2017-04

COMPANIES JOIN TOGETHER TO FUND PRESERVATIVE RESEARCH

HAPPI: April 2017

The Green Chemistry & Commerce Council (GC3) and InnoCentive will launch a global competition to identify and award prizes to innovators with promising, safe and effective preservative systems for cosmetics, personal care and household products.  A prize pool of $175,000 is available. 

The competition is sponsored by 10 consumer product companies, two major retailers, four chemical suppliers, an NGO and a government agency: Babyganics, Beautycounter, Beiersdorf, Colgate-Palmolive, Johnson & Johnson (J&J), Method – People Against Dirty, Procter & Gamble (P&G), Reckitt Benckiser (RB), SC Johnson, Unilever, Target, Walmart, Dow Microbial Control, Lonza, Schülke, Thor, Environmental Defense Fund and the Minnesota Pollution Control Agency.  The corporations sponsoring the competition seek to partner with innovators to co-develop, license or invest in new technologies to speed them to market.

Preservatives are substances that are added to products to retard microbial growth, prevent product degradation, and protect consumer safety. In addition to being used in foods, preservatives are added to household and personal care products, ranging from shampoos, hand creams, and laundry detergents.

Due to concerns about the safety of some preservatives that have been in wide use and the potential impact of repeated contact with these chemicals on human health, the sponsors desire new and effective preservatives or preservative boosters with improved environmental health and safety profiles for use in cosmetics, personal care and household products. This competition will award cash prizes from the $175,000 prize pool, with a minimum single prize award of $25,000.  The sponsors seek submissions for broad spectrum or single action chemical agents that are effective on gram-positive bacteria, gram-negative bacteria, yeast, and mold; preservative boosters and multi-functional ingredients that have a primary non-preserving function, yet enhance antimicrobial efficacy.

Up to five finalists will be invited to present their technologies at a meeting in the first quarter of 2018 in the U.S. and to network with representatives from consumer product companies, major retailers, and preservative suppliers.

All innovators who submit to this competition will gain significant visibility and receive feedback on their technologies. An innovator does not have to be a finalist in order to be afforded these opportunities. More info: www.greenchemistryandcommerce.org 

LONZA PRESENTED EMULSIFIERS AND PRESERVATIVES AT INCOSMETICS

Press Release: April 2017

Lonza Consumer Care will highlight how customers can create robust personal care formulations through their preservation portfolio, based on world-leading microbiology capabilities. Lonza will also demonstrate how its formulation-essentials tool box can help enhance the appearance and functionality of the final product. Of particular interest is Lonza's Polyaldo® polyglyceryl esters range, which include proprietary, versatile, naturally derived alternatives that can be customized to suit the formulation needs of the global personal care market.

To demonstrate the versatility of the Polyaldo® range, the company will showcase five new prototype formulations plus the excellent foam properties of Polyaldo® 10-1-CC polyglyceryl ester at its in-booth Inspiration Station. Polyaldo® 10-1-CC offers excellent foam generation while maintaining mildness and is designed for personal care surfactant cleansing systems such as baby shampoos, hand washes and facial cleaners.

Known for its leadership in the global preservation market, Lonza will highlight its advocacy and protection of current technologies, plus its investments in innovation to ensure that the broadest "palette of preservatives" remains available to the broadest array of formulators.

“The risks of not adapting to a changing marketplace are significant,” said Phil Hindley, Lonza Global Marketing Manager, Preservation. “One ultimate scenario is that this ‘palette’ becomes too limited and does not offer the breadth of choice and cost-in-use performance that the market demands.”

CVS TO REMOVE CHEMICALS FROM BEAUTY PRODUCTS

HAPPI: April 2017

The latest news at CVS is the removal of some chemicals from beauty products. Parabens, phthalates and the most prevalent formaldehyde donors will be removed across nearly 600 beauty and personal care products from its store brand CVS Health, Beauty 360, Essence of Beauty and Blade product lines.

According to the company, as part of its ongoing commitment to wellness, CVS Pharmacy will stop shipping products that don’t meet these standards to distribution centers by the end of 2019.

The exclusive to CVS Promise Organic range of products also does not contain any of these ingredients and existing products such as Beauty360 Facial Cleansing Cloths and Beauty360 No Light Gel Nail Polish are free from these chemicals as well. Products such as Beauty360 All-in-One Micellar Cleansing Water, Beauty360 Deep Cleansing Charcoal Bar and more will be included in this healthy beauty initiative. Additionally, CVS Pharmacy has published its full list of restricted chemicals by product category on CVSHealth.com.

