FDA Chemical Regulation: Anti-Anti-Bacterials?
Earlier this month, the Food and Drug Administration (FDA) banned 19 chemicals found in antibacterial hand and body washes. Included in this list is triclosan, a widely used ingredient in antibacterial soap.
The FDA’s new rule has been in the works for nearly four decades. The FDA proposed its first triclosan regulation in 1978 but never moved forward. Then, in 2013, the FDA called for a re-evaluation of over-the-counter antibacterial products. It asked companies to conduct additional studies and provide information on the safety and effectiveness of their antibacterial products containing any of one of 22 different ingredients. That 2013 call to action resulted in the current rule. Manufacturers have one year to reformulate their products to remove the banned chemicals.
The FDA leveled the ban without determining that triclosan is dangerous. Rather, it stated that it had not received sufficient information to allow for the continued sale and marketing of antibacterial soaps containing triclosan.
Triclosan was originally developed in the 1960s to help combat bacterial infections in hospitals and for use by surgeons when “scrubbing in” for surgery. Companies soon used triclosan in consumer products, including soap, toothpaste, mouthwashes, baby pacifiers, kitchen utensils, and fabrics, both because of its effectiveness and growing concerns about bacteria.
Concerns about triclosan grew in the last few years when studies indicated that triclosan can disrupt animal hormone cycles and cause muscle weakness in humans and animals. Doctors have also posited that the use of antibacterial soaps and washes may lead to the growth and creation of more antibiotic-resistant bacteria.
The current ban may affect around 2,100 different products, and responses have been varied. Some companies began phasing out triclosan in antibacterial products when the FDA inquiry began. Others stand behind their product. Colgate, for example, sells the only triclosan-containing toothpaste in the U.S. (Colgate Total), and identifies many reasons for its decision:
The ban is currently based on inadequate information regarding antibacterial products, not conclusive evidence as to lack of safety or effectiveness;
Industry testing of triclosan, indicating the safety of triclosan in toothpaste, is more rigorous than the FDA’s study and has been confirmed by independent studies; and
The new ban targets only antibacterial soaps, not any other products containing triclosan or any of the other 19 chemicals.
What’s next from the FDA is unclear. Critics complain that it takes the FDA too long to issue rules. In fact, the FDA deferred rulemaking on three other antibacterial ingredients that were part of the original list of 22 (benzalkonium chloride, benzethonium chloride; and chloroxylenon (PCMX)). But the agency has signaled that it is moving faster and that this ban may be just the start of its campaign to “clean up” the antibacterial market. For example, it has already asked manufacturers to provide more information for three active ingredients in hand sanitizers: alcohol (ethanol or ethyl alcohol), isopropyl alcohol, and benzalkonium chloride.