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FDA ATTACKS ANOTHER ALTERNATIVE PRACTITIONER

IS THE FDA OUT OF CONTOL?

I do not know Dr. Mercola in any manner. I read his emailed education material, and it is obvious he has a heart for healing people and offers options outside my prescriptions and the surgery of other allopathic physicians like myself.

I worry that the FDA seems to come against and publicly shame many bright and creative medical minds. The FDA does not seem wiling to not allow patients and physicians permission to make informed decisions on the medical literature. Perhaps your government elected representatives need to pass laws to limit FDA control on your freedom of choice while keeping drug safety monitoring.Perhaps FDA officials see injuries from ignorant supplement use, like with massive ephedrine dosing, and become very concerned. Of course those who want nutrition and herbal medicine freedom say the deaths from routine prescriptions are vastly more common. Many nutritionally oriented experts feel the FDA believes ALL SUPPLEMENTS ARE USELESS FOR ANY DISEASE AND PREVENT NO DISEASE. Anyone with any education knows this is not valid. But the FDA wants many expensive studies before a manufacturer on a cheap nutrient or herb can make and health claim.

I have written elsewhere on this site about a proposal for detailed FDA safety ratings which allow them to use their abilities for monitoring, but also allows full patient choice.

This is a better system than attacking a person like Dr. Mercola in a shame letter below in an ugly controlling manner when his positions are not stupid. He has some science to support his points. The options for treatment he offers will never be able to be proven with massive hundred million dollar drug company studies because nutrition and herb companies do not have that type of income. So that means all options are surgical cutting or pharmaceutical drug options. Small nutrition companies cannot master the huge hundreds of pages of FDA regulations and submit drug applications, and perform multi-million dollar studies.

Department of Health and Human Services

Public Health Service
Food and Drug Administration

 

College Park, Maryland 20740

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Joseph Mercola
Optimal Wellness Center
1443 West Schaumburg, Suite 250
Schaumburg, IL 60194

February 16, 2005

Ref. No. CL-04-HFS-810-134

Dear Dr. Mercola:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.mercola.com and has determined that the products Living Fuel Rx, Tropical Traditions Virgin Coconut Oil, and Chlorella are promoted for conditions that cause these products to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S. 321(g)(1)]. The therapeutic claims on your web site establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of diseases. The marketing of these products with these claims violates the Act.

Examples of some of the claims observed on your web site include:

Living Fuel Rx

"In today's society people are simply not meeting their nutritional needs. We see evidence of this with the rampant illnesses including cancer, cardiovascular disease, diabetes, autoimmune diseases, etc. Living Fuel Rx is an exceptional countermeasure to this lifestyle, meeting all of your nutritional needs."

Tropical Traditions Virgin Coconut Oil

"Reduce the risk of heart disease"
"Lower your cholesterol"
"Improve conditions in those with diabetes and chronic fatigue"
"Improve Crohn's, IBS [Irritable Bowel Syndrome], and other digestive disorders"
"Prevent other disease and routine illness with its powerful antibacterial, antiviral and antifungal agents"
"A Delicious Way to Prevent Disease "
"[V]irgin coconut oil is rich in lauric acid, a proven antiviral, antibacterial and antifungal agent that is very beneficial in attacking viruses, bacteria, and other pathogens ."
"Coconut oil also raises metabolic rate . A faster metabolic rate stimulates increased production of needed insulin and increases absorption of glucose into cells, thus helping both Type I and Type II diabetics."
"For those with Crohn's and IBS, the anti-inflammatory and healing effects of coconut oil have been shown to play a role in soothing inflammation and healing injury in the digestive tract."
"The fatty acids in coconut oil can kill herpes and Epstein Barr viruses . They kill Candida and giardia. They kill a variety of other infectious organisms, any of which could cause chronic fatigue."

Chlorella

"Normalize your blood sugar and blood pressure"
"Fight cancer"
"One of the ways to fight cancer is the use of agents to stimulate macrophage production and activity. Interferon is a natural secretion of the body that is thought to be a stimulator of macrophages and tumor necrosis factor (TNF). Chlorella stimulates the activity of T-cells and macrophages by increasing interferon levels thus enhancing the immune system's ability to combat foreign invaders whether they are bacteria, viruses, chemicals, or foreign proteins."

