Union Springs Pharmaceuticals, LLC (Marketing of MyClyns Personal Protection Spray)

Roger D. Griggs, Chairman

Union Springs Pharmaceuticals, LLC

4157 Olympic Boulevard, Suite 200

Erlanger, Kentucky 41018

Dear Mr. Griggs:

This letter concerns your firm's marketing of MyClyns Personal Protection Spray. As presently formulated, labeled and promoted, this over-the-counter (OTC) product violates provisions of the Federal Food, Drug, and Cosmetic Act (the Act). As described in more detail below, this product, which is offered for sale on your website, is an unapproved new drug in violation of sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)]. In addition, this product is misbranded under section 502(c) of the Act [21 U.S.C. § 352(c)] because it does not bear labeling in accordance with 21 C.F.R. § 201.66. For instance, the labeling lacks a “Drug Facts” panel.

Your marketing materials for this product state that it “…contains a 510(k) medical device solution cleared by the FDA as a wound cleanser.” We understand that FDA’s Center for Devices and Radiological Health (CDRH) cleared a premarket notification (510(k)) for Dermacyn Wound Care (K060113) on February 22, 2006. We understand that you market MyClyns Personal Protection Spray under this 510(k) submission. A review of our records indicates that the device was described as “a wound cleansing solution that is intended for the moistening and debriding of dermal wounds. The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris.” The Indications for Use are described as follows, “Dermacyn Wound Care is intended for moistening absorbent wound dressings and for debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, statis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin.”

The cleared primary mode of action of Dermacyn is in the mechanical cleansing and debridement of wounds, not as an antimicrobial. As discussed in detail below, based upon the antimicrobial claims and other labeling claims of MyClyns Personal Protection Spray, this product is a drug as defined by section 201(g) of the Act. Therefore, MyClyns Personal Protection Spray is subject to the drug provisions of the Act and its implementing drug regulations.

Below is an analysis of the regulatory status of MyClyns Personal Protection Spray which includes excerpts of the violative labeling and the specific new drug and misbranding charges. Note that this is not an all inclusive description of all violative labeling for your OTC drug product.

MyClyns Personal Protection Spray

The product labeling for MyClyns Personal Protection Spray represents the product as an OTC topical antimicrobial to be used by emergency medical technicians, law enforcement, the military, school nurses and other healthcare professionals after exposure to bodily fluids and serious pathogenic organisms.

The labeling on your Internet website (www.MyClyns.com) quoted below, describes “Microcyn,” sodium hypochlorite (NaClO), and hypochlorous acid (HOCl) as active ingredients:¹

“Microcyn Technology…The hypochlor[]us acid (HOCl) and hypochlorite ions (OCl-) in MyClyns react with a wide range of biological molecules. HOCl is produced by neutrophils in the human body in its defense against microorganisms.”

The labeling of your Internet website quoted below, describes oxidized water (99.99%), and sodium chloride (NaCl) as ingredients for MyClyns Spray but it does not declare whether these ingredients are active or inactive active ingredients:

“MATERIAL SAFETY DATA SHEET…MyClyns with Microcyn Technology…Product Identification Product Name: MyClyns with Microcyn Technology…”

“…2. COMPOSITION/INFORMATION ON INGREDIENTS Oxidized Water (99.99%), Sodium Hypochlorite (NaOCI), Hypochlorous Acid (HOCI), and Sodium Chloride (NaCl)…”

Your Internet website (www.MyClyns.com) includes the following statements about MyClyns Spray and its uses:²

“MyClyns Personal Spray is a protective spray in an easy-to-use convenient pen-like device that allows you to protect yourself immediately after an exposure…”

“…tests show that the solution in MyClyns Personal Spray demonstrates a 99.99% reduction in over 60 potentially dangerous pathogens.”

Your Internet website (www.MyClyns.com) has a link for frequently asked questions (FAQs) that has the following statements about MyClyns Personal Protection Spray and its uses:³

“When should I use MyClyns?

