Supporting prostate health with a USP-verified saw palmetto extract

Published: 29-Sep-2025

Approximately 94 million men aged 40 and older grapple with lower urinary tract symptoms (LUTS) and/or benign prostatic hyperplasia (BPH), which are a constellation of discomforts that affect normal urination

Both LUTS and BPH can reduce quality of life in otherwise healthy men.¹

Besides making lifestyle modifications such as weight loss, which reduces pressure on the bladder, men’s typical options are pharmaceuticals such as alpha blockers, PDE-5 inhibitors and 5-alpha reductase inhibitors.

But these come with side-effects that may be equal to or worse than the condition for which they are prescribed. 

In the shadow of benign prostatic hyperplasia week, part of the month-long Men’s Prostate Awareness month, a spotlight is on saw palmetto (Serenoa repens), which is likely to be the world’s most studied botanical for men’s urinary and prostate health.

Saw palmetto may be a worthwhile alternative or adjunct to pharmaceutical therapy.

Unfortunately, however, according to Umasudhan Palaniswamy, CEO and president of Valensa International, many saw palmetto products on the market don’t deliver the benefits consumers expect.

Some dietary supplements that claim to contain saw palmetto are sometimes formulated with lower-cost adulterated compounds that don’t deliver the claimed benefits, noted Stefan Gafner, PhD, Chief Science Officer for the American Botanical Council. 

Dr Gaffner, who wrote the Laboratory Guidance Document on saw palmetto extract for ABC’s Botanical Adulterants Prevention Program, explained that unethical suppliers found ways to create low-cost ingredients that have a similar chemical profile to S. repens, spurring the need for methodologies to detect authenticity of the herb.

Why USP certification matters

Science has shown that authentic lipidosterolic extracts of saw palmetto can benefit men concerned about prostate function — but only if the extract meets clinical and pharmacopeial standards. 

To obtain USP verification, the manufacturing plant must pass an extensive GMP facility audit to 21 CFR Part 117 and USP <2750> standards, as well as end-to-end product quality control and (QCM) process evaluation. 

Supporting prostate health with a USP-verified saw palmetto extract

The saw palmetto extract must pass USP laboratory tests for identity, purity and potency, and also must have verification that the standardised profile is consistently met.

USPlus, the only lipidosterolic extract of saw palmetto in the US that is USP verified, can deliver a clinically effective dose of 320 mg with 85–95% total fatty acids and is shown to protect men’s prostate and enhance men’s urinary health.  

A 2024 human clinical study examined key effects of the USPlus lipidosterolic extract of saw palmetto on male LUTS, a result of age-related enlarged prostate.² 

In the study, 45 healthy men (mean age of 55) who were experiencing LUTS secondary to BPH were supplemented with 320 mg USPlus for 12 weeks.

Mean voided volume, voiding time and maximum flow rate were measured at baseline and weeks 6 and 12, and the participants were also assessed utilising the International Prostate Symptom Score (IPSS) and Quality of Life (QoL) score.


At the end of the study, the men in the USPlus group experienced significant improvements in uroflowmetry parameters with increased flow rates as well as improved IPSS and QoL scores. 


Additionally, they had significant changes in voiding and storage sub-scores at week 12.

The authors concluded: “A standardised USP-verified saw palmetto extract shows some promise in reducing LUTS and improving uroflowmetry parameters, especially in [men] with baseline moderate symptoms.”2

Men’s prostate and urinary health products with USPlus will deliver the benefits that they can experience. And when those expectations are fulfilled, product loyalty follows.

References

  1. A.F. Awedew, et al., The Lancet Healthy Longevity 3(11), e754–e776 (2019).
  2. J. Winograd, et al., Canadian Journal of Urology 31(6), 12053–12059 (2024).

    

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