FDA Creates Media Frenzy!

FDAMainstream media has highlighted the FDA’s newly proposed amendment regarding the safety and effectiveness of consumer topical antiseptics found in antibacterial hand soaps and body washes.

The proposed  Amendment?

  • Includes Over the Counter (OTC) Consumer Antiseptics/Antimicrobial Drug products and all active ingredients (including Triclosan)  for use with water
  • Excludes products alcohol-based instant hand sanitizers
  • Excludes antiseptic products used by medical professionals

At this point, the ruling does not require any immediate action from manufacturers. Historically, the FDA’s decision process in evaluating these types of products takes years to finalize.

If and when the proposed amendment is finalized, manufacturers will need to provide additional data in order to support product efficacy and safety. This requires testing to support a reduction in bacteria on the skin, a clinical reduction of infection and increased emphasis on safety and toxicity during repeated daily use.

Betco Corporation®  understands the importance of manufacturing skin care products that are safe and effective.  We are actively investigating the impact this proposed new amendment will have on our skin care products and will do our due diligence to ensure our compliance to the agency’s recommendations.

For more information on this proposal, follow the link below:

https://s3.amazonaws.com/public-inspection.federalregister.gov/2013-29814.pdf

Krysten Comperchio_jpgKrysten Comperchio is a Product Manager for Skin Care and Education at Betco Corporation. During her spare time, Krysten enjoys yoga, running and keeping up on current events. Click here to contact Krysten directly.

Leave a Reply

Your email address will not be published. Required fields are marked *

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>