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New York Society of Cosmetic Chemists (NYSCC) Announces New At Home Live Series

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(New York, NY, April 2020)—The New York Society of Cosmetic Chemists (NYSCC) announces the launch of a new NYSCC “At Home Live” Series featuring current topics and trends in cosmetic chemistry and formulation. These free educational programs will be offered several times a week starting April 16th and cover topics that are relevant and timely to chemists and product development teams in the beauty and personal care industries.

The first At Home Live Webinar will be “Color Trends: Do you want to be the Front-Runner or Follower?,” presented by Amy G. Marshall, Head of Sales – Cosmetics, ECKART America Corporation on Thursday, April 16th.  She will explore the origin, influences and development of today’s colors as well as elaborate on the concept of the Mood Board in developing the trends of tomorrow.  This presentation will provide marketing and sales people with a historic perspective that will empower them to lead the market instead of reacting to it and for cosmetic chemists to initiate the process that may result in the next “Big Thing.”

Future series topics include:  Hand Sanitizers & Hand Hygiene; Sustainability 101; Healthy Habits: Cleanse + Care; and The Fight Against COVID 19, Science, Hand Sanitizers and Other Forms of Personal Protection, as well as selected presentations from the Suppliers’ Day Revolutionary Disruptor Series.

“This new webinar series will offer our members an easy and comfortable way to stay informed and move their professional development forward.  It will also help us stay connected and engaged with our members, colleagues and community while working remotely and in our home offices,” said Giorgino Macalino, Chair, NYSCC.

To register for the April 16th presentation, visit bit.ly/Apr16webinar.  For more information on the NYSCC At Home Live Series visit: https://nyscc.org/at-home-live-series/.

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About New York Society of Cosmetic Chemists (NYSCC)

Dedicated to the advancement of cosmetic science, the New York Society of Cosmetic Chemists, www.nyscc.org, strives to increase and disseminate scientific information through meetings and publications. By promoting research in cosmetic science and industry, and by setting high ethical, professional and educational standards, we reach our goal of improving the qualifications of cosmetic scientists. Our mission is to further the interests and recognition of cosmetic scientists while maintaining the confidence of the public in the cosmetic and toiletries industry. The NYSCC Suppliers’ Day, September 30 – October 1, 2020, at the Javits Center in New York City, has become the most important annual event on the industry calendar in North America for beauty ingredients, formulations, and delivery innovations. It attracts the leading players in the market and has become the showcase for new product launches, and educational programming, on top of being an excellent networking opportunity. For more information and to attend visit: www.nyscc.org/suppliers-day.

The facts you need to know: new FDA proposed Sunscreen Regulation

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Sunscreen Innovation Act

The Sunscreen Innovation Act sponsored by Jack Reed was introduced to the Senate Committee Health, Education, Labor and Pensions on March 13, 2014.  It amends the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter (OTC) sunscreen active ingredients.

FDA Proposes New Safety Testing for Selected Sun Filters

On February 26, 2019 the FDA published a proposed rule that would put into effect a final monograph for non-prescription OTC sunscreen drug products.  It establishes conditions under which certain OTC drugs may be marketed without approved new drug applications, indicating these products would be Generally Recognized as Safe and Effective (GRASE).  The sun care industry was hopeful that data previously submitted to the FDA would lead to the approval of additional sun filters currently used in Europe, under the FDA time and extent rule (TEA) policy.

Significance of the Proposed Safety Testing Protocol

To establish safety in use of sunscreen products, the FDA is proposing a Maximal Usage Trial study (MUsT). This is a human pharmacokinetic test that measures the amount of absorption of a drug into the body.  This study is new to the cosmetics industry and is more commonly used to study absorption of prescription drugs into the body.  The FDA believes this study will help to determine the potential effect of long-term use of an active ingredient.

 


Bio for Howard Epstein, Ph.D.

Howard Epstein is Director of Technical Services for EMD Performance Materials Corporation, Philadelphia, PA., an affiliate of Merck KGaA, Darmstadt, Germany. He was a scholar in residence at the University of Cincinnati department of dermatology and received his Ph.D. in Pharmacognasy from the Union Institute & University in Cincinnati, Ohio during that time. He has been in the cosmetics industry for many years since he began his career formulating cosmetics for Estee Lauder, Maybelline, Max Factor, Bausch & Lomb and Kao Brands. In addition to his interest in botanicals Howard previously served as editor of the Journal of the Society of Cosmetic Science and is a member of the International Academy of Dermatology. He is on the editorial board of the dermatological journals Clinics in
Dermatology and SKINmed representing the cosmetics industry to dermatologists.

Howard has authored chapters in various cosmetic technology textbooks including various chapters in Harry’s Cosmeticology, and holds eight patents and two patent applications.

Clinical Study Dos and Don’ts: Designing Safety & Claim Support Studies

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Clinical Study Dos and Don’ts:  Designing Safety & Claim Support Studies

Nothing makes an R&D director happier than providing a validated sound scientific dossier to his/her marketing team on a technology or formulation that has gone through months, if not years, of development.  From inception to market, there are endless meetings about progress, budgets, resource allocation and most of all, data generation.   When you think about all of the time and energy you have spent on this one aspect of your pipeline, validating your work becomes paramount so that it is universally accepted by not only the market place but by your management and investors as well. Ironically, this is the most crucial and usually the most expensive point of the project as a whole.  What can you do to ensure that you are efficient in your success?

