The Cosmetic Summit - Intermountain West Society of Cosmetic
Transcription
The Cosmetic Summit - Intermountain West Society of Cosmetic
Fourth Quarter 2013 The Cosmetic Summit Intermountain West Society of Cosmetic Chemists IMWSCC Board Chair Ryan Roberts rroberts@nuskin.com Over the year we have enjoyed excerpts from Krissie Bak’s paper on formaldehyde: “Standardization of Analytical Techniques Used to Quantify Free Formaldehyde Concentration in Cosmetics Containing Formaldehyde Releasers.” This final portion will complete that preservation saga. Krissie.bak@gmail.com Part IV Chair Elect Eric Scarborough eric.scarborough@prinovausa.com Secretary Thao Le thaol@neways.com Treasurer Carlos Olmos colmos@nuskin.com Newsletter Editor Rachel Sabin rac.sabin@gmail.com Assistant Editor Aaron Peterson aaron@rossorg.com Newsletter Publisher Brianna Purinton bri.purinton@gmail.com Fourth Quarter Sponsors: Glenn Corporation Active Organics C NMR: A New Hope By: Krissie Bak In many countries the derivatizing techniques continue to be the standard for calculating formaldehyde concentration in cosmetic products. The shift has slowly favored using the acetylacetone method over other reagents such as chromotropic acid, hydrogen peroxide, and DHN because they are more destructive to cosmetic samples. The acetylacetone method has many disadvantages but is still the standard for Europe and Japan. The data for FFA concentration exaggerate the true concentrations which limits the amount of formaldehyde releaser used in a product for preservation. This forces manufacturers to choose other preservatives in cosmetic products to limit ACD instead of using formaldehyde releasers. As shown in Table 1, other preservatives are less effective in preventing fungal and bacterial contamination. As formulas increase in complexity by increasing the number of ingredients, the need for higher preservative concentrations increases. However, some countries put legal limits on the FFA concentration allowed in the products; therefore, limiting the complexity of some cosmetic products, demanding the use of other preservatives, or underpreserving cosmetics by decreasing the amount of formaldehyde releaser allowed in the products. Several analytical techniques have been developed to accurately quantify the formaldehyde concentration. These methods include HPLC, liquid chromatography with refractomeric detection method, and combined headspace-solid-phase microextraction-gas chromatography. However, Emeis et al3 and Tallon et al.1 indicate using 2C NMR that these techniques do not accurately calculate the FFA concentration. 2C NMR is the most accurate analytical technique currently for determining FFA concentration but may not be used as often because of the cost. The machinery needed for measurement is expensive and may not be reasonable for small companies. However, to meet the legal standards set by countries, formaldehyde must accurately be calculated. 2C NMR seems to be the only method that accurately calculates the FFA concentration from the other oligomers and can be done at user appropriate value of pH, concentration, and temperature. Therefore, 2C NMR should become the new worldwide standard for determining free formaldehyde concentration in cosmetic and personal care products. Table of Contents Free Formaldehyde p.1, 3 Geek is Chic p.5-6 Chemists Corner p.8 Patent Law 112 p.10-11 Grand Seminar Meeting Agenda p.12-13 IMWSCC Spotlight p.14 Third Quarter Meeting Synopsis p.16 The Regulatory Department p.19 Read to Win! Somewhere in the newsletter we’ve hidden the IMWSCC favicon symbol it looks like this - . Spot it and email Ryan (rroberts@nuskin.com) the page number and place where it is and you’ll be entered in a drawing for a chance to win a $25 gift card at the next meeting. 2 IMWSCC 4th Quarter 2013 Annual Scientific Meeting & Technology Showcase Dec 12-13th NYC, NY Snow ‘n Learn February 27th Park City, UT Free Formaldehyde Continued: Table 1. Effectiveness of common preservatives against bacteria and fungi. Data from Roden, Ref. 4 3. Class Active Efficacy Bacteria Fungi Gram-positive Gram-negative + - + Phenocyethanol +/- + +/- Benzyl alcohol + - - Formaldehyde Formaldehyde + + +/- Formaldehyde Imidazolidinyl urea + + - releasers Diazolidinyl urea + + +/- Soldium hydroxymethylglycinate + + +/- DMDM hydantoin + + +/- Halogenated Methylchloroisothiazolinone + + + compounds 2-bromo-2-nitropropane-1,3-diol + + + Chlorphenesin - - + Iodopropynyl butylcarbamate - - + Methylisothiazolinone + + - Benzisothiazolinone + +/- +/- Phenols Nonhalogenated isothiazolinones Parabens References 1. Tallon, M.; Merianos, J.; Subramanian, S. Non-Destructive Method for Determining the Actual Concentration of Free Formaldehyde in Personal Care Formulations Containing Formaldehyde Donors. J. Cosmet. Sci. 2009, 135, 22–32. 