FDA Bans Triclosan and 23 Other Antiseptics from Healthcare Products
By Heather Callaghan, Editor
Triclosan, and to a lesser extent, other antiseptics, have gone through a well-deserved pruning process with the FDA.
But it’s not quite over yet. In 2015, the FDA determined that anti-bacterial soaps were no more effective than regular soap. In fact, triclosan – the former active ingredient in many antibacterial products – required up to 9 hours to break down bacteria cell walls. However, the substance was corrosive to organs and linked to other serious health problems, putting the consumer, and especially the healthcare worker, at great personal risk.
In 2016, the FDA ordered antibacterials like triclosan out of soaps and gave companies one year to reformulate. Note: I’m still seeing antibacterial soaps for sale online with this ingredient for some reason. Most companies voluntarily removed it from soap, thanks to consumer health awareness. But the chemical remained in the healthcare field. In late 2017, the FDA issued a full-out ban on the marketing of OTC healthcare products containing triclosan and other antiseptics on their hit-list.
Despite triclosan being implicated in the rise of antibiotic-resistance and considered an environmental hazard – the chemical is still allegedly in toothpaste! The 2016 ruling only applied to soaps, not other products like shaving creams, cosmetics or oral products. So it doesn’t appear quite banished yet. But healthcare workers do have a reason to celebrate.
The US Food and Drug Administration (FDA) has finalized a rule that bans the marketing of over-the-counter (OTC) healthcare antiseptic products containing triclosan or any of 23 other active ingredients.
The FDA found that these ingredients are not generally recognized as safe and effective (GRASE), inasmuch as the companies that manufacture them have failed to provide additional safety and efficacy data. The FDA first proposedthe rule in 2015; affected products include hand washes and rubs, surgical hand scrubs and rubs, and patient antiseptic skin products.
Products containing these active ingredients must now undergo premarket review; the FDA will consider these products to be new drugs and will require manufacturers to gain approval through new drug applications.
The FDA is giving manufacturers 1 year to reformulate or remove these products from the market, although manufacturers have already stopped using many of these ingredients. This rule will not affect most healthcare antiseptics currently on the market. Triclosan is the only non-GRASE active ingredient being used in healthcare antiseptic products on the market today, according to a statement from the agency.
The FDA has deferred final rule-making for 1 year on the six most common active ingredients in OTC healthcare antiseptic products currently on the market. Those ingredients are alcohol (ethanol), isopropyl alcohol, povidone-iodine, benzalkonium chloride, benzethonium chloride, and chloroxylenol. The deferral, which is subject to renewal, will give manufacturers additional time to conduct safety and efficacy studies.
The final rule does not apply to healthcare antiseptics presently on the market under new drug applications and abbreviated new drug applications.
FDA Commissioner Scott Gottlieb, MD, said in a Dec 2017 news release:
This action only concerns OTC products that are commonly marketed to health care providers and used primarily in medical settings like hospitals, health care clinics, and doctors’ offices. We’ve determined that 24 ingredients, including triclosan, most of which were infrequently used, cannot be used in OTC health care antiseptics without pre-market review because there was a lack of sufficient safety and efficacy data.
But there’s a hitch…
However, it’s important to note that this action does not impact all health care antiseptic ingredients. Rather, given the public health importance of these products, the FDA is deferring final rulemaking on the six most commonly used ingredients while manufacturers collect the data needed to properly weigh their safety and efficacy. Manufacturers using these six active ingredients in OTC health care antiseptics have known since 2015 that the FDA sought additional information on these products. The FDA expects that this information may help better inform us on antiseptic resistance and antibiotic cross-resistance in the health care setting. Importantly, this doesn’t mean that products containing these six ingredients are ineffective or unsafe. These antiseptic products remain an important resource in health care settings. Personnel should continue to use these products consistent with infection control guidelines while the additional data are gathered.
Alternative health websites have jumped the gun a few times in recent years with the FDA’s rulings on triclosan. We all wanted to believe the chemical was outright banned, but that wasn’t the full story. Despite some of the loopholes available, it looks like triclosan is finally exiting stage left – at the very least it has seriously lost credibility in the eyes of public health.
The consumer should still be weary since triclosan could still be lurking in toothpaste and cosmetics (unregulated). Fortunately, this endocrine disrupting chemical will leave the body with discontinued use.
DISCLAIMER: This article is not intended to provide medical advice, diagnosis or treatment.
This article (FDA Bans Triclosan and 23 Other Antiseptics from Healthcare Products) was created by and appeared first at Natural Blaze. It can be reshared with attribution but MUST include link to homepage, bio, intact links and this message.
Heather Callaghan is an independent researcher, writer, speaker and food freedom activist. She is the Editor and co-founder of NaturalBlaze as well as a certified Self-Referencing IITM Practitioner.
Photo: by Jeff