CleanWell Hand Sanitizer Class Action Lawsuit
Our attorneys are investigating a class action lawsuit against Oh So Clean, Inc dba CleanWell Company (“CleanWell”) based on a FDA warning letter sent to the company on April 18, 2011. The warning letter addressed the company’s marketing of CleanWell All-Natural Foaming Hand Sanitizer, CleanWell All-Natural Hand Sanitizer, CleanWell All-Natural Hand Sanitizing Wipes, and CleanWell All-Natural Antibacterial Foaming Handsoap drug products.
Free consultation regarding a CleanWell class action lawsuit >>>
The FDA warning letter states that there is not sufficient evidence of the validity of CleanWell claims that these products are effective in preventing infections from E. coli, Klebsiella pneumoniae, MRSA, Pseudomonas aeruginosa, Salmonella, and Staphylococcus aureus. Consumers were mislead by these claims, giving rise to a false advertising claim under the Federal Trade Commission Act.
According to the FTC’s Deception Policy Statement, an ad is deceptive if it contains a statement – or omits information – that:
- Is likely to mislead consumers acting reasonably under the circumstances; and
- Is “material” – that is, important to a consumer’s decision to buy or use the product.
CleanWell should be held accountable for any false advertising.
CleanWell All-Natural Foaming Hand Sanitizer
Below are excerpts from the FDA warning letter explaining the company’s claim that CleanWell All-Natural Foaming Hand Sanitizer kills dangerous bacteria.
The product’s uses are described in the following statements on its label addressed in the warning letter:
“All-Natural CleanWell™ is a patented formulation of essential plant oils proven to kill 99.99% of germs including MRSA, Salmonella, Staph and E. coli.”
“Use: Sanitize hands when you can’t wash with soap and water”
“Kills 99.99% of germs naturally”
Labeling on CleanWell’s website (www.cleanwelltoday.com) also included the following statements about CleanWell All-Natural Foaming Hand Sanitizer and its uses:
“Kills 99.9% of harmful germs on contact. Including MRSA (resistant Staph), E. Coli and Salmonella.”
The website also included a “Technology Brief” entitled “Cleanwell Botanical Germ-Killing Technology” that has the following information about CleanWell All-Natural Foaming Hand Sanitizer:
CleanWell Hand Sanitizer Laboratory Data
Testing Method Organisms CleanWell Results GLP Bacteria Kill (In Vitro) • MRSA
• Staphylococcus aureus
• Klebsiella pneumoniae
• Pseudomonas aeruginosa
• Escherichia coli>99.99% (15 sec)
>99.99% (15 sec)
>99.99% (15 sec)
>99.99% (15 sec)
>99.99% (15 sec)
The FDA stated in the warning letter that it is not aware of sufficient evidence that shows CleanWell All-Natural Foaming Hand is safe and effective in preventing individuals from becoming infected by E. coli, Klebsiella pneumoniae, MRSA, Pseudomonas aeruginosa, Salmonella, and Staphylococcus aureus.
CleanWell All-Natural Hand Sanitizer
Below are excerpts from the FDA warning letter explaining the company’s claim that CleanWell All-Natural Hand Sanitizer kills dangerous bacteria.
The product’s uses are described in the following statements on its label addressed in the warning letter:
“All-Natural CleanWell™ is a patented formulation of essential plant oils proven to kill 99.99% of germs”
“Use: Sanitize hands when you can’t wash with soap and water”
“Kills 99.99% of germs naturally”
Labeling on CleanWell’s website also included the following statements about CleanWell All-Natural Hand Sanitizer and its uses:
“Kills 99.9% of harmful germs on contact. Including MRSA (resistant Staph), E. Coli and Salmonella.”
