Cosmetiscope - March 2016

MARCH 2016 • Vol. 22 No. 3

New York Society of Cosmetic Chemists

www.nyscc.org

The Control and Examination of the Microbial Content of Processing Water used in Cosmetic Preparations …by Joseph Albanese

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etting up a complete quality assurance program for the microbiological content of cosmetics is an enduring task.

Since so many products are water based, the program must place emphasis on the control and inspection of processing water.

It is well documented that water is a major source of bacterial contamination in cosmetics.1-4 A technical understanding of a system for the control of processing water is essential for the microbiologist. This article is mainly concerned with this aspect of the microbiological quality assurance of cosmetics.

In order to set up a program for the microbiological quality assurance of cosmetics, the microbiologist must know the FDA regulations and Personal Care Product Council guidelines for cosmetics. A system that will assure the quality of processing water must be properly designed. For that purpose, knowledge of the effectiveness of ultraviolet light and how it works to destroy microbes is important. Methods of enumerating and identifying bacteria must be readily available to the cosmetic microbiologist.

Introduction The cosmetic microbiologist must perform quality control measurements on finished products for bacterial contamination before releasing them for retail. This is necessary to prevent spoilage of the product, the possible spread of disease, and noncompliance with federal and self-imposed regulations.

Product spoilage in the forms of altered pH, separated emulsions, created malodors and discoloration, fungal growths, etc. can be the results of microbes growing and metabolizing in cosmetic products. This loss of aesthetic appeal can lead to product recalls and significant economic losses.

Pathogenic bacteria isolated from cosmetics have proven to be etiological agents of disease. Lotions applied to injured skin of burn victims have even produced disease.1,4,5 It has even been shown

that mascaras contaminated with bacteria produce injury to the eyes.1,5,6 Companies have a moral responsibility to ensure that their product does not harm the consumer. Such unfortunate events may result in costly litigation and damage to the company’s public image.

The FDA compliance program for the microbial control of cosmetics states that: 1. All gram-positive microorganisms present in cosmetic products at levels greater than 1000 per gram must be identified.

2. All gram-negative isolates from cosmetic products are to be identified at any level as to genus and species.1 The FDA’s laws controlling cosmetics are few and the agency’s authority to regulate these products is limited.7 However, FDA inspectors do check to ensure that proper tests are performed for microbiological contamination on all susceptible raw materials. They also inspect production facilities to certify that all equipment coming in contact with the product is cleaned and sanitized as necessary.

Not surprisingly, federal regulations regarding microbial content are more rigorous for drugs than for cosmetics. Therefore, (Continued on page 2)

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March 22 • The Chart House, Weehawken, NJ

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2016 NYSCC BOARD OF DIRECTORS & PROGRAM CHAIRS CHAIR Rey Ordiales (732) 878-7798 reyordiales@outlook.com

CHAIR-ELECT Marie Thadal (609) 712-3716 chairelect@nyscc.org

TREASURER Cathy Piterski (201) 675-3799 cpiterski@essentialingredients.com

SECRETARY Giorgino Macalino (862) 324-2749 Secretary@nyscc.org

ADVISOR Kim Burch (609) 443-2385 Kim.Burch@elementis.com

HOUSE Mohamed Abdulla (973) 487-6572 mohamed.abdulla@airliquide.com

MEMBERSHIP

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The Control and Examination of the Microbial Content…

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in order to avoid expenditures of time and money to comply with tough federal laws for drugs, manufacturers often formulate in such a manner to have their product labeled as a cosmetic rather than a drug.

The Food Drug and Cosmetic Act defines cosmetics as products whose ingredients are intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance without affecting the body’s anatomy or physiological function. Products that affect anatomy or physiology are considered drugs.

Products like anti-dandruff shampoos, suntan lotions, and antiperspirants are examples that fall into both categories.7 Furthermore, guidelines were prepared by the Personal Care Products Council Microbiology committee.

These guidelines are an attempt by manufacturers to regulate their products without federal intervention. The Personal Care Products Council Microbial Content subcommittee defines a ‘standard’ as an administrative regulation with the force of law and a ‘limit’ as a suggested maximum number of organisms as determined by prescribed methods.

The following guidelines were proposed by the subcommittee: 1. Baby products should not contain more than 500 microorganisms/ml.

2. Products used around the eye region should not contain more than 500 microorganisms/ml.

3. Oral products should not contain more than 1,000 microorganisms/ml.

4. All other products should not contain more than 1,000 microorganisms/ml.

Roger McMullen roger_mcmullen@fdu.edu

In addition, no product shall have a microbial content recognized as harmful to the user as determined by the standard plate count method.8 All microorganisms need water to survive and water based products are highly susceptible to bacterial contamination.9 Products like alcoholic preparations (greater than 25%), deodorants and antiperspirants, bath salts, and aerosol products have low susceptibility to microbial growth.

Inspecting raw materials of animal or botanical origin is important. Even water contains enough organic matter to sustain bacterial growth. The fact that Pseudomonas sp., in particular, can grow in distilled water is well noted.1,2,5,10 Pseudomonas cepacia grown in distilled water can reach levels of 106 to 107 bacteria/ml.5,10 Unfortunately, a normal cosmetic preservative system cannot handle such high bacterial insult incurred during manufacturing.

Pseudomonads are the most commonly found contaminants isolated from the water-based products.

In fact, five of the eighteen different species isolated by Blachman and Elowitz-Jeffes from cosmetic products were pseudomonads.1 Pseudomonads are gram-negative pathogens and must be kept out of cosmetics.

All this makes processing water perhaps the single most important raw material worthy of bacterial examination. In order to keep count within acceptable limits the microbiologist must be concerned with the operation of the processing water system.

