Regulation of Nutraceuticals/Food Supplements in BPH and LUTS


A brief overview of regulation in nutraceuticals/food supplement use for patients with benign prostatic hyperplasia and lower urinary tract symptoms.


Bilal Chughtai, MD: The US Pharmacopeia [USP] is an independent not-for-profit company that has been present to help standardize and enrich the supplement market. This is done by standardizing labeling, what’s in the bottle, and ensuring that the compound that you have is what it is, and there are no harmful additives or other components.

Right now, there’s only 1 USP-verified saw palmetto with the brand name of Flomentum. It’s the only one that’s listed on their website.

The European Pharmacopeia is very similar to the USP, where they help standardize the compounds as well as the additives that are put in to ensure that the patients receive a standardized compound. Unlike the United States, Europe sometimes considers these compounds almost first-line agents. For those with mild lower urinary tract symptoms secondary to BPH [benign prostatic hyperplasia], it’s common to use these compounds.

The American Neurological Association guidelines don’t recommend the use of supplements for lower urinary tract symptoms secondary to BPH. Their stance is that it’s a relatively unregulated market. If you look at the studies that have been done with most of the supplements, there isn’t a clear-cut standardization. The data have been mixed at best, especially when you look at trials such as CAMUS or STEP.

Transcript edited for clarity.

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