"Rotten cheese steep'd in tobacco": The history of saw palmetto (Serenoa repens) from crop and foodstuff to a recognised medicinal plant

Background: Serenoa repens (saw palmetto) is a Florida‑centred palm whose fruits transitioned from food/fibre to pharmacy. Indigenous uses are diverse but largely non‑medicinal; medical adoption accelerated in the late 19th/early 20th century and was later standardised via USP/NF. Modern EU regulation distinguishes extract types.

Aim: To document the trajectory from utilitarian plant to medicinal product; to trace commercialisation and pharmacopoeial status; to appraise current evidence and regulation (HMPC/EAU).

Sources and methods: Critical reading of primary/secondary sources in ethnobotany and pharmacy history (18th–20th c.); USP/NF; eclectic/homoeopathic literature; EMA/HMPC monographs; evidence syntheses (Cochrane 2023; meta‑analysis 2024) and clinical reviews; EAU guideline 2024.

Results: Historically, preparations and indications proliferated; fruits were listed in USP (1906–1916) and NF (1926–1950). Today, product quality is specified in Ph. Eur.; hexane extracts (HESr) show small, extract‑dependent benefits for LUTS/BPH with good tolerability; ethanolic/aqueous preparations show heterogeneous findings. HMPC classifies HESr as well‑established use; ethanolic/aqueous as traditional use. EAU 2024: offer HESr when tolerability is prioritised, informing about modest effect size.

Update since 2017: New evidence syntheses (Cochrane 2023; WJMH 2024) and an EAU 2024 update; HMPC status unchanged.

Conclusion: Saw palmetto illustrates the path from regional resource to regulated phytotherapy. Clinically, HESr remains an option for symptomatic BPH when minimising adverse effects is important; extract type is decisive.

Keywords: Serenoa repens; saw palmetto; ethnobotany; USP; NF; HMPC; HESr; BPH; LUTS; EAU guideline; pharmacopoeia; traditional use; hexane extract; safety