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April 2021 • Vol. 27 • Issue 4

Strategic Development of Botanical Antiperspirants

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…by Phil Klepak and Barbara Schmidt

here has been a growing trend over the last several years of using natural products with medicinal activities, particularly in overseas markets. Plant extracts have been identified for the treatment of acne, psoriasis, and dandruff. At present, the FDA has only classified a few botanicals as GRASE for a specific OTC drug use. This article addresses whether some plants contain sufficient bioactive phytochemicals that could function as “natural” antiperspirants when applied from a topical formulation. According to the U.S. FD&C Act, the FDA classifies antiperspirants (reduce underarm perspiration) as OTC drugs, while deodorants are classified as cosmetics. Globally, most countries classify antiperspirants as cosmetics, including those products with duration of effect claims. This is true in the European Union, Australia, New Zealand, South Africa, and Latin America. In Canada, classification depends on the claims, and in Japan they are “quasi-drugs” (the difference vs. a cosmetic is somewhat ambiguous). Only the U.S. and UK have quantitative standards for antiperspirant performance. Therefore, if your product reduces perspiration statistically better than a control, you can label your product an antiperspirant.

Ingredients from Nature

Natural products have a range of bioactivities to reduce sweating including astringency to contract skin pores, absorbency, decreased sweat stimulation via the parasympathetic nervous system, and protein aggregation forming sweat pore plugs. Plants have been used for centuries to reduce excessive sweating, but in Traditional Chinese Medicine and Ayurveda, most were taken orally for fever diseases like malaria or perceived systemic health issues. Topical sweat reducers for everyday sweating are uncommon in ethnobotanical literature and even fewer have been tested clinically in controlled trials. In Traditional Chinese Medicine, Chinese sumac galls, turmeric, schisandra, ephedra root, mulberry leaf, and Amur cork tree bark are applied topically to reduce excessive sweating. All of these herbs can be mixed with minerals or starches to help absorb sweat. Chinese sumac galls contain gallotannins with astringent and protein cross-linking properties that may reduce sweat. The other herbs contain primarily polyphenols (turmeric, schisandra) and/or alkaloids (Amur cork tree bark, mulberry leaf, and ephedra) with little scientific validation aside from polyphenol astringency. Mulberry leaves and ash tree bark (Qin Pi) were tested in a clinical trial for foot sweating. When used as a 15-minute foot soak, they reduced foot sweating by an average of 15% in a pilot study with 20 healthy volunteers.1 Both herbs have antibacterial properties, which could help reduce foot odor. A combination of five Ayurvedic herbs (Himalayan cedar, nut grass, jasmine, black turmeric, and vetiver) traditionally used as a topical remedy for foot odor and excessive sweating were tested in a controlled clinical trial.2 After 15 days, there was a reduction in foot odor, sweating, and itching. The herbs contain a variety of phytochemicals such as essential oils rich in antimicrobial terpenes that may be responsible for the positive results. (continued on Page 8) In North America, the Navajos used rough cocklebur liniment for underarm sweating. In Europe, traditional

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2021 NYSCC EXECUTIVE BOARD & COMMITTEE Chair Susanna Fernandes chair@nyscc.org Chair-Elect Giorgio Dell’Acqua chair-elect@nyscc.org Treasurer Mohamed Abdulla treasurer@nyscc.org Secretary Leor Fay Tal secretary@nyscc.org Advisor Giorgino Macalino advisor@nyscc.org Program Cathy Piterski program@nyscc.org By-Laws Amy Marshall amy.marshall@altana.com Communications Maria Sousa socialmedia@nyscc.org Special Events Amy Marshall amy.marshall@altana.com Cosmetiscope Editor Roger Mcmullen roger_mcmullen@fdu.edu Cosmetiscope Advertising Bret Clark rbclark@ashland.com Social Media Maria Sousa socialmedia@nyscc.org

