FDA WARNING_LETTER - Master Peace Inc - March 31, 2011
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This FDA Warning Letter (CIN-11-124368-14) dated March 2011, issued to MasterPeace, Inc., addresses violations concerning their Disintegrate Formula, Detox Formula, Echinacea/Golden Seal, and Burdock products. The FDA and FTC reviewed the company's website, masterpeaceinc.com, and determined that these products are promoted for conditions that classify them as 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)] due to therapeutic claims for cure, mitigation, treatment, or prevention of disease.
Specific claims cited for Disintegrate Formula include treatment for HIV-1, HPV, cancer, jaundice, asthma, colds, flu, anemia, ulcers, Parkinson's Disease, and various other ailments. Echinacea/Golden Seal was promoted for HPV, poisons, abscesses, diabetes, syphilis, gonorrhea, and stomach ulcers. Burdock was advertised for skin diseases and shingles, while Detox Formula was marketed for Hepatitis, HIV-1, HPV, high blood pressure, cancer, epilepsy, and liver protection.
These products are deemed "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe
ID · 139a118c-fb67-4cd5-9291-7748305049e4
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