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.
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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.
Tags: CleanWell class action lawsuit, Hand Sanitizer Class Action Lawsuit
