All Systems Go

By Christine Esposito, Associate Editor | September 28, 2012

Working with the right testing service provider can make all the difference in getting products to market faster and in compliance.

It seems like everyone from FDA to QVC to John Q. Public factors into how household and personal care companies test their products. Whether it is a new monograph or claims substantiation, a retailer-specific requirement or the need to adhere to consumers’ stance on sensitive subjects (like animal testing), companies must navigate through a wide range issues during the testing process.

It’s the ticket to entry into the highly competitive health and beauty sector, a category that’s moving at a faster clip than ever before.

“The home and beauty products industry has become increasingly competitive. Whether it is a current customer or prospective customer, all are under intense pressure to release products faster,” said Christine Kreitzer, director of home and beauty for Celsis, which specializes in rapid absence/presence microbial screening. “There’s a greater awareness of quality issues and getting safe products to market. Manufacturing puts pressure on the lab for micro/quality to release product faster. The lab managers we work with are keenly aware of the economic impact that long hold time can have.”

Celsis recently worked with an independent, high-end skin care company that tests its products at the raw material, in-process and finished goods stages. According to Kreitzer, by employing Celsis technology, the firm was able slash its cumulative hold time per lot from 18 to 10 days.

“Time was cut throughout the production process, and that offers significant cost savings for their entire supply chain,” she said.

Celsis’ clients include a number of Happi’s Top 50 and International Top 30 firms, including P&G, which recently implemented the Celsis ReACT molecular assay at its liquid detergent manufacturing sites worldwide. The two-hour ReACT test is being used as a follow-up to Celsis’ AKuScreen test (an adenylate kinase (AK)-based assay that generates definitive microbiological test results in less than 24 hours), which P&G, Unilever and others currently use as a primary screen for the release of their products.

Anything from a slow down in shipping due to wait time in microbial detection or inability to secure documentation for specific retailer debut (a primetime premier on QVC, for example) can affect a launch or shipment date for your products—and that translates into money left on the table, say testing experts.

“Clients are under huge constraints with regard to time and money,” said Dr. Robert Harper, president of Hill Top Research, a clinical research services company based in St. Petersburg, FL. According to Harper, his firm works with companies to try and “combine potential studies so that as many endpoints can be measured in one study instead of having to conduct two or three studies.”

Having a ‘Data’ Plan
At Happi’s First Annual Anti-Aging Conference & Tabletop Exhibition, which was held Sept. 18-19, 2012 in New Brunswick, NJ, several speakers touched on critical nature of testing in this category, which is pushing product performance to new levels.

While there are many tests companies can conduct to showcase an anti-aging product’s efficacy in tackling wrinkles, fine lines and age spots, claims experts at the conference said the key issue is compiling data that enables your firm to back product claims—any of which could be challenged by a competitor or regulatory bodies like the Federal Trade Commission or the FDA.

In fact, FDA recently warned Lancôme USA about claims that Genifique Repair cream could “boost the activity of genes” or “stimulate cell regeneration” to reduce signs of aging. On its website, Lancôme describes the Genifique Repair cream as “our first night care that boosts the activity of genes” and cites an in-vitro test on genes to back up the claim.

In its warning letter posted mid-September, FDA said that any product that is intended to affect the structure or function of the human body is classified as a drug. The FDA said failure to fix the advertising claims could lead to enforcement actions, such as seizure of the products and injunctions against their manufacturers and distributors.

Information Driven
“One issue that has surfaced recently for the large personal care companies is that the FDA is putting pressure on heretofore ‘personal care’ type studies to be conducted more like drug studies,” said Dr. Harper. According to Dr. Harper, Hill Top Research plans to have new testing facilities and equipment online in St. Petersburg by January 2013. With its partners in India, the Cliantha Group, Hill Top Research can offer clients new services with very competitive pricing.

“Because of our history, Hill Top is in a good position to help these companies because of our history with conducting studies following regulatory guidances,” he said.

Howard Kaminsky of cosmetic testing provider AMA Laboratories, New City, NY, reports that there has been an increase in what his firm describes as “special studies”—antiperspirants, hair and nails, wrinkle reduction, etc.—especially those that require photographic analysis/support.

Personal care marketers can employ AMA’s proprietary tool, PhotoMetrix, for those tests.

