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

Public Health Service
Food and Drug Administration
  One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 596-7700
FAX: (781) 596-7896

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

David Goldsmith
Managing Director
Aidance Skincare and Topical Solutions, LLC
P.O. Box 138
Harmony, Rhode Island 02829

March 3, 2008

WARNING LETTER
NWE-09-08

Dear Mr. Goldsmith:

This letter concerns your firm's marketing of the products Tetrasil and Genisil on your websites, www.myskincure.com, www.genisil.com and www.aidanceskincare.com. According to information on your websites, your "Tetrasilver Tetroxide (TST) Ointments," are intended to prevent, treat, or cure disease conditions. Statements on your websites that document these intended uses include, but are not limited to, the following:

Tetrasil (www.myskincure.com)

Genisil (www.genisil.com)

Duplicate Testimonials regarding Tetrasil and Genisil; found on each website www.myskincure.com & www.genisil.com:

Claims for TST Ointments found on www.aidanceskincare.com

These claims are supplemented by the metatags that you use to bring consumers to your websites. The metatags include "cold sores," "oral herpes," "shingles," "treatment for skin disease or disorder," "herpes," "herpes simplex," "genital herpes," "herpes simple virus," "HSV," "vaginal herpes," "penal herpes," "herpes infection," "bacterial infection," "viral infection," and "fungal infection."

Your "Tetrasilver Tetroxide (TST) Ointments," including "Tetrasil," and "Genisil," are drugs, 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 they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Moreover, these products are new drugs, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because they are not generally recognized as safe and effective for their 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 Tetrasil and Genisil without approved applications violates these provisions of the Act.

Furthermore, because Tetrasil and Genisil are offered for conditions, such as herpes, which 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 their intended uses. Thus, your products' labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).

Moreover, your Tetrasilver Tetroxide (TST) Ointments, to the extent that they are labeled and promoted for over the counter (OTC) use, are subject to 21 CFR § 310.548, which states that there is a lack of adequate data to establish general recognition of the safety and effectiveness of silver salts for OTC use in the treatment or prevention of any disease. Any OTC drug products containing these ingredients that are promoted, labeled, or represented for the treatment or prevention of any disease are regarded as new drugs within the meaning of section 201(p) of the Act, 21 U.S.C. § 321(p), and require approved applications under section 505 for marketing. Thus, Tetrasil and Genisil are unapproved new drugs and their delivery into interstate commerce violates section 301(d) of the Act, 21 U.S.C. § 331(d).

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 products. 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 your firm complies 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 Tetrasil and Genisil, your response should so indicate, including the reasons that, and the date on which, you ceased production. Additionally, if another firm manufactures the products identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the products 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, 1 Montvale Avenue, Stoneham, MA 02180, Attention: Anthony P Costello, Compliance Officer, 781 596-7716.

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/

Mutahar Shamsi
Acting Director
New England District

Cc: Marvin Antelman, PhD.
Scientific Affairs
Aidance Skincare & Topical Solutions, LLC.
P.O. Box 138
Harmony, Rhode Island 02829

Rhode Island Board of Pharmacy
Catherine A. Cordy
Executive Director
3 Capitol Hill, Room 205
Providence, RI 02908-5097

This page was posted on July 19, 2010.

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