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U.S. Department of Health and Human Services

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Enforcement Actions

Vibrant Life 8/7/13

  

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

Public Health Service
Food and Drug Administration
 
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
 
Telephone:    949-608-2900
FAX:    949-608-4415 

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE                                                                     
 
 
August 7, 2013                                                                                                                WL# 50-13
 
Vibrant Life Vitamins
Attn: Clifford Woods
1310 W. Chestnut St.
Burbank, CA 91506
 
Dear Mr. Woods:
                                                                             
This is to advise you that the Food and Drug Administration (FDA) reviewed your websites at the Internet addresses www.oralchelation.com, www.ChelationTherapyOnline.com, www.arthritisinformation.net, www.vibrantlifemsm.com, www.vibrantlifenews.com, www.bulkmsm.com, and www.heart-disease-bypass-surgery.com in April 2013 and at https://www.facebook.com/oralchelation in May 2013 and has determined that you take orders there or provide links to websites that take orders for the products Life Glow Plus, Super Life Glow, Life Glow Basic, Taheebo Life Tea, Vibrant Life MSM, Herbal MSM, and Organic Germanium, which your websites promote for conditions that cause the products to be 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)]. The therapeutic claims on your websites establish that the products are drugs 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 through links on FDA’s Internet home page at http://www.fda.gov
 
Examples of some of the website claims that provide evidence that your products are intended for use as drugs appear below. The claims that reference oral chelation apply to your Life Glow Plus, Super Life Glow, and Life Glow Basic products, while other claims relate to specific products, as detailed below.
 
On the website, www.oralchelation.com:
 
On the homepage:
 
  • “Help prevent hardening of the arteries.”
  • “[O]ral chelation formulas which are being sold by Vibrant Life … is a very superior method of preventing cancer.”
 
On the webpage titled, “The Wednesday Letter,” http://www.oralchelation.com/wednesday/previous/2007/2007May7taheebolifetea.htm:
 
Under the heading, “Taheebo Life Tea”:
  • “The inner lining of the bark of either the Red or the Purple Lapacho (Taheebo) Tree has been used for enturies [sic] as an effective treatment for cancer and other dread diseases. News of the benefits of drinking a tea prepared from Red or Purple Lapacho (Taheebo) has been widely reported.”
  • “Numerous South American physicians tried Lapacho (Taheebo) with their patients and the claims of cures of cancer and other diseases became abundant.”
  • “Over the past 20 years reports from doctors and patients have indicated that this bark, when ingested (usually in tea form), has cured terminal leukemia, arthritis, yeast and fungus infections, arrested pain, stopped athlete's foot and cured the common cold.”
  • “(Taheebo) "is currently being hailed for its effects on cancer and candida ..." and is currently used as a remedy for immune system related problems such as colds, flu, boils, infections, and that "tests have anti-malarial and anti-cancer activities”
  • “(Taheebo), a proven antibiotic, is often used in America to treat yeast infections, but is touted in South America as a cure for cancer and other diseases. The experts say it can also arm the body against viral infestations like AIDS…”
 
Under the heading, “Power Natural Antibiotic”:
  • “Lapacho (Taheebo) tea … contains a chemical chain, anti-tumor agent. … “ Lapacho (Taheebo)… found it to be a powerful antibiotic, with virus-killing properties.”
  • “Lapacho (Taheebo) undoubtedly contains a substance found to be highly effective against cancer.”
  • “Lapacho (Taheebo) can be used … in conjunction with … medical therapy. Some report that the tea appeared to increase effectiveness of chemotherapy with a … decrease in deleterious side effects when Lapacho (Taheebo) tea is used.”
 
On the webpage, “Products,” http://www.oralchelation.com/oral_chelation_products.html:
 
Under the titles, “Support Arthritis Capsules” and “Support Arthritis Powder”:
  • “Supportt™ [sic] Arthritis (Herbal MSM)…will help you experience less pain and suffering from arthritis, back pain, Fibromyalgia…”
 
Under the title, “Organic Germanium”:
  • “Germanium has shown results in tumor reduction, boosting the immune system and relieving rheumatoid arthritis.”
 