2. Rivero, R. T.; Topiwala, V. Quantitative determination of formaldehyde in cosmetics using combined headspace-solid-phasemicroextraction-gas chromatography. J. Cosmet. Sci. 2004, 55, 343–350. 3. Emeis, D.; Anker, W.; Wittern, K. Quantitative 13C NMR Spectroscopic Studies on the Equilibrium of Formaldehyde with Its Releasing Cosmetic Preservatives. Anal. Chem. 2007, 79, 2096–2100. 4. Roden, Kevin. Preservatives in Personal Care Products. Microbiology Austrailia. 2010 195–197. 4th Quarter 2013 IMWSCC 3 AMERICAN GLITTERS | FULL RANGE OF COSMETIC GLITTERS PRODUCED WITH PERMITTED, APPROVED COLORANTS BAYLISS RANCH | CERTIFIED ORGANIC BOTANICAL DISTILLATIONS BLP | FUNCTIONAL AND SPECIALTY ACTIVE INGREDIENTS CREMER OLEO GMBH & CO KG | NATURALLY-DERIVED FATTY ACID ESTERS CR MINERALS | PUMICE CULINARY FLAVOR SOLUTIONS | CUSTOM DEVELOPED SIGNATURE FLAVORS, SOLVE TECHNOLOGY PROBLEMS DRACO NATURAL PRODUCTS | BIOACTIVE, FULL-SPECTRUM BOTANICALS, OFFERING CUSTOM FORMULATION AND INSIDE-OUT SOLUTIONS EARTH SUPPLIED PRODUCTS | ECLECTIC MIX OF ALL-NATURAL AND CERTIFIED ORGANIC INGREDIENTS EMD | SPECIAL EFFECT PIGMENTS, COSMETIC ACTIVES AND SUNSCREEN INGREDIENTS FLORIDA FOODS | ALOE VERA GELS, OILS AND POWDERS, PLANT AND VEGETABLE EXTRACTS FRANK B. ROSS | NATURAL AND SYNTHETIC WAXES AND BUTTERS FUJI SILYSIA | SYNTHETICALLY PRODUCED AMORPHOUS SILICA GELS GO WILD HARVEST | ORGANIC AUSTRALIAN SUPERFRUITS, BUSH BOTANICALS AND INGREDIENTS 4 IMWSCC 4th Quarter 2013 NUROZ | HAIR CARE AND SKIN CARE SPECIALTY INGREDIENTS: SODIUM SALICYLATE, THICKENERS, VITAMIN E OIL, VITAMIN H AND SODIUM HYALURONATE PREMIER SPECIALTIES | FRAGRANCES, FLAVORS, EXTRACTS AND FRUIT SEEDS RML | PRESERVATIVES AND NATURAL FORMALDEHYDE-FREE HAIR STRAIGHTNER SASOL | SPECIALTY EMULSIFIERS, NATURALLY-DERIVED HYDROCARBONS, AHA-ESTERS, MIPA-LAURETH SULFATE SEIDECOSA | NATURAL HYDROLYZED SILK PROTEINS SOUTHERN CLAY PRODUCTS, INC. | CLAY RHEOLOGICAL, STABILIZATION AND SUSPENDING CONTROL ADDITIVES SYTHEON | PROPRIETARY INNOVATIVE INGREDIENTS FOR HYPERPIGMENTATION, ACNE, AGING AND SUN PROTECTION UNIVAR COLOURS | NATURAL AND SYNTHETIC COLORS WORLD MINERALS | DIAFIL & CELITE DIATOMACEOUS SILICAS WORLEE | FILM-FORMING AGENTS: AQUEOUS ACRYLATE DISPERSIONS AND SOLUTIONS EQUIPMENT & SUPPLIES FAWCETT | LAB & DRUM MIXERS, PUMPS (ELECTRIC & AIR DRIVEN) Rachel Sabin: rac.sabin@gmail.com Geek Is Chic: A Tale of Two Cons By: Rachel Sabin My husband and I have attended San Diego Comic-Con for a few consecutive years now. As the elves migrated west to the Undying Lands, we too have gladly traveled westward to be part of the eternal...the eternally nerdy that is. So, of course, when we heard that Salt Lake City would be hosting a Comic Con event and the gift of geekery would be left like a chest full of Star Coins on our doorstep, we registered quicker than Sonic runs a Shuttle Loop. For those of you that missed my riveting article a couple of years ago, San Diego’s Comic-Con is the largest convention of its kind in the world. This year its registration was capped at 140,000 attendees yet sold-out in minutes. Never underestimate the power of the dark side. While attending San Diego’s Comic-Con in July, we heard from Harrison Ford and Asa Butterfield in the Ender’s Game panel. We met most of the cast of Divergent. Joss Whedon singlehandedly blew us away with his insight and wit in what turned out to be our favorite panel of the year. We heard from talented directors such as Edgar Wright, Alfonso Cuaron and Marc Webb. Karl Urban good-naturedly humored us, and thousands of other eager geeks, with his McCoy maxims. We listened to the perspectives and scores of some of TV’s favorite actors and cinema’s best superhero composers. can’t make any guarantees. As Salt Lake Comic Con approached, the numbers registered for this convention skyrocketed. They passed 20,000, 30,000 and then, during its last day, they exceeded 70,000, a record for an inaugural regional Comic Con. That final afternoon the crowds got so massive that the fire marshal closed the doors to the convention center and wouldn’t let anyone else enter until some legions of clone troopers left. Despite those historic numbers, compared to the relentless crowds at San Diego this baby was as empty as the sandy deserts of Tatooine. You actually had room to expand your lungs on the convention floor, AKA breath. I’m not complaining though, I’m a fan of that whole inhale/exhale thing. Breathing On the SDCC exhibit floor we ran into many of the famous