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

Public Health Service
Food and Drug Administration

 

Chicago District
550 W. Jackson Blvd,15th Fl
Chicago, IL 60661
Telephone: 312-453-4863

May 20, 2003
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Meryl J. Squires,
President,
Merix Pharmaceutical Corp
18 Dundee Rd, Bldg 3, Ste 204
Barrington, IL 60010

Ref. No. CHI-14-03

Dear Ms Squires:

This letter is in reference to your firm's marketing and distribution of ViraMedx® with Viracea®, ViraMedx® with Viracea® Shingle-EEZE Topical Anti-Vial Spray, and ViraMedx® RELEEV™. The labeling for these products states that they contain Viracea, in addition to other ingredients, During the inspection of your Grm, our investigators were told that Viracea is a combination of benzalkonium chloride and echinacea (also identified as Echinacea pupureu). Statements on the immediate containers and/or cartons for these products include claims that cause them to be drugs [Section 20 l(g) of the Federal Food, Drug, and Cosmetic Act (the Act)]. Additionally, promotional literature that you distribute in connection with your products as well as the information on two of your Internet web sites: www.viramedx.com and www.herpescontrol.com, bear claims such as those listed below that cause the products to be drugs.

ViraMedxQD with ViraceAD:

"The Solution x Cold Sores x Fever Blisters x Other Herpes Related Outbreaks"

"…ViraMedx® 'kills' the herpes virus in cultured human cells. It stops the virus that causes cold sores!" (carton)

Other promotional claims on both Internet web sites include the following:

"ViraMedx® demonstrates antiviral activity so that it actually inactivates the herpes virus."

"…ViraMedx® is antiviral to the herpes virus and is effective on acyclovir resistant strains of herpes."

"Viracea is a new antiviral treatment of the herpes family of viruses: Herpes Simplex Virus 1 (HSVl), Herpes Simplex Virus 2 (HSV2), Varicella Zoster Virus (WV) or shingles, and cytomegalovirus. In laboratory testing Viracea 2,4 has demonstrated Anti-Viral™ activity and effectiveness against the HIV virus. Potential uses and markets for Viracea as a new Anti-Viral™ are: Topical treatment of cold sores / fever blisters, Genital herpes, Herpes keratitis, Herpes conjunctivitis, Oral gingival stomatitis, Shingles, Human papillomavirus (warts).… Based on the laboratory results of the Viracea 2,4 formula, potential additional uses and markets are: Systemic treatment of HIV, Hepatitis C, Mononucleosis, Cytomegalovirus."

"Viracea has demonstrated effectiveness on: oral labial tissue, herpetic gingivostomatitis, herpes genitalis, herpes keratitis, and herpetic whitlow."

ViraMedx® with ViraceaQD ShingbEEZE Topical Anti-Viral Spray:

"Even better when used with ViraMedx® with Viracea® Internal Anti-Viral Support." (immediate container)

"Viracea is a new antiviral treatment of the herpes family of viruses: Herpes Simplex Virus 1 (HSVI), Herpes Simplex Virus 2 (HSV2), Varicella Zoster Virus (WV) or shingles, and cytomegalovirus. In laboratory testing Viracea 2,4 has demonstrated Anti-Viral™ activity and effectiveness against the HIV virus. Potential uses and markets for Viracea as a new Anti-Viral™ are:

"Topical treatment of cold sores/fever blisters, Genital herpes, Herpes keratitis, Herpes conjunctivitis, Oral gingival stomatitis, Shingles, Human papillomavirus (warts).… Based on the laboratory results of the Viracea 2,4 formula, potential additional uses and markets are: Systemic treatment of HTV, Hepatitis C, Mononucleosis, Cytomegalovirus.

"Viracea has demonstrated effectiveness on: oral labial tissue, hetpetic gingivostomatitis, herpes genitalis, herpes keratitis, and herpetic whitlow."

Other promotional claims for this product on both Internet web sites include the foIlowing:

"Shingle-BEZB is the topical spray formulation for use in treating shingles. Caused by the varicella zoster virus (XV), there is currently nothing on the market that directly treats this very painful disease effectively until now … May decrease mortality rate of sufferers. Viracea has demonstrated effectiveness on: oral labial tissue, herpetic gingivostomatitis, herpes genitalis, herpes keratitis, and herpetic whitlow."

ViraMedx RELEEV™

"Published laboratory testing at The [sic] leading proves RELEEV ™ 'kills' the herpes virus, both HSVl & HSV2, in cultured human cells. It stops the virus that causes cold cores." (carton)

Other promotional claims on both Internet web sites include the following:

"ViraMedx Releev™ is an over-the-counter topical formulation of Viracea targeting the herpes virus … resolved herpes virus outbreaks … When ViraMedx Releev was applied at the initial prodromal period, the outbreak and [sic] never occurred … is marketed for the topical treatment of infectious skin lesions caused by the herpes virus. …primarify for cold sores, oral gingival stomatitis, herpes genitalis, shingles and chicken pox."

"ViraMedx Releev™ demonstrates antiviral activity so that it actually inactivates the herpes virus…, consistently relieved all pain associated with herpes outbreaks in minutes … is antiviral to the herpes virus and is effective on acyclovir resistant strains of herpes … Newborns have died recently due to acyclovir resistant strains of herpes."

"Viracea is a new antiviral treatment of the herpes family of viruses: Herpes Simplex Virus 1 (HSVl), Herpes Simplex Virus 2 (HSVZ), Varicella Zoster Virus (VZV) or shingles, and cytomegalovirus. In laboratory testing Viracea 2,4 has demonstrated Anti-Viral™ activity and effectiveness against the HIV virus. Potential uses and markets for Viracea as a new Anti-Viral™ are: Topical treatment of cold sores / fever blisters, Genital herpes, Herpes keratitis, Herpes conjunctivitis, Oral gingival stomatitis, Shingles, Human papillomavirus (warts). Based on the laboratory results of the Viracea 2,4 formula, potential additional uses and markets are: Systemic treatment of HIV, Hepatitis C, Mononucleosis, Cytomegalovirus."

"Viracea has demonstrated effectiveness on: oral labial tissue, herpetic gingivostomatitis, herpes genitalis, herpes keratitis, and herpetic whitlow."

Based on the intended uses cited above, these products are drugs as defined in Section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act). As drugs, the labeling claims made for these products subject them to the requirements for new drugs [Section 201(p) of the Act] because there is no evidence that these products are generally recognized as safe and effective for their claimed uses. A new drug may not be legally marketed in the U.S. without prior approval from FDA as described in Section 505(a) of the Act [21 USC 355(a)].

These drugs are also misbranded because their labeling fails to bear adequate directions for the conditions for which they are offered [Section 502(f)(1) of the Act].

The above-listed violations are not intended to be an all-inclusive review of your web site and products your firm may market. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations. We request that you take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.

Please notify this office in writing within 15 working days of receipt of this letter, of the specific steps you have taken to correct and prevent the recurrence of these objectionable conditions. 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 completed.

Your reply should be sent to George F. Bailey, Compliance Officer, at the address listed above,

Sincerely,
\s\
Arlyn H. Baumgarten
District Director

cc: [redacted]

This page was posted on July 31, 2005.

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