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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Optimal Wellness Center 21-Sep-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, IL 60661
Telephone: 312-353-5863


 

September 21, 2006

WARNING LETTER
CHI-7-06

CERTIFIED MAIL
RETURN RECEIPT REOUESTED

Joseph M. Mercola, D.O.
Optimal Wellness Center
1443 West Schaumburg Road, Suite 250
Schaumburg, IL 60194

Dear Dr. Mercola:

The Food and Drug Administration (FDA) conducted an inspection at your facility at the above address on April 24, 2006. During that inspection, the investigator collected various product labels including, but not limited to, the following products: Vibrant Health Research Chlorella XP, Fresh Shores Extra Virgin Coconut Oil, Momentum Health Products™ Vitamin K2 ™, and Momentum Health Products™ Cardio Essentials™ Nattokinase NSK-SD. In addition, we reviewed labeling on your website at http://www.mercola.com. A review of this labeling found that the products listed above are promoted for conditions that cause these products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C.321 (g)(1)(13)]. These claims on your labeling, including your website, establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act. You can find the Act and FDA's regulations through links on FDA's Internet home page, http://www.fda.gov.

Examples of disease claims observed in your products' labeling, including your website and product labels, include:

Vibrant Health Research Chlorella XP

  • "In Japan, interest in chlorella has focused largely on . . . its ability to neutralize or remove poisonous substances from the body."

  • "Eliminating processed foods with whole foods like chlorella will help to virtually eliminate your risk of developing cancer in the future."

Further, the main Chlorella XP page of your website (http://www .mercola.com/forms/chlorella.htm) links to a page captioned "Chlorella
Scientific Research" where several publications reporting on human and animal studies of chlorella products are cited. Under each citation is an abstract of the publication. Many of the publications cited and summarized on this page concern therapeutic uses of chlorella. When scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product's intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered a claim about disease treatment or prevention if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies that the product is useful for treatment br prevention of a disease.

The following are examples of reference citations on your website that are used to promote Vibrant Health Research Chlorella XP for treatment or prevention of various diseases:

  • "Nutritional supplementation with Chlorella pyrenoidosa for patients with fibromyalgia syndrome: a pilot study." Merchant RE; Carmack, CA; Wise CM. Phytother Res 2000 May; 14(3):167-73. The abstract of the study on your website states, in part: "Any amelioration of symptoms was validated and quantified . . . at clinic visits on days 0, 30 and 60 of the diet therapy. . . . After two months the average pain decrease was 22%."

  • "Effect of dried, powdered Chlorella vulgaris on experimental atherosclerosis and alimentary hypercholesterolemia in cholesterol-fed rabbits." Sano T; Tanaka Y. Artery 1987;14(2) :76-84.

  • "Effect of hot water extract of Chlorella vulgaris on cytokine expression patterns in mice with murine acquired immunodeficiency syndrome after infection with Listeria monocytogenes." Hasegawa T, Kimura Y, Hiromatsu, K, et al. Immunopharmacology. 1997 Jan;35(3):273-82.

  • "Augmentation of antitumor resistance by a strain of unicellular green algae, Chlorella vulgaris." Tanaka K; Konishi F; Himeno K, et al. Cancer Immunol Immunother 1984;17(2):90-4.

  • "Oral administration of Chlorella vulgaris augments concomitant antitumor immunity." Tanaka K; Tomita Y; Tsuruta M, et al. Immunopharmacol Immunotoxicol 1990;12(2):277-91.

  • "Oral administration of a unicellular green algae, Chlorella vulgaris, prevents stress-induced ulcer." Tanaka K, Yamada A, Noda K, et al. Planta Med 1997 Oct;63(5):465-6.

Fresh Shores Extra Virein Coconut Oil

  • "Coconut oil is . . . uniquely rich in lauric acid, which is converted to the same disease-fighting substance--monolaurin--that nursing babies derive from lauric acid in mother's milk. Research has demonstrated coconut oil's anti-microbial, anti-viral and anti-parasitical properties . . .."

  • "Pure Virgin Coconut Oil: The Healthy Fat That ... Banishes Infection, And Heads Off Heart Disease"

  • "The numerous health benefits of coconut oil are finally again reaching the mainstream. Benefits like:

    Reducing your risk of heart disease . . .
    Reducing your risk of cancer and degenerative diseases . . .
    Preventing infections due to harmful bacteria, viruses, yeasts and other microorganisms . . ."

