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U.S. Department of Health and Human Services

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Beck Network, Inc. 19-Jul-05

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

Public Health Service
Food and Drug Administration

 

New Orleans District
Southeast Region
6600 Plaza Drive, Suite 400
New Orleans, LA 70127
Telephone: 504-253-4519
FAX: 504-253~4520




July 19, 2005

WARNING LETTER NO. 2005-NOL-29

FEDERAL EXPRESS
OVERNIGHT DELIVERY

Tanya M. Beck, President
David W. Beck, Vice President

Beck Network, Inc.
Advanced Alternatives Center
Blue Cap USA
9340 Helena Rd Suite F-193
Birmingham, AL 35244

Beck & Beck, Inc .
10693 Wiles Road, 223
Coral Springs, FL 33076

Dear Mr. and Ms . Beck:

This is to advise you the U.S. Food and Drug Administration (FDA) has reviewed your Web sites at the Internet addresses http://www.aacstore.net, http//viusid .net, http://www.oncoxin.net,and http://www.bluecapusa.net and has determined the products Viusid, Diamel, Oncoxin, Alzer, Asbrip, Adrenal Cortex Glandular Extract, Kalsis, Relaxnova, and Herpigen are promoted for conditions which cause these products to be drugs under Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.), Section 321(g)(1)]. You can find this Act and associated regulations through links on FDA's Internet home page at http://www.fda.gov. The therapeutic claims on your Web sites establish 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, and may subject you, or the products, to regulatory action without further
notice.

Examples of some of the claims, including claims in the form of testimonials, observed on your Web sites include:

Viusid (http://www.aacstore.net,http://viusid.net,and http//www.bluecapusa.net)

"The following health conditions may be a direct result of immune system dysfunction: AIDS, Allergies and Asthma, Chronic Fatigue, Fibromyalgia, Candida Yeast Overgrowth, Parasitic Infections, Psoriasis and Eczema, Rheumatoid Arthritis, Heart Disease, Alzheimers, Shingles, Viral Disorders, Inflammatory Bowel Disease, Hepatitis, Cancer, Diabetes, Multiple Sclerosis, Lupus, Frequent Colds and Flu, Digestive Disorders, Parkinson's Disease"

  • "What can VIUSID do for me? . . . .

    • will help reduce infections . . . .

    • helps with the prevention of many viral and bacterial infections . . . .

    • acts as an analgesic . . ..

    • it will help prevents [sic] the appearance of buccal ulcers."

  • Clinical Studies have proven that Viusid is highly effective for treating AIDS/HIV. With this extremely high efficiency, just imagine how effective it will be for other diseases.

  • Ingredients of Viusid and how it can help you become well again . . ..

    • Folic Acid . . . It prevents the appearance of buccal ulcers . . . It acts as an analgesic . . . .

    • Malic Acid. Potential antiviral character . . . .o Arginine . It increases the size of the thymus and the number of the T lymphocytes, and thus reduces the infections. It helps with the immunological response and the healing of wounds. . . . It has antitumoral properties

    • Glucosamine . Potential antiviral character

    • Glycyrrhizinic Acid. Potential antiviral character . . .. _ .

    • Calcium Pantotenate. Necessary for the synthesis of antibodies, avoiding thus infections"

Viusid's intended use, for the cure, mitigation, treatment, or prevention of disease, is further established by the immunological pictorial depictions. For example, the pictorial representations titled "Production of numerous viral particles in a cultured T4 lymphocyte," "Limphocyte [sic] that is being attacked by HIV," and "HIV viral
partical [sic]."

Diamel (http://www.aacstore.net and http://www.bluecapusa.net)

  • "Diamel. Specifically formulated for Diabetic patients"

  • "The natural solution to regulate your blood sugar levels"

  • "Food Supplement Made of Lettuce and Oligoelements for Diabetic Patients"

  • "Diamel - Nutritional supplement for the treatment of Diabetes"

Oncoxin (http://www.aacstore.net,http://www.oncoxin.net, and http://www.bluecapusa.net)

  • "Nutritional Supplement to help fight Cancer"

  • "Defend your body against harmful diseases such as Cancer, heart disease, Parkinson's disease, rheumatoid arthritis, Alzheimer's, AND MORE!"

