Inspections, Compliance, Enforcement, and Criminal Investigations
Water Oz 08-Mar-06
Department of Health and Human Services
Public Health Service
March 8, 2006
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 06-21
Gregory W. Towerton, General Manager
1753 Stites Road
Grangeville, ID 83530
Dear Mr. Towerton:
The Food and Drug Administration (FDA) has reviewed your website at the intemet address www.wateroz.com, and we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and FDA's regulations through links on FDA's Internet web site at http://www.fda.gov.
Under the Act, articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man are drugs as defined in section 201 (g)(1)(13) of the Act [ 21 U.S.C. § 321 (g)(1)(13)]. Articles other than food that are intended to affect the structure or function of the body of man or other animals are also drugs as defined in section201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(C)]. Products meeting the definition of"dietary supplement" under section 201(ff) of the Act [21 U.S.C. 321(ff)] may bear claims regarding an effect on the structure or function of the body (structure/function claims) if the requirements of section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)] are met. Topical products and products intended to enter the body directly through skin or mucous tissues are not dietary supplements. For such products, both disease and structure/function claims cause them to be drugs.
The internet labeling of the products on your website that appear to be intended for ingestion includes the following claims:
Germanium also is believed to act as an anti-cancer agent, has proved itself effective in viral, bacterial and fungal infections and is known to stimulate production of natural killer cells and T-suppressor cells."
"It is believed that gold helps repair damaged DNA. Effective against joint inflammation, gold, when used with aspirin for arthritis, relieves pain. Gold is not an analgesic but may have anti-inflammatory effects."
"Platinum is used in the treatment of cancer and as a base in some of the chemotherapeutic treatments in conventional hospitals, although not in the proper (natural) form."
"Platinum may be effective in killing disease-causing bacteria, fungi, viruses . . . ."
"A deficiency in chromium is a major factor in the development of heart disease (heart attacks, hardening of the arteries)."
"Boron . . .helps prevent osteoporosis, arthritis, and tooth decay."
"[T]here is evidence that it can help the body fight cancer."
"Pain and inflammation associated with various muscle and skeletal disorders indicate a deficiency of sulfur. It is believed that sulfur can repair the myelin sheath . . . . [D]amage to the myelin sheath causes the shaking condition in palsy, Multiple Sclerosis, Lorenzo's Disease and many other disease conditions. . . ."
"It . . .reduces back pain, relieves migraine headaches . . . and speeds wound healing."
Additionally, when we reviewed your website several months ago, the Internet labeling for the topical and olfactory products you marketed and distributed at the time included the following claims:
"May assist when used for intestinal problems, repairing connective tissue, asthma, emphysema, bronchitis, chronic nasal catarrh, whooping cough, sinusitis, poor memory, mental fatigue, lack of concentration, insect and snake bites . . . wasp stings, gout, muscular aches and pains, rheumatism, constipation, fainting, earache, gas, dyspepsia, nausea, cramps, scanty periods, colds, fever, flu, loss of smell, prostate problems, infectious disease, anxiety, depression, migraine, nervous tension . .. ."
"May be antiseptic, anti-infectious, anti-spasmodic, and a restorative (stimulant for nerves, adrenal cortex)."
Basil, Holy India
"[I]s commonly used for coughs, colds, mild indigestion, diminished appetite and malaise."
"[U]sed in ear infections and may be anti-fungal and anti-bacterial."
"It has been used for ringworm, malaria and dysentery, and has been found to reduce stress, modulate immunological functions (including allergies and asthma)"
"[H]as been effective for diabetes."
"Holy Basil has been used in catarrh and bronchitis, in gastric disorders in children and some hepatic conditions, for fevers, dropsy and anasarca, hemiplegia, vomiting, constipation, cholera, post natal complaints, and hemorrhagic septicemia. It is capable of rejuvenating the system quickly and is a deodorant, stimulant, anti-inflammatory, cardiotonic, blood purifier, useful in skin diseases, and an antipyretic (particularly in malarial fevers)."
"Useful for nausea, abdominal pain, worms, allergic rhinitis, and all types of respiratory disorders."
Clove Bud (Madaqascar)
"This may assist the respiratory system, toothache pain, infectious diseases, formerly used against the plague, memory deficiency, impotence, infected wounds, anti-inflammatory, anti-viral, anti-bacterial, anti-fungal, anti-tumoral, anti-parasitic, athlete's foot, bruises, burns, cuts . . . arthritis, rheumatism, sprains, asthma, bronchitis, colic, nausea, colds, flu, flatulence, cancer, Hodgkins disease, dental infections, virus of the nerves (MS), cystitis, diarrhea, amoebic dysentery, viral hepatitis, bacterial colitis, cholera, sinusitis, tuberculosis, hypertension, thyroid dysfunction and fatigue, analgesic, antiseptic."
Lemon, Organi (USA Pressed Peel)
"May assist digestive problems, cleansing of the lymphatic system, fever reduction, infectious diseases, colds, throat infection, asthma, anemia, heartburn, varicose veins, gout, rheumatism, uterine infections, intestinal parasites . . . immune system (may stimulate red and white blood cell formation), acne, brittle nails, boils, corns, herpes, warts, arthritis, cellulitis, nervous conditions, high blood pressure, nosebleeds, stopping bleeding, obesity (congestion), poor circulation, rheumatism, gallstones, bronchitis, dyspepsia, flu, debility, anxiety, astringent, antiseptic, emotional clarity, apathy, awareness, bringing joy, relieving touchiness, grudges, resentment, concentration and focus."
Tea Tree (Australia)
"May be beneficial for respiratory, infectious disease such as chickenpox, healing wounds, fungal infections (athlete's foot, candida, jock itch), sore throat, tonsillitis, gum disease, rash, sunburn, digestion, diarrhea, vaginal thrush, immuno-stimulant, abscess, acne, cold sores, herpes, burns, shock, hysteria, warts, lice, tuberculosis, whooping cough, colds, flu, sinusitis, tissue regenerator, anti-septic, anti-fungal, anti-viral, and anti-bacterial."
These claims cause the foregoing products to be drugs, as defined in section 201(g)(1)(B) and/or section 201(g)(1)(C). Because your products are not generally recognized as safe and effective when used as labeled, they are also new drugs as defined in section 201(p)of the Act [21 U.S. C. 321(p)]. Under section 505 of the Act [21 U.S.C. 355(a)], a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA). These products are also 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.
This letter is not intended to be an all inclusive review of your products and labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
We request that you take prompt action to correct these violations. Failure to immediately cease distribution of your violative products could result in enforcement action by FDA without further notice. The Act provides for the seizure of illegal products and injunctions against the manufacturers and/or distributors of violative products.
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct these violations, including any steps taken with respect to violative products currently in the marketplace, and an explanation of each step taken to ensure that violations do not recur. Your reply should be sent to the Food and Drug Administration, Attention: Lisa Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421.
Charles M. Breen