| UNITED STATES OF AMERICA FEDERAL TRADE COMMISSION BUREAU OF CONSUMER PROTECTION WASHINGTON, D.C. 20580 | DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION WASHINGTON, D.C. 20740 |
April 28, 2011
VIA UNITED PARCEL SERVICE
WARNING LETTER
CIN-11-124368-14
MasterPeace, Inc. Headquarters
Attn: Karen A. Bodnar
8742 Cleveland Avenue NW
North Canton, OH 44720
Dear Ms. Bodnar:
This is to advise you that the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) reviewed your website at the Internet address http://www.masterpeaceinc.com in March 2011. FDA has determined that your Disintegrate Formula, Detox Formula, Echinacea/Golden Seal, and Burdock products are promoted for conditions that cause the 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)(B)]. The therapeutic claims on these websites establish that the 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 the FDA’s regulations through links at FDA’s home page at http://www.fda.gov.
In addition, it is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. See FTC v. Direct Mktg. Concepts, 569 F. Supp. 2d 285, 300, 303 (D. Mass. 2008); FTC v. Nat’l Urological Group, Inc., No. 1:04-CV-3294-CAP, 2008 U.S. Dist. LEXIS 44145, at *43-44 (N.D. Ga. June 4, 2008); FTC v. Natural Solution, Inc., No. CV 06-6112-JFW, 2007 U.S. Dist. LEXIS 60783, at *11-12 (C.D. Cal. Aug. 7, 2007). More generally, to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act. See In re Daniel Chapter One, No. 9239, slip op. 18-20, 2009 WL 516000 (F.T.C.), 17-19 (Dec. 24, 2009) (http://www.ftc.gov/os/adjpro/d9329/091224commissionopinion.pdf).
Examples of some of the claims observed on your website www.masterpeaceinc.com include:
Disintegrate Formula
On your webpage titled, “HIV-1 Suggested Treatment,” you list this product as part of the treatment along with several other products.
On your website titled, “HPV (Human Papilloma Virus) Suggested treatment, you list this product as part of the treatment along with several other products.
On the webpage titled, “Disintegrate”:
• “PROPERTIES AND USES: [A]nti-cancer… jaundice, insomnia, asthma, bronchitis…colds, flue [sic] ...anemia…ulcers, cholesterol …radiation poisoning...pain relief…Parkinson's Disease, cancer disorders and tumors...Bells' Palsy...duodenal ulcers…fistula (abnormal tube growth between body parts)…”
• “Blue Violet [an ingredient in your product]…It has a long history as . . . aiding in the treatment of bronchitis . . . , and has a reputation as an anti-cancer herb.”
• “Celandine [an ingredient in your product]…Recommended for rheumatism and gout sufferers caused by kidney trouble. It is a specific for liver disease such as jaundice, as well as swelling of the gallbladder.”
• “Chickweed [an ingredient in your product]...It has been used on… pleurisy…colds, bronchitis...It also provides relief for rheumatism...kidney trouble, ,....”
• “ Elderberry [an ingredient in your product] has been used…for relief of headache due to cold…rheumatism, jaundice, kidney problems, epilepsy, and syphilis.”
• “Flax Seed [an ingredient in your product]…It dissolves cholesterol and reduces triglycerides…”
• Sheep Sorrel's [an ingredient in your product]…resolve cancer disorders (as well as tumors)…”
• “Skunk Cabbage [an ingredient in your product]…correction of…epilepsy, Parkinson's disease…”
• “St. John's Wort [an ingredient in your product]…[I]ts properties also treat victims of Bell's Palsy…bronchitis, and bleeding of the lungs.”
• “Tansy [an ingredient in your products] kills parasites, aids duodenal ulcers, it’s used for heart palpitations…”
• “White Oak Bark [an ingredient in your product] is employed for…goiter, to correct bloody urine discharge due to ulcerated bladder...”
• Witch Hazel [an ingredient in your product] helps heal…painful tumors, skin ulcers ….
