aging process alone may not be effective in eliminating viable H5N1 virus in raw milk cheese. Note: additional studies have confirmed that pasteurization inactivates the virus. Consumers should check the product label to see if a product has been made with raw or pasteurized milk. https://lnkd.in/dHegjp2J

Today, the peer-reviewed scientific journal American Journal of Preventive Medicine published a study co-authored by FDA scientists showing that the agency’s youth e-cigarette prevention campaign, “The Real Cost,” prevented an estimated 444,252 American youth from starting to use e-cigarettes between 2023 and 2024. https://lnkd.in/eWcGWhKP

I am directing the FDA commissioner to start the process of changing the rules to eliminate the self-affirmed GRAS pathway for new ingredients. I am also calling on the FDA and NIH to continue to conduct and improve post-market assessments of GRAS chemicals currently in our food so we can rapidly identify the compounds that are making Americans so sick, and so that American consumers and regulators can make informed decisions. This is an important step in our pursuit to Make America Healthy Again.

Today, FDA made recommendations to vaccine manufacturers for the strains to be used in flu vaccines for the 2025-2026 U.S. flu season following a thorough and comprehensive review of U.S. and global surveillance data. With today’s action, we anticipate there will not be any impact on timing or availability of vaccines for the American public. https://lnkd.in/eFYB-RND

FDA published two case studies and a case study user guide developed as part of the Accelerating Rare disease Cures (ARC) Program’s Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D) initiative. The ARC Program launched LEADER 3D to better understand and address the unique challenges in bringing rare disease products to market. These case studies highlight approaches successfully used by sponsors when designing and conducting rare disease drug development programs. The materials on the LEADER 3D website are reflective of the needs and priorities heard from our valuable partners in the rare disease drug development community. Learn more and read the case studies: https://lnkd.in/eEW-xreB

FDA announced that American Society of Addiction Medicine - ASAM has issued the final guideline, The Joint Clinical Practice Guideline on Benzodiazepine Tapering: Considerations When Benzodiazepine Risks Outweigh Benefits: https://lnkd.in/gwdAm_hS This guideline focuses on evidence-informed and consensus-based strategies to help clinicians determine whether tapering benzodiazepine medications may be appropriate for a given patient, and if so, how to taper them. FDA awarded a grant to ASAM in 2022 to develop this guideline, which will serve as a standard of care for safe tapering of benzodiazepines: https://lnkd.in/ezz_X4Ez