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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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The Master's Miracle, Inc. 09-Jun-05

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

Public Health Service
Food and Drug Administration

 

Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612) 768-7114
FAX: 4612) 334-4142



June 9, 2005

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 05-14

Michael Schlegel
CEO/Director of Marketing
The Master's Miracle, Inc.
9060 Zachary Lane North, Suite 104
Maple Grove, MN 55369

Dear Mr. Schlegel:

This letter is in reference to your firm's manufacturing, distribution, and promotion of various products documented by our inspection conducted December 28-30, 2004, and January 5-6, 11, 13 and 24, 2005, at your facility located at 9060 Zachary Lane North, Suite 104, Maple Grove, Minnesota, and by a review of your Internet website at www.themastersmiracle.com. These activities were conducted to determine your firm's compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and applicable implementing regulations contained within Title 21, Code of Federal Regulations (21 CFR).

Our review of your products, labeling, and promotional materials reveals serious violations of the Act. You can find the Act and implementing regulations through links on FDA's Internet home page at www.fda.gov.

Adulterated Cosmetic Charge

FDA conducted an analysis of a sample of your Skin Moisturizer product collected during the inspection. This analysis revealed bacterial contamination and aerobic plate counts at levels that pose a potential health risk for the uses recommended in your labeling. Your product is therefore adulterated under section 601(a) of the Act because it contains a poisonous or deleterious substance that may render the product injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual [21 U.S.C. 361(a)].

Drug Charges

Under the Act, articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man are drugs [section 201(g)(1)(B) of the Act, 21 U.S.C. 321(g)(i)(B)]. Promotional materials that accompany your products in interstate commerce, label claims, and claims on your website and in your promotional audiocassettes show that your products are intended for use in the cure, mitigation, treatment or prevention of disease.

Examples of disease prevention and treatment claims for NatureRich™ Greens product in your Master's Miracle Product Guide and brochure entitled "Give Your Body the Richness of Nature" are as follows:

  • "Nutritional deficiencies may play a major role in health problems such as heart disease, cancer, diabetes and obesity. . . . The Master's Miracle NatureRich™ Greens provide power-packed super foods. ..to nourish the body."

  • "Disease and pain flourish in an acidic environment. A balanced pH provides the best environment to assimilate nutrients in the body and enhance the body's healing ability . ..naturally. NatureRich™ Greens is a special formulation of greens that help promote a balanced pH. . . .".

Examples of disease prevention and treatment claims for your Flax Hull Lignans product in the Miracle of Flax Hull Lignans booklet, the Master's Miracle product guide, and the immediate product label are as follows:

"Help the body combat disease by fortifying the immune system with Flax Hull Lignans. . . . The end result is a potent antioxidant that . . .has antiviral, antibacterial and antifungal properties. Historically, studies have shown that lignans may help prevent the three leading major illnesses in the U.S. heart disease, cancer and diabetes."

  • "[L]ignans . . .may interfere with the development of breast, prostate, colon, and other cancers . . . . These lignan compounds have-been studied . . . for their cancer preventative properties. The SDG lignan not only has anticancer properties, it also has anti-viral, anti-bacterial, and anti-fungal properties. . . . Studies indicate that people who eat more lignan-containing foods have a lower incidence of breast and colon cancer, due to the phytoestrogen effect."

  • "[L]ignans reduce estrogen's effects by displacing it from cells. This displacement of the hormone can help prevent those cancers, such as breast cancer, that depend on estrogen to start and develop . .. .SDG is beneficial throughout the promotional phase of carcinogenesis, and at the stage when tumors have already been established . . .lignans taken during early postnatal life may reduce the risk of developing breast cancer."

  • "SDG is particularly effective in combating cancer of the colon."

  • "[F]laxseed ingestion produced anticarcinogenic lignans in the colon."

  • "[F]laxseed decreases the risk for colon carcinogenesis ."

  • "[C]onsumption of flaxseed and its lignans may reduce the risk for colon carcinogenesis ."

  • "[O]ver the long term flaxseed lignan still exerts a colon cancer protective effect."

  • "[L]ignans are growth inhibitors of colon tumor cells and may act through mechanisms other than anti-estrogenic activity."

  • "[L]ignan SDG. . .can help prevent or significantly delay the development of diabetes."

  • "SDG reduced the development of adult-onset (type 2) diabetes by 80 percent, and delays the development of the disease significantly."

  • "SDG reduced the development of the type 1 diabetes by 71 and 75 percent respectively."

  • "It is well known that flax oil fights heart disease by lowering dangerous LDL cholesterol and trigiycerides, and reducing the build up of atherosclerotic plaque on artery walls. But now, evidence is revealing that SDG lignan . . .has an equal or greater effect in fighting heart disease."

