Noni - Get the Facts on Herbal Supplements

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Noni site:.gov

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  • Noni has not been well studied in people for any health condition.<a href="#hdng0">(More...)</a>

  • A large marketing enterprise and at least eleven different suppliers supports the food supplement's popularity.<a href="#hdng1">(More...)</a>

  • This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address: http://www.energyforlife.com <a HREF="http://www.energyforlife.com/">http://www.energyforlife.com</a> and has determined that the product "Hawaiian Island Noni" being offered is promoted for conditions that cause the product to be a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).<a href="#hdng2">(More...)</a>

  • "North Shore Noni is uniquely grown and produced in Hawai`i by Native Hawaiians with a desire to share the health benefits of noni, an ancient traditional Hawaiian medicine," says Spencer Kamauoha, general manager."<a href="#hdng3">(More...)</a>



<a name="hdng0"></a>Noni has not been well studied in people for any health condition. Recent NCCAM-funded research includes a study on noni for cancer to determine its safety and potential effects on tumors and symptoms. <a href="http://nccam.nih.gov/health/noni/" TARGET="_blank" [1]</a> In laboratory research, noni has shown antioxidant, immune-stimulating, and tumor-fighting properties. These results suggest that noni may warrant further study for conditions such as cancer and cardiovascular disease.<a href="http://nccam.nih.gov/health/noni/" TARGET="_blank" [1]</a> Noni has been traditionally used in Polynesia as a dye, but it also has a history of use as a topical preparation for joint pain and skin conditions. Today, people drink noni fruit juice as a general health tonic, as well as for cancer and chronic conditions such as cardiovascular disease and diabetes.<a href="http://nccam.nih.gov/health/noni/" TARGET="_blank" [1]</a> Traditionally, the leaves and fruit of noni have been used for health purposes.<a href="http://nccam.nih.gov/health/noni/" TARGET="_blank" [1]</a>

The National Cancer Institute is funding preliminary research on noni for breast cancer prevention and treatment.<a href="http://nccam.nih.gov/health/noni/" TARGET="_blank" [1]</a> There have been reports of liver damage from using noni. It should be avoided if you have liver disease because it contains compounds that may make your disease worse.<a href="http://nccam.nih.gov/health/noni/" TARGET="_blank" [1]</a> Mueller BA, Scott MK, Sowinski KM, et al. Noni juice ( Morinda citrifolia ): hidden potential for hyperkalemia? American Journal of Kidney Disease. 2000;35(2):310-312.<a href="http://nccam.nih.gov/health/noni/" TARGET="_blank" [1]</a> Several noni juice manufacturers have received warnings from the U.S. Food and Drug Administration about making unsubstantiated health claims. Although there have been few reported side effects from using noni, its safety has not been adequately studied.<a href="http://nccam.nih.gov/health/noni/" TARGET="_blank" [1]</a>

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<a name="hdng1"></a>A large marketing enterprise and at least eleven different suppliers supports the food supplement's popularity. The broad long range objectives which this study will initiate are to define the usefulness of noni extracts for cancer patients. <a href="http://clinicaltrials.gov/show/NCT00033878" TARGET="_blank" [2]</a> The hypothesis to be tested is that noni at a specified dosing provides cancer patients with a sufficient benefit to toxicity profile to be useful as a therapeutic. Specific aims of this study are: 1.<a href="http://clinicaltrials.gov/show/NCT00033878" TARGET="_blank" [2]</a> Detailed Description: This Phase I study of noni in cancer patients represents a first step in the systematic study of Complementary and Alternative Medicine (CAM) practices that draw on Asian and Pacific Island cultural traditions of healing to control cancer and its related symptoms.<a href="http://clinicaltrials.gov/show/NCT00033878" TARGET="_blank" [2]</a> Collect preliminary information on the efficacy of noni in respect to anti-tumor and symptom control properties to help select specific patients for subsequent Phase II studies. 4.<a href="http://clinicaltrials.gov/show/NCT00033878" TARGET="_blank" [2]</a>

Noni, extracted from Morinda citifolia or the Indian mulberry plant, is included in the traditional pharmacopoeias of Native Hawaiians, other Pacific Islanders and Asian populations, and has been used to treat various diseases for hundreds of years. It is now commonly taken by cancer patients based on purported usefulness in the disease although there is little scientific evidence to either support or refute these claims.<a href="http://clinicaltrials.gov/show/NCT00033878" TARGET="_blank" [2]</a> Identify chemical constituents of the extract that can be used to characterize the bioavailability and pharmacokinetics of noni food supplement.<a href="http://clinicaltrials.gov/show/NCT00033878" TARGET="_blank" [2]</a>

