FDA Bans Triclosan From Over-the-Counter Antibacterial Hand and Body Washes

Personal care products, salts, shampoo and conditionersTriclosan Banned from Consumer Hygiene Products

Antimicrobials are chemical additives used for the preservation of products from microorganisms such as bacteria or fungi, and inhibition of cosmetic and hygiene issues created by the growth of these microorganisms.  There are many antimicrobial products registered for use in both industrial and consumer products.  Generally, their use and applicability is governed by both the governmental regulatory approvals, and their fitness for purpose in a particular application.

Triclosan is one of the most studied and recognized additives used for antimicrobial purposes in industrial and consumer products.  Its broad applicability includes use in liquid formulations as a preservative such as in shampoo, as well as body solutions in personal care products. It is also used in durable products such as textiles, coatings, resins, and even composite stone (resine and stone) counter tops.

Triclosan belongs to a large class of antimicrobials containing a phenolic ring as its chemical backbone.  This type of chemistry is more specifically known as bisphenol or estrified phenol molecules.  Like many phenolic based antimicrobials, it is highly stable and has relatively poor water solubility.

The usefulness of this additive is in part derived from these chemical features.  Its stability allows it to be used in relatively diverse environments such as high temperatures without it breaking down and becoming ineffective.  Low water solubility means that it can be used in water environments, without it being too mobile to maintain good durability.  By contrast due to low water solubility, aqueous formulations lacking surfactant type stabilizers are typically not appropriate for its use.

FDA Ban In September, 2016, the Food and Drug Administration released an announcement that it would no longer permit the use of triclosan  and 19 other active ingredients in antibacterial hand and body washes.  The rule only applies to consumer products and does not affect hand sanitizers or antimicrobials used in health care settings. The FDA stated that, “for these ingredients, either no additional data were submitted or the data and information that were submitted were not sufficient for the agency to find that these ingredients are Generally Recognized as Safe and Effective.”

Dangers of long-term exposure to triclosan poses a variety of health risks. Studies have shown possible hormonal effects, food allergies, and disruption of the gut micro biome as a result of long-term triclosan exposure.  Over-use of triclosan and other powerful antimicrobial agents may also cause increased bacterial resistance.  There are plenty of safe antimicrobial agents to use instead. The FDA states that hand-washing with regular soap and water is still the safest and most effective practice to reduce exposure to harmful microbes.

“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 Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”

ASTM ISO AATCC hygiene 2

Use in Industrial and Health Care Settings The FDA does not restrict the use of triclosan in industrial and health care settings.  These applications are considered less harmful to humans due to their limited exposure. Hand sanitizers, antimicrobial wipes, cleaning prodcts, and industrial products may still employ the use of triclosan.


Reference Articles

Shots: Health News from NPR. 2 September 2016. FDA Bans 19 Chemicals Used In Antibacterial Soaps. Kodjak A.

Food and Drug Administration> Press Announcements. 2 September 2016. FDA issues final rule on safety and effectiveness of antibacterial soaps.

Dermal exposure to the antimicrobial triclosan affects the gut microbiome and augments Th2 allergic responses mediated through Toll-like receptor 4.Marshall NLukomska E, Long C, Anderson S.

Clinical and Translational Allergy20166:13.  Published: 5 April 2016. Triclosan promotes epicutaneous sensitization to peanut in mice. Tobar S Tordesillas L, Berin M. DOI: 10.1186/s13601-016-0102-2

PLoS ONE 11(5): e0154632. Published: May 18, 2016. Triclosan Exposure Is Associated with Rapid Restructuring of the Microbiome in Adult Zebrafish. Gaulke C, Barton C, Proffitt S, Tanguay R, Sharpton, T.  doi:10.1371/journal.pone.0154632.

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