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A Journey into Color Cosmetics and Lip Product Development

by james.runkle@drummondst.com james.runkle@drummondst.com No Comments

Introduction

The birth of color cosmetics is said to be traced back all the way to Mesopotamia over 5000 years ago where gems and semi-precious gems were ground up and applied to both the lips and the eyelids. In 4000 BCE, Egyptian women would apply Mesdement, a dark grey ore of lead, Galena chemically known as Lead Sulfide, and Malachite (bright blue green paste of Copper minerals) to color their faces for color. They also extracted color from seaweed, Iodine, and beetles to further add to their makeup palette. (1) Somewhere around 3000BCE women in in Greece applied a paste to their face consisting of white chalk, or lead, mixed in with crushed fruits such as Mulberries. They also used lipsticks comprised of clays mixed with red Iron.(1) During the Renaissance Era it was recorded that women use Arsenic in their face powders to replace lead and it wasn’t until the early 1800s that both of these were replaced by what is commonly known today as Zinc Oxide. In 1894 we saw the birth of what is known today as the PCPC, or Personal Care Products Council. Soon thereafter and beginning in the 1900’s the world saw a rapid increase in popularity of color cosmetics as well as the conception of many cosmetic companies commonly known today such as L’Oreal, Max Factor, Avon, and Maybelline to name a few. With this surge came new product forms such as hair dye, mascara, the first liquid nail polish, the powder compact, and in 1928, the very first lip gloss. In the 1940’s leg makeup was developed out of a need of necessity to fulfill the shortage in stockings due to World War II. Over the course of the next 60-70 years the beauty industry would experience a rapid growth spurt in not just technology but also in regulatory bodies that formed the very foundation for what our industry is today.

Color Ingredients

When we speak of color cosmetic formulations, the primary desired end benefit of these products is the same as it was thousands of years ago and that is to impart color to a part of the face to enhance one’s beauty and feel good about oneself. Whether it be a lipstick, foundation, concealer, eye shadow or pressed powder, the color additives are the main constituent and the base formula is what delivers the color and differentiates the product form. These color additives typically consist of pigments, lakes, dyes, and mica and their differences are explained below:

Pigments– Insoluble particles that impart a color to a product. Inorganic pigments are derived from minerals and have good stability to heat and light. Organic pigments, by nature, are carbon based and tend to have a brighter appearance to them. Commonly, pigments are often surface treated and sold in dispersions of various esters and oils to facilitate ease of use in manufacturing and ensure homogeneity of the color.

Lakes– Produced through precipitation of FD&C soluble dyes with metallic salts such as Aluminum salts. Lakes are useful to extend the color range of a shade palette. These ingredients are often surface treated and sold in dispersions of various esters and oils to facilitate ease of use in manufacturing

Dyes-Predominantly water-soluble, these ingredients are used in skin care, body care, fine fragrance, hair care, and color cosmetics. There are some dyes that are oil soluble as well.

Mica– A name given to a group of silicate materials that are used to add shimmer and sparkle

 

Even though all the ingredients above can be used across the broad category of color cosmetics from eye shadow and pressed powders to lipsticks and foundations, for the purposes of this article we will focus solely on the formulation of lipsticks and liquid lip products.

Physiology of the Lips

The physiology of the lips plays a key role when developing lip products. By nature, the lips are thinner than the skin on the rest of your body and therefore are more sensitive to changes in temperature and texture of a product. Therefore, comfortability and wear are 2 key product parameters that must be properly balanced during development. The lips also do not have hair follicles or oil glands and as a result of this are more prone to drying out especially in the winter months or in low humidity climates. As a result of this, key benefit claims such as hydration and intense moisturization are common for this product type. Finally, the lips do not contain melanocytes found in the skin and as such the color from the lips comes from the blood vessels directly under the surface of the lips.