Your products are not generally recognized as safe and effective for the above referenced conditions and therefore, these products are also "new drugs" under section 201(p) of the Act [21 U.S.C. ¤ 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. 355(a)]. FDA approves new drugs on the basis of scientific data submitted by a drug sponsor to demonstrate that the drugs are safe and effective.

FDA is aware that Internet distributors may not know that the products they offer are regulated as drugs or that these drugs are not in compliance with the law. Many of these products may be legally marketed as dietary supplements if claims about diagnosis, cure, mitigation, treatment, or prevention are removed from the promotional materials and the products otherwise comply with all applicable provisions of the Act and FDA regulations. With regard to your Living Fuel Rx product, which your website describes as an "optimized superfood meal replacement," please note that products represented for use as a meal replacement do not meet the definition of a dietary supplement in section 201(ff) of the Act [21 U.S.C 321(ff)] and may not be marketed as such.

Under the Act, as amended by the Dietary Supplement Health and Education Act, dietary supplements may be legally marketed with truthful and non-misleading claims to affect the structure or function of the body (structure/function claims), if certain requirements are met. However, claims that dietary supplements are intended to prevent, diagnose, mitigate, treat, or cure disease (disease claims), excepting health claims authorized for use by FDA, cause the products to be drugs. The intended use of a product may be established through product labels and labeling, catalogs, brochures, audio and videotapes, Internet sites, or other circumstances surrounding the distribution of the product. FDA has published a final rule intended to clarify the distinction between structure/function claims and disease claims. This document is available on the Internet at http://vm.cfsan.fda.gov/~lrd/fr000106.html (codified at 21 C.F.R. 101.93(g)).

In addition, only products that are intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter the body directly through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements. For these products, both disease and structure/function claims may cause them to be new drugs.

Certain over-the-counter drugs are not new drugs and may be legally marketed without prior approval from FDA. Additional information is available in Title 21 of the Code of Federal Regulations (21 C.F.R.) Parts 310 and 330-358, which contain FDA's regulations on over-the-counter drugs.

This letter is not intended to be an all-inclusive review of your web site and products your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.

If you need additional information or have questions concerning any products distributed through your web site, please contact FDA. You may reach FDA electronically (e-mail) at Kenneth.Taylor@CFSAN.FDA.GOV, or you may respond in writing to Kenneth M. P. Taylor, Ph.D., Chemist, Food and Drug Administration, Division of Dietary Supplement Programs, 5100 Paint Branch Parkway, College Park, Maryland 20740-3835. If you have any questions concerning this letter, please contact Dr. Taylor at (301) 436-1439.

Sincerely,

Susan J. Walker, M.D.
Director
Division of Dietary Supplement Programs
Office of Nutritional Products, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition

This page was posted on March 15, 2005.

 

I Would Not Dare Support These Products Above,
Since The FDA Does Raids Some Critics With Guns

I do, however, think I might be safe if I merely post some interesting abstracts on one product.

 

 

1: Med Hypotheses. 2005 Jul 1; [Epub ahead of print]

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Therapeutic potentials of unicellular green alga Chlorella in advanced glycation end product (AGE)-related disorders.

Yamagishi S, Nakamura K, Inoue H.

Department of Medicine, School of Medicine, Kurume University, 67 Asahi-machi, Kurume 830-0011, Japan.

