Supplement regulation, decoded.
Curated updates from the FDA, EFSA, MHRA, TGA and other agencies — what changed, what it means for ingredients in the index, and where to read the source.
FDA reaffirms NMN is excluded from the dietary supplement definition
The FDA reissued guidance that nicotinamide mononucleotide (NMN) does not meet the definition of a dietary ingredient under the FD&C Act because it was first studied as a drug. Brands marketing NMN as a supplement in the US remain at enforcement risk.
EFSA tightens limits on Monacolin K in red yeast rice supplements
EFSA's NDA Panel confirmed that monacolin K from red yeast rice raises safety concerns at intakes ≥3 mg/day. EU products must now be reformulated below this threshold and carry updated cautionary statements.
MHRA opens consultation on ashwagandha hepatotoxicity reporting
Following pharmacovigilance signals from Nordic agencies, the MHRA has opened a UK consultation on adverse-event reporting requirements for ashwagandha root extract products, with a focus on liver-related adverse events.
FDA finalizes enforcement discretion for N-acetylcysteine (NAC)
The FDA published its final guidance formally exercising enforcement discretion for NAC in dietary supplements, ending the multi-year ambiguity for US brands while maintaining its position that NAC is technically excluded from the supplement definition.
EFSA raises adult tolerable upper intake level for Vitamin D to 100 µg/day
Updated EFSA opinion confirms 100 µg/day (4000 IU) as the tolerable upper intake level for adults, harmonising with US IOM guidance. Children's ULs were also revised upward.
Coordinated SARMs enforcement action across AU, US, and EU
Australia's TGA, the FDA, and several EU member states announced a coordinated enforcement action against products spiked with SARMs (ostarine, ligandrol, RAD-140) marketed as 'natural' supplements. Lab testing of 47 brands found 31% adulteration.
FDA reiterates CBD requires a new regulatory pathway, not supplement status
The FDA confirmed in testimony to Congress that it will continue to decline supplement status for CBD and is awaiting legislation for a dedicated CBD regulatory framework.
EFSA rejects new health claims for BCAAs in muscle recovery
The EFSA Panel on Dietetic Products, Nutrition and Allergies issued an unfavourable opinion on three proposed health claims for branched-chain amino acids related to recovery and muscle protein synthesis, citing insufficient cause-and-effect evidence.
FDA warns consumers about tianeptine ('gas station heroin') sold as supplement
The FDA issued a public health alert about tianeptine products marketed as dietary supplements or 'cognitive enhancers,' linked to a sharp rise in poison-control calls. Tianeptine is not approved for any use in the US.
MHRA expands OTC availability of low-dose melatonin in the UK
MHRA reclassified select 1 mg and 2 mg prolonged-release melatonin products to pharmacy (P) status for short-term jet lag use, easing access without changing the prescription requirement for chronic use.
Editorial note
SuppIndex curates publicly available regulatory communications from agencies including the US FDA, European EFSA, UK MHRA and Australian TGA. Summaries are written for clarity and do not constitute legal or medical advice. Always consult the linked source for the authoritative text.