Saw Palmetto and BPH - Past, Present, and Future
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madman
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USPlus® Pure Lipidosterolic Extract - Valensa
valensa.com
madman
Super Moderator
An overview of USPlus® Pure Lipdosterolic Extract of Saw Palmetto (Serenoa repens) from berry to bottle. This new video explains the benefit for prostate health, Valensa’s unique supply chain approach, clinical evidence, and one of the industry’s biggest challenges: adulteration.
madman
Super Moderator
Valensa’s USPlus® Remains First, Only US Pharmacopeia Verified Saw Palmetto Extract For Third Year In A Row
ORLANDO, Fla. (April 5, 2021) — Valensa International announced today that for a third consecutive year the company’s USPlus® Pure Lipidosterolic Extract of Saw Palmetto, is the only saw palmetto extract to be verified under the United States Pharmacopeia (USP) Ingredient Verification Program for Dietary Ingredients (IVP-DI). This certification demonstrates Valensa’s product and process deliver the quality, potency, and purity as recommended by the independent scientific experts at USP. The company’s efforts set the gold standard for consumer trust and transparency amid new standards from Amazon and key retailers.
Valensa pioneered the Saw Palmetto industry 20 years ago and initiated a GEMS™ Supply Chain Excellence Program in 2019. The program substantiates the company’s commitment to providing a clinical-strength lipidosterolic extract of saw palmetto and to give customers confidence in a market proliferated by outright fake and adulterated products.
The GEMS Supply Chain Excellence Program specifies the quality of saw palmetto berries harvested to ensure the resulting extract meets the USP monograph. ” said Larry McCarty, Valensa’s Head of Manufacturing and Supply Chain. “GEMS focuses on creating positive outcomes for the supply chain including landowners, harvesters, drying companies, and the environment, through education and standards.”
The outcome GEMS strives for include: traceability, sustainability, purity, and responsibility — four attributes that many saw palmetto purveyors ignore, McCarty added. “Unfortunately, the market continues to allow unripe green berry powder supplements or adulterated oil versions that do not meet the clinically-proven profile of a pure lipidosterolic extract.”
To obtain USP verification, Valensa undergoes rigorous third-party auditing of its Supercritical CO2 extraction process for cGMP compliance. Each batch of USPlus® Pure Lipidosterolic Extract is also tested to ensure that it consistently meets the USP monograph. According to Steve Hill, VP of Product Management and Technology, “Valensa’s commitment to providing an effective product is demonstrated by the verification that USPlus® delivers exactly what’s promised in the nutritional profile.”
The power of Saw Palmetto lies in the full spectrum of a pure lipidosterolic extract with a specific ratio of 85-90% total fatty acids and other phytonutrients as per USP. In the U.S., saw palmetto is regulated as a dietary supplement, but in Europe, a pure lipidosterolic extract of saw palmetto is sold and regulated as an herbal medicine at a recommended daily dose of 320 mg.
Having earned the IVP-DI status from USP, Valensa International continues to be listed on USP’s website, a resource for finished product manufacturers seeking ingredient manufacturers who have earned the right to use the USP verified mark. The mark can be used on the bulk label of each container of USP Verified ingredients, on the certificate of analysis, and on marketing collateral. USP is an authoritative source for quality verification services because the United States Pharmacopeia-National Formulary (USP-NF) is an official compendium of scientific quality standards for drugs, dietary supplements, and their ingredients in the United States.
Click here for more information about USP’s IVP-DI Program and the process by which Valensa International earned this certification.
ORLANDO, Fla. (April 5, 2021) — Valensa International announced today that for a third consecutive year the company’s USPlus® Pure Lipidosterolic Extract of Saw Palmetto, is the only saw palmetto extract to be verified under the United States Pharmacopeia (USP) Ingredient Verification Program for Dietary Ingredients (IVP-DI). This certification demonstrates Valensa’s product and process deliver the quality, potency, and purity as recommended by the independent scientific experts at USP. The company’s efforts set the gold standard for consumer trust and transparency amid new standards from Amazon and key retailers.