During aging the lips begin to undergo biological changes like that around other parts of the face and body. The shape of the lips begins to become narrower and longer. They begin to lose volume and color overtime making them appear paler and less vibrant in color and the lines on the lip surface begin to deepen often causing the unwanted side effect of bleeding and feathering. Furthermore, they often present themselves with an unsmooth color tone and appearance.

Environmental exposure can also cause premature aging and thinning of the lips. Chronic UV exposure causes a breakdown in the collagen making the lips appear less full and voluminous. Dehydration from extreme weather conditions or poor health habits can lead to premature and undesirable chafing while exposure to environmental pollutants, i.e., free radicals, and smoking can lead to premature lip lines above the top lip.

Lip Product Formulation

Given the sensitivity of the lips and the desire to keep them young and vibrant looking there are multiple lip products out on the market today each with their own unique benefits and performance. Typically, colored lip products are found in 4 distinct anhydrous forms:

  1. Lipsticks
  2. Liquid Lipsticks
  3. Lip Gloss
  4. Lip Balms

Traditional lip formulations are composed of emollients, oils, waxes, and colorants with the ingredient ranges varying to deliver a stick or liquid format. Emollients/natural oils such Castor Oil, Lanolin, Shea Butter, are primarily used to help disperse colorants, while providing moisture and smooth application. Structuring agents such as Ozokerite, Polyethylene, and Carnauba and gellants are often used to give the sticks rigidity and stability while film formers are often utilized to improve the transfer resistance and wear properties. Benefit ingredients such as vitamins, natural oils, Hyaluronic acid, fragrance, etc. can all be added as well based on the target audience and desired claims.

In terms of finish, lip products typically are found in multiple styles ranging from matte, satin, pearl and shine with sheer to full coverage levels. From a performance perspective, today’s products are a great evolution to those from a century ago offering intense, continuous hydration, waterproof and transfer proof properties, SPF protection, and even all-day long wear.

Conclusion

Over the years the line between color cosmetics and skin care has become less defined. While the primary function of a color cosmetic is to provide color to the face, lips and eyes, the formulas themselves have become more technologically advanced and multi-faceted. Today’s products offer the consumer benefits beyond color such as anti-aging (wrinkle reduction), sun protection, anti-pollution, reduction of oily and acnegenic skin, minimization of scars, and even  tattoo and hyperpigmentation coverage. Additionally, companies continue to innovate in new color cosmetic product forms and test methodologies to deliver aesthetically pleasing, high performance products. For certain, this is a space that will continue to not only innovate but also adapt to today’s complex global challenges while pivoting to consumer needs for years to come!

References

  1. https://cosmeticsinfo.org/Ancient-history-cosmetics

 

Authors

 

Peter Konish has been in the industry for 25 years and is currently the Director of the Lip Category, Product Development and Innovation for Coty. Prior to this, he was the Global Director of Technical Operations in the Skin Health division of Johnson and Johnson. In this role Peter was responsible for Process Development, Packaging Development, and External Development/Innovation. Before moving to Technical operations, Peter spent 13 years at NeoStrata in Product Development overseeing the development of numerous Anti-Aging, Prestige Beauty, and Dermatological skin and body care. Peter also spent 9 years at L’Oreal in its Fine Fragrance division working on such brands as Ralph Lauren and Kiehl’s. Peter has a background in polymer chemistry, he has co-authored numerous book chapters and scientific publications, and has been an industry speaker at SCC events and annual AAD meetings.

 

 

Jeanine Smith has been in the industry for 19 years with her core focus in color cosmetics.  She is currently the Senior Manager of the Lip Category at Coty.  Prior to joining Coty, Jeanine was a Senior Manager at Avon Products where she worked in product development for the Eye, Nail and Lip categories.

 

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

by NYSCC NYSCC No Comments

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

by NYSCC NYSCC No Comments

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.

 

 

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

A polymer chemist in the personal care industry, Dr. Diane Lye is a product developer and formulator, translating novel raw materials into stable color, SPF, and skin care actives-containing consumer products. She studies the physicochemical properties of raw ingredients and finished formulas to map the consumer experience onto quantifiable entities.

