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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Aviralex Int. 03-Mar-08

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

Public Health Service
Food and Drug Administration

 

San Francisco District

1431 Harbor Bay Parkway
Alameda, CA 94502-7070 Telephone: 510/337-6700


WARNING LETTER

VIA FEDEX

RETURN RECEIPT REQUESTED

March 3, 2008

Aviralex Int.
Registrant
Caroline Buckley
760 Market Street, Suite 315
San Francisco, CA 94102

Dear Ms. Buckley:

This letter concerns your firm’s marketing of the product “Aviralex.” Based on promotional claims made on your website, www.aviralex.com, Aviralex is intended to prevent, treat, or cure disease conditions in humans and to affect the structure and function of the body. Statements on your website that document these intended uses include, but are not limited to, the following:

Aviralex

“Stop the painful, ugly outbreaks of ALL Herpes.”

“With only ONE application of the proven herpes treatment Aviralex”

“Aviralex is the only laboratory-tested all natural topical solution herpes remedy on the market today. Proven to provide immediate relief and cessation of ALL herpes outbreaks.”

Independent Clinical Trials show that 85% of users have no further outbreaks for months after treatment. 10-15% needed to reapply Aviralex on the next outbreak to get the desired results. In addition, lesions dried within a matter of hours and new uncontaminated skin appeared within 72 hours. Your healing begins immediately, giving you back control of your life. No need to worry about outbreaks anymore.

“Since 2 years, I had Genital herpes. I did try the most expensive tablets but it was all in vain since my outbreaks were every 2-3 weeks at the beginning. I used Aviralex only one time once I had an outbreak, as advised and I was really surprised when everything was gone in no more than 3 days and my next outbreak was 10 months later.”

• “We are so sure that you will find satisfaction with the proven herpes remedy Aviralex that our Guarantee is 180 DAYS.”

• “It is this combined effect that causes the Aviralex to penetrate through the membrane of the herpes virus, hence the destruction of the virus on contact.”

• “Aviralex is an antiviral topical application that is effective in clearing both oral and genital herpes outbreaks rapidly and reducing, if not eliminating, recurrences. It has been demonstrated to successfully end outbreaks in many cases.”

• “Aviralex works by killing the herpes virus it comes in contact with.”

• “It is a great medicine and you have to try it to believe on it.[sic] and[sic] now I don't care any more if I am going to get an outbreak since I have a very strong weapon against it, and I don't go anywhere without it. Thank you very much for this wonder liquid and your support for many people, who were really suffering from herpes."

• "I was suspect of Aviralex when I bought it. But given the sores I was experiencing, I figured it was worth the $100 if I could resolve them. Well, it took about a week and they all disappeared and haven't returned. I couldn't be happier. I researched the other medical options and none of them offered the hope for complete cure. Only Aviralex did - and it delivered. "

• “This clinical trial included a double-blind controlled trial comparing Aviralex to herpes prescription remedies and placebos. The study compared the time it takes for each patient to form a scab and to heal. Subject's lesions dried up in six hours and new skin appeared in 72 hours. Results show that Aviralex measurably speeds healing time when compared to both prescription remedies as well as placebos.”

These claims are supplemented by the metatags that you use to bring consumers to your website. The metatags include “herpes treatment,” “herpes genital treatment,” and “herpes simplex treatment.”

Aviralex is a drug, as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and to affect the structure and function of the body. Namely, the product is promoted as intended to cure, mitigate, treat, and prevent herpes or herpes-related conditions and to affect the structure and function of the body. Moreover, this product is a new drug, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for its labeled uses. Under sections 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. Your sale of Aviralex without an approved application violates these provisions of the Act.

Furthermore, because this product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use it safely for its intended uses. Thus, Aviralex’s labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).

The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that you comply with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you no longer manufacture or market Aviralex, your response should so indicate, including the reasons that, and the date on which, you ceased production. Additionally, if another firm manufactures the product 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 manufacturer.

Please direct your response to the U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502, Attention: Marshalette Edwards, Compliance Officer.

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 this process 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.


Sincerely,

/S/

Barbara Cassens,
Director San Francisco District

Cc:

[redacted]

Virginia “Giny” Herold
Executive Officer
California State Board of Pharmacy
1625 N Market Blvd, N219
Sacramento, CA 95834