| Public Health Service Food and Drug Administration |
Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 98021-4421 Telephone: 425-486-8788 FAX: 425-483-4996 |
Department of Health and Human ServicesApril 18, 2011
VIA UPS
In reply refer to Warning Letter SEA 11-13
Steve D. Smith, President
Tec Laboratories, Inc.
7100 Tec Labs Way SW
Albany, Oregon 97321
WARNING LETTER
Dear Mr. Smith:
This letter concerns your firm's marketing of the Staphaseptic First Aid Antiseptic/Pain Relieving Gel. 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 is an unapproved new drug in violation of section 505(a) of the Act [21 U.S.C. § 355(a)] and misbranded under sections 502(e) and 502(a) of the Act [21 U.S.C §§ 352(e) and 352(a)].
Below is an analysis of the regulatory status of Staphaseptic First Aid Antiseptic/Pain Relieving Gel 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.
The product labeling for Staphaseptic First Aid Antiseptic/Pain Relieving Gel represents the product as a combination topical first aid antiseptic and topical pain reliever. The Staphaseptic First Aid Antiseptic/Pain Relieving Gel Drug Facts panel, found on its package labeling and quoted below, describes benzethonium chloride and lidocaine as its active ingredients.
Drug Facts
Active Ingredient
Benzethonium Chloride 0.2%.......................................................First Aid Antiseptic
Lidocaine 2.5%........................................................................Topical Pain Reliever
The product labeling, which includes statements found on your website (http://www.staphaseptic.com/news.cfm?id=21A4442F-03E7-6F49-1C8924273A3E630C), quoted below, describes tea tree oil, thyme oil and essential oils as active ingredients that provide an antimicrobial effect for Staphaseptic First Aid Antiseptic/Pain Relieving Gel.
“Researchers tested four strains of CA-MRSA isolates: three of USA 300 and one of USA 400. They then chose three commercially available OTC topical products marketed for the prevention of wound infections: benzethonium chloride 0.2 percent tea tree oil and white thyme oil (StaphAseptic, Tec Laboratories); neomycin 3.5 mg/g and polymyxin B sulphate 10,000 U/g (Maximum Strength Antibiotic Cream, Rite Aid Corp.); and polymyxin B sulphate 10,000 U/g and gramicidin 0.25 mg/g (Polysporin Cream, Pfizer).”
“Benzethonium chloride with essential oils was more active at 24 hours than polymyxin B/gramicidin against all four strains, and more active than neomycin/polymyxin B against three of the isolates.”
“The role of additional essential oils in the activity of the commercial product StaphAseptic is not currently known, but the oils may play a role in its antibacterial activity, Dr. Bearden says.”
These statements represent that benzethonium chloride, tea tree oil, white thyme oil, and essential oils are active ingredients in your product because they furnish some pharmacological activity, as defined in 21 CFR § 201.66(b)(2).[1]
The product’s uses are described in the product name itself (Staphaseptic First Aid Antiseptic/Pain Relieving Gel) and the following statements on the product’s package labeling:
“KILLS STAPH*”
“APPLY TO MINOR CUTS, SCRAPES AND BURNS…RELIEVES PAIN-PREVENTS INFECTION…KILLS OVER 99.9% OF MRSA, STAPH AND STREP”
Your website (www.staphaseptic.com) includes the following statements about Staphaseptic First Aid Antiseptic/Pain Relieving Gel and its uses:
“FIRST AID ANTISEPTIC/PAIN RELIEVING GEL”
“HELPS PREVENT SKIN INFECTIONS caused by bacteria such as MRSA, staph, strep and other germs”
“To help prevent skin infections caused by bacteria such as MRSA and other germs, it’s essential to treat your minor cuts and scrapes with StaphAseptic® First Aid Antiseptic / Pain Relieving Gel.”
Your website also includes an online brochure entitled “FACTS ABOUT METHICILLIN RESISTANT STAPH (MRSA)!” (http://www.staphaseptic.com/FactFictionAboutMRSA.pdf) which touts the effectiveness of Staphaseptic First Aid Antiseptic/Pain Relieving Gel. The following quotes are from the brochure:
“HOW CAN I PREVENT STAPH OR MRSA SKIN INFECTIONS? …Treat cuts and scrapes with StaphAseptic First Aid Antiseptic / Pain Relieving Gel”
“StaphAseptic kills 99.9% of antibiotic resistant staph (MRSA).* Topical triple antibiotics have not been found to be effective against MRSA.”