Dr. Lye cut her fundamental scientific teeth by working on the design, synthesis, and bulk property characterization of main-chain block copolymer materials with supramolecular self-recognition end groups with the Weck Lab at the NYU Molecular Design Institute. She has 10 academic publications in her time in academic institutions, and developed a market commercialization assessment and plan for a dermal technology in conjunction with NYU Stern and NYU Langone.

Protection from Artificial Visible Light (and not just Blue Light)

by NYSCC NYSCC No Comments

One of the most relevant cosmetic-industry trends in recent years – “blue light protection” – is also one of the most widely misunderstood; this article will help dispel some of the mysteries surrounding the concept of skin damage from exposure to digital screens.

 

Blue light is not the whole story

“Blue light” is a catchy phrase that is easily recognized, probably because ambient light from TV screens tends to appear “bluish”. According to Esther Ingliss-Arkell (Gizmodo, 2012), “As you go down a dark street at night, you won’t just see televisions lighting up windows and making them blue. You’ll also see a light bulbs lighting up windows to make them yellow. Have you ever noticed those light bulbs making every room you enter at night a deep shade of yellow? No, of course not. Your eyes adjust and see it as more white. Light bulbs are about 3200° K, and so are yellow when looked at briefly from someone who has other things to compare them to. TVs, on the other hand, give off shades of red, green, and blue which combine to have a color temperature in the 5500° to 6500° K range. That’ll make them look bluish for someone walking on the street and comparing them to yellow streetlights and yellow house lights. It will also make them blue if someone is sitting in a room illuminated by a light bulb and looking at a room illuminated by a television.”

A recent study by Gattefossé examined eight different devices (Apple iPhone 4S, Apple iPhone 5S, Samsung Galaxy S4, Apple iPad 2, Samsung Galaxy Tab, Samsung Galaxy Note2, DELL screen U2312MHT, DELL screen E7440) with a high spectral resolution spectrophotometer, and found that the artificial visible light (AVL) from all of these screens is composed of three distinct peaks in the spectrum, corresponding to blue, green and red light in equal parts (See Figure 1).

Figure 1. Peaks represent the dominant wavelengths emitted by the devices tested.

Therefore, any study of potential damage from artificial visible light (AVL) must cover the full spectrum of blue, green and red, not just “blue light” alone.

 

AVL is not like sunlight, and does not cause the same damage to the skin

As we all know, sunlight produces UV radiation that can damage the skin via the generation of free radicals; we protect ourselves against UVA and UVB rays by using sunscreens (with organic and/or inorganic filters) that act to prevent DNA damage that can result in age spots, deep wrinkles, dry skin and potentially skin cancer. But AVL is in the visible spectrum and does not carry the same potential for damage – so it cannot be treated in the same manner! In other words, while AVL causes some generation of free radicals in the skin, these free radicals are NOT the main driver of damage (see below), so a simple sunscreen or free radical scavenging ingredient (antioxidant) will not sufficiently protect your skin from AVL-induced damage.

 

So what does AVL actually do?

Gattefossé conducted a human genome microarray-based gene expression analysis, and found that the pathways related to mitochondria and cell cytoskeleton were significantly affected (down-regulated) (See Figure 2). These pathways are critical to the normal function of the skin:

Mitochondria are responsible for cellular respiration (taking in glucose and oxygen, and releasing energy in the form of ATP)

The cytoskeleton is a network of filaments which not only supports the plasma membrane and gives the cell an overall shape, but also allows the cell to move and mediates communication across the entire cell

Figure 2. The expression of genes related to mitochondria and cytoskeleton is significantly decreased in fibroblasts exposed to AVL (*** p<0.001)

Therefore, exposure to AVL damages the energetic machinery of skin cells and weakens their mobility and communication properties, resulting in increased cellular fatigue. Exhausted and isolated, fibroblasts are less able to produce key matrix components and less functional to interact with their environment, hindering proper matrix remodeling process. In plain English, your skin will look duller, faded, with less vitality and “glow”.