Reducing sugars can react non-enzymatically with amino groups of protein to form Amadori products. These early glycation products undergo further complex reaction such as rearrangement, dehydration, and condensation to become irreversibly cross-linked, heterogeneous fluorescent derivatives, termed advanced glycation end products (AGEs). The formation and accumulation of AGEs in various tissues has been known to progress at an accelerated rate under hyperglycemic conditions in diabetes. Recent understanding of this process has revealed that AGEs have been implicated in the development of many of the pathological sequelae of diabetes and aging, such as atherosclerosis and diabetic microangiopathy. Furthermore, recently, AGE-their receptor (RAGE) interaction was also involved in neurodegenerative diseases, melanoma growth, expansion and metastasis. These observations suggest that blockade of AGE formation may be a novel promising target for therapeutic intervention in these devastating AGE-related disorders. We have recently found that unicellular green alga Chlorella inhibited the formation of AGEs in vitro. Since several lines of evidence have shown anti-atherogenic effects of Chlorella on animal models, we hypothesize here that the beneficial aspects of Chlorella on atherosclerosis could be ascribed, at least in part, to its AGE inhibitory property and that Chlorella may have therapeutic potentials in treatment of patients with other AGE-related disorders such as diabetic microangiopathy and Alzheimer's disease. In this paper, we would like to propose the possible ways of testing our hypotheses. Does daily intake of Chlorella reduce the risk of the incidence and progression of diabetic vascular complications including atherosclerosis? Does Chlorella treatment prevent the development of Alzheimer's disease and/or improve the cognitive impairment of patients with this disorder? If the answers are yes, are plasma or tissue levels of AGE in these patients actually suppressed by Chlorella treatment? And, does the extent of the AGE reduction by Chlorella predict the beneficial effects of Chlorella on these disorders? These prospective studies will provide further valuable information whether blockade by Chlorella of the AGE formation could be clinically relevant.

PMID: 15996828 [PubMed - as supplied by publisher]


2: J Agric Food Chem. 2005 May 18;53(10):4207-12.

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Antioxidant and antiproliferative activities of Spirulina and Chlorella water extracts.

Wu LC, Ho JA, Shieh MC, Lu IW.

Department of Applied Chemistry, National Chi-Nan University, Puli, Nantou, Taiwan. lw25@ncnu.edu.tw

Liver fibrosis is a chronic liver disease that will further develop to cirrhosis if severe damage continues to form. A potential treatment for liver fibrosis is to inhibit activated hepatic stellate cell (HSC) proliferation and, subsequently, to induce HSC apoptosis. It has been reported that antioxidants are able to inhibit the proliferation of HSCs. In this study, the aqueous extract of spirulina was chosen as the source of antioxidant to investigate the inhibitory effect on the proliferation of HSC. The growth inhibitory effects of aqueous spirulina and chlorella extract on human liver cancer cells, HepG2, were also studied and compared in pairs. Results indicated that the total phenol content of spirulina was almost five times greater than that of chlorella (6.86 +/- 0.58 vs 1.44 +/- 0.04 mg tannic acid equivalent/g of algae powder, respectively). The antioxidant activity of spirulina determined by the ABTS*+ method was higher than chlorella (EC50: 72.44 +/- 0.24 micromol of trolox equivalent/g of spirulina extract vs 56.09 +/- 1.99 micromol of trolox equivalent/g of chlorella extract). Results of DPPH* assay also showed a similar trend as the ABTS*+ assay (EC50: 19.39 +/- 0.65 micromol of ascorbic acid equivalent/g of spirulina extract vs 14.04 +/- 1.06 micromol of ascorbic acid equivalent/g of chlorella extract). The aqueous extracts of these two algae both showed antiproliferative effects on HSC and HepG2, but spirulina was a stronger inhibitor than chlorella. Annexin-V staining showed that aqueous extract of spirulina induced apoptosis of HSC after 12 h of treatment. In addition, the aqueous extract of spirulina triggered a cell cycle arrest of HSC at the G2/M phase.

PMID: 15884862 [PubMed - indexed for MEDLINE]


3: Life Sci. 2005 May 13;76(26):3001-13.

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Preventing dyslipidemia by Chlorella pyrenoidosa in rats and hamsters after chronic high fat diet treatment.

Cherng JY, Shih MF.

Department of Pharmacy, Chia-Nan University of Pharmacy and Science, 60 Erh-Jen Road, Sec.1, Tainan, 717, Taiwan ROC.

