Inspections, Compliance, Enforcement, and Criminal Investigations

Chaya Herbal Food Inc 12/9/15

  

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) 729-8765 

 

December 09, 2015
 
WARNING LETTER
16-SJN-WL-02
 
VIA UNITED PARCEL SERVICE
NEXT DAY - SIGNATURE REQUIRED
 
 
Mr. Gerardo Tirado
President
Chaya Herbal Food Inc.
P.O. Box 789 (San Antonio)
Aguadilla, Puerto Rico  00690
 
Dear Mr. Tirado:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.chayaherbal.com in August 2015, and has determined that you take orders there for your products “Chaya Capsules”, “Chaya Tea”, “Chaya and Aloe Tea”, Sacha Inchi product (“Omega 3-6-9”), “Chaya Deodorant” cosmetic product, and for your topical products “Chaya Foot Creme” and “Chaya Aloe Gelee.” As described below, the claims on your website establish that your products are drugs under the Federal Food, Drug, and Cosmetic Act (the Act) because of their intended uses. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
 
The claims on your website establish that your “Chaya Capsules”, “Chaya Tea”, “Chaya and Aloe Tea”, and Sacha Inchi “Omega 3-6-9” products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. 
 
Examples of some of the website claims that provide evidence that these products are intended for use as drugs include:
 
Chaya ingredient claims related to your “Chaya Capsules”, “Chaya Tea”, and “Chaya and Aloe Tea” products:
  • “Entre sus beneficios esta la regulación de la diabetes, cáncer, presión (hipertensión-hipotensión), mejora la circulación sanguínea (varices), reduce el peso (obesidad) y aumenta el calcio (osteoporosis) y muchas otras dolencias del ser humano.”
English Translation: “Among its benefits is the control of diabetes, cancer, pressure (hypertension-hypotension), improves blood circulation (varicose veins), weight loss (obesity), and increases calcium (osteoporosis) and many other diseases of the human being.”
  • “[D]esinflama las venas y hemorroides…, baja el nivel de colesterol…, descongestiona y desinfecta los pulmones, previene la anemia,…previene la artritis, cáncer y la diabetes entre otras dolencias” 
English translation: “[R]educes vein and hemorrhoid inflammation…reduces cholesterol levels…lung decongestant and disinfectant, prevents anemia,…prevents arthritis, cancer and diabetes among other diseases.”
  • “[E]s como la medicina química...”
English translation: “[I]t is like a chemical drug.”
  • “Indicaciones…La Chaya es óptima para prevenir la enfermedad…pero también puede usarse como complemento en el tratamiento de numerosas dolencias entre las que se encuentran las siguientes: …Alzheimer, anemia, anorexia, arteriosclerosis, artritis, ...asma, …cáncer, …Depresión, …Impotencia Sexual, Infecciones en general,…Leucemia,…Osteoporosis, …Problemas Cardiovasculares,…Tuberculosis…”
English translation: “Indications… The Chaya is optimum to prevent diseases…and it can also be used to complement the treatment of numerous diseases including the following: …Alzheimer, Anemia, Anorexia, Arteriosclerosis, Arthritis…Asthma…Cancer…Depression…erectile dysfunction, infections in general…leukemia …osteoporosis…cardiovascular problems…tuberculosis.”
 
Sacha Inchi Ingredient related to your “Omega 3-6-9” product:
  • “El poder natural del Sacha Inchi,… disminuye…el colesterol …  Además, contribuye a regular la presión arterial, arritmia y muerte súbita; combate la neumonía bacteriana,…diabetes; también tiene efectos anticancerígenos y es excelente antiinflamatorio, es reductor del colesterol”.
English translation: “The natural power of Sacha Inchi…reduces…cholesterol … Furthermore, it contributes to control arterial pressure, arrhythmia and sudden death; combats bacterial pneumonia…diabetes; it also has anti-cancer effects and is an excellent anti-inflammatory, reduces cholesterol”.
  • “Controla y regula el colesterol,… Previene el infarto del miocardio y de la trombosis arteria… Beneficia en el tratamiento de Crohn…Posee propiedades antiinflamatorias en las articulaciones, artritis, reumatismo, arteriosclerosis, osteoporosis,… Combate el cáncer…”
English translation: “Controls cholesterol …Prevents myocardial infarction and arterial thrombosis…Benefits in the treatment of Chrohn’s…has anti-inflammatory properties in joints, arthritis, rheumatism, arteriosclerosis, osteoporosis… fights cancer…”
 