Under the title, “Taheebo Life Tea”:
  • “Vibrant Life Taheebo Tea seems to bring improvement in cases of cancer, viral problems and yeast infections…”
 
On the webpage, “FAQs,” http://www.oralchelation.com/oral_chelation_faq.html:
 
Under subtitle, “What results can I expect?”:
  • “Angina pain levels may disappear or greatly reduce (one year)”
  • “Reduction in artery plaque blockage (variable)”
 
On the website, www.ChelationTherapyOnline.com, on the webpage titled, “Cancer Can Be Prevented!”:
 
  • “The formula recommended on this page   … does handle the problem   … that causes cancer.”
  • “Vibrant Life formulas is called Life Glow Basic. It is well suited to taking as a cancer prevention supplement …” resistance to any cancer.”
  • “If my formula can remove the metals that cause heart disease, then the very same process (my oral chelation formulas) remove the metals that cause cancer.”
  • “[T]he thousands of my customers who have been singing the praises of Life Glow Plus, Super Life Glow or Life Glow Basic … didn't even know it, but they were being protected against cancer … My oral chelation formulas remove a particular type of metal that is found … to cause cancer … and I am confident that ... my formulas remove the metals that cause heart disease and also cancer.”
 
On the website, www.arthritisinformation.net:
 
  • “This web site offers many of the products, as single ingredients, that have been found to be useful in treating arthritis.”
 
On the website, www.bulkmsm.com:
 
  • “This entire web site is devoted to the substance called MSM … It is widely used around the world for relief of pain from arthritis, back pain or muscle pain.”
  • “[I]ncreasing permeability” of cells explains its ability to relieve pain. Pain is often caused by an accumulation of toxic buildup in the joints, muscles and fluids. Inflammation of joints is often … caused by toxic buildups … MSM is a powerful detoxifier.”
 
On the website, www.heart-disease-bypass-surgery.com:
 
  • “Alternatives To Heart Disease & Bypass Surgery Web Site Consider The Alternative of Oral Chelation”
  • “It is also the web site to find out what are the benefits of using chelation therapy as an alternative to cholesterol-lowering drugs…or even bypass…”
 
We also noted claims made on your Facebook page, accessible at https://www.facebook.com/oralchelation.The following is an example of these claims:
 
  • “My right foot swelled and started to turn black. I went to my family Doctor … The Specialist said I had Gout …” “I was given a prescription to have filled when my friend called and advised me to try Life Glow Plus … “ “I took Life Glow Plus for two months, 20 capsules a day, and my foot started to get well and the swelling went down.”
  • “In 2004 I had bypass surgery, which in three weeks failed. “… [H]aving exhausting all conventional treatments for heart disease, we went searching on the internet and discovered Life Glow Plus. “Within one month … [M]y agina was much improved.” “I have been taking life Glow Plus for the past seven years and continue to enjoy its benefits.
 
Testimonials
 
Your websites also contain evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment, or prevention of disease. 
 
Examples of such testimonials found at www.oralchelation.com/oral_chelation_testimonials.html include:
 
Under the heading, “REMARKABLE IMPROVEMENTS ARE COMMON WITH ORAL CHELATION”:
  • "[T]he results are so amazing. I still can hardly believe it. … I no longer have any of that angina pain.”
  • "They then told me it was the blood profile of someone between 18 and 23 ... I was 48 years old and about thirty pounds overweight. This, after three months of oral chelation, and about six months after I had a heart attack. Now two years later, I take no medications at all … I no longer have chest pains, and I feel like I’ve never had any heart problems ...."
 
Under the heading, “Life Glow Plus”:
  • “[C]helation formulas which are being sold by Vibrant Life are … a ,,, method of preventing cancer. The full story about cancer is at this site, including … why the oral chelation formula is such a good prevention for cancer. The chelation therapy has proven to reduce death rates from cancer by 90% compared to a similar group that did not get the chelation.”
 
Examples of such testimonials found at http://www.oralchelation.com/wednesday/previous/2007/2007May7taheebolifetea.htm include:
 
  • “My first experience with Taheebo Life Tea was seven years ago … the doctors had just told us my husband … had malignant lymphoma and six months or less to live, if he didn't start radiation and chemo right away. At one point [my husband] thought the cancer had spread to his bladder. I opened six capsules of Taheebo Life Tea, mixed the contents with Aloe Vera Gel and spread it on the swollen belly. In less than a week the swelling was gone. Then [my husband] asked me to put the same black stuff on those swollen lumps on his neck and shoulders…In three months there were no swollen lumps and he had not had one sick day.”
  • “My younger sister had cancer, a rare type that chemo will not work for…They did surgery instead…they didn’t get it all. They then gave her thirty eight treatments of radiation. She was told she would never walk without aid and it might come back in the liver. Soon as she had her last radiation treatment, I sent her Taheebo Life Tea…Now it’s three years later…No sign of cancer.”
 