The website also included a “Technology Brief” entitled “Cleanwell Botanical Germ-Killing Technology” that has the following information about CleanWell All-Natural Hand Sanitizer:
CleanWell Hand Sanitizer Laboratory Data
Testing Method Organisms CleanWell Results GLP Bacteria Kill (In Vitro) • MRSA
• Staphylococcus aureus
• Klebsiella pneumoniae
• Pseudomonas aeruginosa
• Escherichia coli>99.99% (15 sec)
>99.99% (15 sec)
>99.99% (15 sec)
>99.99% (15 sec)
>99.99% (15 sec)
The FDA stated in its warning letter that it was not aware of sufficient evidence showing that CleanWell All-Natural Hand Sanitizer is safe and effective in preventing individuals from becoming infected by E. coli, Klebsiella pneumoniae, MRSA, Pseudomonas aeruginosa, Salmonella, and Staphylococcus aureus.
CleanWell All-Natural Hand Sanitizing Wipes
Below are excerpts from the FDA warning letter explaining the company’s claim that CleanWell All-Natural Hand Sanitizing Wipes kill dangerous bacteria.
The product’s uses are described in the following statements on its label addressed in the warning letter:
“Kills 99.99% of germs naturally”
“For hands and face”
“Use: Sanitize hands when you can’t wash with soap and water”
Labeling on the company’s website also included the following statements about CleanWell All-Natural Hand Sanitizing Wipes and its uses:
“Kills 99.9% of harmful germs on contact. Including MRSA (resistant Staph), E. Coli and Salmonella.”
In the warning letter, the FDA state that is was unaware of sufficient evidence that shows CleanWell All-Natural Hand Sanitizing Wipes is generally recognized as safe and effective for the uses noted above. In particular, the FDA was not aware of sufficient evidence that the wipes are safe and effective in preventing individuals from becoming infected by E. coli, MRSA and Salmonella.
CleanWell All-Natural Antibacterial Foaming Handsoap
Below are excerpts from the FDA warning letter explaining the company’s claim that CleanWell All-Natural Hand Sanitizing Wipes kill dangerous bacteria.
According to the FDA, the product’s uses are described in the product name itself, CleanWell All-Natural Antibacterial Foaming Handsoap, and the following statements on its label:
“Use: For handwashing to help eliminate bacteria on skin”
“Proven to kill 99.99% of germs”
“All-Natural CleanWell ™ is a proprietary formulation of essential plant oils proven to kill 99.9% of germs including MRSA, Salmonella, Staph and E. coli”
Labeling on the website included statements such as the following about CleanWell All Natural Antibacterial Foaming Handsoap and its uses:
“Kills 99.9% of harmful germs on contact. Including MRSA (resistant Staph), E. Coli and Salmonella.”
Based on the labeling described above, CleanWell All-Natural Antibacterial Foaming Handsoap is a “drug” as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because it is intended for use in the cure, treatment, mitigation, or prevention of disease, or is intended to affect the structure or any function of the body of man.
In the warning letter, the FDA stated:
We are not aware of sufficient evidence that shows CleanWell All-Natural Antibacterial Foaming Handsoap 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 E. coli, Methicillin Resistant Staphylococcus aureus (MRSA), and Salmonella infections.
Safe4Hours Class Action Lawsuit against JD Nelson and Associates
Our attorneys are investigating a Safe4Hours class action lawsuit against JD Nelson and Associates, LLC (“JD Nelson”) based on an FDA warning letter sent to JD Nelson on April 18, 2011. The warning letter addressed the firm’s marketing of Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant.
Free consultation with an attorney regarding a Safe4Hours class action lawsuit >>>
Safe4Hours Hand Sanitizing Lotion
Below are excerpts regarding Safe4Hours Hand Sanitizing Lotion found in the FDA warning letter.
The product labeling for Safe4Hours Hand Sanitizing Lotion represents the product as an over-the-counter topical antimicrobial hand antiseptic with the active ingredient triclosan, 1%. The product’s use is described in the product name itself, Safe4Hours Hand Sanitizing Lotion, and the following statement on its label:
“KILLS 99% OF GERMS”
The Safe4Hours website included the following statements about Safe4Hours Hand Sanitizing Lotion and its uses:
“Alcohol Free Hand Sanitizer Safe4Hours® Hand Sanitizer is effective against a broad spectrum softest pathogens, including MRSA.”