COSMETISCOPE ASSISTANT EDITOR

The Processing Water System

John Carola JohnC@protameen.com

PROGRAM John Goffredo (267) 318-6168 john.goffredo@univarusa.com

COMMUNICATIONS Stephen Weinberg (973) 307-4854 webmaster@nyscc.org

SPECIAL EVENTS Gillian Ratto (723) 788-7320 Gillian.Ratto@elementis.com

COSMETISCOPE EDITOR

Joe Albanese (908) 456-2968 joealbanese2@gmail.com

COSMETISCOPE ADVERTISING Bret Clark rbclark@ashland.com

COSMETISCOPE EMPLOYMENT Joel Diaz diaz.joel.a@gmail.com

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Water used in cosmetic preparations must be as pure as possible. Purity means free from particulate matter, minerals, and biological contamination. The more pure the water is the higher its specific resistance (ohm/cm).11 Coarse filters remove particulates and prevent turbidity. UV radiation is commonly used to kill microorganisms. Factors affecting the penetration of UV radiation through the water are turbidity, metal salts, and organic compounds.12 UV light is unable to penetrate glass and therefore the UV lamp must be housed in a quartz sleeve.12,13 Ion exchangers remove minerals from processing water.

In any event, eliminating bacteria from water is easier than waiting for them to contaminate the finished product. This may lead one to ponder, which method is best to remove biological contamination?

There are six methods of killing microorganisms.

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1. Tyndallization: Three successive 30 min boil/cool cycles.

2. Autoclaving: Apply steam (121 °C) at 15 PSI for 20 min.

3. Chemical treatment: Treatment with Hg or halogens (Cl, Fl, and I).

4. Millipore filtration: 0.1 to 0.2 μm.

5. Radiation treatment: Short wave ultraviolet radiation.

6. Pasteurization: 72 °C for 15 min.

Five of the methods listed above result in sterility or 100% kills. The sixth method, pasteurization, removes all pathogenic or disease causing organisms. Only two methods are practical for the removal of microorganisms from processing water. These are Millipore filtration and radiation treatment. A combination of these two methods provides an efficient and practical means of removing microorganisms from processing water.

System Set-up and Maintenance A schematic diagram of a simple, but proven, process water plant, designed to provide deionized water on-demand, is shown in Figure 1. Even without a holding tank for the deionized water, it is highly recommended that there should be continuous recirculation of water contained in the system to prevent the buildup of a microbial film of bacteria proliferating along the interior of pipes and elsewhere. The first in line is the coarse filter, which removes particulates from incoming water. Downstream is the first of two UV lamps, which provides the initial kill. It is followed by two ion exchange filters, which remove cations.

This reduces the hardness of the water making it more suitable for cosmetic preparations. It also increases the specific resistance.

After the ion exchangers, the second UV lamp is positioned. This second lamp kills any bacteria that survived exposure to the first lamp. It is particularly important to place a UV lamp in-line after the ion exchangers, because the resin beds tend to filter out and accumulate bacteria.5,11 The submicron filter (0.2 μm) is last in-line at the point of exit. It should be noted that McCarthy points out that water-borne P. diminuta could permeate 0.2 μm filter cartridges.4 The submicron filters not only filter Figure1: Schematic diagram of a process water plant. bacteria, but also prevent back contamination. Maintenance of this system includes replacing the UV lamps once per year, or even every six months if in continuous use.12 The UV lamps must be cleaned daily with a mechanical scrubber. In addition, the UV monitor must be examined daily to ensure that the lamps are emitting the correct wavelength of light. The flow rate through the UV purifier must be controlled at 2,400 gallons per hour. The temperature of the quartz sleeve must be maintained at 20 °C. Temperatures higher or lower than this value reduce the germicidal efficiency of the purifier.

If bacteria counts are above acceptable limits, the resin beds must be replaced or flushed with 0.25% formaldehyde for 3–5 hours. An alternate method employs sterimine at a concentration of 6 g/ft3 of resin bed. It is important to note that hydrogen peroxide and cationic germicides are harmful to the resin bed.11 Finally, part of routine maintenance must include sampling for microbial examination.

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Sampling Techniques Dunnigan suggests that bacteriological tests should be carried out daily on the water, although this may seem excessive.5 Weekly sampling should be sufficient in most cases. Water samples must be collected (Continued on page 4)

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in sterile sample bottles. If residual chlorine is suspected to be present in the sample, 0.1 ml of 10% sodium thiosulfate solution must be added as a de-chlorinating agent. The sample bottle should remain unopened until the moment it is to be filled. The water should be taken from a tap that is not malfunctioning. The tap should be swabbed with alcohol to kill bacteria on its exposed surfaces. Also, the tap should be fully opened and the water allowed to run long enough to remove stagnant water and for the collection of a representative samples. Naturally, the technician collecting the water must be well aware of aseptic techniques.

Function of the UV Lamps The entire UV radiation spectrum (200–400 nm) is not as efficient from a germicidal perspective as the 200–295 nm range. The mercury vapor lamp converts electrical energy to UV shortwave radiation energy of 254 nm. This is in the region of maximum germicidal effectiveness.14 The dose necessary to kill microorganisms is dependent on time of exposure and intensity of the lamp.

The survival ratio of water borne E. coli is given as:

P⁄ where:

P = Po = E = t = Q=

Po = e

-Et

⁄Q

(1)

avg. number of surviving organism the original number of organisms present lamp intensity time of exposure dose (Et) or exposure; termed a limit lethal exposure found to be approximately 40 μW•min/cm2

Most bacteria require 6–1,300 μW•s/cm2 for destruction. As two representative examples, P. aeruginosa requires 10,500 μW•s/cm2 and P. fluorescens requires 6,600 μW•s/cm2.

