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FDA Bans Antibacterial Soaps; "No Scientific Evidence" They're Safe, Effective

posted by martyb on Saturday September 03 2016, @07:11AM   
from the washing-their-hands-of-it dept.

DeathMonkey writes:

In a final ruling announced Friday, the Food and Drug Administration is pulling from the market a wide range of antimicrobial soaps after manufacturers failed to show that the soaps are both safe and more effective than plain soap. The federal flushing applies to any hand soap or antiseptic wash product that has one or more of 19 specific chemicals in them, including the common triclosan (found in antibacterial hand soap) and triclocarbon (found in bar soaps). Manufacturers will have one year to either reformulate their products or pull them from the market entirely.

[...] The ruling does not affect alcohol-based hand sanitizers or wipes, which the agency is reviewing separately. It also does not affect antiseptic products used in healthcare settings.

http://arstechnica.com/science/2016/09/fda-bans-antibacterial-soaps-no-scientific-evidence-theyre-safe-effective/

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Original Submission

• uh oh uh oh (Score: 3, Informative) by takyon on Saturday September 03 2016, @07:26AM

  by takyon (881) <takyonNO@SPAMsoylentnews.org> on Saturday September 03 2016, @07:26AM (#396934) Journal

  https://en.wikipedia.org/wiki/Benzalkonium_chloride [wikipedia.org]

  In 2011, a large clinical trial designed to evaluate the efficacy of hand sanitizers based on different active ingredients in preventing virus transmission amongst schoolchildren was re-designed to exclude sanitizers based on benzalkonium chloride due to safety concerns.[17]

  Benzalkonium chloride has been in common use as a pharmaceutical preservative and antimicrobial since the 1940s. While early studies confirmed the corrosive and irritant properties of benzalkonium chloride, investigations into the adverse effects of, and disease states linked to, benzalkonium chloride have only surfaced during the past 30 years.

  Benzalkonium chloride is classed as a Category III antiseptic active ingredient by the United States Food and Drug Administration. Ingredients are categorised as Category III when "available data are insufficient to classify as safe and effective, and further testing is required”. Benzalkonium chloride is excluded from the current United States Food and Drug Administration review of the safety and effectiveness of consumer antiseptics and topical antimicrobial over-the-counter drug products, meaning it will remain a Category III ingredient.[18] There is acknowledgement that more data are required on its safety, efficacy and effectiveness, especially with relation to:

  • Human pharmacokinetic studies, including information on its metabolites
  • Studies on animal absorption, distribution, metabolism, and excretion
  • Data to help define the effect of formulation on dermal absorption
  • Carcinogenicity
  • Studies on developmental and reproductive toxicology
  • Potential hormonal effects
  • Assessment of the potential for development of bacterial resistance

  [...] Benzalkonium chloride is a human skin and severe eye irritant.[20] It is a suspected respiratory toxicant, immunotoxicant, gastrointestinal toxicant and neurotoxicant.[21][22][23]

  Benzalkonium chloride formulations for consumer use are dilute solutions. Concentrated solutions are toxic to humans, causing corrosion/irritation to the skin and mucosa, and death if taken internally in sufficient volumes. 0.1% is the maximum concentration of benzalkonium chloride that does not produce primary irritation on intact skin or act as a sensitizer.

  They went all the way to 0.13% with mine.

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• Re:uh oh (Score: 2) by frojack on Saturday September 03 2016, @04:25PM

  by frojack (1554) on Saturday September 03 2016, @04:25PM (#397056) Journal

  I have several giant bars of lye soap bought in Mexico....

    Rubber gloves are recommened.

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