In order to properly validate your mechanism of action and support your claims, an outside lab is usually brought into the fray for good reason: you want an objective 3rd party verification of all you have done to this point.   This will entail having all of your project management skills ready to go. This is akin to getting to the championship game in your favorite sport.  The whole season now rides on how well you do in the next game or series.  How do you position yourself for success?  Below you will find some do’s and don’ts that I have been faced with, both as a client and as a provider of clinical testing for personal care and cosmetic products.

Are you Ready to Test?

From the service side of the industry, I find that many clients come to the table thinking they are ready to test with a 3rd party laboratory. However, after the first meeting is over, they are usually going home with a to-do list longer than the questions they had for me.  So, ask yourself, are we ready to test?  No matter your title or level of responsibility, you must build a team to answer this question.  Having a team in place that represents all facets of the project, including where you have been and where you are going is the first step.  Understanding how you landed on the functional claims, category and target consumer/customer are going to lay the foundation of what type of 3rd party lab you will need and what type of study design is warranted, as not all testing labs are created equal.  All of your team members must bring their information and needs to the table to answer that question before you pick up the phone and ask for 3rd party commitment.  Have a timeline built and map out the approval process commensurate with your company’s policies.  There are some companies that inherently have more red tape than others.  Know and understand your internal process before bringing in outside counsel.  This will certainly convey confidence and keep you in the driver’s seat.

Represent your Stake Holders

Having a good mix of representation on your team of R&D, marketing, operations, regulatory and sales personnel, especially in the initial meetings with a 3rd party laboratory, will ensure that everyone’s needs are accounted for and visible.  This will also make for a much smoother utilization of data when it comes time to launch.  Some of the best launches are the result of this synergy alone.

Communication

Gathering, moving and analyzing information is the norm in today’s market place and is critical for success.  It is imperative that the team you build have an open channel of communication within its team members and the lab when necessary.  As the team leader/project champion, you must know who your go-to people are.   There are often cases of misplaced assumptions regarding who knows what, and who is responsible for deliverables and decisions.  Many times I work with a project team looking to perform validation studies only to find that delays are imposed from executing as planned because the test materials are not available or not delivered on time to the testing facility.  There are many reasons for this.  Some examples include delays in release from QA, test materials that have not passed physical or chemical stability, last minute changes to the formulation design and for our international clients, test materials getting stuck in customs at the border.  All of these issues can be mitigated with proper channels of information being open.  If one person is the gate keeper of all the information, that person needs to have access to all facets of the project and to includes information that the team members possess.  Establishing portals for information sharing especially when collaborations exist over multiple time zones is something to also consider. At the end of the day, proper, concise and efficient communication is paramount to keeping all stakeholders informed and abreast of the status of your project.

Understand your Goals

Have a holistic view of the expectations and goals.  I always say to prospective clients, “work your project backwards”.  Assuming that you get the best data possible, what will you say about it?  Understanding the end game allows everyone to see the goal in the detail that is needed.  Having a vague undefined goal is grounds for confusion, uncertainty and delays to market.  Having the goal in mind is also crucial for developing the protocol to get you to the desired objective.  One of the most common delays and unpredicted expenses companies incur are due to last minute protocol changes.  These cause delays in final approvals, delays in recruiting the required subjects, and ultimately delays in study execution at the 3rd party lab. There is a high risk for decisions being made before final protocols are signed by not having your team review the protocols early on. This can lead to re-works, delays and loss of access to resources, equipment and personnel needed to perform the study.

Know your Financial Limitations

Budget, budget, budget, how many times have we all heard, “we can’t do that, it’s too expensive”?  Have a deliberate budget in mind when you are ready to validate claims.  You can start off shooting for the stars but inevitably, you land back on earth holding your budget in hand saying, “we need a new plan”.  Match your needs within your budget.  So many clients come to me with a beautiful study design only to realize that it is light years beyond what they budgeted for.  Factors that drive price in any clinical study are of course the time and resources allocated by the lab; however, there are study design oversights that drive up study costs significantly.  Having time points that can be managed Monday through Friday and within a regular work day reduces overtime commitment by the lab.  Choosing technicians (or expert graders) to perform evaluations other rather than MD’s (where appropriate) is another way to save money.  IRB cost, interim data requests, expedited reports and last minute changes to the schedule once protocols are signed are huge drivers of cost, and many of these can be avoided with proper planning and good team building.

Focus on what you want to Achieve

Validation of claims or target mechanism of action is in the eyes of the beholder.  Keep in mind, in the personal care industry, consumer perception trumps all.  If your technology/finished product does not deliver on consumer perceivable results, you most likely will not get a return customer and the market will quickly lose interest in your product.  The good news is, consumer use studies are not that expensive.  Know your consumer base, ask the right questions and provide the best use instructions possible.  Many clients like to marry consumer use data with objective instrumental measures and/or expert grading.  This is the trifecta of clinical study success.  If you can show agreement with consumer perception, instrumental measures and expert assessment, you have a solid foundation for a bullet proof marketing campaign.

Understand your Consumer

Consider the consumer experience when designing your study.  Have you prepared use instructions that best represent how the product will be used?  Do you have a mechanism in place to understand off indication used of your product?  Factoring in these questions is critical to reduce the variation in consumer generated data.  People in general are variable in their recollection of experiences.  Having a way to reduce this through easy to read, easy to understand, and simple use instructions makes for a happy experience.  Consumers/subjects evaluating a product will, when asked, provide valuable negative feedback as well.  Ask for it, don’t wait for it.  It’s better to understand the short comings of using your product before it hits the market.  Is your product providing comfort and ease of use?  If so, it will be viewed in a better light.  Ask for diary comments, proof of use, have a hot line into the testing company for adverse event reporting.  All of these provide subjects on your study with a positive experience which will ultimately be reflected in your data on product performance.