UV radiation penetrates right to the “heart” of the microorganism. It causes genetic damage in the nucleus, causing the DNA to improperly transcribe resulting in total destruction of the microorganism. The modifications to the genetic material are the result of unsaturated bond disruption, in particular to the purine and pyrimidine nucleotides. Covalent bonds are formed between adjacent pyrimidine residues resulting in the formation of pyrimidine dimers. These dimers distort the conformation of the DNA, which interferes with normal base pairing, eventually killing the organisms since they no longer effectively perform transcription and translation.

Enumerating and Identifying Bacteria The cosmetic microbiologist must be able to identify and enumerate bacteria isolated either from raw materials or finished products. Gucklhorn provides two methods for enumerating bacteria: the viable count and total count.15 The viable count assesses the number of living organisms present. It may be performed by any one of several techniques. In each technique, a series of dilutions is made of the test sample. A fixed quantity of each dilution is inoculated into separate samples of nutrient agar. After incubation, the number of colonies is counted and multiplied by the dilution factor to give the number of organisms per ml in the original sample. Three methods for conducting the viable count are: the Pour Plate or Standard Count Method; Roll Tube Method; and the Miles and Misra Method.

The total count assesses the number of living and dead organisms without differentiation. The two

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methods provided for performing a total count are Brown’s Opacity Tube Method and Helber Counting Chamber Method. Detailed, stepwise procedures for performing these tests are available in an article by Gucklhorn.15 In the analysis of processing water, the most commonly used methods are the Standard Plate Count, the Most Probable Number (MPN), and Membrane Filtration.

An alternative method is the Presumptive Coliform Count. This is perhaps the most used method for assaying water. It is useful for determining not only the amount of coliforms present, but also the presence of other pathogens.15,16

Identification The department head must decide which organisms to identify. He uses the Personal Care Products Council limit guidelines and FDA regulations to guide his decision. Basically, the organisms that get identified are those termed “objectionable.” These are the organisms that have pathogenic potential, are deleterious to product integrity, or are present in extremely large numbers.1 Strict aerobes and anaerobes can be separated by controlling the oxygen supply. Incubation temperatures may be set to give optimum growth for either psycrophiles, mesophiles, or thermophiles.

Selective media cultivate specific organisms, thereby eliminating those organisms that cannot metabolize the nutrients in that media.

Before bacteria can be identified, they must be isolated from the product. To carry out this task, a “key” is used, such as Bergey’s Manual of Determinative Bacteriology. Bacteria are classified according to their morphology, physiology, pathogenicity, and immunological reactions.

Perhaps the single most important test to separate and identify bacteria is the Gram stain. This separates all bacteria into two groups: gram-positive and gram-negative. There are nine steps involved: 1. Prepare a bacterial smear.

2. Heat fix (prevents washing away of the smear).

3. Primary stain (crystal violet penetrates the cell walls of all bacteria).

4. Wait 1 min and wash with water.

5. A mordant (fixative) iodine penetrates cell wall complexes with the crystal violet; forms crystal violet iodine complex (CVIC).

6. Wait 1 min and then wash with water.

7. Flush with acetone or ethanol for 10 s; gram-positive – CVIC does not wash away and the organism is stained; gram-negative – CVIC washes away and the organism is colorless.

8. Counterstain with a red dye (basic fuschin) for 30 s.

9. Wash with water; gram-positive will stain blue; gram-negative will stain red.

After the gram staining procedure is completed, the cells are examined with a microscope. This provides only some clues toward solving the mystery of identification. This is but one procedure for the identification of bacteria; there are many more in the literature.

The identification of pseudomonads is most important. They are gram-negative rods, obligatorily aerobic, asporogenous, polarly flagellated, usually motile, catalase positive, oxidase variable, and glucose non-fermenting. Identification to species level requires many different test procedures. Or, bacterial identification kits can be used, which contain many selective media on a single card, which can be used to identify bacteria quickly and easily.

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References 1. U. Blachman and L.S. Elowitz-Jeffes, Microbiology of cosmetics—regulatory and quality assurance aspects, Cosmet. Technol., 24-54, January 1982.

2. C.L. Goldman, Microorganisms isolated from cosmetics, Drug Cosmet. Ind., 117, 40-41 (1975).

3. T.J. McCarthy, Microbiological control of cosmetic products, Cosmet. Toil., 95(8), 23 (1980).

4. S. Tenenbaum, Microbiological limit guidelines for cosmetics and toiletries, CTFA Cosmet. J., 4(3), 25-32 (1972).

5. A.P. Dunnigan, Microbiological control of cosmetic products, Proc. Joint Conf. Cosmet. Sci., Toilet Goods Association, Washington, D.C., pp. 179 (1968).

6. L.A. Wilson, J.W. Kuehne, S.W. Hall, and D.G. Ahearn, Microbial contamination in ocular cosmetics, Am. J. Ophthalmol., 71, 1298-1302 (1971).

7. H.J. Eiermann, FDA regulation of cosmetics, Cosmet. Toil., 98(4), 67-71 (1983).

8. J.G. Mone, Ultraviolet water purification, Pollution Eng. Mag., 5(12), (1973).

9. S.R. Marouchoc, Cosmetic preservation, Cosmet. Technol., 38-44, October 1980.

10. L.A. Carson, M.S. Favero, W.W. Bond, and N.J. Petersen, Morphological, biochemical, and growth characteristics of Pseudomonas cepacia from distilled water, Appl. Microbiol., 25, 476-483 (1973).

11. M.G. DeNavarre, The Chemistry and Manufacture of Cosmetics, Vol. II, D. Van Nostrand Co.: Princeton, NJ (1962).

12. C.B. Huff, H.F. Smith, W.D. Boring, and N.A. Clarke, Study of ultraviolet disinfection of water and factors in treatment efficiency, Public Health Rep., 80, 695-705 (1965).