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Letter from the Chair

…Susanna Fernandes

pring has sprung and NYSCC membership activities and educational programs are flourishing! Although not our typical technical focused type program, the month-long webinar series, “Celebrating Women in Science,” in March was a success. We were able to shine light on the career paths and opportunities for women in science and the cosmetics industry, which is often overlooked and underrepresented. The program concluded with a lively roundtable discussion featuring women who have pushed forward and excelled in historically male dominated fields of the industry—R&D, Product Development, Marketing, and Sales. The NYSCC is grateful to our sponsors who made this unique program possible as well as to the women-owned vendors who contributed to the “Experiential Box” given to lucky participants. In March, we also offered a timely and technical At Home Live program on “Trends and Formulation Strategies for Gentle Cleansing” that attracted over 700 registrants and online viewers from all over the world including Argentina, Belgium, Finland, France, Japan, South Africa, and Thailand. This well received program featured key strategies and insight for formulators to help meet this growing consumer need. The Program and Scientific Advisory Committees have been hard at work finalizing our At Home Live webinar, and in-person educational calendar for the rest of the year. On the horizon will be programs on Skin Aromachology, Ethoxylated World of Personal Care, Sourcing Sustainably in Bioactives as well as sessions on Mentorship, Regulatory Updates, and more. We are also developing content on Exposome, Color Trends, and Antioxidants. A return to our fun social events is also being planned with a Golf Outing in July and the popular Culinary Event in October. I am excited about April’s on point educational offerings focused on “Elastomers—The New Wave of Sensory,” presented by Tania Vania, Global Technical Director, Grant Industries, Inc. taking place on April 22nd. Then on April 29th, moderated by our Chair-Elect, Dr. Giorgio Dell’Acqua, will be an intensive webinar on “Wellness in Beauty.” This prestige panel—featuring a top dermatologist, innovative brand founder, technical marketer, and wellness influencer—will explore how our senses, our body, its functions, and its appearance are interconnected. Behind the scenes, Suppliers’ Day continues its progression to a live, in-person event on November 10th-11th at the Jacob K. Javits Center in New York City with a virtual day being held on November 12th. In future issues of Cosmetiscope, I’ll be sharing the latest developments and updates of this important event. I am truly looking forward to coming together as an industry at North America’s premier trade show and conference for ingredients and formulation. As always, I am always open to hear from our members about how the NYSCC can better serve you. Please do not hesitate to contact me. Here’s to brighter days ahead—stay safe and be well!

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NYSCC Volunteers

s we prepare for the future, I would like to remind you that even during these unpredictable and challenging times, the NYSCC has remained a vibrant source of education and engagement. There is still time to be a part of this and make your mark in NYSCC history! As your Chair for 2021, I am in the midst of finalizing programming, special events, and awards programs. All of these events are conceptualized and brought to fruition by you, our members. Member volunteers gain incredible networking opportunities that span the globe while providing real value to their colleagues. If you have not already done so, I urge you to consider becoming a part of this incredible team! We are now accepting applications for volunteers: please click through and COMPLETE THE FORM to receive consideration for a volunteer position. After we review your application, we will contact you and arrange a call so together we can ascertain the best fit for you within our committees and future projects. Stay safe and I hopefully look forward to being with all of you soon! Susanna Fernandes 2021 NYSCC Chair 2

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NYSCC Programs

BEAUTY

begins here. Safe, sustainable, bio-based ingredients for personal care.

Wellness in Beauty

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GO

April 29, 2021 Virtual Event

ellness in Beauty is one. Consumers, brands, and scientists recognize that our body, its functions, and its appearance are interconnected. Feeling well is often associated with looking good! During this two-hour event you will have the chance to listen to experts taking a deep dive into wellness and beauty market trends as well as how ingredients and nutraceuticals affect beauty— the inside/out trend. Our speakers will also explore the science that explains why our senses can influence our look and take on holistic wellness and its connection with nature and beauty.

Organizer and Moderator

To register, visit the Events section of the NYSCC website: www.nyscc.org.

• Giorgio Dell’Acqua, Ph.D. – NYSCC Chair-elect

Speakers

• Prof. Paul L. Bigliardi, M.D. – Skin Sense: The Skin in the Center of Peripheral Sensation and its Connection to Wellness

• Dr. Sophia Kogan, M.D. – Hair Wellness – An Innovative, Science-Based Approach to Addressing Hair Thinning from the Inside Out • Jennifer Walsh – Beauty Connection with Nature and its Relationship to Wellness • Leor Fay Tal – Beauty Meets Wellness and the Ingredient Landscape