 

Protection against AVL – This is not a passing trend!

Protection against AVL, also referred to as “digital pollution”, is becoming a critical part of today’s personal care routine. Gattefossé’s Lauren DelDotto said, According to a recent study, the time spent on smartphones by millennials is estimated at 3.2 hours a day = 22 hours a week = 49 days a year1. Another report records that US consumers own 4 digital devices on average and spend 60 hours a week consuming content through digital media2.” And these figures are only for leisure activities and do NOT count time spent in front of screens for work activities.

(1)  http://www.tns-sofres.com/publications/les-millennials-passent-un-jour-par-semaine-sur-leur-smartphone

(2) http://www.nielsen.com/us/en/insights/reports/2014/the-us-digital-consumer-report.html

The use of digital screens is a permanent part of our lives and will only increase. Think about what you do as soon as your alarm goes off in the morning – before eating, showering, dressing or preparing for work, you pick up your smartphone and check out what’s been happening, thus receiving an immediate and direct dose of AVL before you even get out of bed. Consumers are beginning to be concerned about this, and are looking for ways to protect themselves.

A recent Gattefossé consumer study conducted in both Thailand (to gauge consumer reaction from the Asia Pacific/Eastern market) and in France (for reaction from the European/Western market) found over 80% of the subjects found the concept of screen-light protection “seducing”, and over 90% of the subjects found the concept “brings novelty and differentiation to the facial care offer”.

Figure 3. Consumer test conclusions on the AVL concept and novelty.

 

Conclusions

If you are developing a product line with “blue light protection”, you need to keep these important facts in mind:

  1. Blue light is not the whole story – you must test against the full spectrum of artificial visible light (AVL), equal parts blue, green and red wavelengths.
  2. AVL is not sunlight – and you cannot protect against AVL the same way you protect against the sun’s rays. UV filters and antioxidants will not be effective against digital pollution; you need an active that protects against the actual effects of AVL – disruption of the mitochondrial network and disorganization of the cellular cytoskeleton.
  3. The “trend” is here to stay – screens are getting larger (100 inch TV, anyone?), more prevalent, and most people use multiple screens at the same time. Consumers are receptive, and eager, to incorporate AVL-protection into their normal skin care routine.

 

 

About the Author

Ben Blinder – Senior Director, Gattefossé

Ben Blinder is the Senior Director for Gattefossé USA – Personal Care Division, where he is responsible for the strategic direction and performance of the cosmetic business for Gattefossé in the US and Mexico. Ben holds a chemical engineering degree from Lehigh University and has been working in the personal care industry for 32 years, with extensive experience in strategic and long-range planning, sales and technical management, and new technology search/discovery.  Ben also serves on the NYSCC Scientific Committee.

Natural Sun-filters

by Webmaster Webmaster No Comments

Solar Ultraviolet Radiations UVA and UVB are complete carcinogens. They both cause DNA damage and, in the process of DNA repair, mutations are generated at non-negligible rates. Some mutations provoke the so-called transformation in which a cell acquires unlimited replication potential and loss of growth control.

UV radiation is also known to be the single most effective factor of skin aging. This occurs via the elicitation of a strong inflammatory reaction that provokes multiple oxidative cascades as well as the release of Matrix Metallo Proteinases, the consequent disorganization of the elastic fibers and a massive deposition of elastin.

Since the early twentieth century it is known that sunburn is provoked by UVB and the cosmetic industry developed UVB filters to protect against it. For two generations, between 1935 and 1985, UVB filters were used to protect the skin. In spite of the use of these filters it was observed that the skin of sun-worshippers became sagging and accumulated wrinkles, as if something else than UVB could accelerate skin aging. Experiments performed in the late 80s and early 90s by casting UV radiation of defined wavelengths on the skin of hairless rodents allowed scientists to realize that skin sagging is the consequence of UVA irradiation (1). UVA was also shown to induce DNA damage when in the presence of Oxygen and transition metals (2), as is the case in vivo. The cosmetic industry therefore developed UVA filters.