13. B.M. Mitruka and M.J. Bonner, Methods of Detection and Identification of Bacteria, CRC Press: Cleveland, OH (1977).

14. R.Y. Stanier, J.L. Ingraham, M.L. Wheelis, and P.R. Painter, The Microbial World, Prentice Hall: Englewood Cliffs, NJ (1986).

15. I.R. Gucklhorn, Cosmetic microbiology, Manufact. Chem. Aerosol News, 23-35, December 1968.

16. A.D. Eaton, L.S. Clesceri, A.E. Greenberg, and M.A.H. Franson., Standard Methods for the Examination of Water and Wastewater, American Public Health Association, American Water Works Association (1995).

About the Author:

Joe Albanese is currently the Regional Sales Manager Personal Care for Sytheon Ltd.. During his career in the personal care industry, Joseph Albanese worked for Avon, Shulton, and Colgate-Palmolive in both process and product development groups. His employment on the supply side of the industry included more than 12 years at GAF/ISP where he went from formulation chemist to manager of the Hair Care Applications/Tech Service lab. He is a graduate of the F.D.U. Cosmetic Science M.A. Program. He has been a member of the SCC since 1984. This year he is volunteering his time as the Assistant Editor of the Cosmetiscope and Co-Educational Program Chair for the New York Chapter.

Call for Papers

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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. Also, authors 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 would reserve 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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JOURNAL OF COSMETIC SCIENCE The Official Journal of the Society of Cosmetic Chemists CALL FOR MANUSCRIPTS

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he Society of Cosmetic Chemists is soliciting scientific manuscripts concerned with cosmetics or the sciences underlying cosmetics, as well as papers of interest to the cosmetic industry for publication in the Journal of Cosmetic Science, The Official Journal of the Society of Cosmetic Chemists.

The JOURNAL will consider manuscripts for publication in the following categories, provided they are prepared in proper scientific style and adequately referenced: • Original articles • Review articles • Technical notes • General articles • Preliminary communications • Letters to the Editor SUBMISSION OF MANUSCRIPTS Manuscripts submitted for publication should be accompanied by a cover letter and sent via e-mail to dscelso@scconline.org. Additional information is available from the SCC National Office: www.scconline.org.

Make note of it…

Send news of interest, guest editorials, and comments to Roger McMullen, Editor • E-mail: roger_mcmullen@fdu.edu

Upcoming 2016 NYSCC Events Calendar • For updated NYSCC information, visit us on the web at: www.nyscc.org • For National SCC information: www.scconline.org March 22 Perfumery Association Joint Seminar Dinner Meeting, Chart House, Weehawken, NJ May 9 NYSCC Symposium on Product and Process Development, Sheraton Edison Hotel, Edison, NJ May 10-11 Suppliers’ Day, NJ Convention and Exposition Center, Edison, NJ June 8 NYSCC Cruise – Aqua Azul: Preservation Seminar, Weehawken, NJ July 21 Golf Event, Crystal Springs, Hamburg, NJ September 6 Cosmetic Claim Substantiation, Location TBD September TBD Culinary Event, Location TBD October TBD Personal Professional Development, Location TBD Oct. 30-Nov. 2 IFSCC Congress, Orlando, FL November 15 Rheology Symposium, Cook Campus Student Center, Rutgers University

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presents

Inspired Art & Science

Our Fragrance World Today March 22, 2016 The Chart House Lincoln Harbor, Pier D-T 1700 Harbor Boulevard, Weehawken, NJ 07086 Tel: (201) 348-6628 Join us for a highlight tour of the world of fragrance with expert speakers in fragrance safety, the emotional impact of smell and the role of the creative perfumer in the 21st Century.

Enjoy the magnificent view of Manhattan while networking with members of these two great Societies.

Agenda: 4:00 - 4:45 p.m.

James Romine — President RIFM The Science of Fragrance Safety

4:45 - 5:30 p.m.

Avery N. Gilbert — Synesthetics, Inc. The Golden Age of Fragrance and How We Got Here

5:30 - 7:00 p.m.

Cocktails/Dinner

7:00 - 7:45 p.m.

Vincent Kuczinski & James Krivda — Perfumers MANE Developing Perfume—Fantasy and Reality

Pre-registration: $30 • At the door: $50 Students: $10 ($50 at the door) • Emeritus: Free ($40 at the door) For registration and more information: www.nyscc.org.

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The Science of Fragrance Safety James Romine — President RIFM Abstract:

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ragrances have come under increased scrutiny by regulators and by consumer activists. The scientific basis for assuring ingredient safety is an essential element in maintaining a robust and innovative fragrance industry. The Research Institute for Fragrance Materials (RIFM) provides the latest methodologies and assessments that can sustain consumer confidence in the products they buy.

Biography:

im Romine is President of the Research Institute for Fragrance Materials. He leads a nonprofit organization dedicated to the science that supports the safety of materials used in the fragrance industry. Jim provides strategic direction for a staff of highly qualified chemists and toxicologists who conduct research and generate safety assessments that are made available to industry and the public through peer-reviewed scientific publications.

Prior to joining RIFM in 2015, Jim had a successful 35-year career with the DuPont Company. His last position at DuPont was Vice-president of Product Stewardship and Regulatory Affairs, a role he created in 2008. During his tenure, Jim helped guide the DuPont commitment to responsible creation, manufacture, and sales of products as diverse as chemicals, advanced polymers, agricultural chemicals, biotech seeds, and industrial enzymes. He currently serves on the board of the Product Stewardship Society, the Keystone Policy Center, and the Kalmar Nyckel Foundation. Jim received his B.S. in Chemistry from the University of MissouriRolla in 1974 and was awarded a Ph.D. in Organic Chemistry from the University of Michigan in 1980.

