In May 2025, the EMA published a PSUSA for magnesium sulfate combined with sodium sulfate and potassium sulfate, resulting in a variation to the marketing authorization. (ema.europa.eu)
In January 2026, the FDA issued Import Alert 54-14, targeting dietary supplement products from firms that have not met dietary supplement GMP requirements. While not specific to magnesium products, this alert emphasizes the FDA's focus on manufacturing standards.
In March 2024, the UK's Food Standards Agency (FSA) completed a safety assessment of magnesium L-threonate as a novel food for use in food supplements, indicating ongoing evaluations of new magnesium compounds. (food.gov.uk)
In October 2024, the FDA updated Import Alert 66-66, addressing APIs that appear to be misbranded under section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act, highlighting the importance of compliance with labeling and manufacturing standards.
In May 2025, the EMA published a PSUSA for magnesium sulfate combined with sodium sulfate and potassium sulfate, resulting in a variation to the marketing authorization. (ema.europa.eu)
These developments underscore the dynamic regulatory environment surrounding magnesium-based pharmaceuticals and the necessity for manufacturers to stay informed and compliant with evolving standards.