The preparations of formulas to protect against UV radiation is not straightforward, insofar as the protection afforded by the filters is not proportional to their concentration, that is that in order to double the SPF of a formula one might need to increase the concentration of the filter by a factor of three or four, and the filters at high concentration affect the esthetics of the formula and might affect the health of the skin as well. In addition, the UVA filters agreed to be in the positive list of the FDA are unstable. Remarkably, the FDA opposes the addition to the positive list, of new, stable UVA filters that transfer energy to molecular Oxygen and produce singlet Oxygen, the most reactive of the Reactive Oxygen Species. The FDA is probably right: with Quantum Yields of singlet Oxygen generation that reach up to 0.09, these UVA sun-filters could safely be called photosensitizers.

There is a need for new, safe, non-expensive UVA filters. They can be found in nature, for instance as components of edible algae (3). Plants and algae are particularly interesting insofar as they are accessible to investigation and constitute a sustainable material for extraction or production. Porphyra umbilicalis (also known as Nori) is an alga growing on Asian coastal lines. It is used to wrap sushi pieces in Japanese cuisine. It contains relevant amounts of Mycosporine–like amino acids (MAA) which absorb UV radiation with a sharp peak in the UV-A region, centered at 334 nm. Its molecular weight is around 350 and its molar extinction coefficient at 334 nm is 44,000. This is to say that its K-value is similar to the one of Parsol 1789. Nori extracts can be used to dramatically improve the broad-spectrum absorption of sunscreens. Materials absorbing at 330-340 nm are also demanded globally, for products aimed at evening skin tone, because they absorb in the UV-A region known to provoke the immediate pigment darkening.

Oftentimes the process of extraction of the material of interest only offers a limited yield, as it is the case when the material of interest is unstable in the conditions of the extraction, but this is not the case for the MAA from Nori. The biomass is suspended and incubated in diluted acetic acid (~0.5%) (1:50 w/v) to avoid the extraction of large cellular polymers such as DNA and RNA. Upon separating the biomass from the extraction fluid, a second round of extraction and possibly a third round of extraction can be performed, so as to extract as much of the molecule of interest as possible, when this is compatible of the cost of the extraction itself. The extraction fluid is then concentrated and reduced to a powder state by the process of Spray-drying.

At this stage the extract is appropriate for being used in cosmetic formulas. The cost of extraction is minimal and the abundance of the biomass is such that the cost of the bulk of algae is negligible. This makes the MAA from Porphyra umbilicalis an ingredient of choice for new sunscreens. As a matter of fact, this MAA does not absorb in the UVB and as such, technically, it is not considered to be a sun-filter by the FDA and can therefore be used to boost the protection of broad-spectrum sunscreens.

 

References

1- Bissett DL, Hannon DP, Orr TV (1989) Wavelength dependence of histological, physical and visisble changes in chronically UV-irradiated hairless mouse skin. Photochem Photobiol 50 : 763-769

2-Audic A, Giacomoni PU (1993) DNA nicking by UV radiation is enhanced in the presence of Iron and Oxygen. Photochem Photobiol 57 : 508-512

3-Sinha RP, Singh SP, Häder DP (2007) Database on mycosporine and mycosporine- like amino acids (MAAs) in fungi, cyanobacteria, macroalgae, phytoplankton and animals. J Photochem Photobiol B 89 : 29-35

 

Paolo Giacomoni acts as an independent consultant to the Skin Care industry.  He has served as CSO of Élan Rose International (2015-2-2018), as VP of Skin Care R&D with Herbalife (2011-2014) and was Executive Director of Research at Estée Lauder (1998-2011). Dr. Giacomoni was also in charge of research and communications for Clinique and has conducted research on cell and surface biochemistry for best-selling products.  During his tenure at L’Oréal, as Head of the Department of Biology, and then as scientific attaché to the Director of Applied Research, he built a record of achievement through research on DNA damage and metabolic impairment induced by UV radiation as well as on the positive effects of antioxidants.  Dr, Giacomoni was one of the founders of the European Society for Photobiology as well as of the European Network for the Study of the Biology of Aging. He has authored 100+ publications and patents. He received his Ph.D., in Biochemistry from Université Paris VI, a Laurea in Atomic Physics from Università di Milano, and had Post-Doctoral Training at Deutsches Krebsforschungszentrum, Heidelberg, at University of Wisconsin, Madison, WI and at University of California, San Diego, CA.