Examples of such testimonials found at www.vibrantlifemsm.com include:
 
Under the heading, “WELCOME TO Vibrant Life MSM”:
  • “I was diagnosed with Hep C in 1998…Chronic fatigue, depression, parathesia, stomach and liver pain…MSM changed all that...it is far superior to any supplement I have consumed.”
  • “To avoid a hip replacement and cure the pain of compression fractures in my spine, I take between 1 to 1.5 ounces of bulk MSM daily.”
 
Examples of such testimonials found at http://www.vibrantlifenews.com/?p=1233 include:
 
In a post dated May 15, 2012, “See Results of Life Glow Plus Here!!”:
  • “I promised you some time ago the story on my husband’s heart condition…About 8 years ago, my husband Ron had a bad cough… He went to the doctor because he had so much pain in his chest and back…To make a long story short…They send him to the hospital and two days later he had a stent. The specialist in the hospital told him that he had just missed a major heart attack because the main artery was blocked for 90%...After a couple of months he had another check up and the doctor told him…your arteries are blocking up again…we see another (or more) stent(s) coming…I then started to search the internet and found Vibrant Life. We showed our doctor the formula of Life Glow Plus and (Life Glow) Basic and she was astonished…she said…’I have never seen a formula that is so complete, so go ahead, I will monitor you.’ After six months my husband had a heart scan, because we could hardly believe he was feeling better, we wanted proof…We were so relieved at what this doctor said… we can only detect one shadow in the arteries and that is where the stent is! So that is now 7 years ago…He only has to go for a checkup once a year and he passes with flying colors!!”
 
Metatags
 
The claims quoted above are supplemented by the metatags used to bring consumers to your websites through Internet searches. The metatags include:
 
 
On your website, www.oralchelation.com:
 
  • “heart disease, heart attack, fight heart disease…”
 
On your website, www.arthritisinformation.net:
 
  • “arthritis…arthritis pain….osteoarthritis…arthritis inflammation…cartilage degeneration, rheumatic arthritis, rheumatoid arthritis…”
 
Your above-referenced products are not generally recognized as safe and effective for the above-referenced uses and, therefore, 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 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, each of your above-referenced products is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that their labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
FDA is aware that Internet distributors may not know that the products they offer are regulated as drugs or that these drugs are not in compliance with the law. Many of these products may be legally marketed as dietary supplements if claims about diagnosis, cure, mitigation, treatment, or prevention of disease are removed from the promotional materials and the products otherwise comply with all applicable provisions of the Act and FDA regulations. 
 
Under the Act, as amended by the Dietary Supplement Health and Education Act, dietary supplements may be legally marketed with truthful and non-misleading claims to affect the structure or function of the body (structure/function claims), if certain requirements are met. However, claims that dietary supplements are intended to prevent, diagnose, mitigate, treat, or cure disease (disease claims), excepting health claims authorized for use by FDA, cause the products to be drugs. The intended use of a product may be established through product labels and labeling, catalogs, brochures, audio and videotapes, Internet sites, or other circumstances surrounding the distribution of the product. FDA has published a final rule intended to clarify the distinction between structure/function claims and disease claims. This document is available on the Internet at http://www.gpo.gov/fdsys/pkg/FR-2000-01-06/html/00-53.htm (codified at 21 C.F.R. § 101.93(g)). 
 
In addition, only products that are intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter the body directly through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements. For these products, both disease and structure/function claims may cause them to be new drugs. 
 
Certain over-the-counter drugs are not new drugs and may be legally marketed without prior approval from FDA. Additional information is available in Title 21 of the Code of Federal Regulations (21 C.F.R.) Parts 310 and 330-358, which contain FDA's regulations on over-the-counter drugs. 
 
The violations cited in this letter are not meant to be an all-inclusive list of violations that exist in connection with your products and their labeling. 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 your firm complies with all requirements of federal law and 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/or injunction. 
 
Within fifteen (15) working days of your 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 cannot complete corrective action within fifteen working days, state the reason for the delay and the time within you will complete the correction.
 
Please send your reply to the Food and Drug Administration, Attention: 
 
Blake Bevill, Director
Compliance Branch
Los Angeles District
19701 Fairchild
Irvine, CA, 92612-2506
 
If you have questions regarding any issues in this letter, please contact David Whitman, Compliance Officer at (619)-941-3769.
 
 
Sincerely,
/S/                                                                                 
Alonza E. Cruse, Director
Los Angeles District
 
cc:
 
Hugo Cornejo, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
PO Box 997435
Sacramento, CA 95899-7435
Attn: FDA Correspondence
 
 
Clifford Woods
PO Box 10666
Burbank, CA 91510-0666