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Speaker Biographies

NYSCC At Home Live Webinar Series

(continued from Page 3)

n Giorgio Dell’Acqua, Ph.D. – Organizer and Moderator

After obtaining his Ph.D. in Cell Biology in 1989, Giorgio Dell’Acqua worked for 15 years as an investigator in applied medical research in different institutions including Mount Sinai Medical School in New York and Harvard Medical School in Boston. Moving to the private sector in 2000, he has spent the last 20 years as an executive and cosmetic scientist in the personal care industry. As a consultant, he directed R&D, Science, Product Development, and Innovation at contract manufacturers, brands, and ingredient companies (such as La Prairie, Dior, Kiehls, Nutrafol, Induchem, Vantage), specializing in skin and hair care applications. Giorgio Dell’Acqua has helped bring more than 200 successful active ingredients and formulations/products to market, has authored more than 70 publications in medicine and cosmetic science, is an inventor of many patents, and has been a presenter and a keynote speaker in more than 20 events and conferences in the last two years. Some of his recent product development activity has focused on upcycling, prebiotics, adaptogens, clean beauty, and social progress in sustainability. Giorgio Dell’Acqua is an award-winning speaker on natural ingredients and a regular writer on sustainability. He is also the 2021 Chair-elect for the New York chapter of the Society of Cosmetic Chemists and its blog producer. Surface Treated Pigments

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n Prof. Paul L. Bigliardi, M.D. – University of Minnesota

Professor Bigliardi, is a Zelickson Full Professor at the University of Minnesota, Minneapolis, where he leads, as Director of the Allergy Division, all clinical activities in allergy while directing research in neuro-dermatology. Previous to his current appointment, he held positions as: Head of Dermatology and Allergology clinic at the State Hospital of Schaffhausen, Switzerland; Associate Professor and Director of the outpatient clinic and dermato-allergology unit at Lausanne University Hospital, Switzerland; and a senior consultant in Rheumatology and Associate Professor, as well as Director of Clinical Research Unit for Skin, Allergy, and Regeneration, IMB/A*STAR, University Hospital Singapore (NUHS). Dr. Bigliardi is a physician with over 20 years clinical experience in dermato-allergy, focusing on allergic diseases in skin and hair. Dr. Bigliardi’s interests in neuro-dermatology led to the discovery of the opiate receptor system in the skin as well as the discovery of a novel mechanism in hair loss/miniaturization involving PDG1. He was further able to characterize the human follicle microbiome and to study its evolution during miniaturization. Dr. Bigliardi works with engineers, biologists, chemists, and companies to develop and test new sensory, diagnostic, and therapeutic models; concepts; and devices in skin and hair research—mostly related to allergy and neuro-dermatology. He has also been involved in the development of novel human 3D epithelial models using microfluidic and 3D printing techniques for testing of compounds. He has presented numerous times on the intimate connection between our brain, skin, hair, and mechanisms of inflammation. ___________________________________________________________________

n Sophia Kogan, M.D. – Nutrafol

Dr. Sophia Kogan, M.D. is the co-founder and Chief Medical Advisor of Nutrafol, the first clinically effective hair wellness supplement to use medical grade, biooptimized ingredients that target multiple root causes of hair thinning. Dr. Kogan earned her medical degree from SUNY Downstate Medical Center in Brooklyn, NY. She did residency training at Tufts New England Medical Center and SUNY Downstate Medical Center, where she completed a research fellowship in pediatric dermatology. In search of answers to her own health and hair thinning issues during the stress of medical school and residency, Dr. Kogan discovered the benefits of an integrative approach with botanicals. She has dedicated years of study on the effects 4

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of herbs, nutrition, and stress management on overall wellness, and particularly how they manifest in the health of hair. In 2015, she partnered with Giorgos Tsetis and Roland Peralta to co-found Nutrafol, a patented nutraceutical formulation that uses a blend of bio-optimized botanicals to address key underlying factors of hair issues including stress, hormones, and gut health. Dr. Kogan has spent the past decade researching hair loss and has been coined by her peers as an expert in integrative hair health. She has published and co-authored numerous publications on the topic of integrative approaches to hair and clinically effective botanical medicine, including a recent industryfirst study on hair thinning in women through menopause in the premiere Journal of Drugs in Dermatology. She speaks frequently as an expert on the topic at meetings, conferences, and in interviews with prominent media outlets including Shape, Who What Wear, Byrdie, The Knot, Goop, and others. Most recently, she was featured as an expert on the impact of the past year’s stress on hair loss in women in an episode of Dave Asprey’s renowned Bulletproof Radio podcast. In her free time, Dr. Kogan actively practices self-care through dance, yoga, meditation, and clean eating. She is also a certified Kundalini Yoga teacher. ___________________________________________________________________