Chaya Capsules and Chaya Tea
  • “Puede Ayudar A Atenuar; Diabetes, Cáncer…Hemorroides,…Osteoporosis, Colesterol…Artritis…”
English translation: “It may help reduce Diabetes, Cancer… Hemorrhoids…Osteoporosis, Cholesterol…Arthritis…”
 
Omega 3-6-9
  • “[P]ueden ayudarle a Atenuar; Enfermedades Cardiacas, Diabetes, Alzheimer, Déficit De Atención, Hiperactividad, Autismo, Cáncer, Depresión, Osteoporosis, Artritis, Escle-rosis Múltiple…Esquizofrenia, elimina nódulos ya que desintoxica y Regenera Células y muchas otras Dolencias...”
English translation: “[M]ay help you Reduce; Cardiovascular Disease, Diabetes, Alzheimer, Attention Deficit, Hyperactivity, Autism, Cancer, Depression, Osteoporosis, Arthritis, Multiple Sclerosis…Schizophrenia, eliminates nodules as it detoxifies and regenerates cells and many other diseases.”
 
Chaya Aloe Tea
  • “Puede Ayudar a Regular…Estreñimiento …Diabetes, Cáncer… Anemia, Osteoporosis, Colesterol…”
English Translation: “Can Help Regulate…Constipation…Diabetes, Cancer…Anemia, Osteoporosis, Cholesterol…” 
 
The claims on your website establish that your “Chaya Aloe Gelee”, “Chaya Foot Crème” and “Chaya Deodorant” products are drugs under sections 201(g)(1)(B) and/or 201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(B) and/or 201(g)(1)(C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the human body.
 
Examples of some of the website claims that provide evidence that these products are intended for use as drugs include:
 
Chaya Aloe Gelee
  • Psoriasis, Cortaduras, Raspados, Salpullido por calor, Quemaduras leves, Ulceras, Bloqueador Solar, Hand Sanitizer, . . . Picaduras de Insectos, Escamas, Muchos otros Desordenes, Alergias de laPiel y regula el pH.”
English Translation: “Psoriasis, Minor Burns, Cuts, Sores, Scrapes, Sun Burn, Heat Rash, Bed Sores, Hand Sanitizer, . . . Insect bites, Sunblock, and Many other Skin Disorders and regulates pH.”
 
Foot Crème – Crema Para los pies
  • “Uso: Aplique una cantidad generosa en cada pie y masaje suavemente. . . . desinfecta, antiinflamatoria, regenera células, cicatrizante para los pies diabéticos, pie de atleta, hongos.”
English Translation: “Use: Apply a generous amount on each foot and gently massage. . . disinfecting, anti-inflammatory, regenerates cells, healing diabetic foot, athlete’s foot, fungus.”
 
Desodorante:
  • “Uso… regula el pH, reduciendo la transpiración cutánea.”
English translation: “Use… regulates the pH, reducing the skin perspiration.”
 
Your “Chaya Capsules”, “Chaya Tea”, “Chaya and Aloe Tea”, “Omega 3-6-9”, “Chaya Aloe Gelee”, ‘Foot Crème – Crema Para los pies”, and “Desodorante” products are not generally recognized as safe and effective for the above referenced uses and, therefore, these 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 sections 301(d) and 505(a) of the Act [21 U.S.C. §§331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
 
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 C.F.R. § 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your “Chaya Capsules”, “Chaya Tea”, “Chaya and Aloe Tea”, “Omega 3-6-9”, “Chaya Aloe Gelee”, and ‘Foot Crème – Crema Para los pies” products are offered for conditions that are not amenable to self-diagnosis and treatment. Therefore, it is impossible to write adequate directions for a layperson to use these products safely for their intended purposes. Accordingly, these products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
The violations cited in this letter are not meant to be an all-inclusive statement of violations that exist in connection with your products and their labeling. It is your responsibility to ensure that all your products comply with the Act and its implementing regulations.  
 
You should take prompt action to correct the violations cited in this letter and prevent their future recurrence. Failure to promptly correct these violations may result in legal action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. § 332 and 334].
 
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 fifteen (15) working days, please explain the reason for the delay and the date by which the corrections will be completed.
 
Please send your written response to the attention of Mr. Jose Lopez, Compliance Officer, Food and Drug Administration, San Juan District Office.  If you have any questions regarding this letter, please contact Jose Lopez at (787) 729-8603 or via email at JoseR.Lopez@fda.hhs.gov
 
Sincerely,
/S/
Maridalia Torres
District Director
San Juan District

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