Translate your Science and Check Regulatory Requirements

Marketing should play an integral role as a co-champion of the validation process.  They should be able to translate the science to consumer language which in turn should be converted to questions used for consumer perception studies.  Marketing should also understand what the competition in their particular category is saying about similar products.  3rd party labs do not make marketing claims; they provide data to support them.  Your marketing team should also have a hot line to a regulatory expert in the geographic regions of where you plan to sell your product.  So much for world harmonization, the individual regulatory requirements worldwide are ever growing further apart and complex.  Don’t spend your valuable time and resources developing a technology only to find out you can’t sell it in your target region because of regulatory hurdles, restrictions on trade, and/or miss alignment with what is culturally acceptable.

Know your Data

Finally, what to do with your data?  Chances are, you may be in charge of getting a 3rd party laboratory to perform some validation or claim support studies but you don’t remember the first thing about statistics.  Your report comes back from the lab with P values and Z scores.  Paragraphs about significant and non-significant data along with ANOVA analysis….YIKES!, what does all of this mean?

Did you set up the study to have the data be understandable or are you counting on one of your science team members to make sense of it all?  Is the data audited?  So many times as a client, I have asked for the raw data to review and “crunch” myself to better understand the relationships.  On the flip side, as a testing lab, I have had clients spend significant time and money on a study and not know what their data means or how to apply it back to the original objective of the study.

Final Remarks

No matter how you get to your goal, always keep in mind the fundamentals.  They are so easy to take for granted and in retrospect, the lack of attention to the fundamentals is the very reason why projects don’t go as planned.  So, build an effective and comprehensive team, know your budget limitation upfront, manage information in and out of the team efficiently, understand the expectations and stick to the plan. Understand the needs of your customers and translate the data in a way they understand.  Last but not least, know your market and consumer front to back and translate data so that they both understand it to the point at which they come back for more.

 

Author’s Biography:

Michael Anthonavage is the current VP of Operations and Technology at Eurofins CRL Cosmetic Testing. Michael has 20+ years of experience in personal care product development and a career spanning background in skin biology and models and methods development. He specializes in R&D to marketing translation and claims validation, both in vitro and in vivo. Michael is an engaging public speaker and product technology advocate with an ability to marry complex ideas and concepts to various consumer needs; he is also an educator in the area of herbal studies, instructing students in the study of plant chemistry and their impact on human physiology.  Michael has a number publications and patents to his name and continues to be an influential speaker in personal care, bioinstrumentation and skin testing.

 

 

New York Society of Cosmetic Chemists (NYSCC) Announces 2020 Executive Board

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Leaders Representing Prominent Brands, Suppliers & Manufacturers will Chart the Future Course!

 

(New York, NY, November 2019) – The announcement was made by Sonia Dawson, Chair, NYSCC and Regional Marketing Manager -DSM Personal Care North America, that the Executive Board has been confirmed for 2020 with some current board members assuming new roles, and newly elected members joining in roles that will carry through to 2021.  The 2020 Executive Board includes:

Giorgino “Gino” Macalino, Chair
Manager, Makeup Innovation, The Estée Lauder Companies

Sonia Dawson, Advisor/Past-Chair
Regional Marketing Manager, DSM Personal Care North America

Susanna Fernandes, Chair-Elect
Lead E-Sales Executive, TRI-K

Stephen Carter, Treasurer
Business Manager, Jarchem Innovative Ingredients

Mohamed Abdulla, Treasurer-Elect
Account Manager, SEPPIC

Leor Fay Tal, Secretary
Technical Marketing Leader, Gattefossé USA

“I am excited to get down to business and keep building on what my predecessors have done over these past few years,” said Gino Macalino. “Our educational programs anchored by Suppliers’ Day in NYC continue to dominate the landscape of North America.  We are eager to keep the SCC brand flourishing across our region, North America and across the globe!”

With the support of the newly-elected board, 2020 programming is already in place and will embody the  theme of “Revolutionary Disruptors.”  Programs will focus on elements and sectors of cosmetic/personal care product development that are literally changing the traditional landscape.  In addition, NYSCC Show Management has implemented strategies, programs and partnerships for Suppliers’ Day taking place May 5-6, 2020 at the Jacob K. Javits Convention Center.  NYSCC and Suppliers’ Day will continue to have a presence at SCC and industry events across the nation and around the world with the aim of continuing to strengthen the NYC event’s position as the dominant North American tradeshow.

NYSCC Suppliers’ Day 2020 Announces Show Theme & New Programs

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Revolutionary Disruptors Frame the Leading Trade Show & Conference for Innovations in Beauty and Personal Care Ingredients, Raw Materials and Formulations  

(New York, NY, November 2019)—North America’s main event for beauty ingredients, formulations, and delivery innovations, New York Society of Cosmetic Chemists (NYSCC) Suppliers’ Day, recently held a press and friends reception in New York City at Casellula to announce its show theme and new educational programming.  The 41st Annual Suppliers’ Day will take place May 5-6, 2020, at the Jacob K. Javits Convention Center in New York, NY.

At the reception, Giorgino “Gino” Macalino, NYSCC Chair Elect, announced the  theme for Suppliers’ Day 2020: Revolutionary Disruptors”.   Macalino stated, “New educational programs, returning popular content as well as show floor experiences will illustrate how revolutionary disruptors are impacting the traditional way of sourcing and the entire product development cycle.  These disruptors impact what consumers want, as well the companies that manufacturer them.”

