Inspections, Compliance, Enforcement, and Criminal Investigations

Ramon Rosa 6/30/14

  

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

Public Health Service
Food and Drug Administration
 San Juan District
Compliance Branch
466 Fernandez Juncos
San Juan, Puerto Rico 00901-3223
Telephone: 787-729-8500
FAX: 787-729-8826

 

CYBER WARNING LETTER
14-SJN-WL-08
 
Jun 30 2014
 
CERTIFIED MAIL                                                                                    
RETURN RECEIPT REQUESTED
 
Mr. Ramon Rosa
P.O. Box 2111
Morovis, PR 00687
 
Dear Mr. Rosa:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.aceitedeguanabana.com in April 2014 and has determined that you take orders there for the products Ramón Rosa 7 Aceite de Guanabana, Ramón Rosa 7 Diabetes Terminator, and Sanson 1, 2, 3 sublingual pills, are which the website promotes 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 your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
 
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
On your Homepage, “Aceite Puro de Guanabana-Sobre nosotros”:  
 
  • “Aceite Puro De Guanabána
combate Cáncer • Diabetes • Alta Presión
10,000 veces màs potente que la quimioterapia”.
 
English Translation: “Pure Soursop Oil – About us”:
  • “Soursop Pure Oil
combat Cancer •diabetes • high blood pressure
10,000 times more potent than chemotherapy”.
 
On the webpage titled Aceite Puro de Guanabana – English Info / Pure Soursop Oil – English Info:
 
  • “**Purdue University is supported by…the National Cancer Institute. Purdue researchers…found that leaves from the Graviola [also known as soursop] tree killed Cancer Cells. Among six human-cell lines and were especially effective against prostate and pancreatic cancer cells**In a separate study, Purdue researchers showed that extracts from the Graviola leaves are extremely effective in isolating and killing lung cancer cells”.
 
  • “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,…”.   
 
On the webpage titled “Aceite Puro de GuanabanaDiabet[e]s Terminator”:  
 
  • “Combate Tu Diabetes...
La planta que ayuda contra la diabetes “Insulina”
Determinado tipo de diabetes se puede tratar sin necesidad de recurrir a medicamentos[.] Investigadores farmacológicos han demostrado el efecto real que tiene la planta Boussingolfia basselloides, utilizada tradicionalmente por las comunidades campesinas, en el tratamiento de la Diabetes Tipo II.... Esta planta conocida como “insulina” precisamente por su efecto antidiabético, se evaluó en el laboratorio de Farmacología de la Universidad del Valle... producía un efecto hipoglucemiante, es decir lograba disminuir la cantidad de azúcar en la sangre...”
 
  • “El Neem es un excelente auxiliar en el tratamiento y prevención de diferentes padecimientos; muchas de sus  propiedades han sido probadas y aprovechadas en los siguientes casos: Soriasis, Cáncer, Herpes y Diabetes: el Neem puede llegar a reducir [sic] los requerimientos de insulina entre un 30% y un 50%, y muestra excelentes beneficios a los no insulina dependientes.”
 
English Translation: “Pure Soursop Oil – Diabetes Terminator”
  • Combat your Diabetes…
The plant that helps against diabetes “Insulin”
Particular type of diabetes can be treated without resorting to drugs. Pharmacological researchers have shown the real pharmacological effect of the Boussingolfia basselloides plant, traditionally used by peasant communities in the treatment of Diabetes Type II…. This plant known as "insulin" precisely because of its anti-diabetic effect and it was evaluated in the laboratory of Pharmacology, University of Valley … produced a hypoglycemic effect, i.e., could decrease the amount of sugar in the blood…
 
  • “Neem is an excellent auxiliar in the treatment and prevention of various diseases; many of its properties have been tested and made use of in the following cases: Psoriasis, Cancer, Herpes, Diabetes: Neem can get to reduce insulin requirements by 30% and up to 50%, and shows excellent benefits to non-insulin dependents.”
 
On the webpage titled “Aceite Puro de GuanabanaSANSON 1,2,3 (Sublingual)”:
 
  • “SANSON 1,2,3
Todos los genéricos para la disfunción eréctil (ED) pastillas vendidas por Ramon Rosa 7 son medicamentos útiles y fiables…utilizan para recuperar las erecciones largas y duras…
¿La solución? Comprar nuestros medicamentos genéricos.”
 
  • “Invitamos a todos los hombres que sufren de estos problemas para seguir adelante y tratar de tratamientos para la disfunción eréctil. La satisfacción total garantizada de que encontrará un medicamento que pondrá fin a todos los problemas de impotencia.”
 
English translation: “Pure Soursop Oil – SANSON 1,2,3 (Sublingual)
  • SAMSON1,2,3
Allgenericfor erectiledysfunction (ED) pillssold byRamonRosa7 areuseful andreliabledrugs…usedto recover long andhard lasting erections
The solution?Buyour genericdrugs.
 
  • “We invite all men that suffer from these problems to go ahead and get treatment for the erectile dysfunction. Total satisfaction guarantee that you will find a medication that put an ends to all impotency problems.”
 
Your products Ramón Rosa 7 Aceite de Guanabana, Ramón Rosa 7 Diabetes Terminator, and Sanson 1, 2, 3 sublingual pills 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)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. 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.
 
Furthermore, your products Ramón Rosa 7 Aceite de Guanabana, Ramón Rosa 7 Diabetes Terminator, and Sanson 1, 2, 3 sublingual pills are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act, in that its labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 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 or their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
 
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do no occur in the future. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for the delay and the date by which each such item will be corrected.
 
If you need additional information or have questions concerning any products distributed through your website, please contact FDA. You may respond in writing or by telephone to Ms. Maridalia Torres, District Director, at 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding any issue in this letter, please contact Mr. Carlos A. Medina, Compliance Officer, at (787) 729-8617 or via email at carlosa.medina@fda.hhs.gov.
 
 
Sincerely,
/S/ 
Maridalia Torres
District Director
San Juan District

 

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