“More and more of our clients are requesting that AMA include this photographic substantiation with their studies,” he said.

Antimicrobial effectiveness testing (USP 51) or equivalent, Human Repeat Insult Patch (HRIP) testing and OTC sunscreen testing are trending higher in 2012, according to Bradford L. Rope, president of BioScreen Testing Services. Based in Torrance, CA, BioScreen has opened a new clinical facility in Los Angeles to handle demand for year-round clinical testing.

“There has also been an increase in testing requests for unwanted contaminates, such as phthalates, dioxane, formaldehyde and heavy metals,” said Rope. “This is driven by Proposition 65 in California and companies such as Whole Foods who want to make sure that companies do not have unwanted chemicals in the products they sell.”

According to Rope, some of the Proposition 65 chemicals need to be tested using the most sensitive instruments now available, and continued developments in the analytical instrumentation area is changing the testing requirements.

“Newer mass spectrometer instruments have more sensitivity than ever before and clients need to be aware of this issue. Additionally, new developments in HPLC to faster instruments allowing for more rapid test turn around are also changing the testing landscape,” said Rope. “The net effect of this is FDA and state regulators will set tighter limits on contaminants such as lead and clients will come to expect faster test turnaround times.”

The UVA Wave
There are tighter parameters in sunscreens too. The US FDA’s release in 2011 of a final rule on sunscreen caused a major uptick in requests to test UVA critical wavelength properties. (For more information on this test, see the sidebar.)

Testing providers noted the “mushrooming” in demand for UVA critical wavelength testing as numerous firms look to be in compliance with the new guideline, which FDA has since moved to mid-December of 2012.

This is a major change from previous requirements, which were for human testing rather than in vitro, according to Debra Harrison of Harrison Research Labs.

“UVA testing was not defined. Now the in vitro test is a requirement—and that’s a big change,” Harrison told Happi. A Union, NJ-based firm, Harrison Research Labs performs a full range of safety, efficacy and claim substantiation testing of cosmetics and toiletries including UV-B and UV-A SPF/PFA tests.

“We have seen a surge in sunscreen testing, as clients attempt to meet Final Rule compliance deadlines,” noted Bill Neumann, VP-quality assurance and regulatory affairs, Consumer Product Testing Company, Inc. (CPTC), Fairfield, NJ. According to Neumann, CPTC has made major investments in additional sunscreen testing and also diagnostic/calibration equipment for the photobiology lab.

Terry Harding, director of sales and marketing with Solar Light Company, Inc., Glenside, PA, said his firm was also anticipating the finalization and implementation of the FDA Final Rule.

“We are prepared with a broad range of equipment and sensors to meet the pending changes for sunscreen testing. We have broadened our materials testing capabilities with expanded controlled environment lab space for accelerated UV exposure studies,” Harding commented.

International Endeavors
Testing issues also factor in when companies seek revenues streams in different markets. As such, experts in testing have reported an upswing in requests to test products that will be sold in Asian markets—as the region has experienced higher sales growth rates in the US or in Europe.

“We are seeing a lot of work coming from companies that are looking to sell products in Asia-Pacific, as well as the Asia-Pacific companies themselves,” said Harrison, noting that clients need specific paperwork required by the Chinese, Japanese and Korean Ministries of Health.

Requests have been streaming into BioScreen too.

“Recently several companies that wish to market products in China are requesting large subject panels for immigrant or first generation Asian populations,” said Rope. “Due to the unique recruitment requirement to meet this demographic only clinical facilities located in dense Asian population centers can meet this requirement. BioScreen was able to meet the client’s needs for these studies in a timely fashion.”

Alternative Methods
Companies must anticipate other issues when looking to enter a new territory. Take, for example, a recent situation with Urban Decay. This trendy cosmetics brand decided to move into a new territory, China, but consumers balked since the country’s stance on animal testing didn’t mesh with UD’s cruelty free promise.

Urban Decay later pulled back on its plans and released the following statement: “After careful consideration of many issues, we have decided not to start selling Urban Decay products in China. While several factors were important in reaching this decision, ultimately we did not feel we could comply with current regulations in China and remain true to our core principles. We know there are many progressive consumers in China who would embrace an opportunity to purchase non-animal tested products—our hope remains that we have the chance to offer Urban Decay products to these consumers someday in the future.”

