Inspections, Compliance, Enforcement, and Criminal Investigations

Borinquen Natural, Inc. 7/17/14

  

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 Fernández Juncos
San Juan, Puerto Rico 00901-3223
Telephone: 787-729-8500
FAX: 787-729-8826

 

CYBER WARNING LETTER
14-SJN-WL-09
 
July 17, 2014
 
VIA OVERNIGHT DELIVERY                                                                           
RETURN RECEIPT REQUESTED
 
Borinquen Natural
Mr. José Estévez
460 Hostos Avenue
Urb. El Vedado
San Juan, PR 00918
 
Dear Mr. Estevez:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.borinquennatural.com has determined that you take orders there for the products “HCG Premium,”  “Moringa Premium,” “Veggie Collagen Concentrado,” and “Veggie Collagen Ultra Concentrado.” In addition, FDA reviewed your Facebook page at the Internet address www.facebook.com/borinquennatural in May 2014, which has a link to the above-referenced website where products can be purchased directly.  Your Facebook page the promotes the above-referenced products 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 found on your Facebook page establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
 
FDA previously notified you that certain of your products were promoted on your websites www.borinquennatural.com and www.hcgdrospremium.com for conditions that caused the products to be drugs. Specifically, an FDA investigator hand delivered to your firm Untitled Letter 13-SJN-UTL-08 on September 6, 2013 during an inspection conducted at your facility located in Carolina, Puerto Rico.
 
Examples of some of the claims that provide evidence that your product “HCG Premium” is intended for use as a drug include:
 
On the Facebook page titled “Borinquen Natural-Carolina, Puerto Rico — Empresa”:
  • “Té Verde / Green Tea HCG PREMIUM” 
o   Reduce el riesgo de cáncer / English translation: “Reduces cancer risk”
o   Previene la obesidad / English translation: “Prevents obesity”
o   Es bueno para la diabetes / English translation: “Good for diabetes"
o   Alivia el asma / English translation: “Treats asthma”
o   Previene la hypertension / English translation: “Prevents hypertension”
o   Ayuda bajar el cholesterol / English translation: “Helps reduce cholesterol”
o   Reduce los niveles de glucose en sangre / English translation: “Reduces the glucose level in blood”     
 
Further, promotional flyers for your products “Moringa Premium,” “Veggie Collagen Concentrado,” and “Veggie Collagen Ultra Concentrado” were obtained from the health food store Vivamas, located at San Patricio mall in Guaynabo, Puerto Rico. The flyers were located near where the products were being held for sale. Examples of some of the claims on your promotional materials (flyers) that provide evidence that your products “Moringa Premium,” “Veggie Collagen Concentrado,” and “Veggie Collagen Ultra Concentrado” are intended for use as drugs include:
  • “Moringa Premium”
    • Mejora tu salud ayuda a prevenir y tratar mas de 300 enfermedades / English translation: “Enhance your health helps prevent and treat over 300 diseases”
    • Problemas Cardiacos / English translation: “Cardiac problems”
    • VIH/SIDA / English translation: “HIV/AIDS”
    • Depresión / English translation: “Depression”
    • Problemas Renales / English translation: “Renal Problems”
    • Obesidad / English translation: “Obesity”
    • Problemas del Hígado / English translation: “Liver Problems”
    • Disfunción Eréctil / English translation: “Erectile Dysfunction”
    • Alzheimer / English translation: “Alzheimer”
    • Diabetes / English translation: “Diabetes”
    • Cáncer / English translation: “Cancer”
    • Colesterol Malo / English translation: “Bad Cholesterol”
    • Hipertensión / English translation: “Hypertension”
    • Artitris / English translation: “Arthritis”  
  • “Veggie Collagen Concentrado” and “Veggie Collagen Ultra Concentrado” 
Sabías que?...El colágeno regular esta hecho de animales vs Veggie Collagen que es una formula 100% vegetal y con mejores beneficios
 
English translation: “Did you know?.. regular collagen is made from animals vs Veggie Collagen is a 100% vegetable formula and with better benefits”
    • Beneficios / English translation: “Benefits”
      • Anti-envejecimiento / English translation: “Anti aging” 
      • Alivia los dolores / English translation: “Relieves pain”
      • Desintoxica / English translation: “Antitoxin”
      • Anti-inflamatorio / English translation: “Anti-inflammatory” 
      • Anti-tumoral / English translation: “Anti-tumor”
  • Ayuda a Mejorar Condiciones de: / English translation: “Helps improve conditions of:”
      • Artritis / English translation: “Arthritis”
      • Hipertension / English translation: “Hypertension”
      • Colesterol Malo / English translation: “Bad Cholesterol”
      • Corazon / English translation: “Heart”
      • Riñon / English translation: “Kidney”
      • Higado / English translation: “Liver”
      • Diabetes / English translation: “Diabetes”
      • Obesidad / English translation: “Obesity” 
Your products “HCG Premium,” “Moringa Premium,” “Veggie Collagen Concentrado,” and “Veggie Collagen Ultra Concentrado” 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 “HCG Premium,” “Moringa Premium,” “Veggie Collagen Concentrado,” and “Veggie Collagen Ultra Concentrado” 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 their 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 violations that exist in connection with your products or their labeling. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations cited in this letter and to prevent their reoccurrence. Failure to promptly correct these violations may result in legal action without further notice, including 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. Your response should include any documentation that would assist in evaluating your corrections. If you cannot complete all corrections within 15 working days, please explain the reason for the delay and the date by which each item will be corrected.
 
Please send your written response to the attention of Mr. Carlos A. Medina, Compliance Officer, Food and Drug Administration, San Juan District Office. If you have any questions regarding this letter, please contact Carlos A. Medina 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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