Blue Ridge Silver - 566247 - 02/05/2019

WARNING LETTER

VIA OVERNIGHT DELIVERY

RETURN RECEIPT REQUESTED

February 5, 2019

Blue Ridge Silver

Steven Griffin, CEO

7595 Valley Blvd

Blowing Rock, NC 28605

RE: 566247

Dear Mr. Griffin:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.blueridgesilver.com in October 2018 and has determined that you take orders there for your BLUE RIDGE SILVER^TM Colloidal Silver products. The claims on your website establish that these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Examples of some of the claims observed on your website that provide evidence that your products are intended for use as drugs include the following:

On the page of your website, titled “Promises”:

You quote an article titled, “Use of Colloids in Health and Disease” as stating that “all fungus, virii, bacterium, streptococcus, staphylococcus, and other pathogenic organism are killed in three or four minutes.”
“. . . [I]onic silver significantly promotes . . . the regeneration of damages tissues within the body.”

On the page of your website, titled “Frequently Asked Questions”:

Hippocrate, the father of modern medicine, used silver to treat ulcers.”
“Argyrol, a mixture of silver suspended in gelatin, was the first line of defense for American and Allied troops during WWI who were exposed to STDs, especially gonorrhea.”
“What are some Modern Uses for Colloidal Silver? . . . antiseptic for treating burn victims . . . prevent[ing] neonatal conjunctivitis”
“ . . . [T]he ionic form of colloidal silver ingested by millions of people across North America [is used to] fight off or prevent infections, colds, flus, and even help heal serious chronic degenerative diseases.”
“In the 1920’s and 30’s, colloidal silver was widely used to treat many infectious diseases for those who could afford it.”

Under the “News” tab of your website, your article titled “Can Using Colloidal Silver Help You Prevent Dementia?”:

“Experts think oral bacteria may spread to the brain . . . and may contribute to the type of plaque that’s been linked to Alzheimer’s.‘
[citing an article from MensHealthWire.com] “Dementia and mental confusion has also been linked to poor oral hygiene. A recent study showed that people who had cases of gingivitis or periodontal disease tended to exhibit sings [sic] of early Alzheimer’s, dementia or extreme mental confusion.”
“ . . . [G]ood oral health habits – including regular oral colloidal silver usage to keep populations of problematic oral pathogens at bay --- can lower your risk of heart-related ailments.”
“ . . . [C]olloidal silver is a proven effective method for preventing the buildup of bacterial plaque.”
“ . . .[A]ccording to a 1999 study conducted at Brigham Young University, the bacterium Streptococcus mutans, which is a major cause of dental plaque and tooth decay, was inhibited and destroyed using 5ppm of colloidal silver. In fact, in the study colloidal silver was demonstrated to be as good at destroying the bacteria as five different classes of antibiotics, including: the tetracyclines, fluorinated quinolones (Ofloxacin), thepenicillins [sic], the cephalosporins (Cefaperazone) and the macrolides (Erythromycin).”
“. . . [A]ntimicrobial silver is also effective against yeast and fungal oral pathogens”
“. . . [C]olloidal silver can be used to keep oral bacteria at bay. . . . [R]ecent information [shows] . . . the ability of oral bacteria to trigger the onset of dementia…”

Under the “News” tab of your website, your article titled “Colloidal Silver and Mycoplasmas Infections”:

“ . . . [H]igh dosages of colloidal silver are reported to have been used to control mycoplasmas infections. . . . The list of disease that can be caused or triggered by mycoplasma infection is long and includes rheumatoid arthritis, lupus, multiple sclerosis, Lou Gehrig’s disease (ALS) . . . Alzheimer’s disease, heart disease, and even certain forms of cancer!”
“Other mycoplasma-triggered diseases can include Gulf War Syndrome/Gulf War Illness, Chronic Fatigue Syndrome (CFS), chemical sensitivity, HIV/AIDS, and Alzheimer’s.”
“ . . . [One researcher, Dr. See, has had] success using ultra-small particle colloidal silver to treat patients with chronic degenerative disease associated with mycoplasmas pathogens. In published reports Dr. See says he has witnessed . . . patients with known mycoplasmas infections turn from positive to negative with the use of ultra-small particle colloidal silver.”

Under the “News” tab of your website, your article titled “Colloidal Silver Kills Cancer: Info Resources”:

“ . . . [T]here are now over 50 medical studies demonstrating silver to be effective against cancer cells (and tumors) . . . ”
“ . . . [F]rom time-to-time I get testimonials from readers saying they’ve either cured their cancer, or have gotten their cancer under control (i.e., the cancer is still there, but is no longer spreading) by using colloidal silver.”
“ . . . [M]ore than 50 preliminary clinical studies . . . demonstrate[ ] the ability of silver help stop cancer cells”
This article cites to several publication that refer to disease use and that imply treatment or prevention of a disease (see 21 CFR 101.93(g)(2)(iv)(C)):

o “Silver Kills Some Cancer Tumors Better Than Chemotherapy, Says British Researchers”

o “Colloidal Silver Kills Human Breast and Liver Cancer Cells”

o “Silver Induces Cervical Cancer Cells to Destroy Themselves”

o “Study: Silver Nanoparticles Kill Cancer Cells Resistant to Chemotherapy Drugs”

Under the “News” tab of your website, your article titled “The Clear Evidence that Silver Aids the Body in Many Vital Functions”:

“ . . . [A] new medical study . . . demonstrates silver’s incredible ability to quench free radical activity in brain cells . . . As respected drug and nutritional formulator George Foss stated regarding this eye-opening new study: ‘It certainly could have tremendous benefits for victims of Alzheimer’s and other forms of dementia.’”

