Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
Central Region
Minneapolis District

 

212 3rd Ave S
Minneapolis, MN 55401
Telephone: (612) 758-7114
FAX: (612) 334-4142

June 9, 2005
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Michael Schlegel, CEO & Director of Marketing
The Master's Miracle, Inc.
9060 Zachary Ln N #104
Maple Grove, MN 55369

Ref. No. MIN-05-14

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 Ln N #104, Maple Grove, MN, 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 USC 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 USC 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:

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:

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 USC 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 USC 321(p)]. Under section 505 of the Act [21 USC 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 USC 352(f)(1)].

In addition to the claims cited above, your website at www.themastermiracle.com 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:

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:

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 USC 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 USC 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:

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 USC 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 USC 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 USC 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 USC 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 USC 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 USC 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
District Director

This page was posted on March 28, 2006.

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