soy estrogen myth false - dr mercola caught by federal authorities spreading false health info -...

8/3/2019 Soy Estrogen Myth False - Dr Mercola Caught by Federal Authorities Spreading False Health Info - [Soy Found Not t

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DEPARTMENT OF HEALTH AND HUMAN SERVICES PublicHealth Service

Food and Drug AdministrationCollege Park, MD

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Joseph MercolaOptimal Wellness Center1443 West Schaumburg, Suite 250Schaumburg, IL 60194

February 16, 2005

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

Dear Dr. Mercola:This is to advise you that the Food and DrugAdministration (FDA) has reviewed your web site atthe Internet address http://www.mercola.com and hasdetermined that the products Living Fuel

Rx, Tropical Traditions Virgin Coconut Oil, andChlorella are promoted for conditions that causethese products to be drugs under section 201(g)(1) ofthe Federal Food, Drug, and Cosmetic Act(the Act) [21 U.S.C. 321(g)(1)]. The therapeutic claimson your web site establish that theseproducts are drugs because they are intended for use inthe cure, mitigation, treatment, or preventionof diseases. The marketing of these products with theseclaims violates the Act.

Examples of some of the claims observed on your website include:

Living Fuel Rx


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In todays society people are simply not meeting theirnutritional needs. We see evidence of thiswith the rampant illnesses including cancer,

cardiovascular disease, diabetes, autoimmune diseases,etc. Living Fuel Rx is an exceptional countermeasure tothis lifestyle, meeting all of your nutritionalneeds.

Tropical Traditions Virgin Coconut Oil

Reduce the risk of heart diseaseLower your cholesterol

Improve conditions in those with diabetes and chronicfatigueImprove Crohns, IBS [Irritable Bowel Syndrome], andother digestive disordersPrevent other disease and routine illness with itspowerful antibacterial, antiviral and antifungalagentsA Delicious Way to Prevent Disease [V]irgin coconut oil is rich in lauric acid, a provenantiviral, antibacterial and antifungal agent thatis very beneficial in attacking viruses, bacteria, andother pathogens .Coconut oil also raises metabolic rate . A fastermetabolic rate stimulates increased productionof needed insulin and increases absorption of glucoseinto cells, thus helping both Type I and TypeII diabetics.

Page 2 Optimal Wellness Center

For those with Crohns and IBS, the anti-inflammatoryand healing effects of coconut oil havebeen shown to play a role in soothing inflammation and


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healing injury in the digestive tract.The fatty acids in coconut oil can kill herpes and EpsteinBarr viruses . They kill Candida andgiardia. They kill a variety of other infectious organisms,

any of which could cause chronicfatigue.

Chlorella

Normalize your blood sugar and blood pressureFight cancerOne of the ways to fight cancer is the use of agents tostimulate macrophage production and

activity. Interferon is a natural secretion of the body thatis thought to be a stimulator ofmacrophages and tumor necrosis factor (TNF). Chlorellastimulates the activity of T-cells andmacrophages by increasing interferon levels thusenhancing the immune systems ability to combatforeign invaders whether they are bacteria, viruses,chemicals, or foreign proteins.

Your products are not generally recognized as safe andeffective for the above referenced conditionsand therefore, these products are also new drugsunder section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally marketed in theU.S. without prior approval from FDA asdescribed 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 todemonstrate that the drugs are safe and effective.

FDA is aware that Internet distributors may not knowthat the products they offer are regulated asdrugs or that these drugs are not in compliance with thelaw. Many of these products may be


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legally marketed as dietary supplements if claims aboutdiagnosis, cure, mitigation, treatment, orprevention are removed from the promotional materialsand the products otherwise comply with all

applicable provisions of the Act and FDA regulations.With regard to your Living Fuel Rxproduct, which your website describes as an optimizedsuperfood meal replacement, please notethat products represented for use as a meal replacementdo not meet the definition of a dietarysupplement 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 SupplementHealth and Education Act, dietarysupplements may be legally marketed with truthful andnon-misleading claims to affect the structureor function of the body (structure/function claims), ifcertain requirements are met. However, claimsthat dietary supplements are intended to prevent,diagnose, mitigate, treat, or cure disease (diseaseclaims), excepting health claims authorized for use byFDA, cause the products to be drugs. Theintended use of a product may be established throughproduct labels and labeling, catalogs,brochures, audio and videotapes, Internet sites, or othercircumstances surrounding the distributionof the product. FDA has published a final rule intendedto clarify the distinction betweenstructure/function claims and disease claims. This

document is available on the Internet at (codifiedat 21 C.F.R. 101.93(g)).

