june 2012 icmad makes a name at cosmoprof north … icmad june...cosmoprof north america will take...

20
Cosmoprof North America will take place July 22 – 24, 2012, at the Mandalay Bay Convention Center in Las Vegas. Come see ICMAD at the show to network, learn new information and find the newest products and services in the industry. ICMAD will be exhibiting and hosting two educational sessions and a networking breakfast. More in- formation will be available on the ICMAD website at www.icmad.org. As an ICMAD member, you will receive a 50 percent discount to attend the show. Use the code “12ICMAD” when you go online to comoprofnorthamercia.com. For complete information on how CPNA can help grow your business go to comoprofnorthamercia. com. Make sure to attend the three educational opportunities that ICMAD is providing for attendees: ICMAD Makes a Name at Cosmoprof North America SESSION 1: Color Your World: Your Brand in Color Sunday, July 22 1:00 p.m. – 3:00 p.m. Today’s most dynamic brands gain leverage with powerful visuals, clever copy and arresting color combinations. Gone are the days of simple stock packaging: consumers crave colors and designs that are playful and feminine. Is there a connection between con- sumer behavior and color? Find out with moderator Pam Busiek and color experts. SESSION 2: ICMAD Breakfast Monday, July 23 8:30 a.m. – 10:00 a.m. HotTopics from: Sharon Blinkoff, Legal & Regulatory Halyna Breslawec, PCPC, Safety Carl Geffken, International Issues Craig Weiss, Testing Members are invited to discover the hottest industry topics from ICMAD’s team of experts. Join Us June 20th Annual Meeting/CITY Awards New York, NY SESSION 3: It’s all in the Details. A Legislative Update from ICMAD, PBA & PCPC Monday, July 23 11:00 a.m. to 12:30 p.m. The industry is facing its most important legislative battle as a result of the current government’s plan to tighten regulation of cos- metic products. A change in the current laws will impact everyone working in the industry—manu- facturers of private label, contract manufacturers, suppliers and distributors in all facets of the industry. To protect the interest of the industry the top 3 beauty asso- ciations have elected to collaborate to ensure the industry comes out stronger. Learn from Pam Busiek, John Hurson, EVP Government Affairs, PCPC, and Steve Sleeper, Executive Director, PBA. June 2012 See ICMAD at these events: June 20 Annual Meeting/CITY Awards New York, New York July 22-24 Cosmoprof North America Las Vegas Follow ICMAD and the Safe Cosmetics Alliance at www.safecosmeticsalliance.org Insurance Coverage Educational Programs Networking Opportunities Publications Export Assistance Authentication Services Call Me First Directory LinkedIn, Facebook & Twitter Discount Shipping Car Discounts Mentor Program Advertising Sponsorships Independent Cosmetic Manufacturers and Distributors 1220 W. Northwest Hwy Palatine, IL 60067-1803 847-991-4499 • 1-800-334-2623 847-991-8161 (fax) www.icmad.org • [email protected] Upcoming Events Member Benefits

Upload: nguyenthuy

Post on 17-Apr-2018

219 views

Category:

Documents


2 download

TRANSCRIPT

Page 1: June 2012 ICMAD Makes a Name at Cosmoprof North … ICMAD June...Cosmoprof North America will take place July 22 – 24, ... BIR Discount to Members ... experts on FDA and FTC rulings

Cosmoprof North America will take place July 22 – 24, 2012, at the Mandalay Bay Convention Center in Las Vegas. Come see ICMAD at the show to network, learn new information and fi nd the newest products and services in the industry. ICMAD will be exhibiting and hosting two educational sessions and a networking breakfast. More in-formation will be available on the ICMAD website at www.icmad.org.

As an ICMAD member, you will receive a 50 percent discount to attend the show. Use the code “12ICMAD” when you go online to comoprofnorthamercia.com. For complete information on how CPNA can help grow your business go to comoprofnorthamercia.com.

Make sure to attend the three educational opportunities that ICMAD is providing for attendees:

ICMAD Makes a Name at Cosmoprof North America

SESSION 1: Color Your World: Your Brand in

ColorSunday, July 22

1:00 p.m. – 3:00 p.m.Today’s most dynamic brands gain leverage with powerful visuals, clever copy and arresting color combinations. Gone are the days of simple stock packaging: consumers crave colors and designs that are playful and feminine. Is there a connection between con-sumer behavior and color? Find out with moderator Pam Busiek and color experts.

SESSION 2: ICMAD Breakfast

Monday, July 238:30 a.m. – 10:00 a.m.

HotTopics from:Sharon Blinkoff , Legal & Regulatory Halyna Breslawec, PCPC, SafetyCarl Geff ken, International IssuesCraig Weiss, Testing

Members are invited to discover the hottest industry topics from ICMAD’s team of experts.

Join Us June 20th Annual Meeting/CITY Awards

New York, NY

SESSION 3: It’s all in the Details. A Legislative Update from ICMAD, PBA & PCPC

Monday, July 2311:00 a.m. to 12:30 p.m.

The industry is facing its most important legislative battle as a result of the current government’s plan to tighten regulation of cos-metic products. A change in the current laws will impact everyone working in the industry—manu-facturers of private label, contract manufacturers, suppliers and distributors in all facets of the industry. To protect the interest of the industry the top 3 beauty asso-ciations have elected to collaborate to ensure the industry comes out stronger. Learn from Pam Busiek, John Hurson, EVP Government Aff airs, PCPC, and Steve Sleeper, Executive Director, PBA.

June 2012

See ICMAD at these events:June 20 Annual Meeting/CITY Awards

New York, New York

July 22-24 Cosmoprof North America Las Vegas

Follow ICMAD and the Safe Cosmetics Alliance

at www.safecosmeticsalliance.org

Insurance CoverageEducational Programs

Networking OpportunitiesPublications

Export AssistanceAuthentication ServicesCall Me First Directory

LinkedIn, Facebook & TwitterDiscount Shipping

Car DiscountsMentor Program

AdvertisingSponsorships

Independent Cosmetic Manufacturers and Distributors

1220 W. Northwest HwyPalatine, IL 60067-1803

847-991-4499 • 1-800-334-2623 847-991-8161 (fax)

www.icmad.org • [email protected]

Upcoming Events

Member Benefi ts

Page 2: June 2012 ICMAD Makes a Name at Cosmoprof North … ICMAD June...Cosmoprof North America will take place July 22 – 24, ... BIR Discount to Members ... experts on FDA and FTC rulings

IIn Thisss IIssueCosmmopprroff North Ameerica ..........1

Fromm thhee PPresident’s PPen ............2

Memmbeerr NNews.............................3

FDAA WoWorrksshop ..........................4-7

Statte RReeguula ons .......................7

Reggulaatooryy Updates ......................8

Inteernaa onnal Corner .....................r 9

Havve YYou HHeard..........................d 10

Parrtner Neews .............................11

Infoormmaa oon Sheet- Suuunscreen ...12

Advver ssingg & Info Seerrvices ..13-18

Meembeerr Sppotlight .....................t 19

From the President’s Pen…Collaboration: Supporting Modernized Cosmetic Regulations

by Pamela Jo Busiek, President & CEO

Dear friends!