 

 

 

Skin Microbiome

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As a skin biologist and researcher of technology in the personal care field for over 20 years, there are few times in one’s career that you experience a trend that has the legs to become a new playing field in science.  The skin microbiome strides made in recent years have truly been remarkable.  Not only have the number of products available addressing the skin microbiome exploded but the number of research papers and articles on the topic has captivated the industry.  Furthermore, it highlights the direction and utilization of systems biology as a tool by applying the learnings of microbiology, skin biology, biochemistry, genetics and ecology all into one discipline.  The field is still in its infancy and in constant transition as the methods and models being employed are still being optimized to reduce bias and improve precision and accuracy.

The single primary driver of this new frontier are the remarkable advancements in high throughput gene sequencing and the computational analysis required to handle massive amounts of data and put it into a meaningful perspective.  Not only can we identify bacteria faster and more cost efficiently, but now we understand through genetic comparisons that strains of a species can differ significantly resulting in the difference between health and disease under a variety of conditions.  This was one of many topics permeating throughout a recent scientific microbiome congress held in Boston pulling together forces within the industry to form a multi-disciplinary approach to the opportunities and advancements within this growing field.   Other topics included consumer education, regulatory preambles, biological target identification, microbiome relevance, host-biome interactions and advances in technology used to study the human microbiome.

With all science comes controversy.  Areas of debate range from what defines a healthy microbiome to how diverse the microbiome should be and why our skin is losing its biodiversity.  Many claims and research point to our forefathers (hunter gatherer societies today) as having a much more diverse skin microbiome than modern man.  Thus, the prevalence of skin-related issues is markedly reduced in tribes living in the Amazon compared to that of our modern city dweller.  This loss of biodiversity has been linked to a significant increase in allergy-related disease.  Furthermore, the use of preservatives and complex ingredients in skin care products has been deemed suspect.  The relevance to other trendy areas within skin care can now be woven with a new perspective.  These include the role of pollution and the duration of solar radiation exposure.  Since the skin is the youngest organ in our body in terms of evolution, the sun and atmospheric environment plays a major role in its phenotype and function.  Research is now linking the evolution of our skin microbiome to the same influential environmental pressures.

The skin microbiome is the total sum of all microbes that live on or in the skin.  It is a highly dynamic entity that is analogous to a beehive in that it is responsive and adaptive to the many internal and external factors influencing its environment all simultaneously.  The exciting aspect of the skin microbiome is that it will force traditional science to think differently.  Application of environmental science theorems are now being placed into equations, hypotheses,  and experimental designs previously limited to a classical reductionist algorithm that one needs to understand the parts before understanding the whole.  This modality of scientific exploration has been dominated by the study of molecules explaining cells which, in turn, explains the function of tissues and helps us to understand how organs work and interact with in systems.

This is just part of the story.  Moving forward, we now must consider levels of organization that typically ended with an understanding of our own species.  With the skin microbiome, we need to consider the fundamentals of science from a more complex standpoint.  For instance, a full understanding of strain introduction within a species, population diversity with in specific organs, and communities of microbes between body sites are now combined with our classical understanding of skin biology to explain how this entire ecosystem influences our day to day function, health, and disease.  Truly, a new frontier awaits us.   I guess this is what the explorers Louis and Clark felt like starting their journey to the Pacific Ocean.

