Whether a consumer is taking calcium carbonate for strong bones, magnesium to fall asleep, or high-dose caffeine to stay awake, the U.S. Food and Drug Administration (FDA) does not approve dietary supplements for safety and effectiveness. So how do consumers know if a product is safe, and how can manufacturers protect themselves in the case of a problem?
In response to stakeholder feedback, the FDA on February 21, 2024, released its updated directory of FDA actions and communications with respect to “Information on Select Dietary Supplement Ingredients and Other Substances.”
During the past several turbulent weeks for the U.S. health care system, rulings in the case Alliance for Hippocratic Medicine v. FDA have called into question the U.S. Food and Drug Administration’s (“FDA’s”) scientific review process to approve new drug applications. While the U.S. Supreme Court acted on the afternoon of Friday, April 21, 2023 to preserve access to the drug mifepristone while the case continues in the United States Court of Appeals for the Fifth Circuit, the future of mifepristone—and the FDA’s authority to approve new drugs—will continue to be debated on appeal.
Blog Editors
Recent Updates
- Importance of Negotiating Maintenance, Repair and Replacement Obligations in Health Care Leases
- Unpacking Averages: Assessing the Products Included in FDA's Voluntary Malfunction Summary Reporting Program
- Federal Update on Cannabis Scheduling: Are State Legalized Cannabis Dispensaries to Become Pharmacies?
- HHS Extends the Antidiscrimination Provisions of the Affordable Care Act to Patient Care Decision Support Tools, Including Algorithms
- It’s Been a Long Time Coming – FDA’s Final Rule on Regulation of Laboratory Developed Tests (LDTs) as Medical Devices Has Arrived