From Dallas to D.C. to NY to Chicago—the message would be col-laboration! ICMAD was privileged to have the opportunity to par-ticipate with two of our sister trade associations’ Lobby Day in D.C. in May. Professional Beauty Association Executive Director Steve Sleeper, his staff and board included ICMAD in their lobby day fur-ther representing how our industry has come together with one voice. The Personal Care Product Council President & CEO Lezlee Westine followed suit and included us in their Lobby Day as well. We had the opportunity to meet with key congressional members who have votes that impact our industry and... our voices were heard! I have included for you below a recent blog post that further shares the new bill and the importance of your participation. It is important that you log on to the alliance website, www.safecosmeticsalliance.org, and show your support for modernized cosmetic regulations. The Alliance has made it easy and straightforward to participate. If you have any questions or would like to discuss the recent industry bill, please call me. I am more than happy to walk you step by step where we are and where we are going.

Our Annual Meeting and CITY Awards are quickly approaching as is the HBA Global Expo Trade Show…we hope to see many of you there. Please stop by booth number 1257 to share what is happening with your business. Meet with many of our Board of Directors and other members. Also come to “Made in the USA: Winning Global Consumer Appeal” on Wednesday June 20 at 10:15 to 11:30 a.m.

Excerpted from SCA Blog:It is morning in America and the consumer wakes up and prepares for the day. It starts by going into the bathroom and using health and beauty products with the innate assumption that these products enhance their lives. This safety assumption is true and statistics from ICMAD’s insurance program with Cosmetic Insurance Services backs it up.

To continually reiterate the safety of the industry’s myriad of products, ICMAD has partnered with the PCPC, PBA, DSA and IFRA in forming the Safe Cosmetics Alliance to work together in promoting new legislation that will enhance transparency and give the FDA the power to keep unsafe products out of the marketplace, while ensuring that small entrepreneurs will be able to compete globally. You can fi nd out more by going to the website: Safecosmeticsalliance.org. ICMAD believes in science-based research and devel-opment as well as national uniformity that allows one standard for all 50 states.

We support HR 4395, introduced by Rep. Leonard Lance (R_NJ), as the Cosmetic Safety Amendments Act of 2012 and also give credit to Rep. John Dingell in his vigilance over the years to help ensure cosmetic safety. We are most grateful to have had the ear and inter-

Contribute to the Discussion

ICMAD’s social media program is grow-ing as a way to ensure that the cosmet-ics industry is familiar with members, news and information. Follow ICMAD on Twitter, Facebook and LinkedIn.

LinkedIn Group:ICMAD

continued on the next page

2 June 2012

ICMADTalks

www.facebook.com/ICMADTalks

Page 3: June 2012 ICMAD Makes a Name at Cosmoprof North … ICMAD June...Cosmoprof North America will take place July 22 – 24, ... BIR Discount to Members ... experts on FDA and FTC rulings

Pamela Jo BusiekPresident and [email protected]

Diora Professional LLC, Hallendale Beach, FL

Niki Saint Pierre, Fort Lauderdale, FL

Kasny Recon, Inc., Grand Prairie, TX

~ Welcome New Members ~

Eff ective May 1, ICMAD off ers ex-tended authentica-tion services for export documents. In conjunction with Certifi cates of Free Sale ICMAD, will authenticate documents for export that require a member’s signature. We can only nota-rize documents that contain the mem-ber’s signature and title.

Please use the new COFS application form which can be found online at www.icmad.org under Membership and then Export Assistance to request authentica-tion of other documents in addition to a COFS.

The fee for authentication of other documents is $125 for up to 5 docu-ments and $25 for each additional docu-ment. We will only be authenticating additional documents at the time of new Certifi cate of Free Sale requests. We can also send the other documents with the expedited Certifi cate of Free Sale if that method is selected.

For questions regarding this new ser-vice or if you would like a copy of the new application form, contact Alicia Carpenter, Export Programs Coordinator, at 1-800-334-2623 ext. 105 or [email protected].

New Authentication Services for Export Documents

CPNA Discount

See ICMAD at HBA Global

Cosmoprof North America is promot-ing a 50 percent discount to ICMAD members who register to attend the show. When you go online, use the code 12ICMAD. Additionally, you will be able to attend the ICMAD educational ses-sion, “It’s All in the Details: A Legislative Update.” Pam Busiek, CEO & President and Steve Sleeper, Executive Director of PBA, will participate on the panel.

When you register for HBA Global Expo, save 30 percent when you use the code: ICMADSAVE. Then make sure to visit ICMAD at Booth No. 1257 to meet ICMAD Directors and other members. Also make sure to register for ICMAD’s educational program “Made in the USA: Winning Global Consumer Appeal” on Wednesday, June 20 from 10:15 a.m. to 11:30 a.m. ICMAD member Alisa Marie Beyer also will present “The Beauty Business Is Not for Sissies: How to be a Genius, Not a Disaster,” on Thursday, June 21 from 8:30 a.m. to 2:00 p.m. Go to HBAglobalexpo.com to participate.

BIR Discount to Members

ICMAD has developed a partnership with Beauty Industry Report (BIR) to allow new members an electronic sub-scription at no charge for one year. All current members can receive 15 percent off the hard copy subscription or $10 off the electronic subscription. Please send ICMAD your contact information if you would like to take advantage of this of-fer to [email protected]. Send along your full contact info, especially an email address. If you have any specifi c ques-tions regarding the BIR newsletter or would like two complimentary copies, you can contact [email protected] directly.

est of Rep. Frank Pallone (D-NJ), who has been most open to hearing all sides of the issues related to the modernizing of the FDA. It is our hope that HR 4395 will be enacted as a bi-partisan achievement of this Congress. Help us by going to www.safecosmeticsalliance.org and telling your individual member of Congress that you support HR 4395.

As we are all well aware, all areas of commerce are under scrutiny as never be-fore. With that thought in mind, we want cosmetics to be in the forefront of change that continues to protect the American consumer who drives our innovation and our quest to come up with better and better products.

Blessings to you,

June 2012 3

Member News

Page 4: June 2012 ICMAD Makes a Name at Cosmoprof North … ICMAD June...Cosmoprof North America will take place July 22 – 24, ... BIR Discount to Members ... experts on FDA and FTC rulings

2012 FDA Workshop Attracts Largest AudienceBy Sheila Sebor, ICMAD V.P. Operations

The 2012 edition of ICMAD’s popular FDA Cosmetic Regulations Workshop at-tracted an overfl ow crowd to Vanderbuilt Suites in New York City on April 26. The largest group in more than a decade gathered to learn from both legal and regulatory experts and the FDA’s staff ers.

ICMAD President/CEO Pam Busiek welcomed all attendees and thanked the stellar lineup of expert speakers, includ-ing FDA staff traveling from Washington, DC to provide regulatory updates, legal experts on FDA and FTC rulings and ICMAD’s technical consultants. She also recognized several members of the ICMAD Board in attendance and thanked them and ICMAD staff members for their continuing eff orts to address member concerns and provide much needed pro-grams and services. She also spoke about ICMAD’s continuing eff orts on the indus-try’s legislative initiatives and asked for everyone’s support in the coming days to educate their elected representatives about the safety and concerns of the cos-metic and personal care small businesses that make up ICMAD.

ICMAD Board Chair Ian Ginsberg talked about how he had been intro-duced to ICMAD through a previous FDA Workshop and the many advantages of being a member. He suggested that fi rst time attendees whose companies were not yet members review the materials made available and contact the ICMAD offi ce to learn how membership can ben-efi t their companies.

David Adams, Partner, Venable LLP, pre-sented the fi rst session, “Understanding

FDA,” an overview of the Food and Drug Administration, which develops and enforces regulations for the cosmetic and personal care industries. The FDA was created in 1938 to implement the Food, Drug and Cosmetic Act, passed that year. It began with a Bureau in the Department of Agriculture with less than 30 people. Currently the agency employs 12,000. The FDA is not an in-dependent agency, it is located within the Department of Health and Human Services (HHS), and the Secretary of HHS is the fi nal word on FDA policies.