So where are we in this journey?  Researchers have characterized the human skin microbiome as both functional and site specific as it pertains to different regions on the body.  The two most distinct body environments are those with sebum and those without.  Compounding these areas are those under humidity, occlusion, and moisture and those that are not.  Of course, there are other microclimates on or in our skin including the follicular surface areas of hair, sweat and eccrine glands.  Understanding how each of these microclimates works at different stages of life, within ethnic groups, different geographical locations, and between the sexes is just the tip of the iceberg.

Areas of the skin that are rich in sebum have garnished much attention as these areas are most prone to acne as illustrated in work done by Prouty and Pappas.  It is within this area that we see some very interesting correlations with our skin actually regulating its own biodiversity.  Hair follicle-associated sebaceous glands secrete sebum, a highly complex lipid mixture that covers the skin surface and hair shafts. The functional versatility of lipids, combined with the wide array of sebaceous lipid classes, provide skin with a substrate that facilitates adaptation to diverse environmental situations, including interactions with microbes.  Analysis of sebum and its components have shown that a particular specific fatty acid called sapienic acid (16:1 n10), has been shown to be antimicrobial to Staphylococcus Aureus, the very species implicated in flare reactions in atopic dermatitis.  Furthermore, infection by Staphylococcus aureus is associated with a reduction in sapienic acid in the sebum of patients with atopic dermatitis, and topical application of sapienic acid is correlated with decreased bacterial load and reduction of symptoms. Taken together, this strongly suggests that sapienic acid functions as a “first-line” component of the innate immune system at the skin’s surface.

The beauty of this great journey is that it may explain and give way to an entirely new approach to skin care.  Host-biome interactions will be the focus of healthy immune development from birth to treating maladies such as atopic dermatitis, rosacea, acne, and dandruff, and body odor.  Learnings from the skin microbiome are migrating into oral and vaginal health arenas, changing the way we look at health and disease as well.

While research scientists unravel the complexities of the skin microbiome, the interest from within the industry is also buzzing with discovery and innovation.  There seems to be multiple avenues to enter this space and all have shown some level of promise in terms of delivering on claims.  We can certainly thank the yogurt industry for laying the ground work with the consumers.  From study data presented in Boston, consumers (especially Millennials) seem to get the concept of taking care of your skin the same way you take care of your gut microbiome.  Although, most consumers have a rudimentary understanding of microbiome, they are very willing to try products targeting it.  Reinforcing a healthier lifestyle, conforming to more natural-based hygiene practice or looking to change the way their skin behaves is all the motivation consumers need.

New technologies and innovation are taking form in a variety of ways.  Prebiotics seem to be gaining the most momentum in skin care as evidenced by the number of new prebiotic technology offerings seen at the last two In-Cosmetics shows. Prebiotics are those materials that feed, nourish, and/or manage the skin microbiome in some form or fashion.  Examples of prebiotics are polysaccharides, polyols, free fatty acids, fibers nitrogen sources, and lactic acid.  By focusing on prebiotics, many technology companies avoid the complexities of having to grow live cultures of bacteria to generate a second category called probiotics.  With this strategy, we see the use of live bacteria whether sourced from skin or other substrates like soil.  Some are using the very bugs found in yogurt while others are applying species said to be part of our microbiome during earlier times of human existence but were lost.

This category of products is the most complex and wrought with controversy.  Should live or dead microbes be used?  How do skin bacterial communities change with new species introduction?  How much biodiversity is too much?  All of these questions are being studied at every level of complexity.  Another branch of probiotics is now emerging by genetically engineering normal flora strains to secrete enzymes and factors needed to correct deficiencies in skin physiology.  A well-known condition called atopic dermatitis is characterized by inflammation, itch, a reduction in barrier function, and loss of moisturization.  Researchers are now programing Staphylococcus epidermidis, a commensal microbe (found to be reduced in atopic dermatitis) to secrete barrier-related proteins, enzymes to increase lipids, and antimicrobial peptides to reduce the Staph aureus load (which supersedes that of Staphylococcus epidermidis in atopic dermatitis).  Lastly, we have the category of postbiotics.  This group consists of fermentation products and supernatants from bacterial culture.  These materials are the next generation prebiotics.  Designed and targeted to shift to better microbiome health, an increase in biodiversity, and to provide a new way to achieve clean healthy beauty.

