Melissa Meisel, Associate Editor10.01.15
Great claims can provide a big boost to product sales, but claims also require testing, one of the best and most reliable methods for highlighting what consumers love about a product—or for discovering potential hidden problems and avoiding multi-million dollar mistakes.
If your claims are stellar, you’ve got the right marketing tools to move forward with a big splash, according to Denise Herich, co-founder and managing partner at The Benchmarking Company.
“This gives your consumer the all-important proof that buying the product is the right move for them, because they’ve read the claims from women like them,” she told Happi. “Brands that set themselves up with powerful feedback from a beauty product test run by a trusted third-party testing organization are as ready as possible for any outcome.”
Executives from leading testing service companies in the industry took time to Q&A with Happi about the latest trends. Here’s a look at what they had to say about technologies and consumer demand in the marketplace. A directory of testing service provides follows this feature on p. 60.
Happi: What have been the main service requests/jobs your company is seeing over the past year in terms of or personal care care/cosmetics testing? Is this different in any way? If so, how so and what do you think is behind it?
Jane Tervooren, global director corporate strategy and client services, Princeton Consumer Research, Princeton, NJ: We have been seeing an increase in requests for anti-aging products and regimens and Visia CR imaging and analysis. There has also been an increase in clients who would like to market their products on QVC and HSN. I believe this is the result of the significant demographic of aging baby boomers, and the education and exposure of younger generations to the latest products that may prevent premature aging of the skin. We have also seen an increase in AP and deo testing requests. This is a very competitive space, and a high level of quality testing can help give a client the competitive edge.
Dr. Pascal Yvon, PharmD, MBA, US Business Development Head, IDEA Tests, Philadelphia, PA and Bordeaux, France: IDEA Tests specializes in toxicology, tolerance and efficacy evaluation (in vivo and in vitro) for both finished products and ingredients. We act as a real interface between R&D, marketing and regulatory departments, providing suitable tests in perfect agreement with our customer needs and regulations in force. In 2015 we have seen a significant increase in efficacy clinical testing for claim substantiation and solar testing.
And due to the higher demand for safety, we also act more and more in the field of in vitro toxicological testing and regulatory advice (regulatory reviews, safety report and safety assessment).
Howard Baker, managing member, Product Integrity Laboratory, LLC, Landing, NJ: Product-package compatibility testing, stability testing, and other tests that support product development efforts are the key requests we receive. In addition to freeze-thaw cycle testing, which is familiar to many people, we have run a number of heat cycle tests lately. These show whether the package can stand the stress of increased internal pressure that results from temperatures of 50°C (122°F). This kind of temperature happens in trucks during shipment and in cars parked in the sun. The exposures aren’t long, but they can do damage. Pumps don’t always hold their seal, bottle bottoms bulge out and don’t return to their original shape, and the like. Airless packages are vulnerable because there is no headspace to absorb the expansion of the product as it gets warmer.
Quality control testing of ongoing production is also an important area. Many distributors rely entirely on their vendors and their own over-worked product developers for quality control evaluations. We lighten the product developers’ loads and verify the results that contract manufacturers report from their quality testing.
Bradford Rope, founder and president, Bioscreen, Torrance, CA, with clinic locations both Los Angeles and Phoenix, AZ: There has been a significant increase in claims support testing requiring instrumentation for scientific testable claims. This is a change away from the use of questionnaires and subjective evaluation, which was the trend in the past few years. Additionally, Proposition 65 has increased analytical testing requests.
Happi: What are the main challenges your customers have when it comes to their testing?
JT: The main challenges that our clients have when it comes to testing are study costs and meeting timelines. Clients may want a robust study design, but their budget will only allow for a very basic design that will limit the type of claims that can be substantiated.
PY: Customers come to us with a real need in terms of understanding the regulations and mainly to help them determine the right strategy to market their products on a global basis in compliance with the regulations. The information to gather, the number of documents, certificates to obtain, the administrative procedures, etc. are numerous and it can be overwhelming and easy to loose track. With our holistic approach and expertise, we have a strong added value in this field for our customers.