“Alcohol Free, Hand Sanitizer Safe4Hours® Hand Sanitizer is effective against a broad spectrum of test pathogens including the MRSA, E. Coli, and Staphylococcus aureus.”“Is Safe4Hours® Hand Sanitizer effective against MRSA?
Yes. We have tested Safe4hours Hand Sanitizer extensively and have shown the ability to kill and protect against MRSA.”“Is Safe4Hours® Hand Sanitizer effective against H1N1/Swine Flu?
Currently, no hand sanitizers are specifically designated to protect against H1N1. However the Centers for Disease control and Prevention (CDC) recommends products like Safe4Hours® Hand Sanitizer to help stop the spread of H1N1 when soap and water are unavailable … ”“Safe4Hours® Hand Sanitizer helps prevent Occupational Hand Disease (OHD) in environments where repetitive contact with water and detergents can damage skin, such as health care and food handling facilities.”
The FDA stated in the warning letter:
We are not aware of sufficient evidence demonstrating that this product is generally recognized as safe and effective as a topical antimicrobial that can prevent infection from E. coli, Methicillin Resistant Staphylococcus aureus (MRSA), Staphylococcus aureus; or prevent “Occupational Hand Disease;” or mitigate, prevent, treat or cure the H1N1 Flu Virus in people.
Safe4Hours First Aid Antiseptic Skin Protectant
Below are excerpts regarding Safe4Hours First Aid Antiseptic Skin Protectant found in the FDA warning letter.
The product labeling for Safe4Hours First Aid Antiseptic Skin Protectant represents the product as a combination topical skin protectant and first aid antiseptic, with the active ingredients allantoin 1% and triclosan 1%, respectively.
The product’s uses are described in the product name itself; Safe4Hours First Aid Antiseptic Skin Protectant, and the following statements on its label:
“Allantoin 1% Skin protectant
Triclosan 1% First aid antiseptic”“Uses first aid to help prevent infection in minor: cuts scrapes bums”
“Uses skin protectant…helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin…helps prevent and protect from drying effects of wind and cold weather”
“Long-Lasting POWERFUL ANTISEPTIC AND SOOTHING ANTIBACTERIAL SKIN PROTECTANT IN ONE”
“Patented technology forms a long-lasting protective barrier on skin”
The Safe4Hours website includes the following statements about Safe4Hours First Aid Antiseptic Skin Protectant and its uses:
“Safe4Hours® is effective against a broad spectrum of pathogens, including MRSA.”
“How can I protect myself from MRSA… Treat any open wound immediately apply Safe4Hours® First Aid Antiseptic Skin Protectant as quickly as possible. We recommend that you re-apply Safe4Hours® First Aid Antiseptic Skin Protectant 3 times daily or as necessary.”
Furthermore, we are not aware of sufficient evidence that shows this product is generally recognized as safe and effective as a topical skin protectant and first aid antiseptic for preventing infection from Methicillin Resistant Staphylococcus aureus (MRSA).
Free Consultation Regarding a Safe4Hours Class Action Lawsuit
Attorneys Fred Pritzker and David Szerlag are heading up our investigation of a Safe4Hours class action lawsuit against JD Nelson under federal laws prohibiting false advertising. The company advertised that Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant protect against dangerous infections, such as MRSA. According to the FDA warning letter, the FDA does not have sufficient evidence that the hand sanitizer and antiseptic products protect against Methicillin Resistant Staphylococcus aureus (MRSA. To contact our attorneys about a class action lawsuit, call 1-888-377-8900 toll free or submit our online form for a free consultation.
StaphAseptic Class Action Lawsuit against Tec Laboratories
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.
Free consultation with an attorney regarding a StaphAseptic class action lawsuit >>>
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).