• Cat’s Claw [an ingredient in your product] …(take to correct) ARTHRITIS, RHEUMATISM, CANCER, GASTITIS…”
Echinacea/Golden Seal
On your webpage titled, “HPV (Human Papilloma Virus) Suggested Treatment,” you list this product as part of the treatment along with several other products.
On the webpage titled, “Echinacea/Golden Seal”:
• “PROPERTIES AND USES: : [A]ntidote for poisons, repairing abscesses,…antibiotic… diabetes. Known as the herbal penicillin.”
• “Auto-infection…is eliminated by Echinacea [an ingredient in your product]….[H]elps in the following areas...syphilis, gonorrhea, gangrene... sexual impotence…”
• “Golden Seal [an ingredient in your product]...… stomach ulcers...small pox, scarlet fever, enlarged tonsils…colds...It has been found to effectively reduce excess blood sugar in diabetes.”
Burdock
On your webpage titled, “Herpes Suggested Treatment,” you list this product as part of the treatment, along with another product.
On the webpage titled, “Burdock Extract”:
• “BODILY INFLUENCES: Skin diseases of all kinds can be corrected by the use of this herb...painful skin blisters known as "shingles"…”
Detox Formula
On your webpage titled, “Hepatitis Suggested Treatment,” you list this product as part of the treatment along with several other products.
On your webpage titled, “HIV-1 Suggested Treatment,” you list this product as part of the treatment along with several other products.
On your webpage titled, “HPV (Human Papilloma Virus) Suggested Treatment,” you list this product as part of the treatment along with several other products.
On the webpage titled, “Detox”:
• “PROPERTIES AND USES: Antibiotic…high blood pressure...antidote for poisons in the body…cancer and cancer preventative...epilepsy, seizures, cancer disorders and tumors…prevent reoccurrence of cancer...protects the liver from damage caused by viruses...”
• “BODILY INFLUENCES:…[H]erbalist who used it as the remedy for cancer… [L]owering the blood pressure to normal blood pressure (and keeping it there)…anti-cancer herbs…relief of pain from cancer...epilepsy…cancer of the tongue; skin and all type cancer…tumors; leprosy; cancer; bronchitis; diseased spleen …lower chronic high blood pressure...epilepsy…paralysis…prevents the formulations of certain cancers… protects the liver from damage caused by viruses...”
Your products as noted above are not generally recognized as safe and effective for the above referenced uses and therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. Under section 301(d) and 505(a) of the Act (21 U.S.C. §§ 331(d) and 355(a)), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. The introduction into interstate commerce of unapproved new drugs without approved applications violates these provisions of the Act.
Furthermore, because your Disintegrate Formula, Detox Formula, Echinacea/Golden Seal, and Burdock products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use the products safely for their intended uses. Thus, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1). The introduction of a misbranded drug into interstate commerce is a violation of § 301(a) of the Act, 21 U.S.C. § 331(a).
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all of your products are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations described above. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Please notify FDA in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be directed to Mark E. Parmon, Compliance Officer, U.S. Food and Drug Administration, Cincinnati District Office, 6751 Steger Drive, Cincinnati, OH 45237. If you have any questions regarding compliance with the laws and regulations enforced by FDA, please contact him at (513) 679-2700, Ext. 162.
In addition, FTC strongly urges you to review all claims for your products and ensure that those claims are supported by competent and reliable scientific evidence. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or Administrative Cease and Desist Order. An order also may require that you pay back money to consumers. Please notify FTC, via electronic mail at healthproducts@ftc.gov, within fifteen (15) working days of receipt of this letter of the specific actions you have taken to address FTC’s concerns. If you have any questions regarding compliance with the FTC Act, please contact Richard Cleland at 202-326-3088.
Sincerely,
/s/
Mary K. Engle
Associate Director
Division of Advertising Practices
Federal Trade Commission
William Correll
Acting Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Teresa Thompson
District Director
Cincinnati District
Food and Drug Administration
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