Suppliers Day 2020 will also have a full day conference program on one of the beauty industry’s trendiest disruptors, Cannabis, featuring speakers covering sourcing, formulating, testing, branding and distributing as well as legal and regulatory updates.       The latest innovations in the Indie market will be featured in a targeted program featuring an experiential component that will include many of the supplier accelerators on the show floor.

Another trend that Is disrupting product development Mindfulness/Wellness, will be explored in a session highlighting why this is driving consumer purchasing.  Mindfulness/Wellness will also be evident in show floor activations and showcased in the Suppliers’ Day 2020 INNOVATIONS HUB.

Disruptors will be highlighted in Suppliers’ Day core programs, including Digital Age of Beauty, World of Chemistry, Discover Sustainability as well as included in new tracks focusing on color cosmetics, hair care, and healthy aging.

NYSCC Suppliers’ Day also announced it will continue working with other industry-empowering organizations that are committed to helping the beauty and personal care industry innovate and grow including ICMAD, IFSCC, PCPC, and market analyst firms such as Kline, Spate and Mintel.

NYSCC will again partner with CEW on its Supplier’s Award: Ingredients and Formulation, recognizing the role of formulation and ingredients in creating standout products for consumers. The winner will be announced at Suppliers’ Day and then celebrated at the prestigious CEW Beauty Awards luncheon the following week.

The Future Chemists Workshop will be back at Suppliers’ Day 2020.  This “live lab” experience on the exhibit floor is popular with students and will include a wider net  of participating schools, as well as a challenge that will allow winning students to be rewarded; details to be announced shortly.

“Revolutionary Disruptors will take Suppliers’ Day to the next level and provide attendees with relevant content and immersive experiences that will advance their product development and formulations,” said Macalino.

Sunscreen Monograph Proposed New Rules and its Impact on Formulations-Part II

by NYSCC NYSCC No Comments

In my recent blog published in August, changes to the current sunscreen tentative monograph were proposed.  These changes are probably the most drastic changes to the sunscreen monograph since its inception.  In this section, I would like to tackle two key areas related to the changes requested by the FDA.  The first one is the human pharmacokinetics Maximal Usage Trial (MUsT) for sunscreens conducted by the FDA and published in the Journal of the American Medical Association in May 2019.  The second is the response from the Personal Care Product Council (PCPC) to the requests from the FDA for additional safety data.

The FDA conducted a MUsT trial on 4 sunscreen formulations.  The products consisted of 2 sprays, one lotion and one cream. A detailed description of the products used in the study and the sunscreens concentrations used is displayed in Table I below.

Table I

Concentrations of sunscreens in all treatments

Treatment Percent sunscreen contents per label
Avobenzone Oxybenzone Octocrylene Ecamsule
Spray 1 3.00 6.00 2.35 0.00
Spray 2 3.00 5.00 10.00 0.00
Lotion 3.00 4.00 6.00 0.00
Cream 2.00 0.00 10.00 2.00

Twenty-four subjects were enrolled in the study and were randomized into 4 groups.  Each treatment was studied on 6 individuals. All subjects finished the study except one.  Products were applied at a rate of 2 mg/cm2 on 75% of the body area.  Products were applied by a trained expert and were re-applied every 2 hours four times a day.  The study ran for 4 days and panelists were kept indoors.  Thirty blood samples were collected from each panelist over a period of 7 days and were analyzed for their concentration of sunscreens using a validated HPLC method.

Mean maximum plasma concentrations for all sunscreens were calculated for the four treatments and are displayed in Table II.

Table II

Geometric mean maximum plasma concentration for all treatments

Treatment Geometric Mean Maximum plasma concentration, ng/mL (%CV)
Avobenzone Oxybenzone Octocrylene Ecamsule
Spray 1 4.0 (60.9) 209.6 (66.8) 2.9 (102) Not applicable
Spray 2 3.4 (77.3) 194.9 (52.4) 7.8 (113.3) Not applicable
Lotion 4.3 (46.1) 169.3 (44.5) 5.7 (66.3) Not applicable
Cream 1.8 (32.1) Not applicable 5.7 (47.1) 1.5 (166.1)

As seen from the table, all sunscreens tested had higher blood levels than the FDA proposed threshold of 0.5 ng/mL.  These levels were also achieved on the first day of treatment.  The levels obtained triggered the FDA to request safety data not only on the sunscreens studied but also on the 12 sunscreens listed in the monograph.  In addition, the FDA requested MUsT studies to be conducted by the manufacturers on several dosage forms to establish proper guidelines for usage based on safety and efficacy.  Regardless of the results obtained, the FDA insisted on the fact that individuals should not refrain from using sunscreens.

In response to the request from the FDA, the PCPC sent a letter to describe the protocols and studies suggested by the council as well as a timeline.  The PCPC suggested to conduct, in addition to MUsT studies, several surveys on usage of sunscreen products to guide the council in designing the MUsT studies.  The timeline extends till 2023 which should give the industry some breathing room in terms of formulations.  Once the studies are received and completed, an additional timeline delineating the safety of the selected molecules will be proposed.  In the council’s response, two sunscreens were not considered for MUsT studies.  These are Cinoxate and Dioxybenzone.  The fate of these two sunscreens is not determined at this stage yet.

The sunscreen monograph has been evolving for the past 35 years to keep up with the advancement in science.  Formulators, and companies in the field of sun care will have to adjust one more time to the changes.  These changes bring a lot of new challenges and opportunities to innovate and lead.


 

Biography

Dr. Fares started his career in personal care studying the effect of solvents on sunscreen chemicals.  His interest in skin drug delivery especially from polymeric matrices grew during his graduate work at Rutgers, where he completed his Ph. D. in Pharmaceutics.

