StaphAseptic Class Action Lawsuit against Tec Laboratories

Posted on May 3, 2011 in Medical Products

Our attorneys are investigating a StaphAseptic class action lawsuit against Tec Laboratories based on a FDA warning letter sent to Tec Laboratories, Inc. on April 18, 2011.

The U.S. Food and Drug Administration (FDA) sent a warning letter to Tec Laboratories, Inc., an Albany, Oregon, firm, regarding the firm’s marketing of the StaphAseptic First Aid Antiseptic/Pain Relieving Gel (“StaphAseptic”). According to the FDA:

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)].

StaphAseptic Product Labeling Includes False Information Warns FDA

The labeling for StaphAseptic stated:

“KILLS STAPH”

“APPLY TO MINOR CUTS, SCRAPES AND BURNS…RELIEVES PAIN-PREVENTS INFECTION…KILLS OVER 99.9% OF MRSA, STAPH AND STREP”

According to the FDA warning letter dated April 18, 2011, the Tec Laboratories website (www.staphaseptic.com) included 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.”

The Tec Laboratories website also included an online brochure entitled “FACTS ABOUT METHICILLIN RESISTANT STAPH (MRSA)!” which touted 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.”

The FDA stated “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.”

StaphAseptic Misbranded under Federal Law

According to the FDA, StaphAseptic is misbranded under sections 502(e) and 502(a) of the Act [21 U.S.C §§ 352(e) and 352(a)] in that statements on your website (quoted below) 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:

“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.”

The FDA found that 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 FDA found that “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.”

Footnote: [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).

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