n Jennifer Walsh – Nature GreenPrint

During the last 24 years, Jennifer Walsh has communicated on wellness, beauty, and business both on air and as a writer for publications and for online platforms. Jennifer is a true architect of the beauty and retail landscape. In 1998, she launched Beauty Bar, the very first omni-channel beauty brand in the U.S., changing the way people shopped for beauty. Beauty Bar was the vehicle that allowed its early shoppers and adopters to see and try out niche beauty products in her brick-andmortar locations, website, and weekly TV show. Jennifer grew her business until it was ultimately sold to Amazon in 2010. Since then, Jennifer has created multiple beauty and wellness brands. Jennifer intuitively knew that her connection to the beauty industry was always deep rooted in nature and how we connect with the natural elements around us. She started spending time with neuroscientists around the country to learn more about our connection to the natural world and its effects on the brain. She began leading people on Wellness Walks to educate others firsthand how the amount of time spent outdoors affects our bodies and brains. Through her The Walk with Walsh video series she was able to share stories of people, products, places, and spaces that were bringing us back to the natural world, both outdoors and indoors with biophilic design. ___________________________________________________________________

n Leor Fay Tal – Gattefossé

Leor Fay Tal, who earned her a Bachelor’s degree in Biological Sciences from Rutgers University, is a multifaceted cosmetic industry professional with experience in R&D, Regulatory Affairs, and Marketing in the B2B environment. As the current Technical Marketing Leader for the Personal Care division of Gattefossé USA, she delivers insight on market and consumer trends; provides technical marketing support to the company’s sales teams and distributors across North America, Canada, and Mexico; and reinforces the knowledge and understanding of the company’s ingredients. Using creative skills in graphic design, copywriting, and video production, she also generates informative and entertaining content for the company website, webinars, newsletters, e-mail campaigns, and customer presentations. Leor has presented at tradeshows, including TeamsWorks 2020 and ExpoCosmetica 2019, and institutions such as UNAM, University of Toledo, and Manhattan College. Prior to Gattefossé, Leor Fay worked in the R&D Powder Laboratory and then as the Raw Material Regulatory Affairs Specialist at MANA Products. Leor Fay is also an active member of the NYSCC. She organized the April 2018 event Cosmetics in the Middle East, A Regulatory Perspective; co-wrote the May 2020 blog, “Formulating effective and stable W/O emulsions;” presented “The Blue Light Myth” for the At-Home-Live Series in October 2020; and serves as the Secretary for the executive board.

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NYSCC Focuses on the Future Formulation Expert!

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hile providing education and engagement for our members and the cosmetic chemistry community at large is paramount to our mission, equally important is engaging and empowering those who will be the future force of the industry. The 2021 NYSCC Suppliers’ Day event will be the epicenter for these next generation leaders with programs designed that allow them to envision their future. Here’s an overview of what’s planned:

Future Chemists Workshop (FCW)

A staple at Suppliers’ Day in New York City, the FCW provides an interactive learning and challenge based environment for university students and leaders of tomorrow. Our goal is to host and instruct approximately 50 university students from chapters across the U.S. in a safe and compliant real-life lab experience. This is scheduled to take place on Day 1 of Suppliers’ Day – November 10, 2021.

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Mentor-Mentee Icebreaker and Mixer

This event brings students from the FCW, as well as NYSCC student members, together with seasoned industry professionals to highlight and reinforce the professional development programs offered at Suppliers’ Day and throughout the year by the NYSCC. The committee spearheading this program will also introduce the sophisticated database which will match mentors and mentees while fostering interaction through fun, thoughtprovoking icebreakers. This is scheduled to take place over breakfast on Day 1 of Suppliers’ Day – November 10, 2021.

Kamini Barot Sales Director - Americas kbarot@orchidia.com (732) 353-9706 www.orchidia.com

SCC Career Day

NYSCC Suppliers’ Day will join forces with National SCC to complete this trifecta of offerings. Details are still being finalized, but topping off the activities for junior members of the SCC at large will be an opportunity to meet significant stakeholders of the cosmetics and personal care industry who will come together to share information on what the industry needs from its future workforce. During the event, information will also be presented by academia and corporate professionals providing attendees with vital information on how to take the next step in their cosmetic science career.