and should-be famous. Between David Duchovny, Gillian Anderson, Sean Astin, Steve Blum, Brent Spiner, Marina Sirtis, Michael Dorn, Max Brooks and Brandon Sanderson we definitely encountered enough stars to be struck. So how did our own salty city’s con compare to this behemoth of nerdom? Read on and all will be revealed, probably at least a few million years faster than Deep Thought’s answer but I 4th Quarter 2013 IMWSCC 5 Geek Is Chic Continued: Salt Lake’s Comic Con may have been smaller and less showy than San Diego’s but, as The Blob can attest, being bigger doesn’t always win you the battle. Salt Lake proved itself the quiet superhero of cons in one department: costumes. The get-ups in Salt Lake were more impressive and prevalent than in San Diego. Is it possible that the people of Salt Lake have nothing better to do than sew sequins on their Green Lantern unitards? Perhaps. Since my husband and I didn’t have to squish our handmade outfits into a suitcase, we were all for dressing up. Although we weren’t planning on donning garments de la geek every space aside, there was plenty to see in the exhibit hall. Not so much that you felt completely overwhelmed, like at that other con, but definitely plenty to keep you drooling and ogling for hours. We bought author-signed books, artist originals, nerdy t-shirts and prop replicates. All the wishes of my little geeky heart were granted; take that Zahra! The panels were, in general, not as good as those in San Diego but I went to a few that surprised me with their informative insightfulness, namely those hosted by various sci-fi and fantasy book authors. The Will Shatner and Stan Lee panels weren’t half bad either and by “not half bad” I mean that they were awesome! Ample stars congregated at Salt Lake Comic Con. Perhaps some of these enduring personalities would have been outgleamed by new-found heartthrobs in San Diego but in the Beehive State they were bigger than the latest Mo Tab album: Will Shatner, William Kircher, Henry Winkler, Taimak Guarriello, Ray Park, John de Lancie, Dwight Schultz, Lou Ferrigno, Peter Mayhew, Kevin Sorbo, Stan Lee and David Prowse. Most of these fellows were pleasant and friendly but William Kircher, who plays Bifur in Peter Jackson’s hobbit movies, was exceptionally nice and courteous. Henry Winkler was also very cheerful and gracious. He wandered through his line of fans shaking hands, giving hugs and doing magic tricks. 6 IMWSCC 4th Quarter 2013 day of the con, that’s what we ended up doing. It’s hard to resist transforming into an uber-nerd when you can smell the stench of nerdery all around you. From Frodo to Katara the waterbender, I looked the part of the hopeless fan girl. Salt Lake Comic Con was a nerdy delight. Being its first time, it had some glitches but to a veteran of San Diego, where everything is chaotic lines and stacks of stinky humanity, it seemed comparatively relaxing. I’m sure the enormous number of attendees this year attracted the attention of many self-important celebrities and next year’s con will be wilder and more packed than the Mos Eisley Cantina. And, unlike Chalmun’s, at Comic Con droids are always welcome. You can get updates and articles on the web! www.imwscc.org A LEADING SUPPLIER OF UNIQUE SPECIALTY CHEMICAL INGREDIENTS TO THE COSMETIC AND PERSONAL CARE INDUSTRY BARNET WHERE SCIENCE MEETS FASHION to us, innovation comes... naturally www.kinetiktech.com e-mail: info@kinetiktech.com t: (732) 335-5775 Kinetik_SCC2x2_2011FINAL.indd 1 1/28/11 4:10 PM Over 100 in vivo tested actives • Prompt regulatory support Formulation assistance and prototypes • New system formers from Japan We are pleased to present our new Western Region Sales team Michelle Carrillo 818-324-4773 mcarrillo@barnetproducts.com Karen Chun 714-325-3109 kchun@barnetproducts.com Guy Langer (Qumulus Group) guylanger@aol.com 818-606-7060 WWW.BARNETPRODUCTS.COM BARNET PRODUCTS CORPORATION 201.346.4620 140 SYLVAN AVE. ENGLEWOOD CLIFFS NJ 07630 A Vantage Specialty Chemicals Business A Vantage Specialty Chemicals Business www.lipochemicals.com BOTANICEUTICAL PEPTIDES • Botaniceutical MSF Peptide 100% of consumers perceived an increased tanning response (In-vivo) • Botaniceutical CS Peptide 88% Wrinkle depth reduction in 28 days (In-vivo) • Botaniceutical NI Peptide 38% Reduction in wrinkles in 28 days (In-vivo) Exclusively from DD CHEMCO, INC. Tel:818.349.4149 • email: info@ddchemco.com 4th Quarter 2013 IMWSCC 7 Perry Romanowski: ChemistsCorner.com Natural Colorants for Cosmetics By: Perry Romanowski Did you know that in the United States it is not permitted by the FDA to just add any old ingredient into your cosmetic for the