  • "What conditions can ONCOXYN help? cancer heart Disease Alzheimer's Parkinson's Disease Rheumatoid Arthritis"

  • "ONCOXYN contains Antioxidants that have emerged as healthful compounds that reduce inflammation, provide protective benefits that inhibit the development of heart disease, inhibit cancerous growth and delay the development of neuro-degenerative diseases."

  • "VIUSID + ONCOXIN. Two complementary products in the therapy against cancer"

  • "ONCOXIN contains anti-cancerous agents with proven efficacy in Cancer treatments."

  • "ONCOXIN anticancerigenic"

  • "Oncoxin is a nutrient that is high in antioxidants that can help to reduce the risk of different types of cancer ."

  • "Oncoxin . . . in combination with chemotherapy and radiation can help prolong the life span of cancer patients ."

  • "Viusid + Oncoxin. These therapeis [sic] can dramatically improve a patients [sic] life who is suffering from cancer."

  • "Active Properties and what part they play in the overall picture . . . .

    • Green Tea Extract . 'In vitro' studies show that green tea extract inhibits growth of cancerigenic breast cell lines. Its main way of action is to inhibit the interaction of tumorous promoters, hormones and factors of growth of their receptors . . . .

    • Germanium. (Ge-132) intervenes in the replication of DNA, preventing carcinogenic or degenerative mutations as well as inducing the formation of INTERFERON. . .

    • Arginine. . .. Studies have shown that is has improved immune responses to bacteria, viruses & tumor cells; promotes wound healing and regeneration of the liver. . . ."

Alzer (http://www.aacstore.net and http://www.bluecapusa.net)

  • "Combining ihe memory boosters of ALZER with the Antiviral agents of VIUSID have shown to be a highly effective combination in the treatment of Alzheimer's."

  • "Alzer for the treatment of Alzheimer Patients"

  • "Clinical Studies show that Alzer will BOOST Your Memory"

  • "Alzer is meant to work WITH your current Alzheimer's treatment to improve your memory tremendously."

  • "Viusid & Alzer-A NATURAL Alzheimer Therapy"

  • "The combination of VIUSII) & ALZER work both to increase memory and blood flow, while also working to strengthen the immune system, so Alzheimer's symptoms DO NOT WORSEN."

Asbrip (http://www.aacstore.net and http://www.bluecapusa.net)

  • "ASBRIP® is a special formulation designed to bring relief to those suffering from respiratory viruses . [Clhronic sinusitis, Asthma, Influenza"

  • . "For the treatment of Asthma, Influenza, Sinusitis"

  • "The 'activation' of natural ingredients through a new catalytic procedure, has given rise to a series of molecules which have anti-viral effects against different types of vegetal and animal viruses. Several trials `in vivo' have been carried out with positive results against common viruses such as IPN (pancreatic necrosis of fingerlings), TGEV (intestinal gastroenteritis), HSV-2 (genital herpes), zoster herpes, influenza, etc."

  • "The continued medication with ASBRIP has resulted in a complete recovery of asthma and allergic patients, with total disappearance of symptoms in all cases."

Adrenal Cortex Glandular Extract (http://www.aacstore.net)

  • "Adrenal extracts have been recommended and successfully used for a variety of conditions that involve low adrenal function, including . . . asthma, colds, bums, depletion from infectious diseases . . . early Addison's disease, hypotension (low blood pressure), infections . . . tuberculosis . . . ."

  • "Many people that suffer from Fibromyalgia Syndrome and CFS also suffer from adrenal exhaustion."

Kalsis (http://www.aacstore.net and httn://www.bluecapusa.net)

  • "Osteoporosis Treatment"

  • "T]his All-Natural product can halt and even reverse bone loss. See actual results from bone density tests."

  • "Kalsis-Nutritional Supplement for the treatment of Osteoporosis"

  • "Nutritional formulation designed specifically to improve and accelerate the reconstruction of your bones. Case studies have been performed and found significant increases in bone mass after six months of treatment."

Relaxnova (http://www.aacstore.net and http://www.bluecapusa.net)

  • "RELAXNOVA is an Analgesic Cream with Folic Acid Base which achieves spectacular results from its first application in arthritis, rheumatoid arthritis . . . ."

  • "82-year-old patient with chronic advanced arthritis : After having used RELAXNOVA 4 times a day for several days, the patient felt total relief of the leg pains as well as the absence of the frequent cramps which had provoked great discomfort."