HB: Time and samples are the key challenges. Development timetables usually pursue launch dates aggressively and don’t leave time for full evaluation of the product stability and compatibility with the packaging. With old familiar formulas in old familiar packages the risks are often small, but when the elements of a new product are cutting edge, there is no familiarity that justifies taking risks with the product. Package suppliers do some amount of testing with their new designs, but not with your product or under the full range of conditions your product will experience. Their job is to sell you the package. I suppose your job as a product developer is to trust but verify.
Getting enough samples for testing is another common challenge, especially with new, custom designed packages. Doing tests with fewer samples means that the test results aren’t as convincing as they could be. If a package will fail only some of the time, you need to test enough samples to find those few. Making decisions on positive results from performance of only a few samples assumes a greater level of risk.
It’s also fair to say that the usual safety testing done on personal care products—patch testing and preservative effectiveness testing—is a bare minimum for establishing the overall integrity of a product.
BR: The main challenges for clients is the different worldwide testing requirements and an uncertain regulatory environment in the US.
Happi: Has your company invested in new equipment/space/services for household or personal care testing? Please tell us about those enhancements.
JT: Princeton Consumer Research has invested in our 11,000 sq. ft., state-of-the-art global headquarters in Princeton, NJ. This site has one of the largest environmentally controlled rooms in the US, a full service hair salon, and a wide array of the latest bio-instrumentation.
Our newest 12,000 sq. ft. site in St. Petersburg, FL is opening in November, and will offer the same amount of bio-instrumentation as well as two large environmentally-controlled rooms.
PY: This year again we invested in the development of our capabilities in terms of instrumentation on one side, this is the case for the extreme weather conditions room for specific clinical tests (e.g. antiperspirant for extreme sports), or analytical instruments for in vitro tests such as KeratinoSens and DPRA (sensitization), but also in terms of new clinical centers in order to address the growing demand for clinical and solar testing; i.e., Bangkok, Thailand; Jakarta, Indonesia and more recently, in Lille, France.
HB: We expanded our facilities about two years ago to better handle the volume of samples and tests that we conduct.
BR: Bioscreen has invested in a larger clinical facility in Los Angeles and also increased capacity in our microbiology department to meet testing demands. Additional instrumentation for heavy metals testing by ICP/MS and OES has also been added.
Happi: What regulatory issues, whether in the US or globally, are on your radar screen—and why—and what impact might they have on your customers in 2015-2016?
JT: The advances of many new “consumer cosmetic” products being developed or coming to market, can make the appropriate regulations and laws that need to be adhered to difficult to determine, since these requirements are based on the products’ intended use. It is important not to market a cosmetic product with a drug claim or market a drug as if it were a cosmetic product.
Clients need to understand that some claims made on the product labeling, advertisement, etc., may cause the product to be considered a drug by the FDA. Claims that are directed at “any changes that affect the structure or function of the human body” as indicated in the FD&C Act (for example the increase/decrease of melanin in skin), indicate that the product is a drug, and therefore falls under drug testing laws and regulations. Our regulatory department examines the proposed claims and advises clients accordingly.
PY: Companies want or plan from day one to market their products on a worldwide basis, and that includes compliance with European regulations as the EU is the largest market. Among all the pieces of information requested in the Product Information File of the cosmetic product, some are getting more and more critical and difficult to obtain. This is the case for the stability of the product and mainly concerning the compatibility between the product and its packaging (migration of forbidden material issue). The toxicological profile of each ingredient is also important in regard to the animal testing ban, which is becoming global, and GLP compliance.
HB: State regulations, like those in California, are a constantly moving target for the industry. California’s Safe Cosmetic Act, VOC regulations and Proposition 65 regulations are examples where state regulations impose unnecessary duplication of regulations in place from the Federal government. Although states have legitimate concerns for the safety of their people, regulatory uniformity is an important part of a reasonable inter-state commerce regulatory framework. Any efforts toward federal pre-emption of these kinds of regulations will protect the consumer and allow business to grow at the same time.