purposes of changing color? In fact, of all the ingredients in cosmetics, colorants are the most highly regulated. This is most likely because historically colorants have also been the most dangerous. Anyway, the only colorants you are allowed to use in the United States are laid out by the FDA. If you are a “natural” formulator there are only a few on the list of approved colorants that you would be allowed to use. They are as follows: Annatto beta-Carotene Caramel Carmine Chlorphyllin Cu complex Guaiazulene Henna Guanine Annatto This is a yellow to orange colorant derived from a shrub that grows in a number of places in the southern hemisphere. It can be used in the US, EU and China. beta-Carotene Another yellow to orange pigment that can be used for cosmetics around the world. It’s derived from a fungus and exhibits good stability. Caramel A brown colorant that comes from the burning of sugars like sucrose, dextrose, malt syrup, molasses, etc. It’s highly stable and can be used for formulating products around the world. Carmine This is a bright, red colorant which has a bluish shade. It is derived from female cochineal beetles that are collected primarily in Peru. The color can be used in cosmetic products around the world. It was traditionally used to dye textiles. Carmine is also one of the brightest of all natural colorants. Chlorophyll Cu Complex This is a green colorant obtained from alfalfa. To get the final product it is reacted with copper to replace the naturally occurring magnesium found in the molecule. It is approved throughout the world. 8 IMWSCC 4th Quarter 2013 Guaiazulene This ingredient is a blue colorant that is derived from the chamomile plant. It is legal in the US but is not allowed in products in the EU or China. Henna This is a brown dye derived from the Henna plant. It primarily comes from India. This natural colorant is allowed in the US but not in the EU or China. However, it is specifically prohibited for use in coloring eyelashes and eyebrows due to its known ability to cause irritation. Guanine This colorant is derived from herring fish scales and has a purplish color. It is used in all types of cosmetic products. It is approved for use in the US but not in EU or China. This is primarily because it hasn’t been economically feasible to go through the testing to get it approved in these countries. Outside the US While the colors listed are the natural colorants allowed in the US for cosmetics, there are a number of ones approved outside the US so if you are a natural formulator in these markets you might be able to use some of the following: Lycopene – reddish / orange color derived from tomatoes Vegetable Carbon – Black color derived from burnt vegetable matter Curcumin – Yellow color derived from the spice turmeric Capsanthin/Capsorubin – Orange color derived from sweet red peppers. Commonly known as paprika Canthaxanthin – yellow – red color derived from mushrooms or shrimp. There you have it. The color choices for a natural formulator are limited but you do have some choices. AAK Cosmetic Ingredients The natural choice for superior functionality The soul and science of beauty. Biofunctional Lipids Foresight, responsibility, realization. Sensory Improvers Functional Emollients Vegetable Derivatives Evonik Industries AG Essen, Germany PHONE +49 201 173-2854 Evonik Goldschmidt Corporation Hopewell, Virginia, USA PHONE +1 804 541-8658 personal-care@evonik.com responsibility-personal-care@evonik.com www.evonik.com/personal-care Delight the skin, protect the planet E-mail us at Lfc.us@aak.com EVGPC-3148 R2 2013 NewsLetter Ad 4x4.indd 1 2/27/13 9:52 AM 4th Quarter 2013 IMWSCC 9 rmarshall@brinkshofer.com Patent Law 113: Fast Tracking Patent Examination By: Ryan Marshall Patent examination is often a long process with delays that leave the applicant uncertain about the patentability of an invention. Patent applicants are understandably frustrated with such delays because patent rights cannot be enforced until a patent is granted. There are, however, techniques to expedite the examination process. New patent applications are taken up for examination in the order of their effective filing dates, and typically do not receive a first action for almost two years. A final action allowing or rejecting the application typically takes almost three years, and in some technology areas, this period is often five years. In some cases, an extended period of examination is acceptable. Other circumstances may justify faster examination such as business advantages from excluding competitors from the market, the prospect of licensing and other revenue generating opportunities, and in quickly