The FDA is organized by centers, which have responsibility for diff erent products. The Center for Food Safety and Applied Nutrition (CFSAN) regulates foods, dietary supplements, cosmetics and tobacco. The Center for Drug Evaluation and Research (CDER) regulates both prescription drugs and over-the-counter (OTC) drugs. Within CFSAN, key offi ces for our industry are the Offi ce of Cosmetics and Colors, which develops and enforces policies for cosmetics and approves color additives, and the Offi ce of Compliance, which handles labeling and adultera-tion issues and the drug/cosmetic de-termination. CDER is “a little bit more layered,” said Adams, with various offi ces organized by particular kinds of drugs. The Offi ce of Nonprescription Products inherited the OTC drug monograph re-view. Within the FDA, the Offi ce of Chief Counsel provides legal advice when the agency signs off on regulations. However, lately the FDA has been hiring regulatory counsel at the center level.

The FDA oversees a number of pro-cesses for the products it regulates. These include review and determination on citizen petitions, review and approval/rejection of time and extent applica-tions, inspections, investigations and enforcement of the regulations. The agency also coordinates with the Federal

Trade Commission (FTC), which regulates advertising. The two agencies share in-formation and mutually support each other’s enforcement eff orts.

Ed Glynn, Partner, Manatt, Phelps & Phillips, LLP, contin-ued the discussion of the federal agen-cies governing the industry by describ-ing responsibilities of the FTC and why it is relevant to cos-metics companies. Glynn described the diff erence between the FDA and the FTC as that of two diff erent kinds of regula-tors, “licensers” and “cops.” He said, “the FTC is about as close to pure cop as any agency.” It was created in 1914 by legis-lative act, which was amended in 1937 to prohibit unfair practices. Currently FTC has approximately 1200 employees. Although the agency has about 200 law-yers doing all of the consumer protection enforcement at FTC, it also works with the FDA and states’ attorneys general. It also maintains close relations with for-eign anti-trust agencies and is develop-ing relationships with foreign consumer protection agencies, particularly the Canadians. One new activity by the FTC, said Glynn, is its apparent adoption of FDA claims substantiation in its rulings. In a few recent cases, it has identifi ed specifi c requirements for substantiation of advertising and it has looked to the FDA for its technical experts.

Sharon Blinkoff , Of Counsel, Venable, LLP, provided some details on the current federal legislative activity that aff ects cosmetics. The U.S. FDA has indicated that it would like to see the current vol-untary cosmetic registration program made mandatory and it would also insti-tute user fees for cosmetics manufactur-ers to fund several programs on cosmetic safety.

There are now three bills circulating in the U.S. House that would substantially alter the requirements for companies

4 June 2012

Page 5: June 2012 ICMAD Makes a Name at Cosmoprof North … ICMAD June...Cosmoprof North America will take place July 22 – 24, ... BIR Discount to Members ... experts on FDA and FTC rulings

2012 FDA Workshop Attracts Largest Audience, continued

manufacturing, distributing and mar-keting cosmetics and personal care products.

The fi rst bill, The Safe Cosmetic Act of 2011, was introduced June 24, 2011 by Rep. Janice Schakowsky. This bill, backed by activist groups, would regulate cos-metics more strictly than OTC drugs, said Blinkoff . The second bill, H.R. 4262, the Cosmetic Safety Enhancement Act of 2012, was introduced March 26, 2012 by Rep. Frank Pallone and Rep. John D. Dingell. It would require marketers and suppliers to provide safety substantiation for all products on the market, would make the current registration program mandatory and would also give FDA mandatory recall authority. The bill con-tains parallel language to the food bill, but cosmetics do not carry the same risks as ingested foods, said Blinkoff .

On April 18, 2012, Rep. Leonard Lance introduced H.R. 4395, The Cosmetic Safety Amendments Act of 2012. This bill is supported by our industry, said Blinkoff , because although it requires facilities and products to be registered with the FDA, it also provides the agency with the authority to create national standards for the review of cosmetic in-gredient safety that permits stakeholder participation. She asked all attendees for their support of this bill and to contact their U.S. representatives to educate them about the bill and to let them know their concerns about the impact of these bills on their businesses.

Carl Geff ken, President, Carl Geff ken Consultants and Craig Weiss, President, Consumer Product Testing Company, provided attendees with new information about

safety and emerging technologies. Geff ken noted that in the current regula-tory reality, manufacturers, distributors and marketers are all responsible for the safety of the cosmetic products they make and sell, but “if your name is on the

product” you are the responsible party. Safety considerations should cover the ingredient, the fi nished products and more recently, the impact of both on the environment. Within the consumer prod-uct category, cosmetics have the lowest incidence of complaints.

A relatively recent concern has been the increased use of the term “active ingredients” when referring to the chemi-cals used in cosmetic products. That term is reserved for drug products, whether prescription or OTC, said Geff ken. They are defi ned and analyzed using U.S. Pharmacopeia monographs and methods. Inactive ingredients that are used in cosmetics are identifi ed by INCI nomenclature. The latest INCI diction-ary, published in 2012, contains about 19,000 ingredients used in cosmetics. A number of jurisdictions have created positive and negative lists of ingredients. They include California’s Prop 65 list, the Canadian Hotlist, the EU Annexes and FDA’s positive list of approved color addi-tives. In summary, safety substantiation is a regulatory requirement and involves testing of both ingredients and fi nished products.

Craig Weiss provided a detailed sum-mary of what those testing requirements should be. Although the FDA requires that a cosmetic product shall be “gener-ally recognized as safe,” there is currently no FDA safety standard for cosmetic products. Prior to the availability of new testing technology, a number of animal tests were used to determine toxicity, dermal irritancy, ocular irritancy and sen-sitization. Today there are a number of in vitro test methods available for substitu-tion. Weiss said the most popular safety test used today is the Human Repeated Insult Patch Test (HRIPT). This method involves repeatedly applying a patch containing the material being tested on “normal” human volunteers to predict irritation and any allergic response. For known irritants, regime product groups, hygiene products or pediatric products, Weiss recommended In-Use studies, with evaluation by a physician, trained evalu-

ator or the test subject. He briefl y re-viewed the three bills currently circulat-ing in Washington that would aff ect the cosmetic industry and said that although all the bills have diff erent priorities and safety standards, none of them specify testing requirements, which is a concern for the entire industry.

Ken Hegel, Vice President, Cosmetic Insurance Services (CIS), off ered statistical data on the safety of the cosmetic industry, based on his company’s 15 year study

of claims and safety. CIS insures more than $4 billion of products annually. Of the hundreds of millions of cosmetic and personal care products sold during that period, his company received 917 claims, 815 of them for product prob-lems. Skincare products had the highest percentage of claims, at 37%, followed by hair care products at 21%. The major-ity of product liability claims were closed with very little paid for indemnity or damages. As the majority of the costs were driven by legal fees, Hegel noted that even though a company may be found to be not liable for damages, costs can still run well into fi ve and sometimes six fi gures.