The EU’s increasing bureaucratizing of the industry builds barriers for companies outside the EU to do business there. The precautionary principle at the foundation of EU cosmetic regulations creates an almost paranoid concern about theoretical and highly improbable risks that affects everyone’s ability to bring safe and effective products into the marketplace.
BR: USP 232 elemental impurities chapter has been delayed in its approval by FDA but most pharmaceutical and OTC companies are currently testing for elemental impurities by this method.
Happi: Any additional details we may not have covered that you think our readers would want to know about the testing services industry?
PY: Our worldwide expansion through additional clinical centers addresses the growing demand for clinical tests and therefore the higher need for volunteers from various areas in the world.
JT: Consumer product testing will give clients the best chance to position their products more competitively in the marketplace. It also acts as a kind of “insurance policy” which may enable them to make the most robust efficacy and safety claims about their products.
If your claims are stellar, you’ve got the right marketing tools to move forward with a big splash, according to Denise Herich, co-founder and managing partner at The Benchmarking Company.
“This gives your consumer the all-important proof that buying the product is the right move for them, because they’ve read the claims from women like them,” she told Happi. “Brands that set themselves up with powerful feedback from a beauty product test run by a trusted third-party testing organization are as ready as possible for any outcome.”
Executives from leading testing service companies in the industry took time to Q&A with Happi about the latest trends. Here’s a look at what they had to say about technologies and consumer demand in the marketplace. A directory of testing service provides follows this feature on p. 60.
Happi: What have been the main service requests/jobs your company is seeing over the past year in terms of or personal care care/cosmetics testing? Is this different in any way? If so, how so and what do you think is behind it?
Jane Tervooren, global director corporate strategy and client services, Princeton Consumer Research, Princeton, NJ: We have been seeing an increase in requests for anti-aging products and regimens and Visia CR imaging and analysis. There has also been an increase in clients who would like to market their products on QVC and HSN. I believe this is the result of the significant demographic of aging baby boomers, and the education and exposure of younger generations to the latest products that may prevent premature aging of the skin. We have also seen an increase in AP and deo testing requests. This is a very competitive space, and a high level of quality testing can help give a client the competitive edge.
Dr. Pascal Yvon, PharmD, MBA, US Business Development Head, IDEA Tests, Philadelphia, PA and Bordeaux, France: IDEA Tests specializes in toxicology, tolerance and efficacy evaluation (in vivo and in vitro) for both finished products and ingredients. We act as a real interface between R&D, marketing and regulatory departments, providing suitable tests in perfect agreement with our customer needs and regulations in force. In 2015 we have seen a significant increase in efficacy clinical testing for claim substantiation and solar testing.
And due to the higher demand for safety, we also act more and more in the field of in vitro toxicological testing and regulatory advice (regulatory reviews, safety report and safety assessment).
Howard Baker, managing member, Product Integrity Laboratory, LLC, Landing, NJ: Product-package compatibility testing, stability testing, and other tests that support product development efforts are the key requests we receive. In addition to freeze-thaw cycle testing, which is familiar to many people, we have run a number of heat cycle tests lately. These show whether the package can stand the stress of increased internal pressure that results from temperatures of 50°C (122°F). This kind of temperature happens in trucks during shipment and in cars parked in the sun. The exposures aren’t long, but they can do damage. Pumps don’t always hold their seal, bottle bottoms bulge out and don’t return to their original shape, and the like. Airless packages are vulnerable because there is no headspace to absorb the expansion of the product as it gets warmer.
Quality control testing of ongoing production is also an important area. Many distributors rely entirely on their vendors and their own over-worked product developers for quality control evaluations. We lighten the product developers’ loads and verify the results that contract manufacturers report from their quality testing.
Bradford Rope, founder and president, Bioscreen, Torrance, CA, with clinic locations both Los Angeles and Phoenix, AZ: There has been a significant increase in claims support testing requiring instrumentation for scientific testable claims. This is a change away from the use of questionnaires and subjective evaluation, which was the trend in the past few years. Additionally, Proposition 65 has increased analytical testing requests.