In addition, only products that are intended for ingestionmay be lawfully marketed as dietarysupplements. Topical products and products intended to


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enter the body directly through the skin ormucosal tissues, such as transdermal or sublingualproducts, are not dietary supplements. For theseproducts, both disease and structure/function claims

may cause them to be new drugs.

Page 3 Optimal Wellness Center

Certain over-the-counter drugs are not new drugs andmay be legally marketed without priorapproval from FDA. Additional information is available inTitle 21 of the Code of FederalRegulations (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 ofyour web site and products your firmmarkets. It is your responsibility to ensure that allproducts marketed by your firm comply with theAct and its implementing regulations.

If you need additional information or have questionsconcerning any products distributed throughyour web site, please contact FDA. You may reach FDAelectronically (e-mail) [email protected], or you may respond inwriting to Kenneth M. P. Taylor,Ph.D., Chemist, Food and Drug Administration, Divisionof Dietary Supplement Programs, 5100

Paint Branch Parkway, College Park, Maryland 20740-3835. If you have any questions concerningthis letter, please contact Dr. Taylor at (301) 436-1439.

Sincerely,

/s/


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Susan J. Walker, M.D.DirectorDivision of Dietary Supplement Programs

Office of Nutritional Products, Labelingand Dietary Supplements Center for Food Safety and

Applied Nutrition

LINKS:http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2005/ucm076069.htmhttp://www.casewatch.org/fdawarning/prod/2006/mercola2.shtmlhttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/CyberLetters/ucm059189.pdf

-END-

MERCOLA "DANGERS OF SOY" FRAUD: FALSIFIED INFOTRACED TO WAPF WESTON A. PRICE HEALTH FRAUDGROUP.


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THE TRUTH: SOY CONTAINS NO ESTROGEN. SOY BLOCKSESTROGEN. SOY HAS NO EFFECT ON MENSTESTOSTERONE.

SCIENTIFIC LINKS:

- SOY:PUBMED: "Clinical studies show No Effects of Soy protein

or isoflavones on reproductive hormones in men"http://www.ncbi.nlm.nih.gov/pubmed/19524224

- SOY:NIH ANALYSIS: "Soybean isoflavone exposure does Nothave feminizing effects on men" - NIHhttp://www.ncbi.nlm.nih.gov/pubmed/20378106

- SOY:METASTUDY: "Review finds no effect of soy ontestosterone. A review of 15 studies into the influence ofsoy proteins or isoflavones on male hormones has foundno evidence of an estrogen-like effect."http://www.foodnavigator.com/Science-Nutrition/Review-finds-no-effect-of-soy-on-testosterone

- SOY:METAREVIEW: "There was no significant pooled effect ofisoflavone consumption. Furthermore, the authorscriticized the studies that reported lowered testosteronelevels for their methodology. Clinical studies show no


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effects of soy protein or isoflavones on reproductivehormones in men"http://www.foodproductiondaily.com/Quality-Safety/Review-finds-no-effect-of-soy-on-testosterone

- SOY:CANCER RESEARCH: Nutrition: Men Don't Need to FearSoy Foods" -AICRhttp://www.foodconsumer.org/newsite/Nutrition/Food/180820091053_nutrition_notes_men_don_t_need_to_fear_soy_foods.html

- SOY:SCIENCE DAILY: "Soy Phytoestrogens May BlockEstrogen Effects"http://www.sciencedaily.com/releases/2006/01/060115154340.htm

- SOY:PUBMED: "No testosterone level decrease in arandomized soy intervention among men."http://www.ncbi.nlm.nih.gov/pubmed/16775579

- SOY:MUSCULAR DEVELOPMENT: SOY PROTEIN HAS NO

EFFECT ON TESTOSTERONE LEVELShttp://www.musculardevelopment.com/index.php?option=com_content&task=view&id=1623&Itemid=51

- SOY:


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IRONMAN MAGAZINE:http://www.ironmanmagazine.com/site/soy-and-your-testosterone/

- SOY:IRON MAN BODYBUILDING:"Researchers found that soy protein or isoflavone intakehad no significant effects on testosterone."http://imbodybuilding.com/articles/soy-and-your-testosterone/

SOY PROTEIN DOES NOT HAVE ANY EFFECT ONESTROGEN OR TESTOSTERONE LEVELS IN MEN. -END-

###


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PROPER TAGS:

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soy estrogen myth false - dr mercola caught by federal authorities spreading false health info -...

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