Hegel provided fi ve scenarios of ac-tual claims cases that clearly illustrated his point. In one particular scenario, a claimant alleged that he developed leg ulcers from using a skin softening product purchased in a pharmacy. The product had been made by a CIS insured company and the pharmacy was covered under the insured’s vendor coverage. As the plaintiff died two years after the claim, a wrongful death action was also attached to the suit. Testimony from the plaintiff ’s doctor indicated that the leg ulcers had healed and the product did not contribute to the plaintiff ’s death. The insured was dismissed from the case and no indemnity payment was required. However, the legal costs to defend the case totaled $221,812.

Kristen Moe, Compliance Offi cer in

June 2012 5

Page 6: June 2012 ICMAD Makes a Name at Cosmoprof North … ICMAD June...Cosmoprof North America will take place July 22 – 24, ... BIR Discount to Members ... experts on FDA and FTC rulings

2012 FDA Workshop Attracts Largest Audience, continued

the FDA’s Center for Drug Evaluation and Research, Division of New Drugs Labeling and Compliance, provided attendees with information on the Over-the-Counter (OTC)

Review. An OTC drug is used for condi-tions that can be self-diagnosed and self-treated, so that a layman can use them safely for their intended purpose. A prod-uct can be both a drug and a cosmetic, if it meets the defi nition of both. Products such as antidandruff shampoos, fl uoride toothpastes and deodorants with anti-perspirants have two intended uses; as cosmetics and as OTC drugs. The FDA de-termines intended use by reviewing oral or written statements, advertising mate-rial, which can also be the website, and circumstances surrounding the product’s distribution.

For a drug product, there are two legal paths to market, the New Drug Application (NDA) process and conform-ing to an OTC Monograph. The NDA pro-cess is both lengthy and expensive, but provides the advantage of exclusivity, said Moe. OTC drugs do not require pre-approval, but must follow the OTC rule-book, known as the monograph or rule. The monograph process is also lengthy, but it is the responsibility of FDA to pro-vide this “recipe book” for a category of products.

A question that frequently comes up is what if there is no fi nal rule for a particu-lar product category. Moe said the FDA’s general policy is that products on the market at the beginning of the OTC Drug Review (1972) may remain on the market until there is a fi nal rule published, un-less there is a safety concern. Conditions that would render a product an unap-proved new drug would be any active ingredients, inactive ingredients, indica-tions or dosage forms not identifi ed in the monograph. Active ingredients must use the range or concentration listed in the rule. Inactive ingredients must not

have any impact of the fi nal form or use of the product. Some monographs con-tain specifi c dosage forms, other are less defi ned. Any indications not identifi ed in the monograph would require an NDA or NDA-deviation prior to marketing. A drug is considered misbranded if the la-beling is incorrect, false or misleading or the product is dangerous to health when used according to the labeling.

Dr. Linda Katz, Director of FDA’s Offi ce of Cosmetics and Colors (OCAC), pro-vided an “Update from the Offi ce of Cosmetics and Colors.” Dr. Katz began by stating that in past years when she has presented at this workshop, funding for cosmetics has been an issue, but cur-rently fi scal year (FY) funding levels have been stable. When FY 2013 information was publicized, the $11.9M requested for cosmetics included funding beyond that requested by CFSAN, the center that houses the cosmetics offi ce. Regarding OCAC’s core processes, Dr. Katz said the Voluntary Cosmetic Registration Program is now 99.5% electronic and, although there are more registrations this year than last, it is still not a large number. She encouraged attendees to remove their old formulations that are no longer in the market from the VCRP database, to keep it current. The offi ce’s research in cosmetics is done in-house if the exper-tise is available, otherwise the studies are contracted out.

A considerable amount of time and re-sources is devoted to international issues, including import oversight and harmo-nization discussions. Imports have more than doubled from 2007 to 2010. OCAC is an active participant in the International Cooperation on Cosmetic Regulation (ICCR) program and will be hosting this year’s meeting in June. Continuing is-sues include alternative test methods, nanotechnology, trace ingredients, safety assessment approaches, and cosmetic la-beling. ICCR will also be discussing a pos-sible expansion of the program to other countries and/or groups. Other countries that have been invited to the ICCR6 meeting include China, Korea, Australia

and Saudi Arabia.On compliance and enforcement is-

sues, OCAC works closely with the drug center’s compliance offi ce, as a major issue for some products is marketing a cosmetic that makes drug claims. Enforcement activity priorities haven’t changed; OCAC continues to focus on oral care products, particularly low or no alcohol mouthwash, eye-area cosmetics, skincare and hair care products and color additives. In 2011, a total of 277 adverse events were reported and 115 of them required medical care. Hair care products represented 45.7% of the events, many stemming from hair straighteners pro-ducing formaldehyde gas when used with heat. Import enforcement contin-ues, with 39% of the 1687 refusals in 2010 stopped because the products were found to be drugs or medical devices “improperly marketed as cosmetics.”

Dr. Katz discussed OCAC’s intent to revise the cosmetics chapter of the FDA’s Bacteriological Analytical Manual (BAM). The language is arcane and the science and technology also need to be updated. It is OCAC’s intent to remove regulatory policy statements, which are considered inappropriate for an analytical testing manual. The offi ce is looking for input from stakeholders and Dr. Katz asked for attendees’ suggestions.

Future priorities include an updated website, increased hiring to backfi ll for retirees but also to increase personnel, continued involvement in the ICCR pro-cess and developing a laboratory survey for ingredients and contaminants in mar-keted products.

Shontell Fleming Wright, chemist in the OCAC, provided a step by step review of the online VCRP. The paper reporting program was initiated in 1972, but the electronic site went live in 2005. To

get to the VCRP electronic portal, go to www.fda.gov, select “Cosmetics” and then select “VCRP.” Wright highlighted

6 June 2012

Page 7: June 2012 ICMAD Makes a Name at Cosmoprof North … ICMAD June...Cosmoprof North America will take place July 22 – 24, ... BIR Discount to Members ... experts on FDA and FTC rulings

2012 FDA Workshop Attracts Largest Audience, continued

several screens that appear on the VCRP webpages and took attendees through the process of registering a product on-line. There are currently 1,825 unique ac-counts in the program, with 32,517 prod-ucts registered. The product registration form requires the name of the fi ller, the label information, including the name of the manufacturer/distributor and the address, the product category, product name and the ingredients. A simple way to enter the ingredients, said Wright, is to put them in a Word document and then copy/paste them into the fi eld block. INCI names are preferred and there is a drop down list to ensure correct spelling.

Common entry errors include regis-tering products not for sale in the U.S., unapproved color additives and the use of CI numbers instead of FDA names, and ingredients that are either misspelled or not contained in the INCI or the VCRP online dictionaries. If the ingredient names are correct and they are located in a document on the company’s computer, it may take only one or two minutes to enter a product into the online VCRP. Wright encouraged all attendees to regis-ter their products in the system as a way to ensure that FDA has use information. Wright also noted that this system is a stand alone database, and not connected to any other information gathering re-source used by the agency, so companies do not have to be concerned about FDA using this information for its enforce-ment activities.

The day’s fi nal presentation was a group discussion of claim substantia-tion and advertising regulation. Annie Ugurlayan, Senior Attorney with the National Advertising

Division (NAD) of the Better Business Bureau, provided details about how advertising self-regulation works under the NAD program. NAD was formed in 1971 by the advertising industry to counter attacks on the accuracy of con-

sumer ads. The division is national in character and covers print, television, Internet, radio, direct mail and social media advertising. NAD’s oversight of advertising helps to create a level playing fi eld, said Uruglayan, and there is a 95% compliance rate with NAD’s fi ndings. Companies not complying with NAD’s conclusions may fi nd themselves answer-ing to the FTC, as NAD may refer com-plaints to the agency for enforcement.