Happi: What are the main challenges your customers have when it comes to their testing?
JT: The main challenges that our clients have when it comes to testing are study costs and meeting timelines. Clients may want a robust study design, but their budget will only allow for a very basic design that will limit the type of claims that can be substantiated.
PY: Customers come to us with a real need in terms of understanding the regulations and mainly to help them determine the right strategy to market their products on a global basis in compliance with the regulations. The information to gather, the number of documents, certificates to obtain, the administrative procedures, etc. are numerous and it can be overwhelming and easy to loose track. With our holistic approach and expertise, we have a strong added value in this field for our customers.
HB: Time and samples are the key challenges. Development timetables usually pursue launch dates aggressively and don’t leave time for full evaluation of the product stability and compatibility with the packaging. With old familiar formulas in old familiar packages the risks are often small, but when the elements of a new product are cutting edge, there is no familiarity that justifies taking risks with the product. Package suppliers do some amount of testing with their new designs, but not with your product or under the full range of conditions your product will experience. Their job is to sell you the package. I suppose your job as a product developer is to trust but verify.
Getting enough samples for testing is another common challenge, especially with new, custom designed packages. Doing tests with fewer samples means that the test results aren’t as convincing as they could be. If a package will fail only some of the time, you need to test enough samples to find those few. Making decisions on positive results from performance of only a few samples assumes a greater level of risk.
It’s also fair to say that the usual safety testing done on personal care products—patch testing and preservative effectiveness testing—is a bare minimum for establishing the overall integrity of a product.
BR: The main challenges for clients is the different worldwide testing requirements and an uncertain regulatory environment in the US.
Happi: Has your company invested in new equipment/space/services for household or personal care testing? Please tell us about those enhancements.
JT: Princeton Consumer Research has invested in our 11,000 sq. ft., state-of-the-art global headquarters in Princeton, NJ. This site has one of the largest environmentally controlled rooms in the US, a full service hair salon, and a wide array of the latest bio-instrumentation.
Our newest 12,000 sq. ft. site in St. Petersburg, FL is opening in November, and will offer the same amount of bio-instrumentation as well as two large environmentally-controlled rooms.
PY: This year again we invested in the development of our capabilities in terms of instrumentation on one side, this is the case for the extreme weather conditions room for specific clinical tests (e.g. antiperspirant for extreme sports), or analytical instruments for in vitro tests such as KeratinoSens and DPRA (sensitization), but also in terms of new clinical centers in order to address the growing demand for clinical and solar testing; i.e., Bangkok, Thailand; Jakarta, Indonesia and more recently, in Lille, France.
HB: We expanded our facilities about two years ago to better handle the volume of samples and tests that we conduct.
BR: Bioscreen has invested in a larger clinical facility in Los Angeles and also increased capacity in our microbiology department to meet testing demands. Additional instrumentation for heavy metals testing by ICP/MS and OES has also been added.
Happi: What regulatory issues, whether in the US or globally, are on your radar screen—and why—and what impact might they have on your customers in 2015-2016?
JT: The advances of many new “consumer cosmetic” products being developed or coming to market, can make the appropriate regulations and laws that need to be adhered to difficult to determine, since these requirements are based on the products’ intended use. It is important not to market a cosmetic product with a drug claim or market a drug as if it were a cosmetic product.
Clients need to understand that some claims made on the product labeling, advertisement, etc., may cause the product to be considered a drug by the FDA. Claims that are directed at “any changes that affect the structure or function of the human body” as indicated in the FD&C Act (for example the increase/decrease of melanin in skin), indicate that the product is a drug, and therefore falls under drug testing laws and regulations. Our regulatory department examines the proposed claims and advises clients accordingly.
PY: Companies want or plan from day one to market their products on a worldwide basis, and that includes compliance with European regulations as the EU is the largest market. Among all the pieces of information requested in the Product Information File of the cosmetic product, some are getting more and more critical and difficult to obtain. This is the case for the stability of the product and mainly concerning the compatibility between the product and its packaging (migration of forbidden material issue). The toxicological profile of each ingredient is also important in regard to the animal testing ban, which is becoming global, and GLP compliance.