___________________________________________________________________________

The Golden Age of Fragrance and How We Got Here Avery N. Gilbert — Synesthetics, Inc. Abstract:

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he fragrance industry is living through incredibly disruptive times. Methods, markets, and business relationships have been razed and rebuilt. The brand universe is transformed, and consumer segments have been shattered. Yet the world of fragrance is thriving. In science, art, and popular culture awareness of scent is fueling a desire for more access and more products. We may have entered the Golden Age of Fragrance. If we understand how we got here, we can continue to prosper.

Biography:

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r. Avery N. Gilbert is a smell scientist, entrepreneur, and author. He is a Fellow of the Association for Psychological Science and a scientific pioneer in the areas of olfactory mental imagery, multisensory correlates of odor perception, and the psychological factors that bias odor judgments. His book, What the Nose Knows: The Science of Scent in Everyday Life, was a finalist for the Los Angeles Times Book Prize in Science & Technology, and shortlisted for the Royal Society Science Book Prize. Gilbert graduated from the University of California at Berkeley, and holds an M.A. in Biology and Ph.D. in Psychology from the University of Pennsylvania. Following an NIH postdoctoral fellowship at the Monell Chemical Senses Center in Philadelphia, he joined the Monell faculty. While there he co-authored the National Geographic Smell Survey. Later Gilbert left academia to create and lead the Sensory Psychology research group at Givaudan Roure Fragrances, and became a vice-president there.

Gilbert runs Synesthetics, Inc., a company that provides innovative, multisensory research for the development and marketing of consumer products. Dr. Gilbert is a member of the Association for Chemoreception Sciences and the European Chemoreception Research Organization, and is on the advisory boards of Aromyx Corporation and the Institute for Art and Olfaction. He has published thirty scientific articles. He has discussed the science of smell on national television and radio, including FOX, NPR, CNN, CBS, and MSNBC. Gilbert blogs on the science and culture of smell at FirstNerve.com.

(Continued on page 10)

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Our Fragrance World Today

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Developing Perfume—Fantasy and Reality Vincent Kuczinski & James Krivda — Perfumers MANE Abstract:

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n this presentation, we give you a tongue-in-cheek look at the fantasy of what clients want, expect, and demand from fragrance companies and how this quite often runs against the reality of time, price, safety, and science. Vince will assume the role of a client and Jim will be the perfumer. We will relate this to the work of cosmetic chemists, many who are our colleagues and face similar pressures.

Biography: im Krivda is Vice-president and Senior Perfumer at Mane in New York City. He was first exposed to the world of olfaction right out of high school, when he had the unique opportunity to train with French Master Perfumer Elie Roger. Growing up in the farmlands of Pennsylvania, he always enjoyed the great outdoors, and he continuously draws his inspiration from nature itself. An avid fisherman, water skier, and traveler, Jim also loves art and cooking. He views the craft of perfumery as an endless opportunity to translate feelings and emotions into scent.

Biography:

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ince Kuczinski is Vice-president and Senior Perfumer at Mane in New York City. He came of age in a chemistry lab, where his first job as a lab tech ignited his fascination with the magic of perfumery. He sees the craft as a dynamic balance of art and science—a balance that is always moving, changing, and evolving.

For inspiration, Vince turns to music, from Bach, Mozart, and Beethoven straight through to the Beatles and Pearl Jam. He is apt to describe his fragrance creations in the language of color, and has an instinctive feel for the nuances of subtle variation in value and tone. Vince loves orchids for their dazzling variety of inspirational colors, as well as for the breadth and depth of olfactive experience that orchids convey.

Monthly Meeting Group Discount The NYSCC is offering a group discount of 15% to companies who send 5 or more employees to a monthly meeting. All five employees would need to be registered at the same time to receive the discount. Once purchased, registrations are non-refundable.

Employment Opportunities For complete ads please go to the NYSCC website: https://www.nyscc.org/employment-listings.html.

n Product Development Manager StriVectin Operating Company, Inc. New York, NY

n Personal Care Account Manager Superior Materials, Inc. • Northeastern U.S. n Ester Sales Manager ICOF America Inc. (Musim Mas Group) Northeastern U.S. n Manager, Applications Development, Personal Care and Consumer Specialties Interpolymer • Canton, MA n Marketing Coordinator Miyoshi America, Inc. • Dayville, CT 10

n Junior Commercial Assistant – Personal Care Market Bloomage Freda Biopharm USA Inc. Parsippany, NJ n Color Chemist Process Technologies and Packaging Scranton, PA area n Key Account Manager – Northeast Beraca International North America Northeastern U.S. n East Coast Account Manager SILAB • New Jersey

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2016 Naturally Kiawah Symposium April 21, 2016 Kiawah Island Golf Resort • Kiawah Island, South Carolina Carolina Society of Cosmetic Chemists

Nextgen To Bridge The Gap Across Professional Levels

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ast year the Society of Cosmetic Chemists introduced a critical initiative, SCC NextGen, that offers the necessary skills and training needed for career advancement. NextGen helps young professionals (with less than five years of industry experience) and students further their education, so that they may attain successful and rewarding careers. NextGen provides registrants with the confidence to enter the workforce knowing that their education and training are aligned with workforce needs and that they have the support of fellow colleagues.

The Society of Cosmetic Chemists plans to accomplish this mission by: 1. Presenting critical education tracks at meetings and events (e.g., Critical Thinking and Innovation, Basic Cosmetic Science, Introduction to Polymer Science and its Applications).

2. Networking at national meetings and events.

3. Coordinating small group projects where mentees and mentors engage in a technical area of shared interest. The goal for the mentee is to present a paper or organize a workshop in his/her second year of the program.

4. Collaborating with universities to supplement the education of their students. All colleges/universities participating in the NextGen program are eligible to provide students with their first year of membership for free.

