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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Zian Medical, LLC 10/10/12

  

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

Public Health Service
Food and Drug Administration
 

10903 New Hampshire Avenue
Silver Spring, MD 20993

WARNING LETTER


OCT 10, 2012

VIA United Parcel Service

Stephen Almeida
Manager
Zian Medical, LLC
813 South Westshore Boulevard
Tampa, Florida 33609

RE:  Simplexus Pro, also known as Cold Sore Stopper
       Refer to GEN1100428 when replying to this letter.

Dear Mr. Almeida:

The Food and Drug Administration (FDA) has learned that your firm is marketing the Simplexus Pro in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).  Under section 201(h) of the Act, 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

The Office of Compliance, in the Center for Devices and Radiological Health, reviewed your firm’s website, http://www.coldsorestopper.com, which shows that the Simplexus Pro is being marketed with the following claims:

What is Simplexus Pro?

The Simplexus Pro prevents prolonged outbreaks of herpes, cold sores,
genital sores, and shingles.

The Simplexus Pro utilizes a unique technology of microprocessor-controlled electrical high-frequency pulses to render the herpes simplex virus inactive . . . .”

“How Simplexus Pro Stops Herpes and Cold Sores

Simplexus Pro can stop the herpes virus before it reaches the skin surface
to form a blister.

The simplex virus propagates slowly up and down nerve channels that are attached to the skin. When the virus reaches the skin, it builds up and forms a blister under the skin that eventually bursts to form a sore.  The virus then propagates back up the nerve channel. This is why outbreaks and cold sores happen on a timed basis.  Time between outbreaks can be weeks, months, or even years apart.

Prior to an outbreak, you can feel a tingling sensation at the area that is ready to form a blister.  Apply the Simplexus Pro at this area 3 times a day for three days . . . .”

Additionally, your frequently asked questions webpage,
http://www.coldsorestopper.com/faqs.php, contains the following:

“Does the Simplex Pro cure the herpes and cold sore virus?

The Simplexus Pro prevents embarrassing outbreaks from occurring by destroying the virus before it penetrates the skin.”

Does the Simplex Pro prevent outbreaks every time?

The Simplexus Pro will prevent outbreaks 88% of the time if you catch it before the blister forms.  For people with very severe outbreaks or low immune systems, the Simplexus Pro may not prevent the outbreak entirely, but it will cause the blister to be much smaller and heal in 3 to 4 days instead of 7 to 10 days.”

A review of our records revealed that your firm did not obtain marketing approval or clearance before it began offering these devices for sale.  Therefore the Simplexus Pro is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g).  The Simplexus Pro is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by sections 510(k) of the Act, 21 U.S.C. § 360(k).  For a device requiring premarket approval, the notification required by section 510(k) of the Act is deemed satisfied when a PMA is pending before the agency per 21 CFR 807.81(b).  The kind of information that you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html.  The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

Under section 510 of the Act, 21 U.S.C. § 360, manufacturers of medical devices are required to annually register with the FDA.  In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Public Law 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act, 21 U.S.C. § 360(p)] during the period beginning October 1st and ending December 31st of each year.  Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2012.

Therefore all of your firm’s devices are also misbranded within the meaning of section 502(o) of the Act, 21 U.S.C. § 352(0), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. § 360, and were not included in a list required by section 510(j) of the Act, 21 U.S.C. § 360(j).

Your firm should take prompt action to correct these violations, including immediately ceasing distribution of the devices and disseminating promotional materials for the same as or similar to the materials described above.  Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice.  These actions include, but are not limited to seizure, injunction, and civil money penalties.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps that your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken.  If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities.  If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed.  Your firm’s response should be comprehensive and address all violations included in this Warning Letter.

Please direct your response to Ms. LaShanda Long, Branch Chief, General Surgery Devices Branch, Division of Enforcement A, Office of Compliance, Food and Drug Administration, 10903 New Hampshire Avenue, WO66-3520, Silver Spring, MD 20993, facsimile at 301-847-8137.  We remind you that only written communications are considered official.

Finally, you should know that the violations discussed in this letter do not necessarily constitute and exhaustive list.  It is your firm’s responsibility to ensure compliance with each applicable requirement of the Act and related regulations. 

Sincerely yours,

/S/

Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health