changing technology fields. How then, can an applicant expedite review of an application? Patent Prosecution Highway (PPH) Several patent offices have agreements enabling an applicant to obtain the same claims at one patent office following the allowance of claims in another office. In such proceedings, the patent applicant presents the allowed claims from a first patent office to a second patent office with a “Patent Prosecution Highway” request. Such requests significantly shorten the examination period by the second patent office. The presented claims will be examined to insure that the claims meet the second patent office’s formal requirements, but the novelty of the claims will be given deference based on the first patent office’s finding of patentability. This procedure works well if you have already received allowance of your claims in some jurisdiction. Special Status Applicants at the U.S. Patent and Trademark Office can request “special status.” An application can qualify for special status based on (1) an inventor’s infirm health or being at least 65 years old or for (2) inventions that materially enhance the environment, conserve energy resources or counter terrorism. Many frustrated applicants, however, have found that special status has not resulted in quicker examination. Accelerated Examination U.S. applicants may also file requests for “Accelerated Examination.” Such requests must be accompanied with a 10 IMWSCC 4th Quarter 2013 statement that the applicant conducted a pre-examination search and provide support documents explaining why prior art identified from the pre-examination search does not defeat the patentability of the claimed invention. This procedure is not often used by applicants because of the amount of pre-filing diligence required, and the risk that someone could challenge an applicant’s characterization of prior art as misleading. Track I Program – Prioritized Examination Track I requests, also called prioritized examination, became available for U.S. applications on September 26, 2011. The U.S. Patent and Trademark Office’s objective with track I requests is to reach a final disposition within twelve months. The patent office, however, will not offer a refund if the deadline is missed. Final disposition occurs when there is a notice of allowance, a final office action, a request for continued examination (RCE) or notice of appeal filed by the applicant, or abandonment. Also, an application reverts to regular status at final disposition or if the applicant files a petition for any extension of time. Eligible applications include utility and plant applications and continuation and divisional applications. Ineligible applications include design, reissue and reexamination applications, and Patent Cooperation Treaty (PCT) applications. The USPTO has stringent formal requirements for an applications qualifying for prioritized examination. For example, an application can have no more than 30 total claims and 4 independent claims and no multiple dependent claims. Normal examination requires payment of a $1,600 filing fee ($800 for small entities). In addition to the normal examination fee, a prioritized examination fee must be paid which is $4,000 ($2,000 small entity) plus $130 petition and $300 publication fees. Patent Law 113 Continued: If a petition for prioritized examination is denied, the prioritized examination fees will be refunded except for the petition fee. Prioritized examination enables a number of new strategies. For example, prioritized examination enables an applicant to quickly ascertain the patentability of an invention. If unpatentable, this early determination may obviate the need for foreign filings and related fees. If an invention is not a strong candidate for a patent, an applicant can request non-publication of the application and maintain the innovation as a trade secret. On the other hand, following a successful prioritized examination, an applicant can pursue Patent Prosecution Highway (PPH) proceedings in some countries to rapidly acquire foreign patent rights and avoid some prosecution expenses. Patent Prosecution Highway and prioritized examination procedures, among others, provide applicants procedural flexibility in expediting patent examination. These options may also enable applicants to reduce their overall patent expenses. This article is intended to provide information of general interest to the public and is not intended to offer legal advice about specific situations or problems. Brinks Hofer Gilson & Lione does not intend to create an attorney-client relationship by offering this information, and review of the information shall not be deemed to create such a relationship. You should consult a lawyer if you have a legal matter requiring attention. For further information, please contact a Brinks Hofer Gilson & Lione lawyer. Snow ‘n Learn February 27, 2014 Hotel Park City Make your plans to SnL next quarter. We will be having breakfast, meeting, and lunch from 9am to 1pm, and then it is off to Gorgoza Park for some fun in the snow. Tubing ends at 4pm. We hope to see you there! 