Inspections, Compliance, Enforcement, and Criminal Investigations

Vacunda & Design 3/20/17

 

  

Black HHS-Blue FDA Logo

 

 

 
San Juan District
Compliance Branch
466 Avenida Fernández Juncos
San Juan, Puerto Rico 00901-3223
Tel: (787) 729-8500
 

March 20, 2017
 

WARNING LETTER
AMENDED

17-SJN-WL-01 / CMS No. 497009

VIA UNITED PARCEL SERVICE
NEXT DAY - SIGNATURE REQUIRED

Mrs. Ramonita Valentin
Vacunda & Design
Ave. Muñoz Rivera # 269
Camuy, Puerto Rico 00627

Dear Mrs. Valentín:

The United States Food and Drug Administration (FDA) conducted an inspection of your facility, located at Avenida Muñoz Rivera # 269 Camuy, Puerto Rico on February 17 and March 1, 2016. During the inspection our investigators collected promotional material, product labels and labeling of your Sinai Cannabis Oil, Sinai Soursop Oil, and Sinai Soursop + CBD products. In addition, the FDA subsequently reviewed your websites in October 2016 at the internet sites http://www.vacunda-sinai.com/index.html, https://www.healthyforlifepr.com/, and your social media website https://www.facebook.com/Vacunda-Sinai-366017686756012/info/. We determined that you take orders at https://www.healthyforlifepr.com/ for the Sinai Cannabis Oil, Sinai Soursop Oil, and Sinai Soursop + CBD products. Further, your Facebook account advertises an online store www.aceitespr.com, which routes to https://www.healthyforlifepr.com/. When ordered, your Sinai Cannabis Oil, Sinai Soursop Oil, and Sinai Soursop + CBD products are then distributed from Healthy For Life in Puerto Rico, along with promotional literature associated with the product.

The claims on your websites establish that these products are 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)] 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. You can find the Act and FDA’s regulations through links on FDA’s homepage at http://www.fda.gov.

Examples of some of the claims that provide evidence that your products are intended for use as drugs include:

1. From your promotional material for the product Sinaí Cannabis Oil which is also posted under the photos tab of your Facebook page at https://www.facebook.com/Vacunda-Sinai-366017686756012/info/:
  

  English Translation:
 
 Según estudios realizados el Cannabis o CBD ayuda a:
 
 “According to studies Cannabis or CBD helps to:
 
 Pacientes con VIH (SIDA)
 
 Patients with HIV (AIDS)
 
 Retrasa avance de Alzheimer
 
 Slows progression of Alzheimer
 
 Inhibe el crecimiento de tumores y células Cancerígenas
 
 Inhibits the growth of tumors and cancer cells.
 
 Potente analgésico, ayuda a Dolores de:
• Artritis Reumatoide
• Fibromialgia
 
 Powerful analgesic helps with pain related to:
• Rheumatoid Arthritis
• Fibromyalgia
 
 Combate
• Depresión
• Ansiedad
• Diabetes tipo II
• Enfermedades neurodegenerativa (es un neuroprotector)
• Ataques Epilépticos
• Endometrosis y PMS
 
 Combats
• Depression
• Anxiety
• Type II Diabetes
• Neurodegenerative diseases (it is a neuroprotector)
• Epileptic attacks
• Endometriosis and PMS
 
 Previene ceguera por Glaucoma…
 
 Prevents blindness caused by glaucoma…
 
 Ayuda a pacientes con Parkinson
 
 Help patients with Parkinson
 
 Ideal para niños hiperactivos, con déficit de atención y ADD
 

Ideal for hyperactive kids with attention deficit and ADD
 

Muy eficaz contra las úlceras en la piel, psoriasis y otras enfermedades de la piel
 
Very effective against skin ulcers, psoriasis and other skin diseases
 
Ayuda a mantenerse sano por fuera y por dentro
 
Helps you stay healthy on the outside and inside
 

We also note that you make claims regarding the purported health effects of CBD on your Facebook page at https://www.facebook.com/galemandist/posts/552633521604755. These claims provide evidence that both your Sinai Cannabis Oil and Sinai Soursop + CBD products, which are labeled to contain CBD as an ingredient, are intended for use as drugs. Examples of such claims include: 

CBD Medical benefits:
 kills breast cancer cells
 stimulates bone growth
 stops inflammation
 anti-inflammatory properties
 anti-psychotic”
 

2. From your promotional material that accompanies the product Sinaí Soursop Oil:
 

  English Translation
 
 “10, 000 veces más potente que una quimioterapia. Según estudios realizados por las diferentes universidades y por la Asociación Mundial del Cáncer, mata células cancerígenas…
Ayuda a combatir:
• Cáncer
• Hipertensión
• Problemas de riñón
• problemas digestivos
• ansiedad
• Fortalece el Sistema inmunológico
• Estrés
• Diabetes
• Artritis…
• Tiroide
• Fibromialgia
• Vitíligo…
 
10,000 times more potent than chemotherapy. According to studies conducted by various universities and the World Association of Cancer, kills cancer cells…
Helps to combat:
• Cancer
• Hypertension
• Kidney problems,
• Digestive problems
• Anxiety
• Fortifies the immune system
• Stress
• Diabetes
• Arthritis…
• Thyroid disease
• Fibromyalgia
• Vitiligo…
 
