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Enforcement Actions

Colloids for Life, LLC 02-Dec-04

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

Public Health Service
Food and Drug Administration

 

Southwest Region



December 2, 2004

Warning Letter

Certified Mail
Return Receipt Requested

Colin D. Eidsness, President
Colloids for Life, LLC
10180 King Street
Westminster, Colorado 80031

Ref#: DEN-05-03

Dear Mr. Eidsness:

This is to advise you that the Food and Administration (FDA) has reviewed your web site at the Internet address h and has determined that the products “Mesosilver®” and “Mesogold®” 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 USC 321(g)(1).] The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.

On your website, the Mesogold and Mesosilver pages allow consumers to click on links entitled “Frequently Asked Technical Questions “, “Scientific & Technical Details about Mesogold,” or "Find out more about ionic gold [silver] and why Mesogold [Mesosilver] is better.” From any of those links, the consumers can search a “condition.” Conditions listed for your products Mesogold and Mesosilver include, among others, the following diseases:

ADD ADHD Hyperactivity
Arthritis

  • Asthma
  • Bacterial Infections
  • Bladder Infection
  • Bronchitis
  • Cellulitis Conjunctivitis
  • Crohn’s Disease
    Depression
    Ear Infection
  • Emphysema
  • Flu
  • Hepatitis C
  • High Blood Pressure
  • HIVAids
    Kidney infection
    Lyme Disease
    Pneumonia
    Prostatitis
    Rheumatoid Arthritis
    Staph Infection

Examples of some of the claims and testimonials observed on your web site when one of the conditions above is selected include:

Crohn’s Disease

Under the heading “How does Mesosilver help Crohn’s Disease?“: “When Colloidal Silver comes in contact with any single celled pathogen, it disables the pathogens [sic] oxygen metabolism enzyme causing the pathogen to suffocate and die. The dead pathogen is then cleared out of the body by the immune, lymphatic and elimination systems.”

Under “Results/Testimonials”: “I was diagnosed with Crohn’s Disease about 16 or 17 years ago. . .I started taking about a tablespoon of Mesosilver every day and my health has dramatically improved - I’d say 50% or more.”

HIV Aids

Under the heading “How Does Mesosilver Help HIV / AIDS?“: “ColIoidal silver . . . is said to have anti-microbial properties. Though it is not approved by the FDA for treatment of HIV AIDS, many HIV+ people are reporting dramatic improvement in their condition through its use.”

Under “Result/TestimoniaIs”: “[S]topped all my meds Feb. 2000 & went 6 months without HIV meds before starting on C.S... just got”my blood work results back the other day....and everything came back much better than I had expected...& much better than they were a year ago!”

Rheumatoid Arthritis

Under the heading “Colloidal Gold in the Treatment of Rheumatoid Arthritis (RA)“: “In a recent study of using colloidal gold for patients with rheumatoid arthritis, statistically significant improvements were found for joint tenderness and swelling, beginning with the first week. In this pilot study colloidal gold was found to be rapid-acting (within one week) by reducing joint tenderness and swelling without side effects.. . .”

Under “Dosage’ “For relief [sic] from Rheumatoid Arthritis mesogold is taken internally.” Under “Results/Testimonials”: “I have arthritis in both hands and had a serious flare up where lost the use of my hands and arms for about two months. After eight weeks of rehab I did regain the use of them, but once I started taking the Mesogold, I noticed a definite improvement; I can now make a fist and am no longer debilitated.”

“I’ve been taking Mesgold [sic] for my arthritis for about a year now. The pain is better and I have more freedom of movement. My arthritis is very much improved over all.”

Lyme Disease

Under the heading “How Does Mesosilver Help Lyme Disease?“: “When Colloidal Silver comes in contact with any single celled pathogen, it disables the pathogens [sic] oxygen metabolism enzyme causing the pathogen to suffocate and die. The dead pathogen is then cleared out of the body by the immune, lymphatic and elimination systems.”

Under “Results/Testimonials”: “I had Lyme disease, which was treated with very aggressive antibiotics that basically destroyed my immune system. I ended up with Epstein-Barr and Chronic Fatigue Syndrome (CFS). I was tired all the time, draggy, fatigued, anti felt like I was in a fog. I also had muscle and joint pain, and got sick all the time. I had tried colloidal silver in the past, with no result. A few months ago, someone convinced me to try Mesosilver. I didn’t realize that there was such a difference in the types of colloidal silver, but apparently Mesosilver is much more effective than other types. Within two weeks of taking Mesosilver (1 TBS, 4 times a day), I started to feel better. Within a month, I was able to function at about 50% of normal, and within two months, I was pretty much back to normal, and could even exert myself (like mowing the lawn) without getting sick.”

Your products are not generally recognized as safe and effective for the above referenced conditions. Therefore, Mesogold and Mesosilver are “new drugs” under section 201 (p) of the Act [21 USC 321 (p)]. A new drug may not be legally marketed in this country without an approved New Drug Application (see section 505(a) of the Act [21 USC 355(a)]). Mesogold and Mesosilver are also misbranded because their labeling fails to bear adequate directions for the conditions for which they are offered [section 502(f) (1) of the Act].

This letter is not intended to be an all-inclusive review of your products and their labeling. You are responsible for ensuring that all products marketed by your firm, whether on your Internet web site or elsewhere, are in compliance with applicable United States laws.

On February 4, 2004, we wrote to [redacted] Agent for Colloids for Life, and advised him that these products were being promoted for conditions that caused them to be drugs on the web site located at: http://www.colloidal-nutritional-health-supplement.com. You replied to this letter on March 4, 2004, stating that Colloids for Life had rewritten its website and was attempting to come into compliance. We note that this website is no longer found on the web; however, your products are being currently marketed on me www.colloidsforlife.com website with claims similar to those found on your previous website.

We request that you take prompt action to correct the violations described above. Failure to promptly correct these violations may result in enforcement action being initiated by FDA without further notice. The Act provides for the seizure of illegal products and for injunction against the manufacturer and/or distributor of illegal products.

Please notify this office in writing within fifteen (15) working days of receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify and make corrections to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be implemented.

Your reply should be directed to the attention of Ms. Shelly Maifarth, Compliance Officer, Food and Drug Administration at the attached letterhead address.

Sincerely,
/s/

B. Belinda Collins
District Director