FDA WARNING_LETTER - Ramon Rosa - April 30, 2014

The FDA issued a Warning Letter to Mr. Ramon Rosa after reviewing his website, www.aceitedeguanabana.com, in April 2014. The FDA determined that products sold on the website, including Ram?n Rosa 7 Aceite de Guanabana, Ram?n Rosa 7 Diabetes Terminator, and Sanson 1, 2, 3 sublingual pills, 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).

The therapeutic claims on the website establish the products' drug intent, as they are marketed for the cure, mitigation, treatment, or prevention of disease. Examples of these claims include: "Pure Soursop Oil combat Cancer ? diabetes ? high blood pressure 10,000 times more potent than chemotherapy," "Graviola [also known as soursop] has shown effectiveness towards: Cancer, Herpes, Hypertension, Palpitations, Influenza, Nervousness, Rashes, Insomnia, Neuralgia, Arthritis, Boils, Rheumatism, Muscle Spasms, High Blood Pressure, Diarrhea, Nausea, Ulcers, Ringworm, Scurvy, Malaria, Dyspepsia," and "SAMSON 1,2,3 All generic for erectile dysfunction (ED) pills sold by Ramon Rosa 7 are useful and reliable drugs? used to recover long and hard