Quadex Pharmaceuticals, LLC 5/7/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Denver District Office|
Building 20 - Denver Federal Center
P.O. Box 25087
Denver, Colorado 80225-0087
May 7, 2012
Boyd Ronald Johnson
Chief Executive Officer
Quadex Pharmaceuticals, LLC
7070 Union Park Center, #380
Midvale, Utah 84047
Dear Mr. Johnson:
The United States Food and Drug Administration (FDA) conducted an inspection of your facility at the address referenced above from June 21, 2011 through June 28, 2011. The inspection revealed that your firm markets and distributes "Viroxyn Professional." The FDA has determined your firm's marketing of this product, which is offered for sale on your website http://www.viroxynstore.com,1 violates the Federal Food, Drug, and Cosmetic Act (the Act). As described in more detail below, this product 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)]. It is further misbranded under section 502(a) of the Act [21 U.S.C. § 352(a)] in that its accompanying labeling is misleading.
Statements from your product labels include, but are not limited to, the following:
Viroxyn Professional with Benzocaine
“Active Ingredients Purposes
Benzalkonium Chloride 0.13%..………………………….Cold Sore/Fever Blister
Treatment Topical Antiseptic
Benzocaine 5%..…………………………………………......Pain Relief During Application”
• To treat cold sores/fever blisters. •To help guard against infection.”
“PROFESSIONAL COLD SORE TREATMENT”
“One Day, One Dose, Healing Begins.”
“Relieves Pain and Burning”
“A cold sore is caused by the herpes virus (Typically HSV-1). “Cold sore” and “fever blister” are just different popular names for the same lesion, which is caused by the herpes simplex virus.”
“Herpes is highly contagious.
• A kiss can transfer the virus to another individual.
• Children are highly at risk.”
“After touching your cold sore:
. . .
• Do not touch your genitals or other parts of the body.
It is possible to transfer the virus to other parts of the body.”
“Viroxyn Professional® is a patented approach to treating cold sores/fever blisters. Rubbing the cold sore with the applicator tip delivers the germicidal medicine to the site of the infection while eliminating the need to touch the sore with your fingers.”
Based on these claims, your product is a drug as defined by sections 201(g)(1)(B) and (C) of the Act [21 U.S.C. §§ 321(g)(1)(B) and (C)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body of man. Furthermore, for the reasons discussed below, the 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, a new drug may not be introduced into interstate commerce unless an FDA-approved new drug application (NDA) is in effect for it. Your sale of “Viroxyn Professional” without an FDA approved application violates these provisions of the Act.
Specifically, “Viroxyn Professional,” based on the above claims, is intended among other uses for cold sore and fever blister treatment. The agency is in the process of evaluating the safety and effectiveness of active ingredients in over-the-counter (OTC) cold sore/fever blister drug products marketed in the United States before the inception of that review. See the Notice of Proposed Rulemaking for Skin Protectant Drug Products for Over-the-Counter Human Use; Fever Blister and Cold Sore Treatment Drug Products (55 Fed. Reg. 3362 (Jan. 31, 1990)) and External Analgesic Drug Products for Over-the-Counter Human Use; Proposed Rulemaking for Fever Blister and Cold Sore Treatment Drug Products (55 Fed. Reg. 3370 (Jan. 31, 1990)). Pending the issuance of final monographs for OTC cold sore/fever blister drug products, the agency does not object to the marketing of products that meet both the formulation and labeling requirements described in the above-cited tentative final monographs or that were otherwise marketed prior to the inception of the FDA’s OTC Drug Review. 3
“Viroxyn Professional,” however, does not conform to the formulation and labeling provisions in the above-cited tentative final monographs. According to your labeling, the active ingredients in “Viroxyn Professional” include benzalkonium chloride. Benzalkonium chloride use in a product that among other uses is intended to treat cold sores and fever blisters is not, nor has it ever been, covered by the developing monographs for OTC cold sore/fever blister drug products. In addition, statements in your labeling suggest that your product is intended for OTC drug use in the treatment of herpes. This indication is not covered by any monograph or ongoing rulemaking under the OTC Drug Review. Finally, one of the indications of “Viroxyn Professional” according to your labeling is “to guard against infection,” which is also not covered by the developing monographs for cold sores and fever blisters, which address symptomatic relief for cold sores and fever blisters, rather than the underlying infection that causes them.
We are not aware of sufficient evidence that shows “Viroxyn Professional” is generally recognized as safe and effective for the uses contained in its labeling, as described above. In addition, we are not aware of any evidence that similarly formulated and labeled products were marketed on or before the inception of the OTC Drug Review. As such, “Viroxyn Professional” is not eligible for evaluation under the OTC Drug Review without submission of a time and extent application under 21 C.F.R. 330.14 and a subsequent determination of eligibility. For these reasons, your product is a “new drug” under section 201(p) of the Act and requires a new drug application. Absent approval of such an application, its marketing violates section 301(d) of the Act.
In addition, we consider the labeling of your product with respect to herpes to be misleading and thus to misbrand the product under section 502(a) of the Act. As noted in a tentative final monograph discussed above, FDA considers the use of term “herpes alone” in labeling for products marketed under the OTC Drug Review for treatment of fever blisters and cold sores to be too broad, because consumers may associate the term with the genital form of herpes. 55 Fed. Reg. at 3373. Your specific product labeling not only references “herpes” as the cause of cold sores but also goes on to warn consumers: “After touching your cold sore:. . .Do not touch your genitals or other parts of the body. It is possible to transfer the virus to other parts of the body.” These statements serve to conflate oral and genital herpes, which is misleading. Thus, “Viroxyn Professional” is misbranded under section 502(a) of the Act [21 U.S.C. § 352(a)].
The 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, the Act and its implementing 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.
We also note that, in the recent past, your firm also distributed a similar product, “Blister Blaster,” which contained benzalkonium chloride as its active ingredient and bore labeling containing the same indications and other language as “Viroxyn Professional.” Your firm, however, appears to have ceased distribution of that product. We request that in your reply, you address whether you have permanently ceased distribution of “Blister Blaster,” and if not, address how you would assure that this product also complies with the requirements of the FD&C Act.
Your reply should be sent to the Food and Drug Administration, Denver District Office, Denver Federal Center – Building 20, 6th Avenue and Kipling Street, P.O. Box 25087, Denver, CO 80225-0087, to the attention of Thomas R. Berry, Pharm.D., Compliance Officer. If you have any questions regarding the content of this letter, please contact Dr. Berry at (303) 236 -3028.
LaTonya M. Mitchell
Denver District Director
1 “Viroxyn” website at http://www.viroxynstore.com/ (last accessed April 27, 2012).
2 This and other emphases reflect the formatting of the packaging.
3 Such marketing, however, is subject to the risk that a final monograph or rule may require reformulation and/or relabeling, or FDA approval through the “new drug” procedures of section 505 of the Act (see 21 U.S.C. § 355).