  • "[H]elps you prevent heart disease, lower cholesterol...."

  • "[L]auric acid is the predominant type of MCFA [medium-chain fatty acid] found in coconut oil . ... [A] great volume of research has been done establishing the ability of lauric acid to fight dangerous micro-organisms . . . like viruses, bacteria, yeasts, fungi, parasites and molds . . . . Numerous studies have indicated that many viruses are inactivated by medium-chain fats-viruses like influenza, measles, HIV, herpes and cytomegalovirus."

Momentum Health Product™ Vitamin K2™

  • "Recent research supporting vitamin K's usefulness against osteoporosis and heart disease is now becoming too abundant to overlook . ... I now offer the most potent disease fighting form of this vitamin available-Vitamin K2-in supplemental form."

  • "[S]cientists are even looking at vitamin K to be the future of treating certain kinds of cancer and Alzheimer's disease."

  • "Research shows that vitamin K regulates calcium and keeps it in the bones and out of arteries-stopping heart attacks and osteoporosis at the same time."

  • "Health Advantages of Vitamin K2

  • . . .[P]revents Osteoporosis

  • " Prevention of atherosclerosis

  • " Inhibits cancer cell growth"

  • Momentum Health Products™ Cardio Essentis™ Nattokinase NSK-SD

    "CardioEssentials is a much safer and effective option than aspirin and other pharmaceutical agents to treating heart disease."

  • "With the discovery of nattokinase, we no have a safe, scientifically-proven and natural way for millions to combat hardened arteries, heart attack, stroke, angina, dementia and senility."

  • "While modern medicine has come up with several clot-busting drugs--they come at a very high price. Among them, tissue plasminogen activactors [sic] (t-PAs) lead the pack. Every year, stroke and heart attack victims are administered t-PAs such as actiase, urokinase and streptokinase. While these treatments do save between 300,000-500,000 lives annually, one dose of urokinase cost approximately $1,500. Comparatively, CardioEssentials is ridiculously cheap.

  • "Prevents heart attacks, strokes, and blood clots"

  • "Lowers blood pressure"

  • "Minimizes joint pain in osteoarthritis and rheumatoid arthritis"

  • "Decreases cholesterol"

  • "CardioEssentials contains a truly revolutionary and powerful enzyme called nattokinase that has produced monumental success for dissolving blood clots!"

  • (under heading "Product and Dosage Information for CardioEssentials")

"Therapeutic dose (e.g., person under medical supervision w/high blood pressure, risk factors for coronary artery disease, high risk for blood clots, DVT). 4,000 fibrin units per day.

Ischemic strokes (e.g., person at risk for ischemic, "dry" stroke, or who is recovering from a stroke, transient ischemic attack, RND {reversible ischemic neurologic deficit], etc. 6,000 fibrin units per day.

These claims cause your products to be drugs, as drug, as defined in Section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)]. Because these products are not generally recognized as safe and effective when used as labeled, they are also new drugs as defined in Section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally marketed in the United States 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.

These products are also misbranded within the meaning of Section 502(f)(1) of the Act, in that the labeling for these drugs fails to bear adequate directions for use [21 U.S.C. 352(f)(1)].

Please note that similar therapeutic claims on you web site were brought to your attention in a letter from FDA's Center for Food Safety and Applied Nutrition dated February 16, 2005. In that letter, we notified you hat claims for several of your firm's products, including chlorella and coconut oil products, caused those products to be unapproved new drugs within the meaning of the Act. A copy of the February 16, 2005, letter, which also provides additional information elated to the Dietary Supplement Health Education Act, is enclosed for your reference.

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.

Failure to promptly correct these violations may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.

Please advise this office in writing, within 15 working days of receipt of this letter, as to the specific steps you have taken or will be taking o correct these violations, including the steps taken to assure that similar violations do not recur. Include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, we expect that yo will explain the reason for your delay and state when you will correct any remaining deviations.

Your reply should be sent to the Food and Drug Administration, Attention: Patrick J. Brown, Compliance Officer, 550 W. Jackson Blvd , 15th Floor, Chicago, Illinois 60661-5716.

Sincerely,

/S/

Scott J. MacIntire
District Director