Based on the labeling described above, Staphaseptic First Aid Antiseptic/Pain Relieving Gel is a “drug” as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because it is intended to prevent disease and (or) to affect the structure or any function of the body of man.
However, we are not aware of sufficient evidence that shows Staphaseptic First Aid Antiseptic/Pain Relieving Gel is generally recognized as safe and effective for the uses noted above. In particular, we are not aware of evidence that this product is safe and effective in preventing individuals from becoming infected by Methicillin Resistant Staphylococcus Aureus (MRSA), Staphylococcus or Streptococcus.
Therefore, Staphaseptic First Aid Antiseptic/Pain Relieving Gel is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] and may not be legally marketed in the United States without an approved application under section 505(a) of the Act [21 U.S.C. § 355(a)].
Further, this product is misbranded under sections 502(e) and 502(a) of the Act [21 U.S.C §§ 352(e) and 352(a)] in that the statements on your website identify tea tree oil, white thyme oil, and essential oils as active ingredients in Staphaseptic First Aid Antiseptic/Pain Relieving Gel, which is inconsistent with the list of active ingredients written on the package labeling for the product. Thus, the label fails to declare all the ingredients represented and suggested as active, and the labeling is misleading in that essential oils are represented as being active therapeutic agents in the product.
Based on the product labeling claims, Staphaseptic First Aid Antiseptic/Pain Relieving Gel is an OTC combination topical first aid antiseptic and external analgesic. For your information, OTC topical antimicrobials include OTC healthcare antiseptics and OTC first aid antiseptics, which are being evaluated under FDA's OTC Drug Review. Tentative Final Monographs (TFMs) for these products were published in the Federal Register of 59 Fed. Reg. 31402 (June 17, 1994) and 56 Fed. Reg. 336444 (July 22, 1991). These TFMs are available on FDA's Internet website at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm070821.htm.
The agency is also evaluating the safety and effectiveness of external analgesics under FDA's OTC Drug Review. TFM for OTC External Analgesic Products was published in the Federal Register of 45 Fed. Reg. 5852 (February 8, 1983). These TFMs are available on FDA’s Internet website at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm155846.htm
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 TFMs.[2] However, your product’s formulation and labeling are not consistent with any of these TFMs.
Furthermore, your product’s formulation and labeling are not being considered under the OTC Drug Review. Specifically, the product’s formulation (the combination of active ingredients, benzethonium chloride, lidocaine, tea tree oil, thyme oil and essential oils in Staphaseptic First Aid Antiseptic/Pain Relieving Gel) and the product’s labeling claims as described above (prevention of infection from MRSA, Staphylococcus or Streptococcus)are not being evaluated under any of the ongoing rulemakings in the OTC Drug Review. Your product’s formulation and labeling are not being considered under the OTC Drug Review because we are not aware of any products with such formulation and labeling that existed in the marketplace in the United States on or before the inception of the OTC Drug Review, or that have complied with the requirements under 21 C.F.R. § 330.14.
We are aware of your letter to the Seattle District Office dated November 18, 2009, that responded to a FORM FDA 483, Inspectional Observations, issued to your firm. In this letter you also explained why the claims noted above are not violative. However, your explanation is not valid and it is without merit.
The violations cited in this letter are not intended to be an all-inclusive list of deficiencies regarding your products. You are responsible for investigating and determining the causes of these violations and for preventing their recurrence and 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.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made. 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 written response should be sent to Patricia A. Pinkerton, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021-4426. If you have any questions about this letter, please contact Compliance Officer Patricia Pinkerton at 425-483-4926.
You can find guidance and information regarding regulations through links at FDA’s Internet website at http://www.fda.gov/oc/industry.
Sincerely,
/S/
Charles M. Breen
District Director
[1] Active ingredient means any component 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. 21 CFR § 201.66(b)(2).
[2] Once a final monograph becomes effective, it may be necessary to reformulate and/or relabel such products to conform to its requirements, or, in the alternative, to seek FDA approval of a new drug application (NDA) under section 505 of the Act [21 U.S.C. § 355].
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