Ugurlayan provided several actual complaints and reviewed NAD’s analysis of the substantiation studies provided as well as the conclusions. Although cosmetics are not a large percentage of the division’s review process, current advertising trends NAD has seen include the use of gene technology, “beauty from within” and organic/”green” claims. She noted that there are still very aggressive claims being made for beauty products. She recommended that companies: 1. Ensure that the claims being made re-fl ect the results of product testing; 2. Do not equate topical cosmetic products to medical procedures; 3. Performance claims using numbers require clinical studies that show statistical results at or above the numbers specifi ed; and 4. Performance claims based on consumer testing should use the language pro-vided to those consumers.

Craig Weiss pro-vided guidance on how testing can substantiate prod-uct claims. He said a cosmetic claim can-not be a structure/function claim, but effi cacy studies can

be used to validate cosmetic claims. He provided some examples of formulation and performance claims. Formulation claims can include, “oil free,” or “contains aloe.” Performance claims can be “mois-turization,” “skin tone,” safe for sensitive skin,” and similar statements. Regulators look for both clinical signifi cance and statistical signifi cance, since “if you can’t see the changes, it doesn’t matter.” He

strongly suggested using photos to doc-ument clinical signifi cance. Quantitative claims, especially if there is “%” attached to it, must be substantiated by objective methods. He identifi ed the various pieces of testing equipment and how they are used. He recommended that companies “know what they’re asking for” and pro-vided a checklist of what a good study should contain.

Tom Cohn, Partner, LeClairRyan, discussed current FTC enforcement activities, saying that while the agency has increased its eff orts against dietary supplements, it has no major law en-forcement activity against cosmetics. However, he cautioned that beauty claims could come under attack if they are strong and objective enough. He summarized an $900k FTC settlement against a skin cream maker for claims of body size reduction. Weight loss claims appear to be the chief focus of the FTC’s enforcement eff orts.

A recent FTC settlement over a com-plaint against replacement windows that alleges “up to X%” energy savings” on claims implied that “all or almost all” consumers are likely to receive such ben-efi t. The FTC issued a consent order that required, for all “up to” claims for the win-dows, the company have substantiation that “all or almost all” customers were likely to receive the benefi t. This conclu-sion may have implications for other in-dustries, including cosmetics, said Cohn.

Attendees were impressed with both topics and speakers. In their own words:

• “Great – embraced both the supplier and customer sides.”

• “I enjoy all the workshops – they are always informative and benefi cial to attend.”

• “Essential; best local one day event; very informative.”

To purchase a copy of the presentations at the price of $100, contact the ICMAD offi ce at 800-334-2623 or write to [email protected].

June 2012 7

Page 8: June 2012 ICMAD Makes a Name at Cosmoprof North … ICMAD June...Cosmoprof North America will take place July 22 – 24, ... BIR Discount to Members ... experts on FDA and FTC rulings

REGULATORY UPDATES

FDA Delays Sunscreen Compliance Date

On Friday, May 11, the FDA published a notice in the Federal Register that it is delaying the compliance dates for the fi nal rule of over-the-counter (OTC) sunscreen drug products. The June 17, 2011 fi nal rule had an eff ective date of June 18, 2012 for products with sales of more than $25,000 and June 17, 2013 for products with sales of less the $25,000. After the publication of the fi nal rule, requests for a six month extension of the compliance dates were submitted by the Personal Care Products Council (PCPC) and the Consumer Healthcare Products Association (CHPA). The re-quests were made by the two associa-tions to allow more time for companies to resolve complex label redesign issues and to complete the required broad spectrum testing. FDA agreed that the operational timeline submitted in the request supported the extension of “the implementation period by an additional six months.” Without the extension, FDA noted that manufacturers that would not be able to comply within the allotted time would either have to discontinue distribution or confi ne “themselves to the labeling for products that have not been established to be broad spectrum,” depriving consumers of additional infor-mation on their choice of sunscreen. The new compliance date for products with sales of $25,000 or more is December 17, 2012, and December 17, 2013 for products with annual sales of less than $25,000.

To review the complete rule, go to: https://www.federalregister.gov/articles/2012/05/11/2012-11390/labeling-and-eff ectiveness-testing-sunscreen-drug-products-for-over-the-counter-human-use-delay-of.

National Advertising Review Council Changes Name

The National Advertising Review Council has updated its name and logo to better describe the growing responsibilities of the organization. It will now be known as the Advertising Self-Regulatory Council (ASRC). ASRC sets the policies and pro-cedures for the advertising industry’s self-regulatory programs. These include the Children’s Advertising Review Unit (CARU), the Electronic Retailing Self-Regulation Program (ERSP), the National Advertising Division (NAD), National Advertising Review Board (NARB) and the Online Interest-Based Advertising Accountability Program (Accountability Program). The Council of Better Business Bureaus (CBBB) administers the system. CARU, ERSP and NAD are the investiga-tive arms of the self-regulatory system and NARB is the appellate body of NAD and CARU. The Accountability Program enforces industry principles regarding consumer choice and transparency in on-line interest-based advertising.

This self-regulatory system monitors the marketplace, holds advertisers re-sponsible for their claims and practices and tracks emerging issues and trends. The rigorous reviews instituted by the programs serve to encourage consumer trust. The system off ers an expert, cost-effi cient, meaningful alternative to litiga-tion and provides a framework for the development of a self-regulatory scheme for emerging issues.

For additional information about the Council and its programs, go to http://www.asrcreviews.org/.

ICMAD Members Learn How to Evaluate Their

Technology

ICMAD’s Call-In Forum with Linda Kuppersmith, President of CMIT Technologies in Stamford, CT, covered information on how to reduce risk and increase productivity. She specializes in small business needs and recommends that when looking for a consultant ICMAD members should hire someone who understands their specifi c issues, especially because small business faces its own set of challenges.

Kuppersmith recommends complet-ing an assessment of one’s technol-ogy. This process can help prepare a company for growth and sales. “When conducting an assessment, you need to ask the following questions: are you cur-rent, what is your need, how much risk do you have, and are you positioned for growth,” she said.

Technology is a necessity in today’s workplace, but it can also drain re-sources. Kuppersmith describes that owners/CEOs need to determine who will be working with what technology and what functions will need to be ac-complished. In other words, “Is that person a user or an information worker?” Specifi c solutions to gain productivity could include dual monitors, free soft-ware options, knowing when to add a server or move to the cloud, and learn-ing how to create a systematic way to fi nd documents.

Protecting yourself from data loss also is urgent for business owners because 1 out of 10 people will experience this is-sue. Make sure the system works by test-ing it. And, watch out for malware since this is the leading cause of identity theft. Finally, to keep everything in order, make sure to develop a written policy for technology so that everyone under-stands the expectations. Simple is better and remember upgrade regularly.

If you missed this Call In Forum, please check your email and the ICMAD web-site (www.icmad.org) for current infor-mation. We look forward to your partici-pation in an upcoming event.

8 June 2012

Page 9: June 2012 ICMAD Makes a Name at Cosmoprof North … ICMAD June...Cosmoprof North America will take place July 22 – 24, ... BIR Discount to Members ... experts on FDA and FTC rulings

June 2012 9

AsiaAccording to GDM Group USA, a mar-keting and branding company, break-ing into the Asian beauty market can be challenging for many companies, as it is dominated by brands from the U.S. and France. Online sales and celebrity advertising are effi cient ways to intro-duce new brands to this marketplace. Although Japan is currently a key beauty market in Asia, China is quickly catch-ing up, with cosmetic sales expected to reach $34.7bn by 2015. In China there is still space for new brands. A key strategy in that market is to make the target au-dience feel important. Ways to become successful in the Chinese market are to focus on online sales or home shopping to cut distribution costs, use celebrities to advertise products and provide free samples.