Under the “News” tab of your website, your article titled “Singer Kris Kristofferson’s ‘Alzheimer’s Disease’ Ordeal & Colloidal Silver”:

“ . . . a natural treatment for Lyme Disease”
“‘Two studies have been conducted with colloidal silver and effectiveness against Borrelia burgdorferi.’”
“[Researcher] Dr. Farber later claimed to have witnessed ‘a 100% killing effect of the Lyme pathogen, Borrelia burgdorferi, ‘within less than five minutes of exposure’ to colloidal silver preparation.”

Under the “News” tab of your website, your article titled “Using Colloidal Silver for Kidney Infections”:

“Colloidal Silver just might be the next germ-fighting wonder drug. And not just for the serious threats making headlines. It’s also effective against bacterial infections like strep throat, viruses like the flu, and fungal infections like Candida.”
“. . . [A] pilot study during the mid-1990s that included human patients suffering from terminal AIDS . . . established solid evidence showing just how quick and effective silver ions can be in the treatment of Candida as well as HIV. . . . The researchers found . . . colloidal silver was capable of killing pathogens and purging the bloodstream of germ defenses in order to restore the immune system.”
“ . . . [C]olloidal silver . . . may be effectively uses as an alternative to antibiotics.”
“I sincerely recommend that everyone have … colloidal silver in their home as an antiseptic, antibacterial and antifungal agent.”

Additionally, your website contains evidence of intended use in the form of personal testimonials recommending or describing the use of for BLUE RIDGE SILVER^TM Colloidal Silver products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

Under the “News” tab of your website, your article titled “Singer Kris Kristofferson’s ‘Alzheimer’s Disease’ Ordeal & Colloidal Silver”:

“I have a friend who was on colloidal silver for his cancer treatment. The other methods did not work for him. Chemo and radiation. But he got silver and his cancer tumors shrunk and went away. He is fine now.”
“ . . . I have suffered with Rheumatoid Arthritis for approximately 7 years now. . . . Then I discovered the Colloidal Silver phenomenon. So six weeks ago I decided to purchase a colloidal silver generator, some silver rods and a book about the subject. . . . The first thing I noticed after a week of taking it was that my asthma symptoms (I got the asthma 2 yrs ago following a flu shot-which I will never take again!) were getting better. The phlegm associated with it was actually loosening up and moving. Then on the second week I started realizing that my badly swollen wrists were getting better. . . . By the third week I noticed that my tendons, ligaments and veins were starting to become more apparent (rather than hiding in a mass of inflammation). I am now on my fifth week and I can actually press my fingertips into my wrists (synovial area) without much pain. I can also reach out further and lift heavier objects. I can also twist my wrist a lot more. The mobility is far from what it used to be but much better (I probably have some damage in there that restricts full movement). The asthma is also diminishing.”

Under the “News” tab of your website, your article titled “Using Colloidal Silver for Kidney Infections”:

“. . . I just used colloidal silver for a kidney infection for three days . . . and my fever is gone . . .. I have a kidney disease that harbors infection in my kidneys continuously, and through the years, I have become resistant to a lot of the heavy antibiotics . . .”
“My sister began using it and her kidney infection cleared right up . . .”
“I have a cousin that is 8 months pregnant. She got a bladder infection, went to the doctor and the doctor gave her antibiotics. Infection got worse and she ended up with a kidney infection. . . . 6 days after she started taking the colloidal silver – infection 100% gone.”

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 C.F.R. § 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your BLUE RIDGE SILVER^TM Colloidal Silver products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your BLUE RIDGE SILVER^TM Colloidal Silver products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].

Further, according to 21 CFR 310.548, any OTC drug product containing colloidal silver ingredients that is labeled, represented, or promoted for the treatment and/or prevention of any disease is regarded as a “new drug” within the meaning of section 201(p) of the Act for which an approved application is required for marketing, without which such product is also misbranded under section 502 of the Act [21 U.S.C. 352].

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that all products marketed by your firm comply with all requirements of federal law, including FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

We also note that some of your colloidal silver products are marketed as nasal sprays. However, the Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i) [21 U.S.C. § 321(ff)(2)(A)(i)] as a product that is “intended for ingestion.” Because oral spray products are intended to enter the body directly through the mucosal tissues at the back of the throat, they are not dietary supplements and are not foods.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your written reply should be directed to Shawn Goldman, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, please contact Mr. Goldman at Shawn.Goldman@fda.hhs.gov.

Sincerely,

/S/

William A. Correll, Jr.

Director

Office of Compliance

Center for Food Safety and Applied Nutrition