FDA Rule Marks Consumer Antibacterial Soaps An Endangered Category

FDA’s final rule “clarifies the mission” for manufacturers of consumer antibacterial soaps, which have a year to demonstrate that benzalkonium chloride, benzethonium chloride and chloroxylenol are safe and effective or risk losing the entire OTC drug category. The rule bars firms from marketing consumer antiseptic wash products containing triclosan, triclocarban and 17 other lesser-used active ingredients.

Industry may have known which way the wind was blowing for triclosan and triclobarban use in OTC consumer antibacterial soaps, but now the pressure is on to demonstrate the safety and efficacy of three remaining active ingredients lest FDA effectively close down the entire category.

The agency released a final rule Sept. 2 establishing 19 active ingredients as not generally recognized as safe and effective for use in consumer antiseptic wash products – those used with water and rinsed off, including hand and body washes – which removes them from the agency’s tentative final monograph.

The list’s inclusion of triclosan and triclocarban – used in antibacterial liquid and bar soaps, respectively – is likely to have the biggest market impact.

“Our concern all along has been that if FDA continues on this path or mindset, they could effectively ban or limit consumer access” to consumer antibacterial soaps altogether, Sansoni said.

However, the American Cleaning Institute’s Brian Sansoni, VP of communication and membership, says companies generally have been transitioning away from the ingredients’ use in recent years and that FDA overstated the immediate impact of the final rule on the marketplace in its same-day media briefing (Also see "FDA: ‘Vast Majority’ Of Antibac Soaps Need Reformulation Under Final Rule" - HBW Insight, 2 Sep, 2016.).

According to the exec, the other 17 ingredients struck from FDA’s TFM “haven’t been used by mainstream manufacturers for years and years.” He characterized them as leftovers from the era when FDA’s TFM first issued in 1978.

All 19 ingredients must be phased out over the next year – by Sept. 6, 2017 – and antibacterial soaps relying on them must be reformulated and relabeled without antibacterial claims.

According to Sansoni, most consumer antibacterial soaps now feature one of the three ingredients still pending under FDA’s deferred rulemaking specific to their use – namely, benzalkonium chloride, benzethonium chloride and chloroxylenol (PCMX).

Industry now has one year to provide FDA with compelling data backing the substances’ capacity for safe and effective use in the category. Sansoni said industry already has delivered strong study data to the agency and will be submitting more over the next 12 months (Also see "Industry Groups Seek Meeting With FDA On Antibacterial Ingredient Studies" - HBW Insight, 8 Jan, 2015.).

The concern at this point is that the entire category of OTC antibacterial soaps could be targeted for elimination from store shelves, which would deal a significant blow to industry and prevent consumer access to popular products that many believe are critical to public health.

“Our concern all along has been that if FDA continues on this path or mindset against the category of products, they could effectively ban or limit consumer access,” Sansoni noted.

Industry stands behind its position that triclosan- and triclocarban-containing soaps are safe and effective, as demonstrated by decades of consumer use, but FDA’s final rule “certainly clarifies the mission,” the exec said. Industry’s focus at this point is squarely on the three active ingredients that remain in question.

Illness Prevention Data Needed

The task before industry is daunting, and visibility is low into how FDA will receive the data coming its way.

Sansoni noted that when FDA proposed amending its TFM in late 2013 to remove antimicrobial ingredients that lack sufficient evidence of safety and efficacy, it “moved the goalposts” in terms of the type of data needed to demonstrate GRASE.

In particular, the agency indicated that studies linking antimicrobial actives to greater reductions in bacteria counts compared with plain soap and water – which industry has argued demonstrate their superior germ-killing potential – are inadequate to show efficacy.

FDA holds that studies also must demonstrate that antibacterial soaps are more effective at preventing illness and the spread of infection – a highly challenging endpoint to verify through clinical trials or other controlled studies.

“It’s a whole new landscape that manufacturers have had to deal with,” Sansoni said. He went on to note the myriad variables that can complicate an assessment of antibacterial products’ ability to defend against illness or infection.

“Consumers use these products in every conceivable location, whether it’s in the home or offices or daycare centers or schools, and they’re interacting with so much in their daily lives, doing literally a million different things – at home, on the way to work, touching things in the subway, going to the office.”

It’s “incredibly difficult” to determine the role that antibacterial soaps play in disease prevention amid this complexity of factors, with so many opportunities for consumers to come into contact with infectious bacteria, he suggested.

Michele urged industry stakeholders to submit progress reports to FDA regarding ongoing studies on the three outstanding antimicrobial ingredients before February 2017, "at which point we'll reassess timing for a GRASE determination and further rulemaking for these ingredients,” she said.

She noted that FDA’s New Drug Application route is an alternative avenue outside of the OTC monograph system for pursuing use of the non-GRASE ingredients in consumer antibacterial soaps.

Antibac Rubs Decision Still To Come

FDA also is reassessing the GRASE status of active ingredients in consumer antiseptic rubs – including hand sanitizers and wipes – under a separate proposed rule issued at the end of June, which gave stakeholders one year to present data supporting continued use (Also see "The 'Rub' On Leave-On Consumer Antiseptics: FDA Seeks Safety, Efficacy Data" - HBW Insight, 20 Jul, 2016.).

Antiseptics used in healthcare settings also are under review.

While FDA says finalization of its proposed TFM for OTC antimicrobial drug products has been a priority since its publication almost 40 years ago, the agency’s work on the issue was spurred by a 2013 consent decree that settled a suit brought by the National Resources Defense Council.

The agreement set deadlines for FDA final rules across the product categories into which the TFM has been divided in recent years. FDA committed to issuing the final rule on consumer antibacterial soaps by Sept. 15.

FDA’s final rules on consumer antiseptic rubs and healthcare antiseptics are due by April 15, 2019 and Jan. 15, 2018, respectively.

ACI also has provided and is in the process of submitting more data to FDA to support the safe and effective use of antimicrobial ingredients in those categories, Sansoni said.

NRDC’s mission in filing the suit that got the ball rolling was primarily to get a decision on triclosan, which NGOs have attacked due to research linking the ingredient to endocrine disruption, bacterial resistance and other health concerns.

Personal-care firms have been eliminating the ingredient from products in response to consumer demand, if not regulatory and NGO pressures.

Procter & Gamble Co. announced in 2013 that it would discontinue use of triclosan due to concerns about its efficacy relative to regular soap (Also see "P&G: Consumer Feedback, Safety Perceptions Behind Ingredient Removal" - HBW Insight, 30 Sep, 2013.). According to P&G’s sustainability webpages, the firm has eliminated the ingredient from more than 99% of its products and has “an exit plan for the few remaining uses.”

In 2012, Johnson & Johnson similarly pledged to rid its products of triclosan, despite its “long and extensive history of safe use,” by 2015 (Also see "J&J To Remove Formaldehyde, Other Concerns From Personal-Care Items" - HBW Insight, 20 Aug, 2012.). J&J indicates on its website that it has followed through on the commitment.

The Colgate-Palmolive Company (Softsoap), Henkel AG (Dial) and Unilever PLC (Lever) are among firms with stakes in the consumer antibacterial soap market.