Agree to take no other CAM treatments while taking noni and agree to keep a diary, recording all medications taken daily, including all non prescription products and to record the time that noni is taken.<a href="http://clinicaltrials.gov/show/NCT00033878" TARGET="_blank" [2]</a>

Determine the maximum tolerated dose of capsules containing 500mg of freeze-dried noni fruit extract. 2.<a href="http://clinicaltrials.gov/show/NCT00033878" TARGET="_blank" [2]</a>

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<a name="hdng2"></a>This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address: http://www.energyforlife.com <a HREF="http://www.energyforlife.com/">http://www.energyforlife.com</a> and has determined that the product "Hawaiian Island Noni" being offered is promoted for conditions that cause the product to be a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act). <a href="http://www.fda.gov/cder/warn/cyber/2002/CFSANhawaiian.htm" TARGET="_blank" [3]</a> "Former University of Hawaii researcher Dr. Ralph M. Heinicke believes that other ailments possibly helped by Noni are menstrual cramps, arthritis, sprains, injuries, mental depression, senility. arteriosclerosis, blood pressure problems, drug addiction, and pain."<a href="http://www.fda.gov/cder/warn/cyber/2002/CFSANhawaiian.htm" TARGET="_blank" [3]</a>

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<a name="hdng3"></a>"North Shore Noni is uniquely grown and produced in Hawai`i by Native Hawaiians with a desire to share the health benefits of noni, an ancient traditional Hawaiian medicine," says Spencer Kamauoha, general manager." <a href="http://hawaii.gov/hdoa/add/soq/companies/kamauohafarms/view" TARGET="_blank" [4]</a> The project"s facilities include a 90-acre farm and food processing plant on Oahu "s North Shore. Its primary crop is noni, used traditionally by Hawaiian healers as a remedy, and is grown with great care, from the planting of the seeds to delivery to the customer.<a href="http://hawaii.gov/hdoa/add/soq/companies/kamauohafarms/view" TARGET="_blank" [4]</a> The Kamauoha Farms project employs over 15 Native Hawaiians and serves 70 community noni farmers on Oahu and the Big Island.<a href="http://hawaii.gov/hdoa/add/soq/companies/kamauohafarms/view" TARGET="_blank" [4]</a>

Organic noni juice also is available. Other products include noni fruit capsules, noni leaf capsules, noni lotion and noni soap.<a href="http://hawaii.gov/hdoa/add/soq/companies/kamauohafarms/view" TARGET="_blank" [4]</a>

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<a name="sources"><a href="#" onclick="toggle_visibility('srcs'); return false;" title="Most Informative Documents, used in preparation of this report.">
SELECTED SOURCES<image src="apx4.jpg" alt="Most Informative Documents, used in preparation of this report."></a>



1. <a href="http://nccam.nih.gov/health/noni/" TARGET="_blank">Noni [NCCAM Herbs at a Glance]</a>
<a href="http://nccam.nih.gov/health/noni/" TARGET="_blank">http://nccam.nih.gov/health/noni/</a>

2. <a href="http://clinicaltrials.gov/show/NCT00033878" TARGET="_blank">Study of Noni in Cancer Patients - Full Text View - ClinicalTrials.gov</a>
<a href="http://clinicaltrials.gov/show/NCT00033878" TARGET="_blank">http://clinicaltrials.gov/show/NCT00033878</a>

3. <a href="http://www.fda.gov/cder/warn/cyber/2002/CFSANhawaiian.htm" TARGET="_blank">Cyber Warning Letter</a>
<a href="http://www.fda.gov/cder/warn/cyber/2002/CFSANhawaiian.htm" TARGET="_blank">http://www.fda.gov/cder/warn/cyber/2002/CFSANhawaiian.htm</a>

4. <a href="http://hawaii.gov/hdoa/add/soq/companies/kamauohafarms/view" TARGET="_blank">Kamauoha Farms -- Hawaii Department of Agriculture</a>
<a href="http://hawaii.gov/hdoa/add/soq/companies/kamauohafarms/view" TARGET="_blank">http://hawaii.gov/hdoa/add/soq/companies/kamauohafarms/view</a>

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