T

Call for Papers

he Cosmetiscope editorial committee invites all interested parties to submit feature technical articles for publication in the NYSCC monthly newsletter. Authors of feature articles are eligible to win the prestigous NYSCC Literature Award ($1,000) for the best front-page article published during the calendar year. Authors also receive $200 reimbursement to attend a theatrical performance of their choice. Writing an article for your peers is a very rewarding experience, both personally and professionally, and will ensure your place in NYSCC history. You may choose whatever topic you feel would be interesting to fellow colleagues in our industry. We also welcome any other types of commentaries or articles that may be published in the Career Corner, Technical Tidbit section, or as a Letter to the Editor. Please send correspondence to: roger_mcmullen@fdu.edu.

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Strategic Development of Botanical Antiperspirants

(continued from Page 1)

antiperspirant formulations include common yarrow (Achillea millefolium), soapwort (Saponaria officinalis), and elderberry (Sambucus nigra) flowers, sage (Salvia officinalis and S. libanotica), horsetail (Equisetum arvense), rockrose (Cistus ladanifer), and Milkvetch (Astragalus spp.). However, there are no published clinical studies to validate any of these herbs as effective antiperspirants.

Research and Development Challenges of a Natural Antiperspirant

Clinical efficacy testing of the final antiperspirant formulation is necessary to support the specific claim of “reduces underarm sweating”. This means that the natural extract should be tested at the level required to demonstrate the intended claim. The performance target can be either a statistically significant sweat reduction compared to a placebo or to meet or exceed the minimum quantitative FDA standard using their statistical standard. Ingredient screening tests could be helpful prior to conducting an underarm wetness clinical study, namely measuring the electrical conductance/impedance of the skin, TEWL from the skin by detecting changes in relative humidity, or protein aggregation in a microfluidic test system. Some challenges should be recognized and factored into R&D plans. First, our evidence from pilot studies suggests that natural extracts may not be as effective as aluminum-based salts. Since natural extracts are a mixture of compounds, there can be substantial variation depending on the source. A standardized phytochemical profile may be necessary for quality control. Furthermore, some natural extracts can be difficult to work with. For example, are they prone to contamination or do they present preservation concerns? Formulations containing natural extracts could have a shorter shelf life due to degradation of the active component over time. It may be appropriate to follow the stability of several marker compounds. Botanical ingredients are available as a liquid extract mixed in solvents like glycerin and glycols or in powder form with or without excipients. Many phytochemicals are easily oxidized, especially at room temperature in the presence of solvents including water and alcohols. We have observed considerable, rapid degradation of phytochemicals in plant extracts when stored in a liquid or cream base. In contrast, we found dry extracts from the same plants retained their phytochemical integrity and clinical antiperspirant efficacy for 18-24 months at room temperature. Also, we have observed a loss of phytochemicals when mixed with certain “inert” excipients, possibly due to irreversible adsorption. One significant hurdle of using dry extracts is difficult dissolution. Experimental trial and error experiments are required to find the optimal solvents, heat, and agitation for dissolution. Many cosmetic chemists are aware of the unique challenge posed by natural products in cosmetic formulations. High batch temperatures must be avoided to reduce phytochemical degradation. When using waxes that require high melting temperatures, the extracts could be incorporated at the end of the batch, after the temperature has dropped. Even after extracts or pure phytochemicals are fully dissolved and incorporated into the formula, they can precipitate once the batch cools or after a longer period of time. They can cause an emulsion to split over time or lose viscosity. They can react with packaging and frequently change the formula color from light to brown. A rigorous experimental process is usually required to find a formula that optimizes both phytochemical and formulation stability. Specific guidelines and protocols for the efficacy assessment of underarm antiperspirants are well documented in a variety of published sources such as the FDA/Federal Register (2003), EEMCO (2003), and Clearcast (2019). These gravimetric protocols quantify the amount of eccrine sweat produced in the underarms during specific time intervals and under controlled conditions. More sophisticated testing options are also possible to support claims such as longer duration of efficacy, physical activity resistance, psychological stress protection, extreme heat resistance, night sweats, etc. Based on our knowledge and testing of natural extracts, they exhibit less efficacy than aluminumbased salts, so it is important to ensure that their wetness reduction performance can be measured with statistical confidence. Also, assessing small amounts of sweat at weak excretion rates is difficult, and requires experimental skill. Therefore, the following is recommended to design and conduct a successful clinical test of natural extracts: 8

