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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Aidance Skincare & Topical Solutions, LLC 03-Mar-08

Department of Health and Human Services' logoDepartment 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


WARNING LETTER
NWE-09-08

Certified Mail

RETURN RECEIPT REQUESTED

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

March 3, 2008

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)

• “Tetrasil's key ingredient, (TST), has a natural attraction to the surface of bacteria, fungi and viruses. These pathogens are responsible for the itching, rashes, redness, burning and other unwanted symptoms of the skin conditions. Upon contact, TST's unique chemical structure releases both a micro electrical charge and oxygen, which immediately begins to kill the pathogens.”

• “Regardless of the stage of your Genital Herpes, Tetrasil may begin to provide relief in as fast as TWO DAYS.”

• “Before using Tetrasil, I had tried using Favmir and Valtrex. Each only worsened the length of my outbreaks and their severity. I had tried numerous expensive substances, ointments, and injections, and found myself being a guinea pig for researchers as well. It had been a long, disappointing five-year search only to find nothing worked. Tetrasil, however, was going to be the last thing I tried, and I am glad I did.”

• “On your lip, Tetrasil's active bio-electro chemistry (TST) surrounds the cold sore and quickly begins to attack the herpes simplex virus (HSV) that causes the tingling, blistering and weeping.”

• “Tetrasil Spells the End of Herpes Related Breakouts”
Hello, I am a woman with a history of Herpes Simplex Virus. About every month I would have a severe outbreak on my face caused by the herpes virus. . . I have tried many other treatments for my outbreaks, but only Tetrasil effectively rid me of them.”

• “People report success and relief from Shingles using Tetrasil during any of the active stages of the shingles virus (Herpes Zoster).”

• “Doctor's Report #2: “Tetrasil is effective for the treatment of Erysipelas infections of the skin caused by the A Group B-Hemolytic Streptococcus and healed the skin in a conducive manner."

• “Tetrasil ointment appeared to be extremely efficient against the opportunistic pathogens present in diabetic feet, as well as the healing of the infection."

Genisil (www.genisil.com)

• “There is NO CURE for Herpes. RIGHT?
Think again! If you’ve been looking for a herpes product that actually delivers on its promises, your search is over.”

• “The silver and oxygen in Genisil will begin to kill the inflammation causing herpes virus quickly and safely upon contact, BEFORE YOU EVER SEE AN OUTBREAK.”

• “EJC Molecules have a selective attraction to exposed nitrogen groups on the membrane proteins of bacteria, viruses and fungi. Upon contact, EJC's go through an oxidation-reduction (redox) reaction, which studies suggest may be instrumental in speeding wound healing.”

• “When oxygen is introduced into the area it attacks microbes without a coating and diseased cells with deficient wall enzymes. It [oxidises] them, allowing them to be cleared from the body and replaced with healthy new cells. The broad application of oxygen therapy in medicine is based on the simple principle that diseased cells cannot exist in the presence of oxygen and that cells cannot become diseased if they are supplied with sufficient oxygen.”

• “Genisil is a uniquely formulated all-natural ointment. It contains a patented compound of the most potent natural anti-virals on earth, plus other ingredients that work FAST to resolve herpes issues.”

• “With four silver atoms, patented EJC Molecules are significantly more potent than other silvers in the speed with which it kills viruses, bacteria and fungi, including Staphylococcus aureus, responsible for bacterial folliculitis and the yeast responsible for fungal folliculitis.”

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

• “Doctor's Report
Two patients with severe recurring genital herpes outbreaks used it, applying the ointment three times daily. Over a period of 2-4 days, the Herpes sores regressed and dried out."

• “the frequency of herpes outbreaks have been reduced by 50%, as well as their healing time. For me, it has been the ONLY product that has helped to reduce the reoccurrence and severity of my outbreaks.”

• “An RN: The sore disappeared in 24 hours
I am a 42 year old female who has suffered from Herpes virus for the last 6 years. Trying most of the pharmaceutical remedies, nothing seemed to work. So I started searching for an alternative. Applying it to an area that was inflamed, red, painful and itchy (signs of an outbreak for me) the sore disappeared within 24 hrs and I have not had a sign of it since. It's almost been a year. Sherry, R.N., Oregon”

Claims for TST Ointments found on www.aidanceskincare.com

• “TsT’s Interaction on Herpes Simplex Virus: As TST makes contact with the HSV virus, it will start electrocuting the gp-G terminals as well as the entire protein envelope. TST will continue its REDOX reaction and form chelate complexes of silver around the entire viral surface. The combination of electrocution and chelation will prevent the virus from performing its essential life functions and cause its death within minutes.”

• “In addition to EJC’s anti-microbial properties, the combination of electrical energy and singlet oxygen apparently promote the growth of tissue, thus serving as a potential treatment for burn victims and other applications requiring a stimulus of tissue growth.”

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.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/

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