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U.S. Department of Health and Human Services

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Enforcement Actions

Antiseptica USA 03-Feb-06

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

Public Health Service
Food and Drug Administration

 

Detroit District
300 River Place, Suite 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139


 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED



WARNING LETTER

2006-DT-20

February 3, 2006

Mr. David Vercammen
President
Antiseptica USA
P.O. Box 863
Birmingham, MI 48012-0863

Dear Mr. Vercarnmen:

This letter concerns your firm's marketing of the products "Vira-Gard Spray," "Vira-Gard Liquid," and "Vira-Gard Liquid Gel" on your website, www.antisepticausa.com. According to your website, all three of these products are intended for topical application to prevent, treat, or cure serious disease conditions. Statements documenting these intended uses include, but are not limited to, the following:

Website (Statements refer to all three Vira-Gard products.)

  • "BIRD FLU, Avian Influenza, HSNl Killed in clinical tests in 15 seconds."

  • "Kills Viruses, Bacteria And Fungi On Hands And Skin "

  • Is So Powerful It Is Approved As A Surgical Disinfectant "

  • "Antiseptica: a patented antivirus, hand and skin antiseptic drug . . , designed by microbiologists to effectively kill a broad spectrum of microbes (i.e. bacteria, fungi, and viruses) . . . ."

  • "VIRA-GARD is not another hand sanitizer . . . but an antiseptic drug. "

  • "Antiseptica's formula, Manorapid Synergy, is a patented anti-virus formula specifically designed to combat cross contamination and provide infection protection from today's emerging infectious diseases. "

  • "Within 30 seconds or less, 3.3 ml of VIRA-GARD on your hands has been clinically proven to be effective . . . against:

    • Avian Flu (Bird Flu)

    • Rhinoviruses, which cause the common cold

    • Influenza A & B, also known as the '"flu"

    • HIV, the virus that causes Acquired Immune Deficiency Syndrome (AIDS)

    • Hepatitis A, transmitted through fecal contamination

    • Hepatitis B, transmitted through bodily fluids, including saliva

    • Herpes Simplex, the virus that causes both cold sores and genital herpes

    • Norwalk or Norovirus, also known as "cruise ship " virus

    • Polio

    • Adenoviruses

    • Respiratory Syncytial Virus, (RSV)

    • The coronovirus family (SARS)

    • Fifth's Disease

    Bacteria:

    • E-coli, bacteria originating in human or animal waste (the fecal-oral route is the most predominant method by which this disease is transmitted)

    • Staphylococcus

    • Streptococcus

    • Salmonella

    • Gram negative and gram positive bacteria

    • MRSA Bacteria -Methicillin Resistant Staphylococcus Aureus

    Fungi:

    • Cutenaeous fungus

  • "It's a fast-acting, broad-spectrum antimicrobial, effective in 30 seconds or less against bacteria, fungi, and viruses."

  • "can provide infection protection against disease-causing germs."

Vira-Gard Spray

Outside Package Labeling

  • "Patented anti-virus formula "

  • "Patented Anti-Virus Antiseptic."

  • clinically proven effective in killing hand-transmitted viruses, bacteria, and fungi in 30 seconds or less. "

  • "Helps to protect yourself from hand transmitted:

    • " E-coli - Cold - Viruses

    • " Klibesslia [sic] Pneumonia

    • " Flu - Staphylococcus

    • " Streptococcus - Bacteria

    • RSV - Hepatitis

" Norwalk (cruise ship virus), . . . "

  • "Vira-Gard demonstrated activity that is fast-acting in killing a broad spectrum of bacteria, fungi', and viruses transmitted by hands."

Immediate Container Label

  • "Patented Anti-Virus Formula "

  • "clinically proven to rapidly destroy a wide range of hand transmitted bacteria, fungus and microorganisms that can cause disease."