  • "[A]ddition of SDG resulted in a 73% reduction in atherosclerotic plaques (fatty deposits) . . . . [T]here was a 33% reduction in serum cholesterol and an increase in the "good" or protective cholesterol in SDG-fed rabbits."

  • "SDG is effective in reducing hypercholesterolemic atherosclerosis. . . ."

  • "The ability of SDG in reducing atherosclerosis is partly due to its antioxidant activity."

  • "[T]he reduction of hypercholesterolemic atherosclerosis is greater with SDG than with the whole flaxseed. The decrease is associated with a reduction of serum cholesterol and LDL-cholesterol."

  • "In a study of 29 hyperlipidemic subjects who were placed on a diet of 50 grams of partially defatted flaxseed, their LDL cholesterol was reduced 7.6% after only three weeks."

  • "[F]lax lignan ha[s] a beneficial role in chronic renal (kidney) disease."

  • "[C]onsumption of flaxseed rich in lignans retards the development and progression of chronic renal disease."

  • "[L]ignans in flaxseed improve kidney function in certain types of kidney diseases. . . . [I]t preserved renal function and reduced histological injury."

  • "[F]laxseed was beneficial in slowing the decline in renal function ."

  • "SDG has a therapeutic role in animal and human lupus nephritis. It is known that in patients with lupus nephritis . ..there is an increase in the production of platelet activating factors (PAF) . . . . Lignans acts as PAF receptor antagonists which means the lignans reduce the accumulation PAFs [sic] . . . . PAF-induced platelet aggregation was inhibited by all doses . . . . In conclusion, the flaxseed conferred significant benefits in reducing inflammatory and atherogenic mechanisms important in the pathogenesis of lupus nephritis."

  • "Prostate Cancer. . . Flaxseed ingestion produces large amounts of mammalian lignans with weak estrogenic/anti-estrogenic properties. In tests, these properties reduced adult relative prostate weight and cell proliferation, suggesting potential protection against prostatic disease .. .."

  • "[B)oth isoflavonoids and lignans are natural cancer protective compounds and are useful against skin cancer."

  • "Flax reduced tumor occurrence by up to 63%."

  • "The addition of flaxseed to the diet also caused a dose-dependent decrease on tumor area and volume, showing that it could be beneficial in both prevention and treatment."

  • "Further, the rich source of lignans reduced metastasis (the spread of cancerous cells) and inhibited the growth of the metastatic secondary tumors. . . ."

  • "[L]ignans . ..can help prevent breast cancer."

  • "Controlling menstrual cycles has several health benefits including decreasing the risk of breast cancer. Lignans in flaxseed have been shown to regulate women's menstrual cycles."

  • "The control which lignan has over the menstrual cycle has an influence on cancer growth. This is because the less time a woman spends in the luteal phase, the lower the risk of breast cancer."

  • "[L]ignans are anti-parasitic."

  • "Dietary supplementation with SDG, the lignan from flaxseed, significantly reduced pulmonary metastasis of melanoma cells and inhibited the growth of metastatic tumors that formed in the lungs. This may aid in the fight against lung cancer."

  • "Flaxseed and its lignan have been shown to reduce inflammatory responses, but it did not prevent macrophages (cells of the immune system) from killing bacteria. The research . . .involving lupus revealed that lignans are beneficial for reducing inflammation."

  • " (Product label) "Researchers have studied its effects on hormone related tumors. . . and heart disease."

These claims cause your Nature Rich™ Greens and Flax Hull Lignans products to be drugs, 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)]. Under section 505 of the Act [21 U.S.C 355], a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA) FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Further, these products are 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)].

In addition to the claims cited above, your website at www.themasterrniracle.comm and audio promotional materials further show the intended use of your products.

Examples of disease prevention and treatment claims on your website are as follows:

  • "Flax Hull Lignans . . .may help prevent three major diseases-heart disease, cancer and diabetes."

  • "Help the body combat disease by fortifying the immune system with Flax Hull Lignans ."

  • " Your website lists the following about acid levels in the body:

    o "Dozens of diseases have a hidden link to excessive acid in the body, contributing to. . .chronic pain and fatigue."

    o "Dozens of health conditions, including asthma, chronic tiredness, depression. . . are present due to an acidic environment.. . . Even serious health conditions such as cancer, autoimmune diseases .. .are - linked to extremely acidic levels . . . ."

    o Another page describing the Fortified Mineral Neutralizer states "Disease [sic] and pain flourish in an acidic environment. A balanced pH provides the best environment to assimilate nutrients in the body and enhance the body's healing ability. . .naturally. The energy and essential minerals in the Fortified Mineral Neutralizer can be beneficial in helping with balancing the body's pH." Taken together, these statements imply that the Fortified Mineral Neutralizer can treat the preceding diseases associated with high acid levels.

Examples of disease treatment and prevention claims from one of your audio cassettes entitled "The Master's Miracle Product and Opportunity Testimonials" are
as follows:

  • "I've suffered from Chronic Fatigue Syndrome and fibromyalgia. .. and [Master's Miracle products are] the answer that people have been looking for for a long time."

