Department of Health and Human Services' logo Department 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

VIA FEDEX
RETURN RECEIPT REQUESTED

March 3, 2008

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

WARNING LETTER

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

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.htm1. 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

This page was posted on July 19, 2010.

Links to Recommended Companies