ChinaAn article on premiumbeautynews.com cited information from PETA (People for the Ethical Treatment of Animals) that Chinese government offi cials may ap-prove the country’s fi rst non-animal test method for cosmetic ingredients. Last year, PETA US awarded a grant to scien-tists at the Institute for In Vitro Sciences (IIVS) to meet Chinese offi cials and share information. This has resulted in the pending approval of the 3T3 Neutral Red Uptake Phototoxicity Assay (3T3 NRU PT) test, an in vitro toxicological assessment test used to determine the cytotoxicity and phototoxicity of chemicals when they come into contact with sunlight. This method is already widely used in the U.S. and the European Union (EU). It is expected to be approved in China by late summer. China has become interested in non-animal testing methods due to the EU’s 2013 prohibition on the sale of cos-metics that have been tested on animals.

In 2011, prestige beauty sales in China increased by 21 percent, with skincare improving by 23 percent and makeup sales growing by 17 percent, according to market researcher NPD Group. The prestige beauty segment is composed of skincare, makeup and fragrance products

sold in department stores and Sephora in the top 10 cities in mainland China. Anti-aging products account for half of the skincare category sales and increased almost 27 percent in 2011, compared to 2010. In the makeup segment, founda-tion and makeup base lead the category, with increases of 24 and 30 percent, respectively. Lip products also drove growth, up 26.5 percent in 2011.

GermanyScientists in Germany have developed a new technology to detect and analyze nano-sized materials in cosmetics and sunscreens. Researchers at the University of Tϋbingen developed the study, called INSTANT (Innovative Sensor for the fast Analysis of Nanoparticles in Selected Target Products). Ten institutions in six diff erent countries are participating in the project. Optical and electrochemical processes are being combined to quickly and cost-eff ectively classify particles and evaluate their sizes, even in complex me-dia such as milk or blood.

U.S. - Colombia Free Trade Agreement

Global Shifts in Beauty Identifi ed

On May 15, over 80 percent of U.S. ex-ports to Colombia will become duty-free. Almost 57 percent of consumer goods will immediately receive duty-free treat-ment; an additional 13 percent will be-come exempt from tariff s over fi ve years and all remaining tariff s will be elimi-nated over a ten year period. From 2008 to 2010, duties on export sales of $160 million in consumer goods to Colombia totaled over $70 million. Current con-sumer goods tariff s average 15 percent, but range from zero to 35 percent. The Agreement also will provide signifi cant new access to Colombia’s $180 billion services market, supporting increased opportunities for U.S. service providers. For more information, go to the Offi ce of the U.S. Trade Representative site: http://www.ustr.gov/uscolombiatpa.

Irina Barbalova, head of global per-sonal care and beauty research for Euromonitor, recently spoke at In-Cosmetics about the 2011 trends in beauty and the future outlook for the sector. Premium sales have nearly matched pre-recession growth, due to robust sales in North America and sustained growth in Latin America. There has been a shift in product po-sitioning, with “category cross overs, multitasking, multi-functionality, and generally a more holistic approach to anti-aging.” Barbalova said nail polish has replaced lipstick as a barometer of industry health, increasing 30 percent in the U.S. alone in 2011 and “the cate-gory is now close to 6 billion globally.” Barbalova predicted that “premium brands will continue to lead innova-tion and set the bar very high in tech-nology and scientifi c innovation….”

EU Guide from ICMADNow Available!

A Guide to European Cosmetics Regulations, 3rd Edition is now avail-able to members. The book is updated with new information about how com-panies can comply with the rules of the EU’s cosmetic legislation that become fully eff ective in July 2013.

The price for the 100 page refer-ence is $150 for members, $250 for non-members. To purchase a copy, click on the Publications link on the ICMAD Website www.icmad.org, or call 1-800-334-2623.

Note: Members must log into the website to obtain member pricing on the guide.

Page 10: June 2012 ICMAD Makes a Name at Cosmoprof North … ICMAD June...Cosmoprof North America will take place July 22 – 24, ... BIR Discount to Members ... experts on FDA and FTC rulings

10 June 2012

• BB Creams have grown signifi cantly in sales in the past several months. These creams are also known as “blemish balms” or “beauty balms” and are expected to con-tinue to grow according to NPD Beauty Trends. BB Creams are multifunctional prod-ucts that combine the functionality of primers, SPF and moisturizers along with the anti-aging benefi ts of skin serums. Although still in its infancy the product is grow-ing in popularity with some U.S. women, with department stores generating close to $9m in the 12 months ending March 2012, according to the market researcher. In its latest study, NPD states that women expect BB creams to provide skincare and make-up benefi ts, although they lack complete understanding of the product and how it works. (cosmeticsdesign.com, May 2012)

• Targeting the affl uent. According to beauty market research conducted by The NPD Group, Inc., total U.S. prestige beauty generated $9.5 billion in 2011. This rep-resents an increase of 11 percent in dollars, compared to the $8.6 billion in 2010. In addition, outstanding dollar results were achieved in all beauty categories, surpass-ing pre-recession levels. This means more brands and companies are targeting the affl uent market as a way to drive growth. Unity Marketing notes that, according to Women’s Wear Daily, Swedish retailer H&M is rumored to be among the mass-mar-ket brands now aiming for more luxury consumer dollars by launching a more luxe line, complete with more luxe prices. Another study from Total Beauty Media Group showed that women, regardless of age or income, spent money on luxury beauty products within the past 12 months, with the study noting that more than 50 per-cent of respondents purchased makeup or skincare as their last luxury brand beauty purchase. Also more than 43 percent of respondents purchased beauty or personal care products through a discount website within the past 12 months. According to the study, this makes beauty and personal care products the most popular category among respondents for online luxury discount shopping, ahead of designer cloth-ing, designer shoes, spa services vacations, fi ne dining, concerts, sporting events and other luxury goods. (GCI, May 2012)

• Social Media plays a key role in reaching consumers for beauty brands. As more and more consumers turn to the Internet and word of mouth becomes more important, social media will play a key role in engaging the consumer, according to a new report by Mintel. In its UK-based study, the market researcher found that 15 mil-lion Brits have interacted with beauty and personal care brands online. According to the report, every day in the UK, 59 percent of Brits log into their Facebook accounts and 13 percent sign into Twitter, and Mintel reveals that Brits increasingly use the Internet to research beauty products for 34 percent of would-be buyers. Mintel fi nds just over two-thirds of Brits who engage with beauty brands have visited the website of a beauty or personal care brand, and almost 10 million people visit beauty and per-sonal care brand websites.(Cosmeticsdesign.com, May 3, 2012)

• Sales demand for cosmetics to rise to $9.9 billion in 2016. In a recent study carried out by market researcher Reportlinker, sales demand for cosmetic and toilet-ries is forecasted to rise by 5 percent per year to $9.9 billion in the United States in 2016. According to the report, several segments in the industry, including organic and natural products, male grooming, ethnic products and anti-aging are poised for rapid growth, directly impacting the mix of the substances used in their formulation. The main growth drivers are said to be trends favoring organic and natural formulations, a growing Hispanic population prompting formulators to provide items that meet the specifi c needs of this segment, and the country’s obsession with youth promoting products. (Cosmeticsdesign.com, May 7, 2012)