Clearly, animal testing remains a hot issue for the cosmetics industry.

“Non-animal testing methods are slowly, but very surely, replacing animal testing,” said Richard Ulmer president and CEO of InVitro International, Irvine, CA. For reasons why, he pointed to the importance of shortening the overall new product cycle by weeks or even months for cosmetic and personal care products, meeting or beating new product introduction deadlines to insure sales and profit budgets are met, overall testing expense as well as NGO and public opinion as main drivers behind the continued move away from animal testing.

Ulmer specifically called attention to the efforts of the European Centre for the Validation of Alternative Methods (ECVAM) to approve as many non-animal eye and skin irritancy test methods as possible over the next two to three years. Many in vitro tests have proven themselves worthy over decades, Ulmer said, and it is now just a matter of time and expense to gain regulatory acceptance. InVitro’s dermal corrosion testing assay is accepted or approved by a number of regulatory agencies including ECVAM, EPA, EU/OECD, OSHA, FDA, Consumer Product Safety Commission, Transport Canada and IATA as a replacement for Draize testing.

Also on the alternative method front, L’Oréal made headlines in March when it announced plans to forge a research collaboration designed to determine if EPA’s chemical toxicity forecaster (ToxCast) could be used in systemic toxicity tests. Specifically, L’Oréal is providing EPA with $1.2 million in collaborative research funding plus “robust safety data” from a set of representative substances from the cosmetic sector, expanding the types of chemical use groups assessed by ToxCast. EPA said it would compare the ToxCast results to the L’Oréal data to determine if the reliability and the relevance are appropriate for use in the safety assessment of chemicals in cosmetics.

“Because of the high costs and length of time it takes for animal testing, not all the chemicals in use have been thoroughly evaluated for potential toxicity. ToxCast is able to rapidly screen thousands of chemicals in hundreds of tests and provide results that are relevant to various types of toxicity,” Dr. David Dix, acting director, EPA National Center for Computational Toxicology, said at the time of announcement.

“For more than 30 years, we have invested in predictive evaluation for safety, in other words, animal-free toxicology. Our new L’Oréal Predictive Evaluation Center‘s activity is based on new-generation tests, using reconstructed human tissues, automated platforms, molecular modeling… In this perspective, the ToxCast program from EPA could enrich our testing platforms and help us to predict earlier the safety of substances for our products,” commented Laurent Attal, EVP, L’Oréal research and innovation.

“The urgent need for more efficient and relevant methods of safety testing is underscored by the tens of thousands of inadequately assessed chemicals in the environment,” said Andrew Rowan, Ph.D., chief scientific officer of The Humane Society of the United States and president and chief executive officer of Humane Society International.

According to Rowan, a successful outcome of the L’Oréal-EPA partnership will go “a long way toward demonstrating the value of advanced, non-animal testing tools and the need for ongoing investment in this area.”

Looking for a Partner?
Testing often requires expertise that must come from outside your firm’s own capabilities. A list of companies begins on page 74.

Shedding Light on the Critical Wavelength Test

• The US FDA, in releasing its new regulations for sunscreens, has adopted a pass/fail test using the in vitro critical wavelength as the only method in assessing UVA or broad-spectrum protection.

According to www.sunscreenguide.com, a website created by dermatologist Dr. Steven Q. Wang, critical wavelength is defined as the wavelength at which 90% of the total area under the absorbance curve resides, with the absorption measures across the UV spectrum from 290 to 400nm.

Dr. Wang’s website offers information on the test. Here is an excerpt:

“To perform the critical wavelength test, a specific amount (i.e., 0.75mg/cm2) of sunscreen product should be applied to polymethylmethacrylate (PMMA) plates. Prior to measuring the UV transmittance through the product, a fixed effective dose of 800 J/m2 (i.e., 4 times the MED of skin phototype II) is delivered to the test product as pre-irradiation dose. This fixed exposure was incorporated in the test to take account of the photostability of the sunscreen formulations.

Products that are not photostable can potentially be degraded with the pre-irradiation, resulting in low critical wavelength measurement. Based on the UV transmittance data, the critical wavelength is then calculated.”

According to Dr. Wang, the method was chosen because the FDA noted that it is “simple, reproducible and inexpensive.”

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