| 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 |
Department of Health and Human ServicesWARNING LETTER
VIA UPS NEXT DAY
October 12, 2010
W/L 05-11
Van Cleve, Alexandra Webmaster
Longevity Plus
600 N Beeline Hwy
Payson, Arizona 85541
Dear Mr. Cleve:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the internet address www.longevityplus.com in July 2010 and has determined that the products "Beyond Chelation Improved," "EndoKinase," "Viral Defense" and "Wobenzym-N 200ct" are promoted for conditions that cause the product 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. The marketing of the products with these claims violates the Act.
Examples of some of the claims observed on your website include:
Beyond Chelation Improved
• "Beyond Chelation Improved has more of the vital ingredients that help fight cancer, health disease..."
• "This formula provides ... oral chelators and help control chronic inflammation, which now is known to be the MAJOR cause of heart attacks and strokes."
EndoKinase
• "Nattokinase [a category of products including your product] ... prevent[s] hardening of the arteries".
• "Nattokinase [a category of products including your product] ... prevent[s] blood clots on long distance flights."
• "Preliminary studies show that Nattokinase lowers blood pressure by an average of twenty-four points".
Viral Defense
• " ...Viral Defense interrupt the process through which a number of serious viruses invade our bodies and spread, influenza, herpes simples, genital herpes, hepatitis C and many others. So if you want to support your body's natural ability to stop the growth of the most common human viruses, try Viral Defense."
Wobenzym-N 200 ct
• "Wobenzym® ... has been shown to:
o "Substantially reduce the incidence of fatal blood clots now known to be induced by the sudden breakdown of vulnerable plaque...
o "Allow fewer heart attacks or strokes because of anti-thrombiotic, anti-spasmodic and anti-arrhythmic abilities ...
o "Improve results with arterial blockages caused by Herpes and CMV...
o "Be beneficial when used to treat Autoimmune, Rheumatic and Cardiovascular Diseases, Inflammations, Injuries, Infections and Tumor Illnesses, Osteo and Rheumatoid Arthritis, Joint and Muscle Pain, Herpes and Other Viral Infections, Cancer and Hepatitis C, Recurrent Miscarriages and many other Degenerative Diseases."
Your website links directly to www.gordonresearch.com which is operated by Garry F. Gordon, MD. On a webpage titled "Biography," Dr. Gordon states that he is "full-time consultant for Longevity Plus" and is "responsible for the design of the majority of their supplements, which are widely used in alternative health practitioners [sic] around the world."
Dr. Gordon's website contains numerous articles, as well as video and audio materials that include disease claims for your products.
Examples of some of the claims for your products found on www.gordonresearch.com include:
• In the article entitled, "BEYOND CHELATION: Finally-A Long Awaited Oral Chelation for Heart Disease" located under Health Topics, Treatments, Oral Chelation cites multiple claims:
o "Patients with angina reported dramatic relief from chest pain. Healing was also reported by patients with gangrene."
o "EDTA chelation therapy has since proven to be safe and effective in the treatment of ailments linked to atherosclerosis such as coronary artery disease (heart attacks), cerebral vascular disease (stroke), peripheral vascular disease (leading to pain in the legs and ultimately gangrene and amputation), as well as arterial blockages from atherosclerosis elsewhere in the body."
o "Other documented benefits of chelation therapy include":
o "Normalization of fifty percent of cardiac arrhythmias"
o "Improved cerebrovascular arterial occlusion"
o "Significantly reduced cancer mortality rates (as a preventive)"
o "Detoxification of snake and spider venoms"
• In the article entitled" "BEYOND CHELATION TECHNICIAL SUPPORT SHEET" located under Health Topics, Treatments, Oral Chelation
o "The purpose of the new Beyond Chelation Formula is to help prevent strokes and heart attacks which are in part the end result of the formation of atherosclerotic plaques and the associated formation of thromboxane which leads first to enhanced platelet aggregation, then to artery blockage, and finally on to thrombosis."
o The Formula... helps to prevent this well recognized pathway leading to vascular disease and eventual death from forming."
• In the article entitled, "BENEFITS OF ORAL CHELATION USING EDTA AND CARDIOVASCULAR NUTRIENT SUPPLEMENTATION" located under Health Topics, Treatments, Oral Chelation cites multiple claims:
o "Helps to prevent Arteriosclerosis (Hardening of the arteries)"
o "Helps to improve conduction in all degrees of A-V heart block"
o "Helps to abolish extra heart beats, skipped beats and rapid heart beats"
o "Helps to decrease ventricular arrhythmias due to digitalis toxicity"
o "Reduces blood pressure and blood cholesterol"
o "Dissolves fats in plaque lined arteries"
o "[P]revents abnormal blood clotting"
Your products are not generally recognized as safe and effective for the above referenced uses and therefore, the products 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.
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. While reviewing your website, we noticed that you were promoting other products for disease treatment and/or prevention. The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter. It is your responsibility to ensure that products marketed by your film comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice.
The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
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 the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to:
Blake Bevill
Director, Compliance Branch
Food and Drug Administration
19701 Fairchild
Irvine,CA 92612-2506
If you have any questions regarding any issues in this letter, please contact Mei-Chen (Jessica) Mu, Compliance Officer at (949) 608-4477
Sincerely,
/S/
Alonza Cruse
District Director
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