4th Quarter 2013 IMWSCC 11 Grand Seminar IMWSCC 4th Quarter Meeting November 14 , 2013 The Grand America Hotel Salt Lake City, Utah Schedule 8:30am – Breakfast, registration, check-in, and announcements 9:30am – Jamie Singer, Creating a Sensory Experience 10:15am – Q&A 11:00am – Robert Harper, Testing of Cosmetics for Claim Substantiation: Past, Present, Future 11:45am – Q&A 12:00pm – Lunch Thanks for your attendance! 12 IMWSCC 4th Quarter 2013 Presenters for Grand Seminar Jamie Singer CP Kelco Robert Harper Consultant, Personal Care Industry Creating a Sensory Experi- Testing of Cosmetics for Claim Substantiation: ence Past, Present and Future IFood science and cosmetic chemistry share many parallels in the consumer marketplace. Both disciplines of science are dedicated to provide consumers with products that evoke emotions and create a sensory experience. Many times the scientist is so focused on the product, that the end result of an emotional consumer experience is forgotten. In culinary innovation, the sensory experience of the consumer is at the forethought and the product is built from the end result backwards. Applying this thought process to food science and cosmetic chemistry allows the scientist to see their product development path from a new perspective, allowing for an expansion of the mental toolbox. Additionally, the scientist can draw from experiences of both disciplines as we see many of the same types of products in both the food and cosmetics marketplace; such as, emulsions, suspensions, and concentrations. Jaime Singer is an accomplished Food Scientist with more than 10 years in the industry and over 200 active products in the Retail and Foodservice markets. Currently in the role of Technical Service Representative with CP Kelco, Jaime is contributing to the company’s success with her unique skill set of Foodservice product development knowledge paired with her passion for Culinology inspired innovation. Culinology inspired Jaime to return to school to become a Certified Culinary Scientist, which should be completed by the end of 2013. She is also an active member in both the Research Chef ’s Association and the Institute of Food Technologists. When Jaime is not driving innovation with her customers she enjoys exploring the culinary and mixology trends in her home town of Chicago, as well as long distance running, and developing culinary delights in her own kitchen. Jaime is a member of the Chicago Area Runner’s Association and acts as a mentor for younger athletes looking to build a lifelong health and fitness routine. Claim support for cosmetics goes back to the 1920’s when statements were made primarily concerning the safety of products. Later in the 1930’s efficacy claims began to emerge based primarily on consumer studies. By the 1980’s non-invasive, instrumental methods were introduced to substantiate skin care product claims. Claims such as skin moisturization, skin lightening, skin firmness and elasticity, skin barrier function, and skin mildness (just to name a few) are now being routinely substantiated by instrumentation. The FDA as well as other regulatory bodies provide oversight for cosmetic product claims. Over the years a number of cosmetic companies have received letters from the FDA stating that the company is making a drug claim rather than a cosmetic claim. Occasionally regulatory actions end up in court as was the case with the cosmetic companies using the term “hypoallergenic” back in the 1970’s. Today testing for cosmetic claim support involves a combination of clinical evaluations by physicians, in vitro assays, consumer studies, clinical studies, and non- invasive instrumentation. With the use of cosmeceuticals, nutraceuticals, nutri-cosmetics, nano particles and cosmetic devices, the testing arena will need to become even more sophisticated that it is today. Dr. Harper is a personal care and pharmaceutical expert with more than 30 years experience in clinical and scientific research in the areas of dermatology and topical products. He obtained a Ph.D. in Biochemistry from N.C. State University and spent 17 years in academic research in dermatology at the Skin and Cancer Hospital, Temple University Medical School , Philadelphia, Pa. and the Connective Tissue Research Institute, University of Pennsylvania. Dr. Harper’s industry experience includes Manager of Biotechnology at Helene Curtis, Chicago, Ill., Director of Product Safety Testing at Hill Top Research, Cincinnati, Ohio, Director of Clinical Research at PRACS Institute, Fargo, ND, and Vice President of Clinical Research at Derm Tech International and Cosmederm Inc., San Diego, CA. More recently, he was President of Hill Top Research, St. Petersburg, FL. Presently, he works as a consultant to the personal care and pharmaceutical industries. 