The journey to understanding the skin microbiome is well underway.  Nobody knows for sure where we will be in the next 5 to 10 years. The models and methods used to study the skin will advance and become more sophisticated as well, as the products and claims associated with these new discoveries develops.  It is exciting to see so many disciplines coming together to unravel the mysteries of our microbial populations and communities living and working with us in so many ways.  New levels of understanding will be achieved in exploring commensal and symbiotic relationships with our tiny friends.  The skin microbiome field will inevitably fall into sub-specialties where you have the folks looking to keep skin clean and free of microbes while others will look to preserve and propagate the populations of beneficial microbes to sustain and promote healthy skin. When it comes to research into the skin microbiome, we truly are the sum of all of our parts and then some.

Michael Anthonavage has 20+ years of experience in personal care product development and a career spanning background in skin biology. Michael has extensive knowledge in product development in the area of personal care product design and specializes in R&D to marketing translation. He is an engaging public speaker and product technology advocate with an ability to marry complex ideas and concepts to various consumer needs. Michael is currently the Director of Advanced Clinical Services at CRL. Michael’s previous positions involved R&D leadership positions at Johnson & Johnson Consumer Products, Presperse and Vantage Specialty Chemicals.  Michael is currently on the NYCSCC Scientific Advisory Board and has a number publications and patents to his name.

Halal certification for personal care raw materials and products

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Muslims around the world used the word Halal for many years to describe a certain dietary regimen. The roots of the word originate from the Quran and Shariah and it typically defines how animals are slaughtered and restricts the consumption of certain animals, and alcohol.  In general, everything created by God is allowed as food with some exceptions.  These exceptions include pork, blood, animal meat that was not properly slaughtered, alcohol, intoxicants, and inappropriately used drugs.  With regard to fish, all fish with scales are allowed but animals that live both in water and on land like frogs are not allowed.  In addition to previously described restrictions, Genetically Modified Organism (GMO) and body parts/fluids are not allowed.  For example, gelatin is not considered Halal if it comes from pigs or from animals that were not slaughtered properly.  Keratin and stem cells from human origin are not allowed as well.

In the last decade, the word Halal was used to describe not only foods but also personal care products as well as cosmetics and a variety of other marketed products. The demand for Halal products has continuously grown over the past few years and is expected to grow even further.  For cosmetics, raw materials as well as finished products are subject to certification.  As a general rule, during the Halal certification process the products should first meet all local guidelines in terms of safety purity and quality.  For example, if the product is under the FDA jurisdiction, it must meet first such guidelines and then be considered for Halal certification.  The certification process typically starts with an application, followed by submission of the documents related to sourcing of all raw materials and is typically finalized with an onsite inspection.  The onsite inspection considers factors like manufacturing, storage, packaging and transportation of such products.

In North America there are several agencies that certify raw materials and cosmetics products. The Halal Advisory group www.halaladvisory.com is one of such agencies and is located in New York city. Another agency of interest is the Islamic Society of the Washington Area known as ISWA www.ushalalcertification.com. This agency is located in Washington DC and like other agencies has an online application.  The Islamic Food and Natural Council of America (IFANCA) is located in Park Ridge, IL and has a web presence at www.IFANCA.org the agency grants Halal certificates as well. For European companies, The Muslim Food Board (TMFB) located in the United Kingdom issues Halal certificates under its division; Halal Certification Europe.  Applications can be submitted online at www.tmfb.com.

I hope this short synopsis will give the reader an overview of the Halal guidelines, and means to obtain certification for raw materials and finished goods. If additional information is needed to understand the Halal standards, one good resource is The Malaysian Standard MS 2200 Pat1: 2008 which describes the practical guidelines for handling Halal cosmetics.

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.

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