HB: State regulations, like those in California, are a constantly moving target for the industry. California’s Safe Cosmetic Act, VOC regulations and Proposition 65 regulations are examples where state regulations impose unnecessary duplication of regulations in place from the Federal government. Although states have legitimate concerns for the safety of their people, regulatory uniformity is an important part of a reasonable inter-state commerce regulatory framework. Any efforts toward federal pre-emption of these kinds of regulations will protect the consumer and allow business to grow at the same time.
The EU’s increasing bureaucratizing of the industry builds barriers for companies outside the EU to do business there. The precautionary principle at the foundation of EU cosmetic regulations creates an almost paranoid concern about theoretical and highly improbable risks that affects everyone’s ability to bring safe and effective products into the marketplace.
BR: USP 232 elemental impurities chapter has been delayed in its approval by FDA but most pharmaceutical and OTC companies are currently testing for elemental impurities by this method.
Happi: Any additional details we may not have covered that you think our readers would want to know about the testing services industry?
PY: Our worldwide expansion through additional clinical centers addresses the growing demand for clinical tests and therefore the higher need for volunteers from various areas in the world.
JT: Consumer product testing will give clients the best chance to position their products more competitively in the marketplace. It also acts as a kind of “insurance policy” which may enable them to make the most robust efficacy and safety claims about their products.
• The US Environmental Protection Agency (EPA) and Unilever announced a research collaboration to develop ground-breaking scientific approaches to better assess the safety of chemicals found in some consumer products without using animal data. The alternative and cutting-edge approaches, which EPA and Unilever are developing, represent the first steps in a paradigm shift for chemical safety testing and risk assessment by making them faster, cheaper and more relevant to humans. These new tools will provide a robust scientific basis for assessing and managing chemical safety and efficiently quantifying human health risks for thousands of chemicals. EPA and Unilever will develop a series of case studies based on chemicals of mutual interest. EPA will develop and provide data using these automated chemical screening technologies. Unilever will use its longstanding expertise in consumer products to estimate exposures for the chemicals. Together, the EPA and Unilever will work to combine the information into a risk assessment. The collaboration will help inform how EPA’s ToxCast project can be used by private and public entities as well as in the development of chemical risk assessments. Unilever is contributing more than $800,000 and considerable scientific expertise to help generate and integrate new exposure data to develop a model approach for high throughput risk assessments that include both hazard and exposure predictions. The Unilever initiative comes from its Safety and Environmental Assurance Centre which, as it celebrates its 25th year of existence in 2015, sees this research area of non-animal approaches as being one of the enduring “big scientific challenges” that has shaped its evolution during the past 25 years (www.tt21c.org). The collaboration will use data from EPA’s ToxCast program and the affiliated Tox21 consortium, which is a collaboration among EPA, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). These programs use automated chemical screening technologies to rapidly and efficiently test thousands of chemicals for their effects on human cells or cellular components that are critical to normal function. Data from these technologies are then incorporated into computational models to predict potential adverse health effects and estimate the amount of chemical that may cause these effects. The new collaboration aims to incorporate elements that have been previously missing from the automated chemical screening approach such as tools for incorporating metabolism of the test chemicals and a more comprehensive evaluation of the human biological pathways that can be affected. Unilever, in providing a statement to Happi, commented: “Since the 1980s, Unilever’s leading-edge science has focused on developing new non-animal approaches that can guarantee that our products are safe, without any need for animal testing. These principles have also been at the heart of ground-breaking computational toxicology research led by the EPA to generate data on thousands of chemicals and figuring how this new data can help assess the safety of chemicals. Through this collaboration, Unilever and EPA will bring together EPA’s new chemical data and Unilever’s understanding of how consumers are exposed to ingredients in products to determine if these new approaches can be used to more effectively and efficiently assess chemicals. We anticipate that both wider Industry and Government will benefit from the use of these advanced tools and non-animal based approaches.” |