Category Analysis: Antimicrobial

US Food and Drug Administration plans to determine the safety and effectiveness of antibacterial soaps are dominating discussion in the market

Antimicrobial and antibacterial is a category that is swathed in legislation, from justifying product claims to complying with the latest health and safety regulations.

That’s nothing new, but the past 12 months have brought about another headache for suppliers, with the US Food and Drug Administration (FDA) issuing a proposed rule to determine the safety and effectiveness of antibacterial soaps. In a statement on 16 December, the FDA said that the rule would require manufacturers of these hand soaps and bodywashes to “demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections”.

It went on to say: “If companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabelled to remain on the market.

“Although consumers generally view these products as effective tools to help prevent the spread of germs, there is currently no evidence that they are any more effective at preventing illness than washing with plain soap and water.”

Antibacterial review

The action is part of a larger, ongoing review of antibacterial active ingredients by the FDA to ensure these ingredients are proven to be safe and effective. 

FDA Center for Drug Evaluation and Research (CDER) Director Janet Woodcock says: “Antibacterial soaps and bodywashes are used widely and frequently by consumers in everyday home, work, school and public settings, where the risk of infection is relatively low. Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk.”

CDER Office of New Drugs Deputy Director Sandra Kweder adds: “While the FDA continues to collect additional information on antibacterial hand soaps and bodywashes, we encourage consumers to make an educated choice about what products they choose to use.”

This all sounds a little, well, federal. But as stated above, it’s an area where the next round of government legislation is never too far away.

This time the proposed legislation would mean manufacturers that want to continue marketing antibacterial products would be required to provide the FDA with additional data on the products’ safety and effectiveness, including data from clinical studies to demonstrate that these products are superior to non-antibacterial soaps in preventing human illness or reducing infection.

When the proposed rule is finalised, companies will have to supply data to support an antibacterial claim or, failing that, remove antibacterial active ingredients or the antibacterial claim from a product’s labelling in order to continue marketing it.

The proposed rule is available for public comment for 180 days, with a concurrent one-year period for companies to submit new data and information, followed by a 60-day rebuttal comment period.

Scientific evidence

Jeff Buysse, VP of Sales and Marketing, Channel Development at leading US manufacturer GOJO, notes: “The FDA has indicated that there is not enough scientific evidence today to show that antimicrobial handwashes used in consumer settings have an added benefit over plain non-antimicrobial handwashes. The proposed rule applies to antimicrobial handwashes used by consumers in residential and away-from-home settings. Healthcare and food industry settings are not included. The proposed rule also does not apply to hand sanitisers and sanitising wipes.”

The private company – which makes the Purell brand – says that demand for antimicrobial products remains strong, particularly in markets like healthcare, food processing and foodservice, where hand hygiene obviously plays a critical role.

Buysse adds that there are a number of key trends developing in the market: “In the office market, we see a number of trends. For several years we have seen product choices trending toward foam soap dispensers, and we see that continuing into the future. Touch-free dispensers are gaining in popularity because the technology continues to advance, and the systems we sell today are quite different from the ones sold ten years ago. We have made significant progress, enabling us to offer lifetime performance guarantees because the technology is much better. Additionally, we see more offices providing hand sanitisers than ever before. There’s a real benefit to businesses in reducing the spread of illness to help keep their workforces healthy.”

Another legislative issue to be aware of is the United Nations’ Globally Harmonised System on the classification, labelling and packaging of chemicals (or GHS, for short). New rules are set to apply in full in the European Union from June 2015 and in the US six months later as part of a worldwide implementation of GHS.

Packaging rules

AF International parent company HK Wentworth has an employee working full time on legislative compliance and has already changed the packaging on its Electrolube industrial products in line with GHS requirements, with AF packaging being updated this year. 

“These regulations are onerous and require a certain level of expertise,” states Group Managing Director Ron Jakeman. “GHS is certainly an issue for private label brand owners, and we are seeing them turning back to established brands in the market because of it.” 

Colop’s range of stamps that are antibacterial-protected continues to benefit from the recognisable and reputable Microban brand partner. In particular, it has seen increased interest from the areas of healthcare, government, tourism and education.

Interestingly, the company says it has enjoyed notable success in the US where its Microban-protected stamps have been very successful in sales through Cosco.

Franz Ratzenberger, Colop Sales and Marketing Director, says: “Some markets are more difficult than others, but we are winning market share and for Colop the last year was very successful. We see general positive signs in the office products industry.”

Office channel demand 

Indeed, Ratzenberger adds that the office channel is driving increased demand for Colop products featuring antibacterial protection. He says: “Health and hygiene plays an increasingly important role in the office. The demand for office and stationery products with antibacterial protection is growing and growing.”

At ITW Professional Brands, the feeling is very much the same with Product Manager Cesar Vargas noticing “an increase in awareness from customers and the public on infection control, which consequently will lead to growth in the office supply channel and schools”.

In terms of all those regulations (with more to come), Ratzenberger says Colop’s worldwide sales network observes each country’s regulations very closely but adds that “it would be helpful if some other brands in the office product industry would join this exciting path”. 

For its part, GOJO has a regulatory team that focuses on ensuring its products meet the regulatory requirements of the markets they serve, considering both the business segment and the geographic location. This helps to ensure that they meet requirements at a federal, state and local level.   

Buysse explains: “GOJO has teams that focus exclusively on specific market segments. This market focus allows us to achieve a high level of intimacy with the people making hand hygiene product decisions, along with any health, safety or hygiene regulations that need to be addressed.”

For European manufacturer T3L Group, the last 12 months have seen “significant growth” for its antibacterial products, particularly in the US and the Scandinavian countries, although Group Marketing Manager Benjamin Baruteaud says the market is waiting for the next phase of these products.

He explains: “Now that the first step has been made by introducing antibacterial products into the OP market, new developments have to be made.”

But Baruteaud firmly believes that hygiene products will play an important role in a market that is evolving due to new regulations and changing attitudes from end users, while the workplace demand for greater efficiency will mean more emphasis on creating better working environments.

He explains: “The lines between workplace and home are becoming more blurred and companies will invest more on well-being at work to make sure that employees are in the best condition to deliver their output. Therefore, it is a great opportunity for antibacterial products as they help to create a healthy workplace.”

Clearly, the past 12 months have been dominated by the FDA’s proposed new ruling on the safety and effectiveness of antibacterial soaps. 

However, while there’s no doubt that these plans have caused a stir in the antibacterial and antimicrobial market, in the long run this is likely to really  prove a win-win situation. After all, consumer confidence is all-important in what is becoming an important adjacent category for many OP resellers.