CERTIFIED MAIL RETURN RECEIPT REQUESTED
Peter W. Manville NJP Products, Inc.
23352 Madero Road, Suite C and 27525 PuertaReal #100-505 Mission Viejo. California 92691
Public Health Service
Food and Drug Administration College Park, Maryland 20740
Ref. No. CL-06-HFS-810-239
Deai Mr. Manville:
This is to advise you fliat the Food and Drug Administration (FDA) lias reviewed your web sites at the Internet addresses http://www.noni-iuice-plus.com and http://www.barlev-green-premium.com and has determined that the products “Noni Juice” and "BarleyGreen Premium” are promoted for conditions that cause the products to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your web sites establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.
Examples of some of the claims observed on your http://www.non i-juice-plus.com web site include:
Noni Juice
Your web site contains disease claims in the form of personal testimonials about the use your Noni Juice product for a wide variety of diseases, including chronic lymphocytic leukemia, arthritis, carpal tunnel syndrome, allergies, asthma, bipolar disorder, depression, migraines, multiple sclerosis, and others. Examples of some of the disease claims observed on your testimonials page include:
“I just want to take the time to let you know that after a month of taking the Noni Juice you supply I noticed a difference in my symptoms, you see I have Lupus Erythematous [sic] and suffer from arthritic like symptoms. The first two weeks after taking I noticed that I did not have joint pain, the swelling m my fingers had disappeared, the fatigue disappeared and I had a lot more energy. Also, I had been suffering from chronic back pain and even that seemed to have disappeared. ...