Valensa Raises Concerns on Saw Palmetto Dosage

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EUSTIS, Fla.—Valensa International, a supplier of branded nutraceutical ingredients, issued a statement to industry and consumers, raising questions about the use of saw palmetto products for prostate health. Specifically, the company stated there is market confusion regarding the efficacy of saw palmetto powder products versus those containing oil extract, which has been shown as clinically efficacious in addressing benign prostatic hyperplasia (BPH). Valensa stated the powder products are often sold in 320 to 500 mg capsules, similar in size to oil extract capsules; however, the products generally contain 10 percent to 12 percent of the oil extract levels of saw palmetto.

According to Rudi E. Moerck, Valensa’s president and CEO, the similarities in the capsule sizing and dosage instructions could easily lead to consumer confusion. “There is a solid body of evidence based on a number of clinical trials that show the 320 mg per day dosage of pure saw palmetto oil extract offers support to men experiencing the common effects of BPH. There have been no studies done on similar levels of the powder-form products," he said. “Just because both product forms start with saw palmetto berries, it doesn’t mean they are equivalent when it comes to achieving the result we expect from saw palmetto oil extracts. … At the end of the day, we should be recommending the oil extract form of the product for supporting prostate health, because the science says it works and it is easier and less expensive for consumers to get the levels required."

Saw palmetto (Serenoa repens) grows wild in Florida and other parts of the southeastern United States; the berries have been harvested and used for prostate support for almost 140 years. Powders are generally made by drying and grinding whole berries. Extracts use more mature berries with higher oil levels; the oil is extracted, often with supercritical CO2 extraction, leaving an inert berry mass. The U.S. Pharmacopeia (USP) has set minimum standards for saw palmetto as a supplement based on total fatty acids, fatty acid profile, total fatty alcohols and phytosterol levels.

Moerck said his concerns in the market relate to ensuring consumers are getting efficacious levels of the key phytosterol and fatty acid compounds in saw palmetto to address their health concerns. “Saw palmetto has been used safely and effectively for decades. The powder-form product is probably fine if you take eight to ten capsules or tablets a day—even if that is a pain in the neck and expensive," he said. “However, if men only use one 320 mg dose of powdered-form product, there is no proof that it will have any impact on the effects of BPH at all. As people who work in the nutritional supplement market, we are doing a disservice to our customers when we make these casual recommendations that are not based on science—and perhaps more importantly, we aren’t helping give men the relief that they so desperately need."

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