CLEANING UP MISCONCEPTIONS ON ANTIBACTERIAL SOAP

HAPPI: April 2017

Portions of the “Defining Clean Skin” article need clarification, specifically in reference to its descriptions of Food and Drug Administration (FDA) policies governing antibacterial soaps and the science behind product and ingredient safety.

First off, the FDA did not issue a “ruling” directing the public to skip using antibacterial soaps. In September 2016, the agency did issue a final rule governing particular active ingredients that can be used in consumer antibacterial soaps and washes. The author of “Defining Clean Skin” makes reference to research questioning antimicrobial ingredient safety and efficacy.

Manufacturers stand behind the product science, research and data submitted over several decades to FDA Based on the newest understanding of the science and how the products are used, the industry was asked to undertake new studies. The data gaps identified by FDA are recent.

A Detailed Plan

Nonetheless, the American Cleaning Institute has laid out a detailed work plan on additional safety and efficacy data for the three major ingredients used in consumer antibacterial soaps that aligns with FDA’s requests. Additional data will be submitted for other ingredients used in healthcare antiseptic products, consumer hand sanitizers, and food handler antiseptics that are covered under upcoming regulations.

The author spends a great deal of time questioning the safety of the antibacterial ingredient triclosan. While triclosan did have a four-decade history of safe and effective use—backed by science—many manufacturers of consumer hand washes have already transitioned to the other major ingredients referenced above: benzalkonium chloride, benzethonium chloride and chloroxylenol. As we have written, what’s most unfortunate about FDA’s recent activity was the highly charged public statements by FDA staff that claimed using antibacterial soaps “may do more harm than good over the long-term,” particularly in trying to tie every-day use of these products to the issue of antibiotic resistance.

A 2011 study, published in the peer-reviewed International Journal of Microbiology Research, compared the use of over-the-counter antibacterial liquid hand and body cleansers and antibacterial bar soaps against the use of non-antibacterial cleansers. Lead author Dr. Eugene Cole, who has spent 40 years in the field of environmental health research, said the study refutes claims that the use of antibacterial wash products have contributed to the selection and spread of drug-resistant bacteria on human skin.

It is important for the American public—and industry consultants—to know that manufacturers are complying with the FDA data requests, as laid out by FDA itself. It is an agency-defined road map to certainty about the safety and efficacy of antibacterial soaps and washes. The formal rulemaking is clear on this. We believe that consumers and commercial customers can continue to use antibacterial soaps with confidence as they have for decades in millions of homes, offices, schools, daycare centers and other office settings.

It is critical that discussions around the research, safety and access to antibacterial products be fully informed so that future regulations are sound and science-based. 

REUTERS REPORTS CHLORHEXIDNE USAGE LINKED TO INDUSTRY FUNDING

Infection Control: April 2017

The news service Reuters is reporting on relationships between industry and researchers in the infection control space, relating to ties that "have helped propel the popularity of chlorhexidine products in hospitals and other healthcare settings where drug-resistant superbugs are a chronic problem," the article says. The authors of the investigative piece continue, "In 2014, 63 percent of hospitals surveyed by the federal Centers for Disease Control and Prevention (CDC) said they routinely bathed patients with chlorhexidine. But as use of chlorhexidine products has grown, so have concerns about their effectiveness and safety — and about the role of industry-backed research in promoting them. The industry money funding chlorhexidine research muddies the message of the results, in the view of many health experts

Sage Products has been generous to science, and science has been kind to Sage Products.

This happy relationship blossomed more than a decade ago, when Sage funded a study at Rush University Medical Center in Chicago to test the efficacy of the company’s new antibacterial wipes on hospital patients.

Researchers published their findings in 2006: Used daily, they said, Sage’s wipes, soaked with  chlorhexidine, were more than twice as effective as sponge baths at preventing the spread of vancomycin-resistant Enterococcus. That’s a group of drug-resistant bacteria that infect thousands of hospital patients every year, killing hundreds.

Shortly after, Rush received a $1 million donation from the family foundation of Sage’s founder, Vincent W. Foglia. The money was earmarked for research by the senior scientist on the study, Dr Robert A. Weinstein, an infectious-disease specialist at Rush.