  • "Well, Master's Miracle products gave my life back. I had a couple bouts with pneumonia. Later, I was diagnosed with emphysema. I was on oxygen 24 hours a day. And three weeks on this product, no daytime oxygen ."

These claims are further evidence that your Master's Miracle products are drugs as defined in section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)], in that they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. These products are 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)].

Unsubstantiated Structure/Function Claims

In addition, the labeling of your Master's Miracle products bears claims regarding the products' effect on the structure and function of the body (structure/ function claims). Examples of such claims are as follows:

  • Product Guide:

    o "The Master's Miracle Natural Simple Solution System can help. . . balance the pH of the body.. . ."

  • " Give Your Body the Richness of Nature brochure:

    o "NatureRich™ Greens Promotes a balanced chemistry/ pH. . . ."
    o "Nature's Rich Greens is a special formulation of greens that-help, promote a balanced pH.. . ."

  • " Would You Sacrifice Your Health For Bubbles? Brochure:

    o "Discover how using our products help to. . .balance the body's pH."

  • " Training Guide:

    o "This `pH Pack' includes The Master's Miracle Neutralizer. . . that help neutralize acids in your body."
    o "The Fortified Mineral Neutralizer can be beneficial in helping with balancing the body's pH."

We have reviewed these claims and have concluded that they are not supported by competent and reliable scientific evidence. Because these claims lack substantiation, they are false and misleading, and cause your Master's Miracle products to be misbranded within the meaning of section 403(a)(1) and 403(r)(6)(B) of the Act [21 U.S.C 343(a)(1) and (r)(6)(13)].

Other Labeling Violations

Even if your Ultra Fortified Mineral Neutralizer and Fortified Mineral Neutralizer were not drugs, as dietary supplements they would be misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)) in that the products' labels do not include a Supplement Facts panel as required by 21 CFR 101.36.

Even if your Flax Hull Lignans were not a drug, as a food it would be misbranded within the meaning of section 403(q)(1) of the Act [21 U.S.C. 343(q)(1)] in that the product is labeled with a Nutrition Facts panel that is not in the format required by 21 CFR 101.9. We also note that you labeled your product as a "food supplement," and included the dietary supplement disclaimer under section 403(r)(6) of the Act. However, these statements are not consistent with other labeling representing your product as a conventional food (e.g., Nutrition Facts panel rather than Supplement Facts panel, suggested uses as a salad or cereal topping). A product that is represented as a conventional food is not a dietary supplement (see section 201(ff)(2)(B) of the Act [21 U.S.C. 321(ff)(2](B)].

Even if your Nature Rich™ Greens were not a drug, as a dietary supplement it would be misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the product is labeled with a Supplement Facts panel that is not in the format required under 21 CFR 101.36.

As a dietary supplement, your Nature Rich™ Greens is also misbranded under section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] because the product labeling bears a nutrient content claim but the product does not comply with the regulation that would allow it to bear such a claim. When used to describe the level of a nutrient, the term "rich in" is defined by regulation to mean that the product contains 20% or more of the Daily Reference Value (DRV) or Recommended Daily Intake (RDI) of that nutrient per reference amount customarily consumed [21 CFR 101.54(b)(1)]. The labeling of your product in the Product Guide bears the claim, "rich. . . in fiber;" however, the product is labeled to contain less than 20% of the DRV for fiber per serving.

This letter is not intended to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all products distributed by your firm are in compliance with the Act and its implementing regulations.

During the inspection, we collected samples of the Fortified Mineral Neutralizer and Ultra Fortified Mineral Neutralizer products. FDA analysis of these products revealed significant bacterial contamination and aerobic plate counts. You were advised of the results of our analysis by telephone on February 24, 2005. You should be aware that consumption of these products may pose a public heath risk. On May 13, 2005, you responded in a letter sent via e-mail to Compliance Officer Tyra Wisecup at the FDA's Minneapolis District Office in part that the results of the FDA analysis for the product tested present no health hazards as opined by the microbiologists from the firm, [redacted] that you hired. You also indicated that you intend to implement "product testing" and hire engineers to address your water systems. Please also be aware that FDA's Center for Drug Evaluation and Research is currently evaluating the safety of these Mineral Neutralizer products for topical use.

We request that you take prompt action to correct the violations listed above. Failure to promptly correct these violations may result in enforcement action being initiated by FDA without further notice. The Act provides for the seizure of illegal products and/or injunction against the manufacturers and distributors of illegal products.

Please notify this office in writing within 15 working days of receipt of this letter of the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify and make corrections to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be implemented.

Your reply should be sent to the attention of Compliance Officer Tyra S. Wisecup at the address on the letterhead.

Sincerely,

/S/

W. Charles Becoat
Director
Minneapolis District