Valensa pioneered the Saw Palmetto industry 20 years ago and initiated a GEMS™ Supply Chain Excellence Program in 2019. The program substantiates the company’s commitment to providing a clinical-strength lipidosterolic extract of saw palmetto and to give customers confidence in a market proliferated by outright fake and adulterated products.
The GEMS Supply Chain Excellence Program specifies the quality of saw palmetto berries harvested to ensure the resulting extract meets the USP monograph. ” said Larry McCarty, Valensa’s Head of Manufacturing and Supply Chain. “GEMS focuses on creating positive outcomes for the supply chain including landowners, harvesters, drying companies, and the environment, through education and standards.”
The outcome GEMS strives for include: traceability, sustainability, purity, and responsibility — four attributes that many saw palmetto purveyors ignore, McCarty added. “Unfortunately, the market continues to allow unripe green berry powder supplements or adulterated oil versions that do not meet the clinically-proven profile of a pure lipidosterolic extract.”
To obtain USP verification, Valensa undergoes rigorous third-party auditing of its Supercritical CO2 extraction process for cGMP compliance. Each batch of USPlus® Pure Lipidosterolic Extract is also tested to ensure that it consistently meets the USP monograph. According to Steve Hill, VP of Product Management and Technology, “Valensa’s commitment to providing an effective product is demonstrated by the verification that USPlus® delivers exactly what’s promised in the nutritional profile.”
The power of Saw Palmetto lies in the full spectrum of a pure lipidosterolic extract with a specific ratio of 85-90% total fatty acids and other phytonutrients as per USP. In the U.S., saw palmetto is regulated as a dietary supplement, but in Europe, a pure lipidosterolic extract of saw palmetto is sold and regulated as an herbal medicine at a recommended daily dose of 320 mg.
Having earned the IVP-DI status from USP, Valensa International continues to be listed on USP’s website, a resource for finished product manufacturers seeking ingredient manufacturers who have earned the right to use the USP verified mark. The mark can be used on the bulk label of each container of USP Verified ingredients, on the certificate of analysis, and on marketing collateral. USP is an authoritative source for quality verification services because the United States Pharmacopeia-National Formulary (USP-NF) is an official compendium of scientific quality standards for drugs, dietary supplements, and their ingredients in the United States.
Click here for more information about USP’s IVP-DI Program and the process by which Valensa International earned this certification.
madman
Super Moderator
post #8
www.excelmale.com
5.2.5 Plant extracts - phytotherapy
Potential mechanism of action: Herbal drug preparations are made of roots, seeds, pollen, bark, or fruits. There are single plant preparations (mono-preparations) and preparations combining two or more plants in one pill (combination preparations) [216].
Possible relevant compounds include phytosterols, ß-sitosterol, fatty acids, and lectins [216]. In vitro, plant extracts can have anti-inflammatory, anti-androgenic and oestrogenic effects; decrease sexual hormone-binding globulin; inhibit aromatase, lipoxygenase, growth factor-stimulated proliferation of prostatic cells, α-adrenoceptors, 5 α-reductase, muscarinic cholinoceptors, dihydropyridine receptors, and vanilloid receptors; and neutralize free radicals [216-218]. The in vivo effects of these compounds are uncertain, and the precise mechanisms of plant extracts remain unclear.
Efficacy: The extracts of the same plant produced by different companies do not necessarily have the same biological or clinical effects; therefore, the effects of one brand cannot be extrapolated to others [219]. In addition, batches from the same producer may contain different concentrations of active ingredients [220]. A review of recent extraction techniques and their impact on the composition/biological activity of available Serenoa repens based products showed that results from different clinical trials must be compared strictly according to the same validated extraction technique and/or content of active compounds [221], as the pharmacokinetic properties of the different preparations can vary significantly.