Dr. Fares worked at Block Drug and GlaxoSmithKline where he held positions in research and development in the areas of skincare and oral care.  After that, he joined L’Oreal where he held several positions of increasing responsibility leading to AVP of skincare.  He is currently the Senior Director of skincare and oral care at Ashland Specialty Ingredients.  Dr. Fares is the author of many publications, and patents and made many presentations in national and international meetings in the areas of suncare, skincare, and oral care.

 

Sunscreen Monograph Proposed New Rules and its Impact on Formulations

by NYSCC NYSCC No Comments

Introduction

In February of 2019, the FDA stunned the cosmetics industry one more time by publishing proposed rules for sunscreens in the Federal Register.  As indicated by its name, these are only proposed rules but historically companies have implemented proposed rules into their formulations to be proactive.  The FDA used the argument that since the issuance of the original Final Monograph in 1999, the use of sunscreens and exposure to UV filters substantially increased.  It was important for the Agency to re-evaluate sunscreens based on current scientific understanding and extend safety assessments for such topical products to include chronic use.

 

What are the changes

The biggest change that the proposed ruling brought was the reduction of the number of Category I (Safe and effective) approved sunscreens that can be used in the US.  The FDA reduced the number of sunscreens in Category I from 16 to 2.  These two sunscreens are Titanium Dioxide and Zinc Oxide and they are approved at a level of 25% in formulations.  In addition, the FDA classified paminobenzoic acid (PABA) and Trolamine Salicylate as Category two II (Not safe and effective) which means that these two sunscreens can no longer be used in sunscreen formulations.  The remaining 12 sunscreens namely, Cinoxate, Dioxybenzone, Ensulizole, Homosalate, Meradimate, Octinoxate, Octisalate, Octocrylene, Padimate O., Sulisobenzone, Oxybenzone, and Avobenzone were classified as Category III (Additional data needed to confirm safety and efficacy).  These 12 sunscreens can be used in formulations until the FDA categorizes them into Category I or II.  From a formulation prospective, the FDA decreased the number of sunscreens to 14 until further action.  The FDA did not address the percentage at which those sunscreens can be used specifically, but probably a good fall back would be to use them at the levels published in the 1999 Monograph.  The proposed rule does not address the sunscreen active ingredients that are being evaluated under a TEA (Time and Extent Application).

In addition, the FDA proposed changes to the types of dosage forms that can be used for sunscreen products.  For Category I, they proposed the following dosage forms: oils, lotions, creams, gels, butters, pastes, ointments and sticks.  The FDA proposed Category I status for sprays subject to testing for inhalation and flammability.  Powders were classified as Category III pending additional data.  All additional dosage forms including wipes, shampoos, body washes, towelettes and others are considered as new drugs.

Broad spectrum testing was also changed.  In most parts of the world, the Critical Wavelength is used to measure broad spectrum.  The FDA is proposing to use the UVAI/UV ratio of 0.7 or higher as a standard for all sunscreens of SPF 15 or higher.  The FDA had previously proposed to make the ratio 0.9 or higher but realized that it is impossible to achieve such ratio with the portfolio of approved Category I sunscreens available in the US.  The new ratio seems reasonable but now manufacturers must perform two tests for global products, the UVAI/UV ratio and the Critical Wavelength.

Final formulation testing and labeling requirements have changed as well.  The FDA proposed to label products with the lowest SPF number achieved in in vivo testing to eliminate the variability associated with such testing.  The FDA also raised the maximum labeled sunscreen product to SPF 60+ and they attributed their decision to the lack of evidence that higher SPF product could bring meaningful clinical benefits.  The FDA proposed to label sunscreens products with an SPF 30 or higher in increments of 10 (i.e. SPF 30, 40, 50 and 60+).  They also proposed labeling sunscreens with SPF 15 to 29 to be in increments of 5 (i.e. SPF 15, 20, and 25).  The FDA also brought attention to products that are labeled SPF2 to SPF 14 and proposed that such products be removed from the market since they do not bring any adequate protection to consumers.

Sunscreens-insect repellant combination products are proposed to be classified as Category II due to incompatibility between FDA and EPA labeling instructions.  In addition, the FDA believes that combining DEET with certain sunscreens may increase cutaneous absorption of either or both.

 

What is the impact

In this proposed ruling, the FDA addressed so many safety concerns that companies and consumers suspected for years.  Many sunscreens used in the US are no longer used in Europe, Asia and the rest of the world due to their safety profiles.  However, these markets have alternative sunscreens in their portfolio that they can use to formulate safe and effective sunscreens.  In the US, such large portfolio of approved Category I sunscreen does not exist, so I would like to urge the FDA to speed the approval of all the molecules awaiting approval in the TEA process.  This will enable US formulators to have the same tools that their counterparts in the rest of the world have.  In the meantime, I am sure that formulators will use their creativity and start adapting their new formulations to the guidelines set forth by the FDA.

 

About the Author

Dr. Hani Fares started his career in personal care studying the effect of solvents on sunscreen chemicals.  His interest in skin drug delivery especially from polymeric matrices grew during his graduate work at Rutgers, where he completed his Ph. D. in Pharmaceutics.

Dr. Fares worked at Block Drug and GlaxoSmithKline where he held positions in research and development in the areas of skincare and oral care.  After that, he joined L’Oreal where he held several positions of increasing responsibility leading to AVP of skincare.  He is currently the Senior Director of skincare and oral care at Ashland Specialty Ingredients.  Dr. Fares is the author of many publications, and patents and made many presentations in national and international meetings in the areas of suncare, skincare, and oral care.