Since then, Sage has provided funding and millions of dollars in wipes for studies by Weinstein and his colleagues. And in that time, Weinstein and his colleagues have published 11 articles on six trials that endorse daily washing of patients with Sage’s patented wipes — an “off-label” use, as the U.S. Food and Drug Administration (FDA) has approved the wipes only for cleaning patients before surgery.

Europe has been faster to recognise chlorhexidine’s potential risks. Studies from the region single out potentially fatal allergic reactions to the chemical as a serious, under-reported threat.

Britain’s Medicines & Healthcare Products Regulatory Agency issued a warning about the dangerous reactions, called anaphylaxis, in 2012. The number of adverse events related to chlorhexidine reported to the agency increased from 14 in 2007 to 117 in 2016.

In the United States, the FDA’s chlorhexidine warning in February came after a similar spike in incidents reported to the agency’s Federal Adverse Event Reporting System. Under the system, drug manufacturers are required to report when their products are suspected of causing illness or injury.

A Reuters analysis of FDA data found that chlorhexidine was listed as the primary suspect in an average of 85 adverse events a year reported from 2007 through 2014. Then, in 2015, the number jumped to 183, and then to 226 in 2016. The FDA said that a reported event is not necessarily due to the product, and that the agency does not receive reports for every adverse event that occurs.

Anaphylaxis or shock was cited in the FDA’s adverse event reports 120 times. Skin irritation, rashes and burns were mentioned 325 times. The tally included 48 life-threatening events and seven deaths.

About a third of the serious allergic reactions were attributed to ChloraPrep, a pre-surgical chlorhexidine applicator previously marketed by CareFusion and now by Becton, Dickinson & Co.

A spokesman for BD, which acquired CareFusion for $12.2 billion in 2015, said in an email that adverse events like anaphylaxis are “rare occurrences” compared to the “BILLIONS of uses” of the product since it entered the market in 2000.

In 2014, the U.S. Justice Department announced that CareFusion had paid $40.1 million to settle allegations that it gave $11 million in kickbacks to Dr Charles Denham to promote its ChloraPrep applicator. The company admitted no liability.

The investigation of CareFusion included allegations that the company generated “enormous growth” in sales by illegally marketing ChloraPrep as a product that could prevent infections, federal records say. The FDA-approved label says only that ChloraPrep reduces the number of bacteria present, not the number of infections.

The BD spokesman said the company acquired CareFusion in 2015, after the settlements. “CareFusion took great care to address the potential concerns raised in the settlement and this continues at BD,” he said.

In response to the FDA’s new guidance on chlorhexidine, Sage will add an allergy warning to labels on its wipes, according to a spokeswoman for Stryker Corp, which acquired Sage Products last year in a deal valuing the company at $2.78 billion. Stryker does not break out Sage’s sales. It told analysts this year that it expects Sage to continue to show exponential sales growth.

Products like chlorhexidine wipes are big business. Global sales of antiseptics and disinfectants were an estimated $5.6 billion in 2015, according to BCC Research. And the total is projected to grow about 40 percent to $7.9 billion by 2020.

The FDA approved the wipes only for cleansing skin before surgery. Sage is prohibited from marketing them for off-label uses, including universal daily bathing. It’s even required to include a warning on the product label against using the cloths as a “general skin cleanser.”

However, Sage is not prohibited from informing medical professionals of scientific studies that tout the virtues of its wipes for off-label uses, leaving it up to the customer to decide whether or not to use them.

In Europe, healthcare providers place greater emphasis on basic infection-control measures like consistent hand-washing and stringent housekeeping. That behavioural approach recently received dramatic support from a U.S. Veterans Administration initiative paid for with federal funds.

Since 2007, the agency has combined active surveillance of patients for MRSA and strict staff adherence to basic infection-control protocols throughout the VA healthcare system. In January, the agency published a study showing an 80 percent drop in MRSA infections systemwide since the program began.

“The reason we’ve had the success we’ve had is because everybody’s engaged,” said Dr Martin E. Evans, lead author of the study. “Even though it’s more work and more expense, it’s a benefit to the patients.”

Weinstein, the Rush infectious-disease specialist who received Sage support, dismissed the criticisms of the “REDUCE MRSA” study. Plenty of studies show chlorhexidine works, and millions of people are benefiting from reduced risk of infection, he said.

“As long as people are benefiting…you use it,” Weinstein said. “If resistance emerges, well, maybe there'll be a new product.”