4th Quarter 2013 IMWSCC 13 Spotlight: Brian Cook Where were you born? Crete, Nebraska What was your favorite subject in grade school? Science As a child, what did you want to be when you grew up? Forrest Ranger Favorite Hobbies? Road Biking, Mountain Biking, Fly Fishing, Skiing Favorite TV Show? I don’t watch much TV but I’ve seen all the Drake Magazine 5-minute videos. . BOTANICAL EMOLLIENTS & SPECIALTY PARTICLES Favorite Movie? Get Shorty On the weekend, you will most likely be found… on a river or on a mountain. Any nicknames we should know about? None, as far as you know. What is the most adventurous thing you’ve ever done? I like to mountain bike and float rivers at night. A headlamp makes everything feel more adventurous. www.floratech.com 24/7 Online Ingredient Information: The Natural Solution i Label ® www.floratech.com/info Intermountain West Region: Brian Pickel | 480.545.7000 | brian.pickel@floratech.com CHT.7022-SCC Chemtec Ad 4 x4 r.1_Layout 1 1/21/13 1:39 PM Page 1 What was your last vacation? A summer trip fishing and biking around Breckenridge, CO with the family. If you could have a super-power what would it be? I always thought that laser beams coming out of my eyes would be handy. What is your favorite quote? “I have not failed. I’ve just found 10,000 ways that won’t work.” - Thomas Edison What are you most proud of? I have a great wife and two super kids. 14 IMWSCC 4th Quarter 2013 CHEMTEC Chemical Company is a member of the NACD and practices product stewardship. Tel: 818.700.0071 • Fax: 818.700.1301 • www.chemteccc.com CHS.7011-2013 SCC Ad Interm_West_qxp 12/17/12 1:06 PM Page 1 Silicone solutions for every body We Provide YOUR Silicone Solutions™ Manufacturer of Specialty Silicones for Cosmetics and Personal Care Represented by: Chemtec Chemical 818.700.0071 877.700.0302 • www.chemsil.com International Cosmetic & Food Regulatory Consultants We’ve got the whole world in our hands………. well 100 countries at least. International product notifications Label development/reviews Responsible party services Product Information Files (PIF) Ingredient/formula compliance reviews Claims development/review In-country regulatory maintenance Vendor documentation assessments www.theregulatorydepartment.com Scott Taylor (801) 754-4443 scott@theregulatorydepartment.com 4th Quarter 2013 IMWSCC 15 Colmos@nuskin.com TNT Synopsis By: Carlos Olmos The 2013 IMWSCC TNT event was a great success. More than 80 people attended and all had a great time. This year’s TNT was hosted in Park City, UT and, as usual, was full of beautiful landscapes and scenery. The event kicked off with presentations by David Fielder from Ceapro Inc. and Jeffrey Easley from Stepan. David gave an overview of oat-based ingredients and how formulators can use them, while Jeffrey explained Hair Shampoo vs. Laundry Detergent. The golf portion of the event was played at the Park City Golf Course. After playing a challenging 18 holes, and losing many golf balls, there was a luncheon with awards for those who swung great and scored high, really high. It was a fun affair filled with education and good golf. 16 IMWSCC 4th Quarter 2013 PersonalCare Lonza Personal Care Recapturing beauty through technology For product information, please visit www.lonza.com or email us at lonzapc.arch@lonza.com. 70 Tyler Place, South Plainfield, NJ 07080 +1-908-561-5200 4th Quarter 2013 IMWSCC 17 Sponsor the IMWSCC in 2014 Because of our sponsors, our chapter goes to only the finest venues. We are also able to provide delicious snacks and beverages at our meetings, and offer fun activities for our attendees. There are two different ways to sponsor the IMWSCC: Newsletter 2013 sponsor have their company ad in each of our four newsletters. This year we are offering a standard “buy now” range of sizes via the IMWSCC website. You can pick one of the preselected sizes and purchase with a credit card. Then all you need to do is send the high resolution graphic to rroberts@nuskin.com and you are all set for the year! If you want to do a different size ad, just