 

Development of Color Products – From William Perkin to Urban Decay

by NYSCC NYSCC No Comments

Russian Red. 999. Ruby Woo. Pioneer. Androgyny. No. 1.

What do these words call to mind?

Beauty product enthusiasts the world over will recognize these iconic shade names currently inhabiting their purse. (The author tips her hat to the product developers and marketers at Dior, MAC, L’Oreal, Chanel, and Jeffree Star.)

At the risk of taking the technology for granted, what went into creating the iconic colors?

Accidental experiments, bold defiance, an enterprising mind, good taste, shrewd manufacturing, and hours of color matching in the product development laboratories.


A Short History Lesson: Accidental Chemistry Makes Mauve

In 1856 over Easter vacation, 18-year-old William Perkin set out to isolate quinine from coal tar. Perkin was student of great German organic chemist August Wilhelm von Hofmann at London’s Royal College of Chemistry. Quinine is a valuable compound with valued anti-malarial properties. However, any chemist who knows its chemical structure would not have attempted this approach. During Perkin’s time however, the structure of benzene was not even understood.

Chemical structure of quinine and benzene

Embarking on what some might call a fool’s errand, Perkin attempted to chemically isolate the compound. With an artist’s eye, he stumbled upon mauve instead, or “aniline purple”, through a series of serendipitous experiments.

Mere luck would not have been enough to produce entire libraries of color additives manufactured today. Against his professor’s recommendation –(proof that we should always make final judgement calls for ourselves rather than obey advice without discernment)– Perkin commercialized his discovery. With the financial support of his father, a construction contractor, he developed the processes for the production and use of the new aniline purple dye. In 1857, Perkin opened his factory at Greenford Green near London. From modest beginnings, the synthetic dye industry and its relative, the pharmaceutical industry, was born.

Despite falling short of his original goal (R&D scientists and research leaders: take note!), Perkin discovered the world’s first synthetic dye, opening up an entire chemical industry and painting the mass markets with bedazzling color.

Each time we swivel up a beloved tube of lipstick for application, we pay homage to Perkin. Our ability to make style statements with color products was enabled entirely by Perkin’s accidental discovery in 1856, shrewd manufacturing, and business development.

 

Color Additives for the Consumer Packaged Goods Industry

Perhaps the most tightly regulated in the cosmetic industry, these ingredients play an important role in making products visually appealing for consumers. With the right product, it empowers the consumer to make artistic statements of her choice through color products, unencumbered.

Modern day color additives have come a long way since 1856, and safely used for more than 150 years. Color additives are used to liven up a product. As industrial research brought science into industry, the industrial colorist was a profession that developed alongside industrial design after World War I. American designers and artists worked together on the design of tasteful and attractive goods to promote culture and civility to a nation that had become overwhelmed with unsophisticated immigrants from largely rural regions of southern and eastern Europe.

For manufacturers, the mass production of different colored goods posed other challenges. The need to predict which colored products would be attractive to the masses required market research, upkeep with Parisian fashion trends, and an understanding of consumer psychology. After World War II, the epicenter of mass market fashion moved to New York, where consumers exercised -and still very much do today- the power of choice over color for self-expression.

In broader contexts in business, color is used to liven a brand or company through its logo, to create instantaneous product recognition, set the visual tone and impression, or even influence consumer psychology. As such, judicious choice and use of color in products, advertisements, and on live consumer lips and faces, can pose as effective marketing campaign strategy to increase a company’s awareness and presence in the marketplace.

 

Judicious use of color even in a company logo can make a difference to a company’s brand, by igniting consumer emotion. Image source: https://www.fastcompany.com/3028378/what-your-logos-color-says-about-your-company-infographic

 

Technology Advancements Empowers the Consumer as Artist

Since the advent of brands like Urban Decay from the 1990s, bold colors have emerged on the cosmetic market, like a relentless catwalk and lightshow of color. Greens, blues, the blackest black, pinkest pink, and everything unicorn, iridescent, pearlescent, glow-in-the-dark, and in-between have become mainstays of any cosmetic product line aiming to market itself as exciting and cutting-edge.

 

Image source: www.urbandecay.com

Owing to technological advancements, consumers no longer have to choose between long-lastingness, comfort, payoff, or value. Oftentimes, a large palette of color options accost her, with the option of layering more than one color over her lips, eyelids, lashes, or face, to achieve her desired shade and look.

 

Less is More?

Presented with the sleuth of options, studies on the paradox of choice by Professors Barry Schwartz and Sheena Iyengar come to mind. While more isn’t always better, in the world of cosmetic products and beauty trends today, more DOES mean more. The wide array of color options delights the beauty consumer.

Today, this consumer is as complex in skin tone, gender, political association, and values, and expects her beauty products to reflect her multidimensional nuanced identity just as effectively. Variety in color and shade options (particularly in skin-matching tones for foundations) have been in long-time demand. Consumers asked, and beauty companies have listened.

The market today has made progress since the era of limited shade range housed in drugstore-branded compacts, where nary a tester was in sight for the consumer to choose a shade that matched her skin tone. “Nude” can mean many different shades. Brands such as Beauty Bakerie were founded upon this very premise of inclusion, turning shade names upon its head. Where brands used to start shade naming from light to dark, Beauty Bakerie makes it a point to call its darkest shade, “1”.