 Pruebas de Laboratorio han comprobado que la guanábana “Graviola” sus tallos y hojas son:
• Anti cancerígeno
• Antibacteriana
• Antiparasitario
• Anti ulceroso
• Antidiabético
• Amebicida
• Vermífugo
 
 Laboratory tests have confirmed that Soursop “Graviola” leaves and stems are:
• Anti-carcinogen
• Antibacterial
• Antiparasitic
• Anti ulcers
• Antidiabetic
• Amebicide
• Vermifuge
 

3. From your website http://www.vacunda-sinai.com/index.html under the “Productos” (Products) tab and from your Facebook page at https://www.facebook.com/366017686756012/photos/a.373059732718474.92233.366017686756012/1110537458970694/?type=3&theater:

Aceite de Guanabana
“Ayuda a combatir el cáncer, presión alta, diabetes, artritis, fibromialgia, problemas de tiroide…. Según estudios realizados es 10,000 veces más potente que una quimioterapia”

English translation
Soursop Oil
“Helps to combat cancer, high blood pressure, diabetes, arthritis, fibromyalgia, problems with the thyroid…. According to studies is 10,000 times more powerful than chemotherapy.”

4. From the website www.healthyforlifepr.com at https://www.healthyforlifepr.com/collections/guanabana/products/cannabis-guanabana?variant=20122849603, regarding your Sinai Soursop + CBD product:

“Esta maravillosa combinación es una de las mejores alternativas para pacientes de cáncer. Funciona como una quimioterapia natural y además alivia los efectos secundarios de la quimioterapia tradicional, entre ellos esta, falta de apetito, nauseas o vómitos, fatiga, depresión, ansiedad, insomnio y dolores. Es ideal para personas que busquen un tratamiento preventivo ya que tiene ambos aceites. Ambos aceites ayudan…la ansiedad.”

English translation
“This wonderful combination is one of the better alternatives for cancer patients. It works as a natural chemotherapy and also alleviates the secondary effects of traditional chemotherapy, such as, less appetite, nausea or vomits, fatigue, depression, anxiety, insomnia and pain. It’s ideal for people looking for a preventive treatment since it has both oils. Both oils help…anxiety.”

Your Sinai Cannabis Oil, Sinai Soursop Oil, and Sinai Soursop + CBD products 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 the 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 CFR 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 products Sinai Cannabis Oil, Sinai Soursop Oil, and Sinai Soursop + CBD are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Sinai Cannabis Oil, Sinai Soursop Oil, and Sinai Soursop + CBD fail to bear adequate directions for their intended uses 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)].

In addition, based on the product label of your Sinaí Cannabis Oil, which indicates on its label “CBD (Cannabidiol) enriched - Dietary Supplement,” it appears that you intend to market this product as a dietary supplement. Furthermore, your Sinai Soursop + CBD product has instructions that are entitled “Instructions (Supplement),” which suggests that you might also intend to market this product as a dietary supplement. You should be aware that, based on available evidence, FDA has concluded that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the act [21 U.S.C. § 321(ff)(3)(B)(ii)]. Under that provision, if a substance (such as CBD) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, the products containing the substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or a conventional food before the new drug investigations were authorized; however based on available evidence, FDA has concluded that this is not the case for CBD.

The existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex.1 FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act. FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act, but you may present the agency with any evidence that has bearing on this issue.

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including but not limited to seizure and/or injunction.

In addition to the above violations, we have the following comments:

Your Sinaí Soursop Oil promotional material asks,

“¿Por que el Aceite de Guanabana Sinai es mas efectivo?”

“D – Registrado y monitoreado por el FDA.”

English translation
“Why is Sinai soursop oil more effective?”

“D - Registered and monitored by the FDA.”

This statement seems to imply that your product is superior to other products because you have registered with the FDA and because FDA has inspected your facility. However, all firms that are under FDA’s jurisdiction must comply with any applicable FDA registration requirements, and must participate in any authorized FDA inspection.

In addition, your Sinai Cannabis Oil and Sinai Soursop Oil product labels also declare “FDA ®.” This labeling statement seems to imply that these products have been endorsed by FDA, which is not the case. Furthermore, this statement seems to refer to FDA as a registered trademark, which is also not the case.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations noted above. Include an explanation of each step being taken to prevent the recurrence of the violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the corrections.

You may respond in writing or by telephone to Ms. Maridalia Torres, Director, San Juan District Office, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding any issue in this letter, please contact Ms. Dayna I. Martínez, Compliance Officer, at (787) 729-8608 or via email at dayna.martinez@fda.hhs.gov.

Sincerely yours,
/S/
Maridalia Torres
Director
San Juan District

__________________________________________________________

1 See “Sativex Commences US Phase II/III Clinical Trial in Cancer Pain,” available at http://www.gwpharm.co.uk/Commences%20US%20Phase%20IIIII%20Clinical%20Trial.aspx and “GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome,” available at http://www.gwpharm.com/GW%20Pharmaceuticals%20Receives%20Investigational%20New%20Drug%20IND%20from%20FDA%20for%20Phase%2023%20Clinical%20Trial%20of%20Epidiolex%20in%20the%20Treatment%20of%20Dravet%20Syndrome.aspx.
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