Please contact the SCC National office at scc@scconline.org, or call (212) 668-1500 for more information on how you or your university can get involved. All are welcome and encouraged to join! ________________________________________________________________________________________________________________________________________________________________________________________________

The official launch of the NextGen program will take place on April 20-22, 2016 at the Carolina Chapter, “Naturally Kiawah Symposium.”

Course: SCC NextGen 101 Instructor: Mark Chandler – ACT Solutions Corp. ________________________________________________________________________________________________________________________________________________________________________________________________

SCC NextGen is a new series of courses designed for individuals who are new to the cosmetic industry as well as those who are more seasoned, but who would like to expand his or her knowledge of the basic concepts underlying the technology of the personal care industry. The NextGen 101 CEP course is a one-day basic overview of the fundamentals of hair care, sun care, skin care, and much more.

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Like, Connect & Tweet About Us!

FACEBOOK: NEW YORK SOCIETY OF COSMETIC CHEMISTS

LINKED IN: NEW YORK SCC

TWITTER: @NYSCC

INSTAGRAM: NYSCCMAIN These connections were made possible by the NYSCC Social Media Committee

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Suppliers’ Day Education Session 1 • May 9

NYSCC Symposium on Product and Process Development Related Considerations Sheraton Edison Hotel Raritan Center • Edison, NJ

Attending the NYSCC Suppliers’ Day this year?

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ell then, you should know that we have added an entire extra day to that eagerly anticipated annual global event. This seminar will cover diverse aspects of the technologies that make up the product and process development steps needed to bring new personal care products to market, from ingredients and formulating, to delivery systems, to testing bench-top prototypes, to scale-up to commercial production—many of the things to consider if you would like your new product launch to succeed in the marketplace.

Do not miss this great event! Please join us at the Sheraton Edison Hotel on May 9th. It is conveniently located close to the Expo Center where the Suppliers’ Day event is being held on May 10th-11th.

Shuttle buses will be available to the Expo Center.

Program: • Aerosol Technology – Fundamentals in Product Development – Dave Streuli (Ashland Specialty Ingredients) • Personal Care Wet Wipes, A Unique Delivery System – Douglas Cole (Rockline Industries) • Formulation Innovation and Optimum Thickening – George Deckner (Deckner Consulting Services LLC) • Testing Fragrance Encapsulation: In-vitro and In-vivo – Dr. Claudio Ortiz (Colgate-Palmolive) • The Prospects of Personal Care Products Minus Polymers – Dr. Robert Lochhead (University of Mississippi) • Skin Bio 101 and Cosmetic Actives Delivery – Marc Cornell (Englewood Labs) • Thinking Fundamental and Integrity Aspects of Formulation Stability – Eric Abrutyn (TPC2 Advisors Ltd., Inc.) • Modern Solutions for Preservation – Steve Herman (Diffusion LLC) • Hair Care – Shampooing and Conditioning – Joseph Dallal (Ashland Specialty Ingredients) • Scale-up Pitfalls in the Cosmetic Industry – David Yacko (Estée Lauder) • Utilization of Sensory Markers in Dermatocosmetics – Samuel Shefer or Colin Scott (Salvona)

Sponsorship Opportunities: Sponsorships will be available to suppliers/vendors. Sponsorship will help defray costs and provide additional exposure at the Suppliers’ Day event, and acknowledge your company as a strong supporter of the New York Chapter of the Society of Cosmetic Chemists helping it fulfill its mission of advancing the science of personal care.

Symposium Chairs:

Daphne Benderly (daphne.benderly@gmail.com) and Joseph Albanese (joealbanese2@gmail.com) For registration, please go to the NYSCC website: www.nyscc.org.

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Suppliers’ Day Education Session 2 • May 10 & 11

Cosmetics and Personal Care – A Roadmap for Navigating Your Career New Jersey Convention and Exposition Center 97 Sunfield Avenue, Edison, NJ Tuesday, May 10 10:00 - 11:00 a.m. Kevin Gallagher (Kevin Gallagher Consulting LLC) 12:00 - 1:00 p.m. Snehal Shah (Estée Lauder Companies) 2:00 - 3:00 p.m. Brian Czetty (P&G)

Wednesday, May 11 9:00 - 10:00 a.m. Tony O’Lenick (Siltech LLC)/Mark Chandler (ACT Solutions Corp) 10:00 - 11:00 a.m. Mike Fevola (J&J) This event will be held at the Suppliers’ Day event in the tent adjacent to the luncheon.

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Suppliers’ Day Education Session 3 • May 11

Skin Toxicology for Cosmetics – Risk Assessment of Skin Exposure New Jersey Convention and Exposition Center 97 Sunfield Avenue, Edison, NJ Presentations from 11:30 a.m. to 3:30 p.m.

This event will be held at the Suppliers’ Day event in the tent adjacent to the luncheon.

Symposium Chair: Nava Dayan

Program description:

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he cosmetic and personal care industry underwent key changes in the past decade to advance regulations and guidelines for safety assessment of consumer products. While regulations are slowly implemented in practice, the methodical technical process of risk assessment is limited and the completion of a “check list” often replaces it. The regulatory framework creates the perception that “safe” products can be launched if certain studies are conducted. However such an approach generates only partial acknowledgement of the limitations of the studies, science involved, and selection of a tier approach that is logical, based on the intended use, and is scientifically savvy. The animal testing ban dictates that risk assessment should be followed by in silico evaluation and a tier of in vitro or ex vivo testing.

While refraining from animal testing adds challenges, it opens up opportunities for better understanding of mode of action and allows us, in many cases, to conduct the studies on more relevant human derived cells and models. Many regulatory guidelines express the need to employ experts in risk assessment of raw materials and finished formulations. Such practice can be faster, cheaper, and business rewarding. This workshop is established to discuss general aspects in risk assessment of skin care products combined with examples of specific studies and initiatives of key national organizations and companies. National leaders in Toxicology are joined to share recent knowledge and address questions and concerns of industry members.