Brands with Staying Power

The 2012 Harris Poll EquiTrend study has assessed 1,500 brands across more than 127 product categories to identify 15 that have fl exed their staying power “muscle” year after year and ranked No. 1 in their respective categories every year since 2005, when the current EquiTrend methodology began. On the list are “mega-brands” that came to defi ne their respective categories, like Coca-Cola, Craftsman, Gatorade and Life Savers. They have signifi cant staying power because each brand consistently delivers on its brand experience and re-mains relevant to today’s consumers, ac-cording to the study. According to Aron Galonsky, SVP, for Harris Interactive’s Brand and Communication Consulting Group, the top 15 brands “have consistently found a way to remain relevant and valuable” to the consumer. “It’s not surprising why these perennial leaders continue to stay on top. They continually deliver a con-sistent and balanced brand experience, year after year, that really resonates with the consumer,” he said. Unfortunately, there’s not a beauty/per-sonal care or household brand in that elite 15. Although brand equity is gener-ally slow moving, strong brands, once established, will typically maintain their brand momentum, according to Harris Interactive. For example, Apple’s iPhone continued its rise and became one of the top technology brands in EquiTrend. Other brands with strong year-over-year performance that garnered them a 2012 “Brand of the Year” distinction, include ICMAD member Physicians Formula Cosmetics. More information on this study is available at www.harrisinterac-tive.com.(happi.com, May 2012)

Have You Heard?

Page 11: June 2012 ICMAD Makes a Name at Cosmoprof North … ICMAD June...Cosmoprof North America will take place July 22 – 24, ... BIR Discount to Members ... experts on FDA and FTC rulings

ICMAD Insurance Benefi ts • By Kenneth C. Hegel, Jr.

ICMAD’s mission is “To represent, educate and foster the growth and profi tability of entre-preneurial companies in the cosmetic and personal care industries worldwide.” Most of our members are aware of

the many programs and services ICMAD off ers

to help them succeed in the glamorous, hectic beauty business. Some of ICMAD’s programs focus on the exciting, trendy, fast-paced beauty aspects of the indus-try. Other programs may not off er the excitement and glitz of the beauty busi-ness, but emphasize the business side of the beauty business.

ICMAD off ers one of these programs through Cosmetic Insurance Services

(CIS), a division of Frenkel & Company. Frenkel was founded in 1878 and is cur-rently the 25th largest broker of U.S. busi-ness, with revenues exceeding $55M. CIS has been part of the “beauty business” for more than 30 years. Their knowledge, commitment and expertise in both the cosmetic and the insurance industry has enabled them to develop exclusive insurance programs tailored for ICMAD members.

The list of key program coverage enhancements is both impressive and unique:

• True Worldwide Liability Coverage Territory on Products Liability

• Product Recall Coverage including Loss of Profi t

• Hired & Non-Owned Auto Liability including Hired Car Physical Damage

• Employee Benefi ts Liability

• Blanket Additional Insured Vendors• Guaranteed Cost/No Products/CGL

Deductible• Defense outside the Limit• Professional Liability Coverage in-

cluded for Demonstrators• Earthquake & Earthquake Sprinkler

Leakage available (including California)

• Full coverage for Windstorm avail-able (including Florida & Texas)

As recent weather-related damage cre-ated problems for a number of ICMAD members, one member insured through CIS remarked, “If I wasn’t with CIS, I might as well have been uninsured.”

To protect your hard-earned success and fi nd out more about the ICMAD en-dorsed CIS cosmetic insurance program for members, contact ICMAD at 847-991-4499 or [email protected].

Since 1989, Masterpiece International has off ered domestic and international transportation services. The company was founded to serve the business of fi ne arts shipping but quickly adapted to serve all industries.

Masterpiece is an International Logistics solution provider. Being a li-censed OTI (both Freight forwarding and NVOCC capable), customs broker and consultant, IATA agent and domestic transportation specialist (air, truck and train), with 13 offi ces nationwide, allows them to off er a one-stop, door-to-door reliable logistics solution package that companies can count on.

Masterpiece International utilizes the most advanced information technologies available today to handle transactions with U.S. Customs. The system provides connectivity with our clients to allow for detailed status reports on a real time basis.

The worldwide network of Masterpiece

Forwarding Your Freight with Masterpiece

offi ces and international agents allows us to provide a true door-to-door service to our clients. A primary resource of the company is the management, who col-lectively has over two centuries of trans-portation experience.

We consider ourselves to be a global partner with the companies we work with. Cutting-edge technology such as remote fi ling capability, AMS automation directly to the U.S. Customs database, and EDI automation for easy response upload to our windows based tracking system, provide the information neces-sary to compete in today’s competitive environment.

The commercial customs brokerage and consulting division of Masterpiece International enjoys the fellowship of 13 offi ces nationwide with more than 20 licensed brokers on staff . Feeling secure that you are in good hands in this ever changing, post 9-11 customs era, will allow you to rest assured knowing you

have an experienced, knowledgeable and reliable broker looking after your im-port needs. For Information. contact Mary Ptak at [email protected].

Masterpiece International provides a wide range of Exhibition and Fine Art Logistical Services, including:

• Licensed Customs Brokerage (ABI) (ACH)

• International and Domestic Freight Forwarding, Specialized Cargo and Global Exhibition Services

• Licensed Air Freight (IATA)• Owner of Multi-Modal International

Shipping, Inc. (NVOCC)• Import and Export Documentation• Cost Eff ective Door to Door

Transportation: Land, Air and / or Sea• Door to Door Insurance Coverage• Worldwide Consolidation Services• Drayage and Storage of Empties• Labor and Support for Set-up,

Dismantle and Disposition of Goods

June 2012 11

Partner News

Page 12: June 2012 ICMAD Makes a Name at Cosmoprof North … ICMAD June...Cosmoprof North America will take place July 22 – 24, ... BIR Discount to Members ... experts on FDA and FTC rulings

C a l l - i n F o r u m s

C a l l - i n F o r u m s

N e t w o r k i n g N e t w o r k i n g

A d v o c a c yA d v o c a c yR e g u l a t o r y

R e g u l a t o r y

c h n i c a l F o r u m s

Te c h n i c a l F o r u m s

I n t e r n a t i o n a lI n t e r n a t i o n a l

E d u c a t i o n

E d u c a t i o nC I T Y A w a r d s

C I T Y A w a r d s

C e r t i f i c a t e s o f F r e e S a l e

r t i f i c a t e s o f F r e e S a l e

r t i f i c a t e s o f F r e e S a l e

c t L i a b i l i t y I n s u r a n c e

C a l l - i n F o r u m s

e t w o r k i n g

A d v o c a c y

R e g u l a t o r y

R e g u l a t o r

Te c h n i c a l F o r u m s

I n t e r n a t i o n a l

I n t e r n a t i o nE d u c a t i o n

C I T Y A w a r d s

C e r t i f i c a t e s o f F r e e S a l eP r o d u c t L i a b i l i t y I n s u r a n c e

