FDA Bans Use of 19 Chemicals in Antibacterial Soaps citing lack of effectiveness.
We reported last week on the ruling by the FDA to ban some common anti-bacterial ingredients like Tricolsan. In this weeks Sales Blast we give you a further deep dive into the ruling and what it effects and what it does not.
The U.S. Food and Drug Administration (FDA) has issued a final ruling banning the use of certain chemicals in consumer antibacterial soaps and body washes.
The FDA’s ruling restricts the use of one or more of 19 specific active ingredients, including triclosan, from use in soaps and washes. Through its research, the FDA has found the banned chemicals are not proven to be safe or effective for long-term daily use.
The active ingredients proposed to be ineligible in the 2013 Consumer Wash PR were:
Alcohol (ethyl alcohol)
Benzalkonium cetyl phosphate
Tea tree oil
Combination of potassium vegetable oil solution,
phosphate sequestering agent, and triethanolamine
"Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in a written announcement.
In response to several comments submitted to the 2013 Consumer Wash PR, FDA has deferred further rulemaking on three specific active ingredients used in OTC consumer antiseptic wash products to allow for the development and submission of new safety and effectiveness data to the record for these ingredients. The deferred active ingredients are benzalkonium chloride, benzethonium chloride, and chloroxylenol (PCMX). Drug products containing these active ingredients are new drugs that will require FDA approval.
Benzethonium chloride is the active ingredient in our RX200 Non Alcohol Hand Sanitizer and it not effected by this change. PCMX is used in our Creamedic also not effected by this change.
Bullen stopped the manufacture of soap products with Tri-closan years ago.
For the full document go to: https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-21337.pdf
For all of the links to past SSB articles you can go to: http://del.icio.us/jancast or past SSB's go to: http://www.bullenonline.com/bullen-blog/
Have a great day and an even better sales week!