 

Jackie Aina, influencer known for pushing companies towards shade diversity and racial inclusivity. She demonstrates Too Faced’s pigmented emulsion foundation product in a range of new shades. Image source: https://www.glamour.com/story/jackie-aina-too-faced

 

Advent of Color via the Chemical Industry, Social Media, and Business

The evolution of consumer tastes tracks the ubiquitous use of social media and the rise of the beauty blogger voice,, both of which continue to drive demand volumes and trends today. Continued delivery of chemical and formulation innovation is what enables the fashionistas’ envelope-pushing on what is considered wearable and trendy. Contrapuntal to the international beauty companies’ main-stream product development approach, the rise of indie brands and the use of direct selling (e.g. Glossier) have sprung up to fill market whitespaces from the supply side. From the formulator’s standpoint, innovation has liberated what is possible in performance and payoff to meet the ever-growing consumer demands for “new”. Consumer force and industry innovation, very much lubricated by social media, has progressed hand in hand dramatically in the last decade.

The consumer voice has gained a significant amount of power in the beauty and consumer products industry today. The onslaught of small beauty brands has forced larger beauty conglomerates to innovate, push daring and imaginative color products, or buy up these small brands in an effort to be more competitive.

Development of technology by material suppliers continues to facilitate the creative explosion of color products. Raw ingredient suppliers in Europe, Asia, and the Americas push the boundaries of surface functionalization, particle, colloidal, material and formulation development, designing polymers and optimizing production capabilities to enable supply and production of novel raw ingredients. The advancement of technology and manufacture production has put high-performing value products directly into the consumers’ hands, democratizing beauty and lowering the cost of self-expression.

With the glut of products and trends, it remains to be seen where the push-pull conversation between consumer and company will take us. It is an exciting time to observe how raw ingredient suppliers and product development companies big and small will respond to market forces.

 

References

[1] https://www.sciencehistory.org/historical-profile/william-henry-perkin

[2] Rydzewski, R. M., Real World Drug Discovery

[3] https://www.sciencehistory.org/distillations/magazine/colors-run-riot

[4] https://medium.com/marketing-and-entrepreneurship/the-psychology-of-logo-color-in-how-consumers-view-your-brand-d3afe84f2bdb

[5] https://www.fastcompany.com/3028378/what-your-logos-color-says-about-your-company-infographic

[6] https://hbr.org/2006/06/more-isnt-always-better

[7] https://www.glamour.com/story/jackie-aina-too-faced

[8] https://www.wsj.com/articles/celebrities-like-kylie-jenner-are-upending-the-52-billion-beauty-industry-1543401001

[9] https://blogs.wsj.com/cmo/2015/06/09/bethany-mota-overtakes-michelle-phan-as-youtubes-top-beauty-producer/

[10]  https://www.huffingtonpost.co.uk/sophie-bianchi/beauty-bloggers-zoella_b_11566248.html

[11] https://www.wsj.com/articles/small-cosmetics-brands-make-over-the-beauty-market-by-targeting-millennials-11556296365

[12] https://www.wsj.com/articles/glossier-tops-billion-dollar-valuation-with-latest-funding-11552993200

 

About the Author

Dr. Diane Lye cut her scientific teeth by working on the design, synthesis, and bulk property characterization of supramolecular block copolymers. She has authored multiple academic publications and developed a market commercialization assessment for a dermal technology. She was lead scientist in a lean ad-hoc team in turning around two global product lines under duress, and developed pigmented dermal products for commercialization. She contributes articles in her spare time. A musician in a previous life, she enjoys using it as a vehicle to reach out to and educate young minds.

NYSCC Suppliers’ Day Supporting the Next Generation of Chemists

by NYSCC NYSCC No Comments

Future Chemists Workshop and Mentorship Launch at Leading Beauty & Personal Care Trade Show

(New York, NY, May 2019)— New York Society of Cosmetic Chemists (NYSCC) is committed to educating and supporting the workforce of the future and will launch a new Mentorship program and continue its popular Future Chemists Workshop at Suppliers’ Day its flagship event.  Taking place May 7-8, 2019 at the Jacob K. Javits Convention Center in New York, Suppliers’ Day is the largest trade show and conference in North America for innovations in beauty and personal care ingredients, formulations and raw materials.

The NYSCC Mentoring Program, spearheaded by NYSCC’s Eileen Kim, Principal Research Scientist, R&D, at CHANEL will launch on May 8th and is designed to bring seasoned formulation professionals together with students, grad students and junior members of the NYSCC to mentor, offer advice, discuss career paths and more.  At Suppliers’ Day, mentors and invited mentees will meet for a program that includes a coaching session, panel discussion on “Evolution of the Cosmetic Chemist,” a networking lunch for mentors and mentees as well as a framework of the mentorship program moving forward.

In its 3rd year, the popular Future Chemists Workshop (FCW) will, once again, be managed by John Carola, Sales Manager with Protameen, and have its largest and most diverse range of participants with students from sister SCC chapters.  FCW is designed for student innovators and leaders of tomorrow and provides real-time insight on how to be a Cosmetic Chemist through a tutorial and practical workshop which is then turned into a mini-challenge.  FCW is led by Team Captain, Christina Ladouceur-Bishop, Senior Manager for Hair Color Product Development, Coty, Inc., and will take place on May 7th in Hall D –“The Chemists’ Classroom.  Participating colleges and universities include:  Fairleigh Dickinson University, FIT, Kean University, Long Island University, Montclair State University, Rutgers, The University of Toledo, and University of Miami Health System.

Past participants of FCW are now working for leading brands and suppliers in the beauty and personal care industry.

“My favorite part about the SCC Suppliers’ Day was being able to formulate on-site! It seemed like a lot of effort went into setting up all of the equipment for this educational session. Not only did we make a cream, but also had a speaker to teach us emulsion formulation basics.  This event was a great way to build connections with suppliers and I enjoyed learning more about the new, innovative raw materials, said Margaret Gorz, Associate Scientist, The Estée Lauder Companies.