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• Baseline sweating values in both armpits should be similar and not skewed. A spread between the lowest and highest sweaters of at least 600 mg is recommended with a minimum of 100 mg sweat per armpit. • Pro-perspirer panelists (i.e., sweating more after product treatment) should not be enrolled. • Mixed gender test panels are not recommended to avoid any questionable results due to surface area and sweat volume differences. Female panelists are generally used. Typical sweat reduction clinical trial results for a formulation containing a combination of two plant extracts rich in polyphenols and diterpenes were as follows: 24% at the original concentration of actives, 29% at twice the concentration of actives, and 20% at the original concentration of actives then aged for 18 months.

Marketing Justification

The global underarm products market is healthy with growth fueled by the youth population. Lifestyle changes which include a focus on hygiene, daily grooming routines, disposable income leading to discretionary toiletry products becoming daily necessities, and product format and ingredient innovations are key factors currently driving the market. A concurrent global trend in the cosmetics market in general is the rising consumer awareness of natural ingredients with therapeutic or biological effects. Despite significant evidence to the contrary, the safety of aluminum salts is under continued scrutiny even though the links to breast cancer, Alzheimer’s disease, and dermal absorption are not generally accepted in the scientific and medical communities, and some studies are even discredited. This continued negative perception of aluminum-based antiperspirants is contributing to a growing consumer demand for natural antiperspirants specifically for sticks, creams, and emulsions. Given the consumer demand for natural antiperspirants, and ethnobotanical knowledge of several herbs used as topical antiperspirants, more resources should be devoted to identifying potential antiperspirant ingredients from natural sources and verifying their clinical efficacy. Once potential candidates have been identified, challenges such as reliable ingredient sourcing, formulation, and stability can be overcome with dedicated R&D investment.

References

1. P.C. Leung, et al. Evaluation of the topical antiperspirant effects of a simple herbal formula, Clin. Med. Invest., 2(1): 1–3 (2016). 2. A.V. Kamble and M.R. Joshi, A clinical study to evaluate the efficacy of Ayurvedic/herbal deodorant on sole, WJPR, 6(13): 862–872 (2017). _______________________________________________________________

About the Authors

Phil Klepak

Phil Klepak retired in 2018 after 31 years of direct experience in all aspects of antiperspirant and deodorant technology with Reheis/SummitReheis/Elementis as Global Director of Technical Services. This included knowledge of chemistry, formulations, process troubleshooting, clinical testing protocols, etc. He also taught the SCC continuing education course on antiperspirants and deodorants for many years.

Barbara Schmidt, Ph.D.

Barbara Schmidt has a Ph.D. from the University of Illinois, Urbana-Champaign where she studied phytochemistry. She specializes in botanical raw materials for the personal care and dietary supplement industries. She authored an enthnobotany textbook in 2017 and is currently teaching phytochemistry for the Rutgers University Global Institute for BioExploration (GIBEX).

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2021 NYSCC Events Calendar

Event Chair: Roger L. McMullen, Ph.D.

• For updated NYSCC information, visit us on the web at: www.nyscc.org • For National SCC information: www.scconline.org April 22

Elastomers—The New Wave of Sensory – Virtual Event

April 29

Wellness in Beauty – Virtual Event

May 12

Exposome – Virtual Event

June 29

Antioxidant Symposium – Virtual Event

July TBD September 14

NYSCC Golf Outing – Crystal Springs Resort, Hamburg, NJ All About the Skin – Chart House, Weehawken, NJ

October TBD

NYSCC Culinary Event – Location TBD

October TBD

Indie 360 2.0 – Location TBD

November 10-11 November 12 November TBD December 14 December 14-15 10

NYSCC Suppliers’ Day – Jacob K. Javits Convention Center, New York, NY NYSCC Suppliers’ Day – Virtual Day Color Event – Lightbox, New York, NY NYSCC Supports Education, New York, NY SCC Annual Scientific Meeting, New York, NY

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