MyClyns should be used in the event a suspected pathogenic exposure has occurred. According to the CDC, healthcare personnel should assume that the blood and other body fluids from all patients are potentially infectious.”

“Where can I use MyClyns?

MyClyns can be used anywhere on the skin and can be used on the face, eyes, mouth, nose, ears and in open wounds. MyClyns contains Microcyn® which has been proven to be non-toxic, non-irritating and non-sensitizing on mucous and non-mucous membranes.”

“Who should use MyClyns?

Anyone who feels they have come into contact with a potentially harmful pathogen and who wants an immediate protection spray.”

Your Internet website further describes its uses as follows:

“MyClyns allows your to protect yourself after exposure to harmful pathogens….”

“MyClyns is intended to be used following exposure to bodily fluids or other materials potentially containing pathogens, including: Blood, Saliva, Vomit, Urine, Feces, Other bodily fluids.”

Your Internet website has the following testimonials from police, fire, and EMS personnel that describe your product’s uses:

“While providing treatment for a patient that had advised my crew of her diagnosis of Hepatitis C, I experienced an incidental exposure to my mouth and face from a piece of equipment. At first I was a little nervous about the exposure until I remembered the packages of MyClyns that we had in the ambulance. My job is risky enough, but it is very reassuring to know that MyClyns takes some of those risks away. MyClyns was very easy to use and didn’t interfere with patient care.”

Assistant Chief

Dry Ridge Fire Department

“While restraining a combative subject with MRSA, one of my deputies suffered some minor cuts and abrasions. Having MyClyns Personal Spray available in the deputy’s pocket allowed him to immediately cleanse the wounds he suffered in the altercation. MyClyns Personal Spray was the tool he needed to address the exposure situation and provide some peace of mind.”

Lt. Col.

Boone County Sheriffs’ Department

“… one of our employees, had a combative patient who was HIV positive spit in his face. In speaking with [the employee], he advised the first thing he and his partner thought of was using the “stuff” (MyClyns Personal Spray) we issued to them during Hurricane Gustav. [He] stated he used it and felt better knowing it was readily available for this incident. As a manager, I cannot tell you how pleased I am to have provided our employee with this added layer of protection and sense of confidence, when they needed it most.”

Acting Deputy Director

New Orleans E.M.S.

Based on the labeling described above, MyClyns Personal Protection Spray is a “drug” as defined by section 20l(g)(l) of the Act [21 U.S.C. § 321(g)(l)] because it is an article intended to prevent disease and to affect the structure or any function of the body of man.[1] Moreover, the claims on your website indicate that your product works as an antimicrobial via chemical reaction, and the definition of a device under section 201(h) of the Act excludes products that achieve their primary intended purposes through chemical action [21 U.S.C. § 321(h)].

However, we are not aware of sufficient evidence that shows MyClyns Personal Protection Spray is generally recognized as safe and effective as a topical antimicrobial that can prevent infection from Methicillin Resistant Staphylococcus Aureus (MRSA) after exposure to this pathogen. Similarly, we are not aware of sufficient evidence that shows MyClyns Personal Protection Spray is generally recognized as safe and effective as a topical antimicrobial that can prevent infection from Human Immunodeficiency Virus (HIV), Hepatitis C, or MRSA after exposure to blood or other bodily fluids. Furthermore, we are unaware of any evidence that any products so formulated and labeled were marketed in the United States on or before the inception of the OTC Drug Review. As such, MyClyns Personal Protection Spray does not qualify for evaluation under the OTC Drug Review for OTC Healthcare Antiseptics.[2]

For these reasons, MyClyns Personal Protection Spray is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321 (p)] and the introduction of this product into interstate commerce without an approved application violates sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)].

MyClyns Personal Protection Spray is misbranded under section 502(c) of the Act [21 U.S.C. § 352(c)] because the product does not bear labeling in accordance with 21 C.F.R. § 201.66. For instance, your product’s labeling lacks a “Drug Facts” panel.