The effects of Chlorella pyrenoidosa on serum lipid profiles, after concomitant long-term treatment of high-fat diet (HFD) in rats and hamsters was studied. Wistar rats and Syrian hamsters were fed with or without various concentrations of Chlorella pyrenoidosa contained high-fat diet (CHFD) for 2, 4 and 8 weeks prior to assay of serum lipids. Fasting triglycerides, total cholesterol, and LDL cholesterol as well as HDL cholesterol levels in high-fat diet treated rats and hamster were determined. Results showed that triglycerides, total cholesterol and LDL cholesterol levels in HFD treated rats and hamsters were increased from the normal rodent diet (NRD) treated controls after 2, 4, and 8-week treatments. However, the presence of Chlorella pyrenoidosa in high-fat diets significantly decreased the levels of triglycerides, total cholesterol and LDL cholesterol with comparison to HFD group in rats and hamsters. The total cholesterol/HDL ratios, an indication of occurrence of coronary heart disease, were decreased in all CHFD treated grouped rats and hamsters which suggests administration of Chlorella pyrenoidosa could lower the occurring risk of heart diseases. In conclusion, Chlorella pyrenoidosa has the ability to prevent dyslipidemia in chronic high-fat fed animals and could be potential in use to prevent intestinal absorption of redundant lipid from our daily intake and subsequently to prevent hyperlipidemia as well as atherosclerosis.

PMID: 15850594 [PubMed - indexed for MEDLINE]


4: J Med Food. 2004 Summer;7(2):146-52.

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Effects of chlorella on activities of protein tyrosine phosphatases, matrix metalloproteinases, caspases, cytokine release, B and T cell proliferations, and phorbol ester receptor binding.

Cheng FC, Lin A, Feng JJ, Mizoguchi T, Takekoshi H, Kubota H, Kato Y, Naoki Y.

MDS Pharma Services Taiwan Ltd., 158 Li-Teh Road, Taipei 112, Taiwan, Republic of China. fong-chi.cheng@mdsps.com

A Chlorella powder was screened using 52 in vitro assay systems for enzyme activity, receptor binding, cellular cytokine release, and B and T cell proliferation. The screening revealed a very potent inhibition of human protein tyrosine phosphatase (PTP) activity of CD45 and PTP1C with 50% inhibitory concentration (IC(50)) values of 0.678 and 1.56 microg/mL, respectively. It also showed a moderate inhibition of other PTPs, including PTP1B (IC(50) = 65.3 microg/mL) and T-cell-PTP (114 microg/mL). Other inhibitory activities and their IC(50) values included inhibition of the human matrix metalloproteinases (MMPs) MMP-1 (127 microg/mL), MMP-3 (185 microg/mL), MMP-7 (18.1 microg/mL), and MMP-9 (237 microg/mL) and the human peptidase caspases caspase 1 (300 microg/mL), caspase 3 (203 microg/mL), caspase 6 (301 microg/mL), caspase 7 (291 microg/mL), and caspase 8 (261 microg/mL), as well as release of the cytokines interleukin (IL)-1 (44.9 microg/mL), IL-2 (14.8 microg/mL), IL-4 (49.2 microg/mL), IL-6 (34.7 microg/mL), interferon-gamma (31.6 microg/mL), and tumor necrosis factor-alpha (11 microg/mL) from human peripheral blood mononuclear cells. Chlorella also inhibited B cell proliferation (16.6 microg/mL) in mouse splenocytes and T cell proliferation (54.2 microg/mL) in mouse thymocytes. The binding of a phorbol ester, phorbol 12,13-dibutyrate, to its receptors was also inhibited by Chlorella with an IC(50) of 152 microg/mL. These results reveal potential pharmacological activities that, if confirmed by in vivo studies, might be exploited for the prevention or treatment of several serious pathologies, including inflammatory disease and cancer.

PMID: 15298760 [PubMed - indexed for MEDLINE]


5: Phytother Res. 2004 Feb;18(2):164-8.

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A hot water extract of Chlorella pyrenoidosa reduces body weight and serum lipids in ovariectomized rats.

Hidaka S, Okamoto Y, Arita M.

