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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Juve International, LLC 4/2/13

  

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

Public Health Service
Food and Drug Administration
 Denver District Office
Building 20-Denver Federal Center
P.O. Box 25087
Denver, Colorado 80225-0087
TELEPHONE: 303-236-3000 

 

April 2, 2013
 
WARNING LETTER
 
 
UPS Overnight
 
Michael Muaina
Juve International LLC
11650 S State Street
Suite #318
Draper, Utah 84020
Ref: DEN-13-10-WL
Dear Mr. Muaina,
 
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website, www.juve-international.com, and the website www.juvejuice.com, in February and March 2013. FDA's review found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR). You can find copies of the Act and related regulations through links in FDA's home page at http://www.fda.gov.
 
Based on claims made in the labeling for this product on your website where product may be purchased, we have determined that your JUVE Juice product is promoted for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of this product with these claims violates the Act.
 
Examples of some of the claims observed on your website selling your Juve Maqui Juice product include:
 
On your homepage under the heading “Yumberry” (an ingredient in your Juve Maqui Juice product):
 
  •  “Reduce your blood pressure … ”
  •  “Lower bad (LDL) cholesterol.”
  •  “… [R]educe your risk of cataracts.”
  •  “Fight … diseases such as arthritis.”
  •  “…inhibit E. coli…”
 
On your homepage under the heading “Goji Berries” (an ingredient in your Juve Maqui Juice product):
 
  •  “ [T]he antioxidant value of goji berries contribute to its ability to… fight infection…. Researchers have questioned whether they can inhibit the growth of cancer cells, prevent Alzheimer’s disease, reduce blood glucose and lower cholesterol levels … ”
 
On your homepage, under the heading “Pomegranate” (an ingredient in your Juve Maqui Juice product):
 
  •  “Prevents Strokes and Other Heart Ailments”
  •  “Reduces Risk of Certain Cancers”
  •  “Helps Prevent Osteoarthritis And Other Bone-related Diseases”
 
On your homepage under the heading “The Science of Antioxidants:”
 
  •  “Fruits such as the superfruit Maqui berry (an ingredient in your product) have the ability to take up free radicals that cause cellular damage that may lead to disease.”
 
            On www.juvejuice.com/health-benefits:
 
  •  “The antioxidants in Maqui berry can offset the effects of free radicals and improve … diabetes, other diseases...”
 
         On www.juvejuice.com/how-to-purchase:
 
  •  “Juve Health Benefits - Promotes anti-cancer … cells … Aides in the fight against diabetes…”
  •  “The antioxidants in Maqui berry … aids in the fight against cancer, diabetes … and other diseases.”
  •  “JUVE Juice aids in disease prevention….”
 
         On www.juvejuice.com/science-of-juve-ingredients:
 
  •  “Research has also shown that maqui berries reduce the amount of cholesterol in your veins, reducing the chance of strokes, heart attacks and even diabetes.”
  •  “Studies have shown that antioxidants help prevent free radical damage that is associated with cancer and heart disease.”
  •  “Many studies show that maqui berries have the highest content of antioxidants over any other plants and that they may reduce the risk of cancer.”
  •  “The use of maqui berries as a dietary supplement for antioxidants could reduce the risk of cardiovascular disease.”
  •  “…some say that pomegranate can be used for dysentery and cholera as well.”
  •  “Raspberries can restrain proliferation of cancer cells and even the formation of tumors in various parts of the body, including the colon.”
  •  “Daily consumption 3 or more servings of raspberry has been seen to lower the risk of age-related macular degeneration (ARMD), the main cause of vision loss in older adults.”
  •  “The anthocyanins present in raspberry have been found to reduce the risk of heart disease….”
  •  “The presence of salicylic acid in raspberries might slow down atherosclerosis….”
  •  “Raspberry is a good source of quercetin, an antioxidant that diminishes the release of histamines and thus, minimizes allergic reactions.”
  •  “Goji berries are also known for their anti-bacterial and anti-fungal properties.”
  •  “Cranberry has been used for treatment of such ailments as wounds, …, diabetes, … liver problems. It is most well-known for preventing urinary tract infections.”
  •  “Cranberry juice has the potential to prevent recurring urinary tract infections.”
  •  “Tummy problems? Get some yum-berry juice. It has the potential to cure persistent purging of the bowels (diarrhea!) … and also can inhibit E.Coli too.”
  •    “Health Benefits of Cherry: - Help fight cancer - Aid in prevention of heart disease - Relieve Pain of Arthritis, Gout, Headaches - Ease the symptoms associated with Fibromyalgia Syndrome …”
 
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 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 product is 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 this drug safely for its intended purpose. Thus, your product is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use. 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 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 above violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and 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 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: U.S. Food & Drug Administration, Denver District, 6th Avenue & Kipling Street, Building 20 DFC, P.O. Box 25087, Denver, CO 80225-0087, Attn: Sarah A. Della Fave, Compliance Officer. If you have any questions regarding any issue in this letter, please contact Ms. Della Fave at 303.236.3006.
 
Sincerely,
/S/
LaTonya M. Mitchell
Director
Denver District