  • "Patient with rheumatoid pain in the left arm causing difficulties when stretching and moving: Starting from the first applications of RELAXNOVA, the discomfort diminished until it finally disappeared ."

  • "Patient with very acute cervical pain. When RELAXNOVA was used, the pain disappeared within a few days."

  • "Patient with contusions produced by a work accident, with large hematomas and great pain in the whole body: The patient was unable to relieve the pain with neither creams nor analgesics. When RELAXNOVA was applied, the pain and the inflammation disappeared in 10 days."

  • "RELAXNOVA for the relief of aches and pains associated with . . . arthritis, rheumatism, contusions . . . ."

Herpigen (http://www.aacstore.net and http://www.bluecapusa.net)

  • "HerpigenTM For the Treatment of Herpes Virus"s

  • "Herpigen® was designed to fight all the infections caused by herpes virus in its different forms."

  • " Stop Genital Herpes & cold sore outbreaks and PREVENT Contagiousness"

  • " Herpigen Extra Strength anti-viral treatment Kills and Eliminates herpes virus in 90% of patients treated ."

  • "All Natural, Non Toxic treatment for your Herpes Virus"

  • "Herpes simplex virus 1 and 2. HSV-1 and HSV-2 . . . can infect the mouth or genitals.

    o 1. Herpes Simplex Virus I: Cold Sores
    o 2. Herpes Simplex Virus II: Genital Herpes
    o 3. Varicella Zoster Virus: Chicken Pox and Shingles
    o 4. Human Herpes Virus 6: Roseola
    o 5. Human Herpes Virus 8: Kaposi's Sarcoma
    o 6. Epstein-Barr Virus
    o 7. Cytomegalovirus
    o 8. Human B-Lymphotropic Virus"

  • " Herpigen Spray contains glycyrrhizinic acid, whose effectiveness against herpes virus, has been proven world wide. Glycyrrhizinic acid has anti-ulcerous, anti-viral and anti-inflammatory induction, stopping viral growth (barrier effect). For that reason, its correct application quickly not only gives relief and speeds up healing, improving the condition, but it may also avoid the recurrence."

Herpigen's intended use is further established by the pictorial representations of a case of oral herpes before and after treatment with Herpigen. Specifically, the first picture presents the inside of an upper lip with several herpes lesions; the second picture presents the inside of the upper lip devoid of lesions, presented in conjunction with the claim "Gone after 6 days."

Furthermore, Viusid, Diarnel, Oncoxin, Alzer, Asbrip, Adrenal Cortex Glandular Extract, Kalsis, Relaxnova, and Herpigen products are not generally recognized as safe and effective for the above referenced conditions, and, therefore, these products are also "new drugs" under Section 201(p) of the Act [21 U .S.C. 321(p)]. New drugs may not be legally marketed in the United States 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 based on scientific data submitted by a drug sponsor to demonstrate the drug is safe and effective. Viusid, Diamel, Oncoxin, Alzer, Asbrip, Adrenal Cortex Glandular Extract, Kalsis, Relaxnova, and Herpigen are also misbranded within the meaning of Section 502(f)(1) of the Act, as the labeling for these drugs fails to bear adequate directions for use [21 U.S.C. 352(t)(1)].

This letter is not intended to be an all-inclusive review of your Web sites and products your firm markets. It is your responsibility to ensure all products marketed by your firm comply with the Act and its implementing regulations.

The Act authorizes the seizure of illegal products and injunctions against the manufacturers and distributors of those products.You should take prompt action to correct any violations identified in this letter. Failure to do so may result in enforcement action without further notice.

You should 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 and to assure similar violations do not recur. If corrective action cannot be completed with 15 working days, state the reason for the delay and the time within which corrections will be completed. Further, if your firm does not manufacture a product identified above, your reply should include the name and address of the manufacturer of such product. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturing firm.

Your reply should be directed to Nicole F. Hardin, Compliance Officer, U.S. Food and Drug Administration, Attention: Nicole F. Hardin, Compliance Officer, at the address above. If you have questions concerning the violations noted, please contact Ms. Hardin at (504) 253-4519.

Sincerely,

/S/


H. Tyler Thornburg
District`Birector
New Orleans District