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 proposed the 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.
"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," FDA Commissioner Scott Gottlieb, MD, said in a news release.
"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," Dr Gottlieb explained.
The FDA addressed consumer antiseptic washes in 2016, with a proposed rule in June 2016 and a final rule in September 2016.
"Ensuring the safety and effectiveness of over-the-counter health care antiseptics has been a priority for the FDA, not only because these products are an important component of infection control strategies in health care settings, but also because of the role these products may play in contributing to antimicrobial resistance if they're not manufactured or used appropriately," Dr Gottlieb said. "Health care providers are on the front lines of care. They need and deserve to have safe and effective means for preventing the spread of infection. That's why the FDA has been vigilant in seeking the data to support the continued use of 30 active ingredients used in over-the-counter (OTC) health care antiseptics."
Cite this: FDA Bans Triclosan, 23 Other Antiseptic Ingredients - Medscape - Dec 19, 2017.