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11:30 a.m. – 12:05 p.m.

Skin as Immune Organ— Implications to Risk Assessment of Dermal Exposure Nava Dayan President, Dr. Nava Dayan LLC

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he skin is the largest immune organ of the human body. As such it combines innate and adaptive immunity to fulfill its role. This introductory talk will discuss healthy skin barrier properties, immunity aspects, and key considerations in safety assessment of exposure.

Biography

Nava Dayan, Ph.D. has 25 years of experience in the skin care segment, and has yielded more than 150 publication credits in numerous industry-respected journals and in four books. She was awarded the In-Cosmetics Gold Award for innovation and commensurate recognition from the NYSCC and the CRS for excellence. Dr. Dayan is the owner of Dr. Nava Dayan LLC, a skin science and research consultancy serving the pharmaceutical, cosmetic, and personal care industries. Dr. Dayan advises on product feasibility in skin care; efficacy and toxicology; and data interpretation for claims, formulation design, delivery for improved efficacy, and attenuated toxicity. Several examples of her company’s expertise include: drug-skin interactions, bio-markers (genomics and proteomics), skin/age related sensitivities, inflammatory skin disorders, innate immunity, and biota.

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12:05 – 12:40 p.m.

Alternative Methods for the 21st Century Helena Hogberg and Thomas Hartung Johns Hopkins Bloomberg School of Public Health, Center for Alternatives to Animal Testing, Baltimore, MD, U.S.

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oxicology in the 21st century is confronted by challenges such as mixture toxicology, susceptible subpopulations, new products, and hazards as well as transparency. Current traditional (animal) tests have several limitations to tackle these objectives including costs, throughput, human relevance, and animal use. The National Research Council report, Tox-21c, suggests moving away from these traditional test methods to modern technologies based on toxicity pathways.

This report emphasizes the need for new high content and high throughput approaches, such as omics techniques, organotypical cell cultures, machine learning, and mathematic modeling. These concepts are already used in a number of programs by federal agencies, human-on-chip programs, the Human Toxome project, efforts for translating evidence-based medicine to toxicology, etc. The Center for Alternatives to Animal Testing (CAAT) at Johns Hopkins is one of the groups involved in these developments. This presentation will give a summary of the overall activities in the field combined with illustrations of proofof-principle work at CAAT.

Biography Dr. Hogberg received her Ph.D. from Stockholm University, Sweden in 2009.

Her experimental work was performed at the European Center for the Validation of Alternative Methods (ECVAM), Joint Research Center, European Commission in Italy. Her thesis work consisted of developing alternative tests for developmental neurotoxicity (DNT) by monitoring gene expression and electrical activity recording.

Together with Dr. Hartung, she started the current laboratory at the Center for Alternatives to Animal Testing (CAAT) as a Postdoctoral Fellow. She was later promoted to a faculty position and later to Deputy Director of the Center. Her current research activity is still in the field of DNT with the use of emerging tools, such as 3-d organotypical cell models and omics approaches.

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12:40 – 1:15 p.m.

FDA Perspectives on the Regulation of Cosmetic Products Nakissa Sadrieh Director of the Cosmetics Division in the Office of Cosmetics and Colors (OCAC), FDA

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his presentation will provide an overview of cosmetic regulations in the U.S. followed by a summary of several priority areas currently active in the Division of Cosmetics at the FDA. Areas such as adverse events analysis, compliance-related activities, labeling, claims, and active cosmetics research will be discussed.

Biography

Dr. Sadrieh obtained her Ph.D. in Toxicology in 1993 from Rutgers University in New Jersey. Following a postdoctoral fellowship in the Laboratory of Chemical Carcinogenesis at the National Cancer Institute, Dr. Sadrieh joined the Food and Drug Administration in 1996 as a pharmacology and toxicology reviewer. In 1998, Dr. Sadrieh became the supervisory pharmacologist in the Division of Medical Imaging and Radiopharmaceutical Drug Products, Center for Drug Evaluation and Research (CDER). In 2002, Dr. Sadrieh joined CDER’s Office of Pharmaceutical Science (OPS) as the Associate Director for Research Policy and Implementation.

In OPS, Dr. Sadrieh’s work focused on scientific research that directly impacted regulatory decisions. As a scientific advisor to the OPS, Dr. Sadrieh supported CDER’s scientific mission by designing, conducting, and managing appropriate research projects aimed at resolving pending regulatory questions. Since 2004, Dr. Sadrieh has assessed the impact of new technologies, such as nanotechnology, on drug development and the regulatory review process, and as such, she is one of the Agency experts in all matters related to Nanotechnology. In October 2013, Dr. Sadrieh Joined the Center for Food Safety and Nutrition (CFSAN) as the Director of the Cosmetics Division in the Office of Cosmetics and Colors (OCAC).

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1:15 – 1:50 p.m.

CIR Safety Assessment of PEGs Cocamine and Application of a Framework for Read-Across Analysis Ivan Boyer Cosmetic Ingredient Review (CIR)

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his presentation will provide a brief introduction to the CIR safety assessment process, CIR’s initiatives and goals for enhancing the process, and a framework for identifying and categorizing analogs for read-across assessments. The presentation will review the recent CIR safety assessment of polyethylene glycol cocamine (or PEGs cocamine) and related ingredients as a case study, including the CIR Panel’s critique of the framework and the computational methods used to implement the framework.