Department of Dental Hygiene, Fukuoka College of Health Sciences, Fukuoka, Japan. sabrnrn@college.fdcnet.ac.jp

The effects of a hot water extract of Chlorella pyrenoidosa, which contains chlorella growth factor (CGF), on the body weight, serum lipids, and the bone mass were evaluated using an ovariectomized rat as a model for postmenopausal bone loss. Rats were divided into four groups: sham-operated (Sham), Sham given the CGF solution, ovariectomized (OVX), and OVX given the CGF solution, respectively. Administration of the extract to OVX rats suppressed the body weight gain. After 7 weeks, the administration of the extract to the OVX group reduced increases in both serum total cholesterols and high-density lipoprotein (HDL) cholesterols. It also normalized the decrease of triglyceride level in the OVX group. The ovariectomy decreased the tibial bone mineral density (BMD) by 19%, and the administration of the extract to OVX rats did not inhibit this decrease. These results suggest that a dietary supplement of CGF may be useful to control the body weight and improve lipid metabolism of menopausal women. Copyright 2004 John Wiley & Sons, Ltd.

PMID: 15022171 [PubMed - indexed for MEDLINE]


6: J Med Food. 2002 Fall;5(3):141-52.

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Nutritional supplementation with Chlorella pyrenoidosa for mild to moderate hypertension.

Merchant RE, Andre CA, Sica DA.

Department of Anatomy and Internal Medicine, Virginia Commonwealth University, Medical College of Virginia, Richmond, VA 23298-0709, USA. rmerchan@hsc.vcu.edu

Pharmacological treatment of hypertension reduces the risk of cardiovascular disease; however, randomized, controlled clinical trials and population studies have also shown that abnormally high blood pressure (BP) can be lowered with diet modification and exercise. The objective of this pilot study was to determine whether daily dietary supplementation with 10 g Chlorella tablets and 100 ml Chlorella extract for 2 months would reduce BP in subjects with a mean sitting diastolic BP (SiDBP) between 90 and 115 mm Hg. Thirty-three people were enrolled and underwent a 4-week washout period from all antihypertensive medications, during which they consumed placebo. At completion of this washout/placebo period, 24 subjects were considered evaluable (i.e., had a SiDBP between 90 and 115 mm Hg) and were continued in the study. After 1 or 2 months of dietary Chlorella supplementation, the average heart rate, sitting systolic BP, and SiDBP changed only slightly; after 2 months of Chlorella consumption, the group's mean SiDBP was 96.5 +/- 6.6. However, a heterogenous response pattern to Chlorella existed, with 25% (6/24) of the subjects achieving their BP goal (SiDBP less than 90 mm Hg). Furthermore, the BP of nonresponders did not increase significantly above washout values. Quality-of-life questionnaires indicated an overall perception that health had significantly improved in conjunction with Chlorella consumption. The results indicate that, for some subjects with mild to moderate hypertension, a daily dietary supplement of Chlorella reduced or kept stable their SiDBP.

PMID: 12495586 [PubMed - indexed for MEDLINE]


7: Altern Ther Health Med. 2001 May-Jun;7(3):79-91.

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A review of recent clinical trials of the nutritional supplement Chlorella pyrenoidosa in the treatment of fibromyalgia, hypertension, and ulcerative colitis.

Merchant RE, Andre CA.

Virginia Commonwealth University, Medical College of Virginia, Richmond, VA 23298-0709, USA. rmerchan@hsc.vcu.edu

CONTEXT: It has been suggested that the consumption of natural "whole foods" rich in macronutrients has many healthful benefits for those who otherwise ingest a normal, nonvegetarian diet. One example is dietary supplements derived from Chlorella pyrenoidosa, a unicellular fresh water green alga rich in proteins, vitamins, and minerals. OBJECTIVE: To find evidence of the potential of chlorella dietary supplements to relieve signs and symptoms, improve quality of life, and normalize body functions in people with chronic illnesses, specifically fibromyalgia, hypertension, and ulcerative colitis. DESIGN: Double-blind, placebo-controlled, randomized clinical trials. SETTING: Virginia Commonwealth University's Medical College of Virginia. PATIENTS: Fifty-five subjects with fibromyalgia, 33 with hypertension, and 9 with ulcerative colitis. INTERVENTION: Subjects consumed 10 g of pure chlorella in tablet form and 100 mL of a liquid containing an extract of chlorella each day for 2 or 3 months. MAIN OUTCOME MEASURES: For fibromyalgia patients, assessments of pain and overall quality of life. For hypertensive patients, measurements of sitting diastolic blood pressure and serum lipid levels. For patients with ulcerative colitis, determination of state of disease using the Disease Activity Index. RESULTS: Daily dietary supplementation with chlorella may reduce high blood pressure, lower serum cholesterol levels, accelerate wound healing, and enhance immune functions. CONCLUSIONS: The potential of chlorella to relieve symptoms, improve quality of life, and normalize body functions in patients with fibromyalgia, hypertension, or ulcerative colitis suggests that larger, more comprehensive clinical trials of chlorella are warranted.