We note with particular concern that you prominently label and promote MyClyns Personal Protection Spray for topical antimicrobial use on wounds or the mucous membranes of the eyes, ears, mouth or nose to prevent infection from serious pathogenic microorganisms. As noted above, claims for the prevention of infection from bloodborne pathogens are not covered by the OTC Drug Review regardless of formulation. Claims of safety and effectiveness as an antimicrobial for use on mucous membranes of the eyes, ears, mouth, and nose are not covered by the OTC Drug Review for topical antimicrobials. We are not aware of evidence that this product is safe and effective as a topical antimicrobial for use on wounds or the mucous membranes of the eyes, ears, mouth or nose.[3]

You should take prompt action to correct the violations cited above. 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 above. 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 any of your drug products, your response should so indicate, including the reasons for, and the date on which, you ceased production.

Your reply should be sent to the following address: Food and Drug Administration, Division of New Drugs and Labeling Compliance, 10903 New Hampshire Avenue, WO51-5234, Silver Spring, Maryland 20993-0002, Attention: Heath Harley, Compliance Officer. If you have any questions regarding this letter, please contact Heath Harley at (301) 796-3341. You can find guidance and information regarding regulations through links at FDA’s Internet website at http://www.fda.gov/oc/industry. ⁴

Sincerely,

Michael M. Levy, Jr., Esq.

Director

Division of New Drugs and Labeling Compliance

Office of Compliance

Center for Drug Evaluation and Research

cc: Bryan H. Benesch, CDRH Office of Compliance

LaShanda Long-Croal, CDRH Office of Compliance

Toniette K. Williams, Compliance Branch Director, Cincinnati District Office

[1] In evaluating the regulatory status of MyClyns Personal Protection Spray, we considered that the labeling does not differentiate oxidized water and sodium chloride as inactive or active ingredients. Therefore, it is our position that that oxidized water and NaCl are active ingredients for MyClyns Personal Protection Spray along with “Microcyn,” sodium hypochlorite (NaOCl), and hypochlorous acid (HOCl). Under 21 C.F.R. § 201.66 (b)(2) any component in a drug that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans is an active ingredient.

[2] For your information and guidance, OTC health care antiseptics, which include antiseptic cleansers, wound cleansers and OTC first aid antiseptics are being evaluated under FDA's OTC Drug Review. Tentative final monographs (TFMs) for these products were published in the Federal Register of June 17, 1994 (59 FR 31402) and July 22, 1991 (56 FR 33644). These TFMs are available on FDA's Internet website at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-
CounterOTCDrugs/StatusofOTCRulemakings/default.htm. To be included in the Review, a product’s formulation and labeling must have existed in the marketplace in the United States on or before the inception of the OTC Drug Review. Pending a final monograph, the agency does not object to the marketing of OTC drugs that meet the formulation and labeling requirements described in the tentative final monograph. Such marketing is subject to the risk that it may be necessary to reformulate and/or relabel such products or seek FDA approval through the NDA procedures of the Act [section 505] once a final monograph is in effect. However, the formulations and labeling for this product is not consistent with any of these TFMs. Nor does the OTC Drug Review cover the indications for use that appear on the labeling of this product.⁵

[3] We further note, for your guidance, that as late as March 25, 2011 you marketed on your website (www.mygermspray.com), MyClyns Germ Protection Spray, an OTC product similar to MyClyns Personal Protection Spray. The website labeling for MyClyns Germ Protection Spray included violative claims and indications similar to that of your MyClyns Personal Protection Spray. We are not aware that you are currently marketing this product. However, if you continue to market MyClyns Germ Protection Spray or intend to market it in the future with such violative claims and indications as discussed above, they would likewise make MyClyns Germ Protection Spray an unapproved “new drug” under section 201(p) of the Act [21 U.S.C. § 321 (p)] and the introduction of this product into interstate commerce without an approved application would violate sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)].