Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
Southeast Region
New Orleans District

 

6600 Plaza Dr #400
New Orleans, LA 70127
Telephone: 504-253-4519
FAX: 504-253-4520

July 19, 2005
WARNING LETTER
VIA FEDERAL EXPRESS, OVERNIGHT DELIVERY

Tanya M. Beck, President
David W. Beck, Vice President
Beck Network, Inc.
Advanced Alternatives Ctr
Blue Cap USA
9340 Helena Rd #F-193
Birmingham, AL 35244

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

Dear Mr and Ms Beck:

This is to advise you the US Food and Drug Administration (FDA) has reviewed your websites at the Internet addresses www.aacstore.net, viusid.net, www.oncoxin.net, and 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 (USC), Section 321(g)(1)]. You can find this Act and associated regulations through links on FDA's Internet home page at www.fda.gov.

The therapeutic claims on your websites 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 websites include:

Viusid (www.aacstore.net, www.aacstore.net, viusid.net and www.bluecapusa.net)

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 (www.aacstore.net and www.bluecapusa.net)

Oncoxin (www.aacstore.net, www.oncoxin.net, and www.bluecapusa.net)

Alzer (www.aacstore.net and www.bluecapusa.net)

Asbrip (www.aacstore.net and www.bluecapusa.net)

Adrenal Cortex Glandular Extract (www.aacstore.net)

Kalsis (www.aacstore.net and www.bluecapusa.net)

Relaxnova (www.aacstore.net and www.bluecapusa.net)

Herpigen (www.aacstore.net and www.bluecapusa.net)

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 USC 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 USC 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 USC 352(t)(1)].

This letter is not intended to be an all-inclusive review of your websites 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, US Food and Drug Administration, 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 Director

This page was posted on March 28, 2006.

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