Publication Types:

  • Clinical Trial
  • Randomized Controlled Trial
  • Review
  • Review, Tutorial


PMID: 11347287 [PubMed - indexed for MEDLINE]


8: Anticancer Res. 1999 May-Jun;19(3A):1887-91.

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Inhibitory potential of Chlorella vulgaris (E-25) on mouse skin papillomagenesis and xenobiotic detoxication system.

Singh A, Singh SP, Bamezai R.

Human Genetics Laboratory, School of Life Sciences, Jawaharlal Nehru University, New Delhi, India.

The present study assesses the modulatory potential of Chlorella vulgaris (E-25) on murine skin papillomagenesis, and the role of xenobiotic detoxication system in modulating the papillomagenesis pattern. Topical application of E-25 (500 mg/kg b.w./day) during peri-, post- or peri- and post-initiational stages of 7,12-dimethylbenz [a] anthracene (DMBA)-induced papillomagenesis, significantly modulated the a) tumor burden to 5.00, 4.33 and 3.94 (positive control value: 5.88 b) cumulative number of papillomas to 90, 78 and 67 (positive control value: 106); and c) percent incidence of mice bearing papillomas to 94, 90 and 89 respectively (positive control value: 100). E-25 treatment alone or during peri-, post- or peri- and post-initiational stages significantly elevated the sulfhydryl (-SH) and glutathlone S-transferase (GST) levels in the liver and skin tissues. However, the levels of microsomal cytochrome b5 (Cyt. b5) and cytochrome P-450 (Cyt. P-450) were not appreciably modulated by the topical treatment of E-25. The results suggest the chemopreventive potential of E-25 during peri-, post- or peri- and post-initiational stages of murine skin papillomagenesis. The possible significance of xenobiotic detoxication system in modulating the papillomagenesis pattern is discussed.

PMID: 10470132 [PubMed - indexed for MEDLINE]


9: J Nutr. 1999 Sep;129(9):1731-6.

 

 
Chlorella accelerates dioxin excretion in rats.

Morita K, Matsueda T, Iida T, Hasegawa T.

Fukuoka Institute of Health and Environmental Sciences, Dazaifu City, Fukuoka 818-0135, Japan.

We investigated the effects of Chlorella on fecal excretion of polychlorinated dibenzo-p-dioxin (PCDD) congeners and polychlorinated dibenzofuran (PCDF) congeners in Wistar rats administered the rice oil that caused Yusho disease, as a substitute for purified dioxin. The rats were fed 4 g of a control diet or a 10% Chlorella diet containing 0.2 mL of the rice oil once during the 5-d experimental period. The amounts of PCDD and PCDF congeners excreted in feces from d 1 to 5 in the group fed 10% Chlorella were 0.2-11.3 and 0.3-12.8 times greater (P < 0.05), respectively, than those of the control group. We then investigated the fecal excretion of PCDD and PCDF congeners from d 8 To Whom It May Concern: 35 in rats administered 0.5 mL of the rice oil. Rats consumed the basal diet for 1 wk. After 1 wk, they consumed either the basal diet or the 10% Chorella diet. The fecal excretions of PCDD and PCDF congeners in the group fed 10% Chlorella were 0.3-3.4 and 0.5-2.5 times greater (most, P < 0.05), respectively, than those of the control group. Thus, the fecal excretions of PCDD and PCDF congeners were greater in rats fed Chlorella. These findings suggest that the administration of Chlorella may be useful in preventing gastrointestinal absorption and for promoting the excretion of dioxin already absorbed into tissues. Moreover, these findings suggest that Chlorella might be useful in the treatment of humans exposed to dioxin.

PMID: 10460212 [PubMed - indexed for MEDLINE]


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