P r o d u c t L i a b i l i t y I n s u r a n c e

C a l l - i n F o r u m s

N e t w o r k i n gd v o c a c y

R e g u l a t o r y

T e c h n i c a l F o r u m s

I n t e r n a t i o n a l

E d u c a t i o n

P r o d u c t L i a b i l i t y I n s u r a n c e

C I T Y A w a r d s

e r t i f i c a t e s o f F r e e S a l e

Cal l - in ForumsAdvocacy

acy

Advocacy

Regulator yhnical Forums

Technical Forums

Internat ional

Internat ional

ternat ional

ion

CIT Y Awards

Cer t i f icates of Free Sale

Product L iabi l i ty Insurance

Product L iabi l i ty InsuranceCall-in Forums

Networking

Advocacy

Regulatory

Technical Forums

InternationalEducationCIT Y Awards

Certificates of Free Sale

Product Liability Insurance

NetworkInformation Sheet

CCCCC aaaaaaaaaaaaaaaaa l lllllllll - iiiiiiiiii nnnnnnn FFFF ooooooooooooooooooooooooooooooo rrrrrrrrrrrrr uuuuuuuuuu mmmmmmmmmmmmmmmmmmmmmmmmmm sssssssssss

C a l l - i n

RRRRRRRR eeeeeeee ggggggggggggggg uuuuuuuuuuuuuuuu l

FFFFFF ooooooooooo r uuuuuuuuuu mmmmmmmmmmmmmm sssssssss

c hhhhhhhhhhhhh nnnnnnnnnnnnn i ccccccccccccccccccccccccccc aaaaaaaaaaaaaaaaaaaaa lllllll FF oo rr uu m sss

E d u c a t i o n

a tt eeeee sssssssssssssssssss oooooooooooooooooooo f FF rrrrrrrrrrrrrrrrrrrrrrrrrrrrr eeeeeeeeeeeeeeeeeeeeeeeeeeeeee ee SSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSS aaaaaaaaaaaaaaaaaaaaaaaaaaaa l eeeeee

i lllllllllllllllll i tt yyyyyyyyyyyyyyyyyyyyyyyyyyyyy IIIIIIIIIIIIIII nnnnnnnnnnnnnnnnnnnnnnn ssssssssssssss u r a n c e

i n g

A d vvvvvvvvvvvvvvvvvvvvvvvvvvvv oo cccccccccccccccccccc a cccccccccccccccccccccc yr u mmmmmmmmmmmmmmm ssr ul e

II nnnnnnnnnnnnnnnnnnnnnnnnnnnnn t e r n a t i o n a lE dE dII

t i oo nnnnnnnnnnnnn

P r o d u c t L i a b i l iiiiiiiiiiii tttttttttttt yyyyyyyyyyyyyyyyyyyyy I n sRRRRRRR eeeeee ggggggggggggggggggggggggggggggg u lgggggggggggg u l

a c yyyyyyyyyyyyyyyyyyyyyyyIIIIIIIIIIIII nnnn

RRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRR eeeeee gggggggggggggggggggggggggggggggg uuuuuuuuuuuuuuuuuuuuuuuuuuuuuu lllll aaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaa tttttttttttttttttttttt oooooooooooooooooooooooooooooo rrrrrrrrrrrrrrrrrrrrrrrrrr yCCCCCCC aaaaaaaa l ll i nnn FF oooooooooooo rrrrrrrrrrrrrrrrr uuuuuuuuuuuuuuu mm ssssssssi

ssssssssss I

EEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEE dddddddddddddddddddddddddddddddddddddddddddddd u

A I

onnnnnnnnnnnnnnnnnnnnalFF

i ll iiiiiii ttttttttttttttttttttttttt yyyyyyyyyyi ll ttt yyyyyyyyyy

wwoorrrrrrkkkkkkkkkkkkkkkkkkkkkkkkkkkkkkiinnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnggggggggggggggggggggCCCCCCCCCCCCCCCCCCCCCCCCCCCCC FF ooooooo rr uuuuuuuuuuuuuuuuuuuuuuuuuu mm ss FF oooooo rr u mm sst ii oo nnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnt ii oo nnnn

RRRRCCCCCCCCCCCCCCCCCCCCCCCCCC

ssssssss

i n g P r oInnttttttttttttttttttttteeerrrrrrrrrrrrrrrrrrrnnnnnnnnnnnnnnnnnnnnnnaaaaaaaaaaaaattttttttttttttttttttiiiiiiiiiiiiiiiiiooooooooooooonnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnaaaaaaaaaaaaaaaaaaaaaaaaaaaaallllllllllllllllllllllllll

RRRRRRRRRRaaaaaaaaaaaaaaaaaaaaaa l FFFFF oooooooooooooooooooooooo rrrrrrrrrrrrrrrrrrrrrrrrrrrrr uuuuuuuuuuuuu m ssssssssssssssssssssssaaaaaaaaaaaaaa l FFFFF oooooooooooooooooooooo rrrrrrrrrrrrr uuuuuuuuuuuu m sssssssssssoooooooooooooooooooooooooooooo ffffffffffffffffffffffffff FF rrrrrrrrrrrrrrrrrrr eeeeeeeeeeeeeeeeeeee ee SSSSS aaaaaa llllllllllllllll eeeeeeeeeeeeeeeeeeeeeeeeeeeeo SS

May 2012

Note: This information is not intended as legal advice. The new reg-ulations are complicated and marketers should solicit advice from their experts.

-ing and testing sunscreen products that are drugs and are covered by the Sunscreen Monograph. While the FDA issued

still subject to changes. Under consideration are whether SPFs greater than 50 can be declared and whether spray dosage forms are acceptable. Also under consideration are whether certain combinations of approved sunscreen ingre-dients will be permitted. The FDA issued proposed regula-tions on the SPF declaration and the sprays. The FDA also issued a Guidance outlining its current thinking on enforce-ment of the new regulations.

The following is a brief summary of the changes. Please refer to the document links at the end of this sheet for more complete information.

The Final Testing requirements have changed the SPF Test, creating a completely new test for broad spectrum products, which replaces the old proposed UVA screening test. The new testing regulations have also changed the wa-ter resistant testing.

The labeling regulations change the required labeling of the Principle Display Panel, the required indications, warn-ings and directions. Most importantly, all sunscreen drug products must have Drug Facts labels. There are no longer exemptions for small packages or products intended for use in small areas such as lip balms. Important: Drug Facts la-bels contain mandatory labeling information; active ingre-dients, indications, warnings and directions as prescribed by the Monograph. Drug Facts labels cannot contain cos-metic claims. The Drug Facts label is the government’s real estate. Under Questions or Other information you can and should give contact information for consumers to report se-rious adverse events and you must include product storage information.

According to the FDA Guidance, “The 2011 ANPR also listed those dosage forms that we did not consider cur-rently eligible for review for potential inclusion in the OTC sunscreen monograph: wipes, towelettes, powders, body washes and shampoos.

OTC sunscreen products in these dosage forms are not currently eligible for review under the OTC sunscreen mono-

graph, because we lack the evidence that such products ex-isted in the OTC drug marketplace on or before May, 1972. OTC sunscreen products in these dosage forms that are marketed without an approved application therefore remain liable to regulatory action unless and until the requirements

use of sunscreens for cosmetic purposes such as product preservation or use in shampoos to protect hair color from fading as these are cosmetic uses.]

The compliance dates for these new regulations are June 18, 2012, and June 17, 2013, for products with annual sales of less than $25,000.

The Guidance notes the FDA would not seek enforce-ment of the new SPF testing rules until June 17, 2013, pro-vided the SPF declared was obtained from tests conducted in accordance with procedures established in the 2007 pro-posed regulations or the 1999 Final Monograph (that was stayed.) The Guidance suggests that it will not take enforce-ment action until 2013 if the product’s labeling does not suggest broad spectrum protection. Note: none of these extended deadlines apply if the product is labeled with un-approved claims - waterproof, sweat proof or sunblock. