Monday, April 25, 2011

FDA warns makers of hand sanitizers on false claims

The FDA sent warning letters to four manufacturers of over-the-counter hand sanitizer products that claim to prevent infection from MRSA, H1N1, and E. coli.  The FDA found insufficient data to support the claims made by these companies regarding their products and considers their labeling a violation of federal law.
The four companies and their products are:
  • Tec Laboratories for Staphaseptic First Aid Antiseptic/Pain Relieving Gel
  • JD Nelson and Associates for Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant
  • Dr. G.H. Tichenor Antiseptic Co. for Dr. Tichenor’s Antiseptic Gel
  • Oh So Clean, Inc dba CleanWell Company for CleanWell All-Natural Foaming Hand Sanitizer, CleanWell All-Natural Hand Sanitizer, CleanWell All-Natural Hand Sanitizing Wipes, and CleanWell All-Natural Antibacterial Foaming Handsoap
Major concerns cited in FDA's letters were:
1.  The manufacturer's claims about the effectiveness of the products fall under the FDA drug category.  FDA defines drugs as anything that cures, mitigates, treats or prevents disease. None of the products have been approved by FDA as drugs.
2.  Some products are defined as new drugs because the combination of ingredients included in the product do not match any similar product that has been approved by FDA as a drug.
3.  Several do not have sufficient details about the ingredients.  FDA requires that the name, quantity and proportion of each ingredient be listed on the label.  The lists must match all product marketing materials.
4.  One citation indicated that a product has a combination of ingredients that have not been tested by FDA in combination.  That is, each ingredient has been found safe alone but not in combination with other ingredients.  However, a troubling citation is a citation for a product that contains Triclosan.  Triclosan has not yet received FDA widespread approval for safety.  The other products contain ingredients that are probably harmless, if not effective, but this product may contain ingredients that are harmful.
5.  Three of the four manufacturers have been notified that they need to respond to the FDA within 15 days of the letter with plans to come into compliance.  In some cases, formal requests for FDA approval are necessary.  However, in others only re-labeling may be necessary.
6.  FDA has ordered the manufacturer of  CleanWell All Natural Foaming Hand Sanitizer to stop producing their product(s).  This company was cited in 2010 for FDA violations and their response has not been approved by FDA.  Their response included "technology" briefs intended to show scientific proof of efficacy.  These have been denied by FDA.  Finally, this company was cited for lack of quality control of the manufacturing process and states that the product may be subject to adulteration because of this.

 So what to look for in a sanitizer?  We recommend a sanitizer that contains at least 61% alcohol and has been approved by the FDA.  Also, look for sanitizers with lotion in them since alcohol alone makes the skin very dry.  

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