These claims are supplemented by the metatags for your website, www.antisepticausa.com which include "Anti-Virus formula," "Kills Cold, Flu, SARS, Small Pox, Norovirus, Hepatitis, Polio,, Herpes, Nail Fungus and. more," and "Antimicrobial . . . kills germs, protect from disease . . . Kills Cold, Rhino"virus, Influenza, Flu, SARS, Small Pox, Norovirus, Norwalk, Cruise ship virus, Hepatitis, Polio, Herpes, Nail Fungus, Fifth's disease, MRSA bacteria, Staphylococcus, Streptococcus, E-coli, salmonella."

Vira-Gard Spray, Vira-Gard Liquid, and Vira-Gard Liquid Gel are drugs, as defined by Section 201(g)(1) of the Federal Food, Drug and Cosmetic Act (Act), 21 U.S.C. § 321(g), because they are intended to cure, mitigate, treat, or prevent disease. Moreover, all three products are new drugs, as defined by Section 201(p) of the Act, 21 U.S.C. § 321(p), because there is no evidence that they are generally recognized as safe and effective for their labeled uses. Under Section 301(d) and 505(a) of the Act, 21 U.S.C. § 331(d) and § 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Vira-Gard Spray, Vira-Gard Liquid, and Vira-Gard Liquid Gel do not have approved applications and their introduction and delivery into interstate commerce violates these provisions of the Act.

Furthermore, the antifungal claims on your website, on the package labels, and the Nail Fungus claim in the metatags, make Vira-Gard Spray, Vira-Gard Liquid, and Vira-Gard Liquid Gel subject to the requirements of the final monograph for over-the-counter (OTC) Topical Antifiingal Drug Products (2) C.F.R. § 333, Subpart C) and 21 C.F.R. § 310.545(a)(22)(iii). The products' formulations, statements of identity, and indications and directions for use do not comply with this final monograph (21 C.F.R. § 333 .250(a)-(d)) . Thus, these products are not generally recognized as safe and effective and are "new drugs" under Section 201(p) of the Act, 21 U.S.C. § 321(p); and they are misbranded under Section 502(f)(1) and (2) of the Act, 21 U.S.C: § 352(f)(1) and (2).

OTC antiseptic cleansers and OTC first-aid antiseptics are being evaluated under FDA's OTC Drug Review. Tentative final monographs (TFMs) for these products were published in the Federal Register of June 17, 1994 (59 FR 31402) and July 22, 1991 (56 FR 33644), respectively. These TFMs are available at www.fda.gov/cder/otcmonographs/Antimicrobial/antimicrobial_antiseptic_TF_PR19940617.pdf and http://www.fda.gov/cder/otcmonographs/Antimicrobial/antimicrobial_topical_first_aidTF_PR19910722.pdf. However, as formulated and labeled, Vira-Gard Spray, Vira-Gard Liquid, and Vira-Gard Liquid Gel are not lawfully marketed under these TFMs.

A description of the new drug approval process can be found on FDA's Internet website at http://www.fda.gov/cder/regulatory/applications/default.htm. Any questions you may have regarding these processes should be directed to the Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.

The above violations are not intended to be an all-inclusive list of deficiencies. It is your responsibility to ensure that the drug products that you manufacture or distribute meet all of the requirements of the Act and its implementing regulations. Federal agencies are advised of the issuance of all warning letters about drugs,and devices so that they may take this information into account when considering the award of contracts.

You must immediately correct these violations. If you do not immediately correct them, you may be subject to enforcement action without further notice. The Act provides for seizure of illegal products and for an injunction against the manufacturers and distributors of illegal products.

You must notify this office in writing within 15 working days, of receipt of this letter as to the steps that you have taken to correct the above-listed violations, and the steps taken to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections 'will be made. Further, if your firm does not manufacture the products identified above, your reply should include the name and address of the manufacturer. 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. Address your reply to the U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, MI 48207, Attention: Judith A. Putz, Compliance Officer.

Sincerely,

/S/

Joann M. Givens
District Director
Detroit District