email rroberts@nuskin.com with the ad size. The cost is $60 per/ sq inch, and you may now pay online by Paypal or credit card. Ads run 4 times each year in the IMWSCC newsletter and are distributed at each of the quarterly meetings: February, May, August, and November. Additionally, the newsletter is available for download on the IMWSCC website. Sponsors have the option of changing their advertisements each newsletter. If you choose to publish a larger ad we pro-rate it based on the previous size. If you choose to publish additional ads you can also do this and that price is also pro-rated based on how many editions the ad will be published in our newsletter(s). Quarterly Sponsorship You can sign up now to be a quarterly meeting sponsor of the IMWSCC. The cost is $350 and there is a limit of 3 sponsors per quarter. Our quarterly sponsors have approximately 2-3 minutes to introduce their company, employees, products, capabilities and services during our meeting. They have the exclusive right to distribute literature and samples at the meeting. We also provide a table adjacent to the registration table to distribute literature and samples by one or two company employees. Your company name will appear for three months on the IMWSCC website main page as a Quarterly Sponsor (sorry we cannot do logos). Your company name will also appear on the front and back cover of the quarterly newsletter as well as on a poster at the quarterly meeting. Visit our imwscc.org now to become a sponsor! 18 IMWSCC 4th Quarter 2013 scott@theregulatorydepartment.com BIG Small Changes Have Regulatory Consequences By: Scott Taylor The formula is finally done, right? It’s sent off to regulatory for review and they come back and say that everything is approved. Product is notified, labels created, customers begin purchasing and the world keeps turning. Marketing comes by a couple months later and says, “You know that formula you just made? Well, our Asian market would like it to be a bit more viscous and less vanillaeee.” Then a couple quick adjustments are made, no ingredient changes just levels, and product is sent back to Asia. No need to notify everyone since no ingredients have changed, everything should be fine. In regulatory we call that “cracking the whip”, not like cracking the whip over a mule’s ear to get it moving, but more like the game you used to play in your neighborhood. (Or, for city slickers, the game you’ve seen in movies.) There’s a long line of kids and they run around the yard with their arms or hands interlocked. Marketing and R&D are in the front of the line where not much happens. They just keep running since they are in the lead but regulatory is the 6-year-old neighbor kid who gets thrown 20 yards when the leader starts in a slightly different direction. From a regulatory standpoint, this is now what has happened with that small adjustment. If the product has been notified with the current formula, notifications may need to be redone and levels of ingredients will have to be checked again to make sure that they are still within the range allowed by each country. If you have compiled a product information file (PIF) for Europe or Asia, that also has to be redone. In some cases, all of the product testing will need to be redone: PET, RIPT, efficacy, substantiation, etc. The label order of ingredients may have changed and the documentation, specs, CofAs, MOMs, SOPs, and multiple other acronyms will need to be updated and changed. I was working at an unnamed company when I received some final formulas. I created the labels, notified the products, etc. A couple of months later I received an email with the formulas attached. I noticed they had some adjustments and, much to my surprise, the preservatives had gone up because of shelf-life issues. I checked the levels and, sure enough, the preservatives were over the allowable amount in multiple products. Launch was already planned, labels printed, etc. I sent the news over to R&D, who hadn’t bothered to tell me that the formulas had changed, and then that can of worms wasn’t opened, it exploded. Needless to say, those adjustments caused some very exciting (sarcasm intended) setbacks. Make sure to involve regulatory in any changes you are making to a formula that has already been checked. What you make and what is notified, labeled, etc. needs to match. A phone call or an email is much better than endless meetings with a cranky regulatory nerd. Freiheit und Gesundheit, D. Scott Taylor The Regulatory Department 4th Quarter 2013 IMWSCC 19 IMWSCC would like to thank our Fourth Quarter Meeting Sponsors: Active Organics Glenn Corporation 20 IMWSCC 4th Quarter 2013