Heterogeneity and a limited regulatory framework characterize the current status of phytotherapeutic agents. The European Medicines Agency (EMA) has developed the Committee on Herbal Medicinal Products (HMPC). European Union (EU) herbal monographs contain the HMPC’s scientific opinion on safety and efficacy data about herbal substances and their preparations intended for medicinal use. The HMPC evaluates all available information, including non-clinical and clinical data, whilst also documenting long-standing use and experience in the EU.
European Union monographs are divided into two sections: a) Well established use (marketing authorization): when an active ingredient of medicine has been used for more than ten years and its efficacy and safety have been well established (including a review of the relevant literature); and b) Traditional use (simplified registration): for herbal medicinal products which do not fulfill the requirements for marketing authorization, but there is sufficient safety data and plausible efficacy on the basis of long-standing use and experience. Table 1 lists the available EU monographs for herbal medicinal products.
Table 2: European Union monographs for herbal medicinal products
Panel interpretation: Only hexane extracted Serenoa reprens have been recommended for well-established use by the HMPC. A detailed scoping search covering the timeframe between the search cut-off date of the EU monograph and April 2020 will be conducted for the update of the 2021 edition of the Guidelines. Following this, a specific recommendation on phytotherapy will be given.
Prostate supplements
Do any of you use a natural supplement for issues related to enlarged prostate (low urine stream, evening trips to the bathroom), and if so, what is the name of it? Thank you.
www.excelmale.com
5.2.5 Plant extracts - phytotherapy
Potential mechanism of action: Herbal drug preparations are made of roots, seeds, pollen, bark, or fruits. There are single plant preparations (mono-preparations) and preparations combining two or more plants in one pill (combination preparations) [216].
Possible relevant compounds include phytosterols, ß-sitosterol, fatty acids, and lectins [216]. In vitro, plant extracts can have anti-inflammatory, anti-androgenic and oestrogenic effects; decrease sexual hormone-binding globulin; inhibit aromatase, lipoxygenase, growth factor-stimulated proliferation of prostatic cells, α-adrenoceptors, 5 α-reductase, muscarinic cholinoceptors, dihydropyridine receptors, and vanilloid receptors; and neutralize free radicals [216-218]. The in vivo effects of these compounds are uncertain, and the precise mechanisms of plant extracts remain unclear.
Efficacy: The extracts of the same plant produced by different companies do not necessarily have the same biological or clinical effects; therefore, the effects of one brand cannot be extrapolated to others [219]. In addition, batches from the same producer may contain different concentrations of active ingredients [220]. A review of recent extraction techniques and their impact on the composition/biological activity of available Serenoa repens based products showed that results from different clinical trials must be compared strictly according to the same validated extraction technique and/or content of active compounds [221], as the pharmacokinetic properties of the different preparations can vary significantly.
Heterogeneity and a limited regulatory framework characterize the current status of phytotherapeutic agents. The European Medicines Agency (EMA) has developed the Committee on Herbal Medicinal Products (HMPC). European Union (EU) herbal monographs contain the HMPC’s scientific opinion on safety and efficacy data about herbal substances and their preparations intended for medicinal use. The HMPC evaluates all available information, including non-clinical and clinical data, whilst also documenting long-standing use and experience in the EU.
European Union monographs are divided into two sections: a) Well established use (marketing authorization): when an active ingredient of medicine has been used for more than ten years and its efficacy and safety have been well established (including a review of the relevant literature); and b) Traditional use (simplified registration): for herbal medicinal products which do not fulfill the requirements for marketing authorization, but there is sufficient safety data and plausible efficacy on the basis of long-standing use and experience. Table 1 lists the available EU monographs for herbal medicinal products.
Table 2: European Union monographs for herbal medicinal products
Panel interpretation: Only hexane extracted Serenoa reprens have been recommended for well-established use by the HMPC. A detailed scoping search covering the timeframe between the search cut-off date of the EU monograph and April 2020 will be conducted for the update of the 2021 edition of the Guidelines. Following this, a specific recommendation on phytotherapy will be given.
Nelson Vergel
Founder, ExcelMale.com
saw palmetto
www.excelmale.com
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