“As a student, I was thankful that the SCC gave me the opportunity to attend and that they place a focus on nurturing young talent within the cosmetic science industry,” she added.

Elizabeth Aquirre, a Chemist at L’Oréal, and past FCW participant said,

“I have learned how to network within the industry and how to communicate more effectively attending events such as the Future Chemist Workshop. It was through these experiences that have helped me gain the confidence I needed to engage in conversations which lead to the employment at my current company, L’Oréal. I am truly thankful to have been a part of the Future Chemist Workshop as it was a place that helped me learn and grow.”

Celebrating its 40th Anniversary, NYSCC Suppliers’ Day will also have educational sessions on “Fragrance: The Invisible Art;” “Microbiome: Inside Out Beauty;” “Innovation & Compliance;” “Discover Sustainability;” “The World of Chemistry;” and “Digital Age of Beauty;” along with the pre-show SCC CEP Courses and the ICMAD FDA Cosmetics Regulation Workshop on Thursday, May 9th.

Specialty areas on the expanded exhibit floor include the Innovation Hub & Theater with the CEW Supplier’s Award finalists speaking and showcasing their nominated ingredients and formulations, Presentation Stage,  a 40 Year Retrospective of “The Evolutions of Beauty,” as well as the Future Chemists Workshop in The Chemists Classroom.

NYSCC Suppliers’ Day Offers New Educational Programming on Fragrance Development and the Microbiome Role in Product Creations

by NYSCC NYSCC No Comments

Leading Global Ingredient Trade Show & Conference for Beauty & Personal Care Takes Place May 7-8 at the Javits Center in NY

(New York, NY, May 2019)—Providing relevant education to chemists and product development teams is the hallmark of the NYSCC Suppliers’ DayFragrance: The Invisible Art and Microbiome: Inside Out Beauty are two new educational programs added to Suppliers’ Day, May 7-8, at the Jacob Javits Convention Center in New York.

Sponsored by the American Society of Perfumers, Fragrance: The Invisible Art will take place on Tuesday, May 7, from 10 am – 3 pm.   Attendees will get an inside journey of the fragrance development process and hear from the various “artists” who create this art composition which is often not seen and only understood by the developers.

Speaking in this program will be the customers who develop a new concept that involves a scent.  The perfumer, who then must translate this concept into fragrance, and uses their knowledge of combining various fragrance materials to develop a target scent.  This also requires working with the trained evaluators, also known as the noses, who will perfect the juice with the perfumer.

The marketer’s contribution to the story will also be discussed as they will be responsible for speaking about the overall appeal of the fragrance composition.  Once the fragrance is determined the technician will work in the lab to stabilize coloring and packaging.  The final result – a masterpiece of art – which may be a back drop to the product or the centerpiece that drives the sale.

Fragrance: The Invisible Art panelists include Shana Finkelstein and Ana Nouel, Brand Product Management Fragrance Development, Maesa as the customers;

Kari Arienti, Founder, Aroma Knowledge and Vincent Kuczinski, Vice President Senior Perfumer, MANE Fragrance, as the perfumers; Pamela Vaile, Founder, Pam Vaile Associates as the evaluator; Jenine Guerriero, Director of Marketing, Givaudan as the marketer; and David O’Halloran, Vice President Fragrance and Cosmetic Technology, Arcade Beauty as the technician and Christopher Diienno, Chairman, American Society of Perfumers as the overall conference instructor.

Top of FormMicrobiome: Inside Out Beauty, an exciting new area of research, will take place on Wednesday, May 8, from 9:15 am -1:15 pm.  This new program, moderated by Tom Branna, VP/Editorial Director, HAPPI, will dive deep into microbiome and biogenetic technologies and how formulating cosmetics and personal care products includes living, tailor-made solutions.

The stage will be set for the program with a co-panel presentation of “Top Trending Ingredients…Microbiome is One of Them!” by Yarden Horowitz, Co-Founder, Spate; followed by” What Does This Mean for Product Development?” presented by  Karen Young, CEO, The Young Group.

The program then takes a deep dive into Microbiome with: “Development of a 3D Skin Model Colonized with an Uncultured Skin Microbiota,” presented by Valérie Cenizo, Skin Biology Lab Manager, L’Occitane; “Skin Microbiome-based Ingredients for Innovative Cosmetic Formulations:  Key Considerations and Evaluation Methods,” taught by Dr. Pascal Yvon, President/Founder, Biosciences Expansion; and “Claim Support for Microbiome Skin Care,” with Christiane Uhl, Sales Manager, Courage + Khazaka electronic, GmbH.

            There will also be an expert Microbiome panel discussion on this emerging trend with Daniel Winn, President, Acetera; Dr. Marielle Le Maire, Global Head of BU Activities, Symrise; Ferderica Carlomagno, R&D Manager Roehlm; and Simon Grundy, Business Development Manager, proDerm.

NYSCC Suppliers’ Day will also have educational sessions on Innovation & Compliance, Discover Sustainability, The World of Chemistry, and Digital Age of Beauty, along with the pre-show SCC CEP Courses and the ICMAD FDA Cosmetics Regulation Workshop on Thursday, May 9th.

Specialty areas on the expanded exhibit floor include the Future Chemists Workshop, Innovation Hub & Theater with the CEW Supplier’s Award finalists speaking and showcasing their nominated ingredients and formulations, Presentation Theater as well as a 40 Year Retrospective from NYSCC past chairs, members, brands, and suppliers.