Inspections, Compliance, Enforcement, and Criminal Investigations
Nutronix International 23-Oct-06
Department of Health and Human Services
Public Health Service
October 23, 2006
RETURN RECEIPT REQUESTED
Bob Bremner, Director
7518 Mechanicsville Turnpike
Mechanicsville, VA 23111
Dear Mr. Bremner:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.nutronix.com, as well as certain labeling for your products, and has determined that the products The New Silver Solution™, which purports to contain 14 parts per million of purified silver, and Omega 3-6-9 are promoted for conditions that cause these 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 site, as well as in the labeling for The New Silver Solution, establish that these 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. You can find the Act and regulations on FDA's website at http://www.fda.gov.
Under the Act, "labeling" is not limited to labels on the immediate containers for your products. "Labeling" is defined in section 201(m) the Act [21 U.S.C. 321(m)] as "all labels and other written, printed or graphic matter upon any article . . . or accompanying such article." Our investigation has disclosed that you distribute brochures with some of your products. Such materials, along with the web site http://www.nutronix.com, are "labeling" for your products under the Act.
Examples of some of the claims observed in the labeling for your products include:
THE NEW SILVER SOLUTION
Claims on your website:
"The New Silver Solution is a very potent and effective nano-particulate solution that is non- toxic and yet lethal to bacteria, yeasts, and some viruses."
"Numerous tests at major universities and commercial labs like: Kansas State, UC Davis, Brigham Young University, have proven the effectiveness of the product in killing hundreds of strains of bacteria like Staph, Strep, TB, E-coli, Salmonella. ..and even the Anthrax spore."
"The New Silver Solution has been proven to kill bacteria that are associated with the following ailments : Food Poisoning, Pneumonia . . .Eye Infection, Skin Infections, Meningitis, Nosocomial Infections (from hospitals), Respiratory Infections, Scarlet Fever, Sinus Infection, Strep Throat ...Urinary Tract Infections. . ."
Claims from "Nature's Silver Bullet - Killing the Fear Factor" booklet:
TOPICAL USES-page 58-59:
"Spray colloidal silver often onto minor burns, cuts, scrapes, wounds, to decrease healing time, prevent infection and reduce scarring."
"Silver may be massaged into gums several times daily or swished in the mouth for oral infections as it kills the bacteria causing dental caries."
"Applied topically silver can relieve athlete's foot, acne, warts, eczema, open sores, rashes and insect bites."
ORAL USES- age 59-60:
"Particulate silver contains solutions can be take orally for conditions such as, parasites, candida, chronic fatigue, fungal infections, herpes, shingles, staphylococcus and streptococcus infections and over sixty viral and bacterial diseases. Silver may be sprayed into the nostrils from a pump applicator for sinus infections, headaches or to abort head-colds."
Claims from "The New Silver Solution - An Information Guide to Silver Solutions" booklet:
Asthma page 37-38:
"One of the most interesting reports coming from the study of the New Silver Solution is its effect on asthma. Several people have reported that the silver solution taken orally can stop asthma attacks."
Diabetic Neuropathy page 39:
"Because of impaired circulation, it is common that for diabetics cuts and scratches heal more slowly. Taking the New Sliver Solution appears to shorten healing time and also to reduce pain in the extremities. The solution should be both taken internally (1-2 tsp per day) and sprayed directly on affected areas two to three times daily."
Hepatitis B & C page 41:
"The product has been found highly effective in in vitro (test tube) tests at inhibiting the hepatitis virus. . . [i]n one case of Hepatitis C here in the US, a doctor was taking four teaspoons of the product daily. In sixty days her viral load had dropped from over seventy five million virus (sic) to thirty-five million -a drop of over half her viral load in just 60 days. Other people have been reporting similar results."
Urinary Tract Infection page 46:
"A woman who had a recurrent urinary tract infection for five years, reported that antibiotics would appear to kill the infection, but that it would reappear soon after she stopped taking the antibiotic. She took two teaspoons a day of the New Silver Solution for ten days and her doctor told her that the infection had cleared up completely. In laboratory tests it has been shown that the New Silver Solution has been able to kill seven different types of bacteria that cause urinary tract infections."
Claims on your website:
"Essential Fatty Acids must be supplied by the diet.... [t]hey aid in the prevention of arthritis, fight cardiovascular disease. . ."
"Studies show that omega-3 can help to protect the cardiovascular system from a host of problems, including blood clots, high blood pressure, and high blood fat levels. Aside from being a rich source of omega-3 fatty acids, flax seed oil also contains substances know as Lignans, which are said to protect against breast, prostate, and colon cancer. Lignans also have anti-viral and anti-bacterial properties."
"Flax seed oil may help . . .alleviate symptoms of depression."
Your products are not generally recognized as safe and effective for the above referenced conditions and, therefore, are "new drugs" 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.
Your products are not generally recognized as safe and effective for the above referenced conditions and, therefore, are "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)]. See 21 C.F.R. § 310.548 (stating, among other things, that products containing colloidal silver ingredients or silver salts that are labeled for the treatment or prevention of any disease are not generally recognized as safe and effective and thus are "new drugs"). 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, The New Silver Solution and Omega 3-6-9 products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that the labeling of these products fail to bear adequate directions for use for their intended uses.
This letter is not intended to be an all inclusive review of your products and their labeling. 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 these deviations. Failure to immediately cease distribution of violative products may result in regulatory action by FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
We request that you notify this office in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations. Your response should address the comments listed above and include examples of documentation showing that corrections have been achieved. If corrective action can not be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.
Your reply should be directed to Randy F. Pack, Compliance Officer, Food and Drug Administration, Baltimore District Office, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions, please do not hesitate to contact Mr. Randy F. Pack at (410) 779-5454, extension 417.