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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CreAgri, Inc. 8/28/14

  

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

Public Health Service
Food and Drug Administration
 San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: (510) 337-6700 

 

WARNING LETTER
 
 
August 28, 2014
 
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
Our Reference: CMS 397679
 
Roberto Crea, CEO
CreAgri, Inc
25565 Whitesell St.
Hayward, CA 94545
 
Dear Mr. Roberto Crea:
 
This is to advise you that the U.S. Food and Drug Administration (FDA) has reviewed your websites at the Internet addresses www.olivenolplus.com and www.creagri.com in November 2013 and August 2014 and has determined that you take orders there for your products “Olivenol plus Easeflex,” “Olivenol plus Essence Capsules,” “Olivenol plus Essence Elixer,” and “Olivenol plus Healing Moisturizer,”which the websites promote for conditions that cause the products to be drugs under sections 201(g)(1)(B) and/or 201(g)(1)(C)  of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) and/or 321(g)(1)(C)]. The claims on your website establish that these products are drugs 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. 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:
 
Olivenol plus Easeflex
  • “OLIVENOL Plus Easeflex reduces joint inflammation and swelling and supports the healing of damaged cartilage.”
  • “Helps in production and repair of cartilage…”
  • “OLIVENOL Plus Easeflex … is proven to help in cases of severe joint disorders like chronic arthritis and osteoarthritis…”
 
Olivenol plus Essence (30 Capsules) and Elixer (60mL)
  • “OLIVENOL Plus Essence is also proven to help in cases of chronic systemic inflammations affecting skin, joints and internal organs”
  •  “It [OLIVENOL Plus Essence] is also indicated as a strong boost of the immune system and in all cases of degenerative diseases.”
  • “[P]roven to help in cases of severe skin disorders like psoriasis, eczema, allergic dermatitis, etc.
 
Olivenol Plus Healing Moisturizer (4oz and 2oz)
  • “[A]ids as a barrier against sun damage (UV A and B rays).” (4oz)
  • “[R]educe skin inflammation (redness and scaling)” (4oz)
  • “Enhance the re-growth of damaged cells” (2oz)
  • “Effectively reducing skin allergies …” (2oz)
 
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment or prevention of disease. Examples of such testimonials include:
 
On the “Success Stories” webpage:
  • “My four year old son has serious eczema…After each round of relief, it is followed by another episode of more nasty flare. At one point, almost 80% of the visible neck area of my son had wet, itchy and painful flaring rash…I am glad those days are now over. A family friend who happened to be a doctor recommended us to try OLIVENOL, an organic olive juice extract. I am grateful he did. The improvements were visible after the first week. His rashes became less red and were no longer oozing wet.”
  • “I must tell you that not only the blistering and the itching disappeared, but I was also able to finish the rest of the radio-treatment without interruption. When I went to talk to my treating physician, I told the story of Olivenol, and he got very impressed and he is interested to the product to the point…”
  • “My son was diagnosed as having psoriasis when he was 12 years old. It was indeed heartbreaking for us to know of his condition. If you have one pimple on your face that made you feel ugly, try to multiply that feelings times many many lesions all over your body that are red, scaly, itchy and leave a trail of dead skin wherever you go; that is what my son has to suffer….I became very excited and hopeful when I stumble upon Olivenol at my local pharmacist. My son has been taking it for a few months and have [sic] shown improvement. At least the flaring episodes is[sic] under control, and he experience[d] much relief from itchiness, and the skin looks less red.
 
Your 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 the 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. 
 
This letter is not intended to be an all-inclusive review of your website and the products your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. 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. 
 
We also note that the product labels collected during an FDA inspection of your facility in March 2013 contained claims similar to those cited in this letter. Therefore, we specifically recommend that you review your product labels to ensure that they are in compliance with the Act.
 
Please notify this office in writing within 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 not 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.
 
Please send your reply to the U.S. Food and Drug Administration, Attention: Lawton W. Lum, Director of Compliance, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. If you have questions regarding any issues in this letter, please contact Compliance Officer Russell A. Campbell at (510) 337-6861.
           
 
Sincerely,       
/S/ 
Kathleen M. Lewis, J.D.
Director
San Francisco District
 
 
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