Biography Dr. Ivan Boyer received his Ph.D. in Toxicology from the University of Rochester School of Medicine and Dentistry in Rochester, New York. He then worked as a post-doctoral fellow in the Pharmacology Department at the University of Medicine and Dentistry of New Jersey, Robert Wood Johnson School of Medicine. His postdoctoral research was supported by a National Research Service Award from the U.S. National Cancer Institute. Subsequently, he served as a Toxicologist/Reviewer at the Center for Food Safety and Applied Nutrition (CFSAN) of the U.S. Food and Drug Administration. Dr. Boyer then served for over 20 years as a Toxicologist and Human Health and Ecological Risk Assessor at The MITRE Corporation and Noblis, Inc., which are non-profit government consulting firms headquartered near Washington, D.C. Currently, Dr. Boyer is the Senior Toxicologist at the Cosmetic Ingredient Review (CIR) in Washington, D.C. Dr. Boyer is the principal author of more than 100 technical reports, and has authored or co-authored peer-reviewed publications in areas ranging from the mechanisms of chemical carcinogenesis to the safety assessment of cosmetic ingredients.

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1:50 – 2:25 p.m.

Tox21 In Vitro Approaches: Quantitative High Throughput Screening and Cellular Secondary Screening David Gerhold Genomic Toxicology NCATS Division of Pre-Clinical Innovation NIH

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he Tox21 Consortium is a collaboration between: the National Center for Advancing Translational Sciences (NIH-NCATS), Environmental Protection Agency (EPA), National Toxicology Program (NTP)/NIEHS, and Food and Drug Administration (FDA); with a mission to replace animal testing with in vitro methods. The Tox21 Consortium is currently screening 10,000 environmental compounds for potential human toxicities using a variety of in vitro cellular screens using Quantitative High Throughput Screening (qHTS). Assay AC50 values are quantitated for each chemical, and active chemicals are pursued through secondary cellular screens including gene expression and computational analyses.

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Biography David Gerhold is a staff genomic toxicologist at NCATS. He is developing in vitro methods to identify toxic compounds by introducing differentiating stem cell models and the gene expression technologies, RNAseq and RASL-Seq. These new technologies support efforts to identify potentially toxic chemicals in the environment through the Toxicology in the 21st Century consortium, identify biomarkers of genetic susceptibility to tobacco, and facilitate drug development through the Therapeutics for Rare and Neglected Diseases program.

Previously, Gerhold pioneered gene expression microarray technology at Merck Research Labs, applying this expertise to identify kidney injury biomarkers.

He subsequently co-led the Kidney Biomarker Working Group within the Predictive Safety Testing Consortium, collaborating across the pharmaceutical industry to qualify seven biomarkers with the Food and Drug Administration and publishing the findings in 2010. Gerhold also worked as a liaison with clinical nephrologists initiating translational studies to improve nephrology standard of care.

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2:25 - 3:00 p.m.

Advanced 3-D In Vitro Tissue Models Offer Valuable Insight into Product Safety Alex Armento MatTek Corporation

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dvancements in tissue engineering combined with a greater understanding of basic human skin biology have driven the development of highly predictive in vitro test methods. 3-D in vitro skin models can be used to evaluate standard toxicity endpoints (irritancy, corrosion, sensitization, etc.) in addition to ever more complex product safety questions, including elucidation of the molecular mechanisms driving skin toxicity. This presentation will provide a current overview of both the advantages and limitations that 3-D tissue models offer for the development of skin care products and outline product development strategies utilizing commercially available 3-D tissue models.

Biography Alex Armento is the Director of Business Development at MatTek Corporation, an in vitro assay development and tissue engineering firm. He joined MatTek in 2008 and has since supported the development and implementation of in vitro safety and efficacy test methods for chemical, cosmetic, personal care, and pharmaceutical organizations.

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3:00 – 3:30 p.m.

Question and Answer Panel Discussion

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Making Personal Personal Car Caree Beautiful®

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www.biosiltech.com

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International Conference on Thermal Analysis and Calorimetry (ICTAC) August 14-19, 2016 Walt Disney World Swan & Dolphin Hotel • Orlando, Florida

Specialty Silicones & Actives Skin Car Caree Hair Care Care Color Cosmetics

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he focus of this global conference is traditional thermal analysis, calorimetry, and rheology applications. A Personal Care session is included in ICTAC 2016. If you use thermal analytical techniques in your Personal Care research, please consider submitting an abstract for this session.

To submit an abstract, please go to the website for the North American Thermal Analysis Society (NATAS): www.natasinfo.org. Once there, go to the Conferences menu and select: ICTAC 2016.

You will then select the link: Abstract & Manuscript Submission Portal. This will bring you to a page where you need to create a user profile for the primary author before submitting an abstract.

The deadline for abstract submission is May 6, 2016.

If you have any questions, please contact Denise Wade Rafferty: denise.rafferty@lubrizol.com.

Cosmetic Claim Substantiation – Science, Marketing and Regulation September 6, 2016 Location TBD in New Jersey

Symposium Chair: Nava Dayan, Ph.D.

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variety of topical human exposure studies are conducted by raw material and finished cosmetic product manufacturers to explore their impact when applied to skin with the aim of drawing consumer appealing claims. Market competition often drives aggressive campaigns that may be confusing and misleading, studies may be poorly designed and executed, and scientific data can be incorrectly interpreted.

The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) are carefully inspecting cosmetic products for non-substantiated misleading claims. The National Advertising Division (NAD) further examines truth and accuracy of national advertising claims. If the claim is indeed misleading, and drives the consumer to purchase a product that will not deliver as promised, this is an ethical matter. With the skin care industry striving to produce safer products, it should also stream its scientific resources towards better testing regimens of product activity on the skin, and provide fair translation into claims. Selecting common criteria for justification of claims is a challenging aspect of product development since it needs to be customized for the purpose of use and nature of the product developed. This workshop brings together experts in industry and regulatory agencies to present current framework to conform to the law, regulations, savvy science, and ethical means.

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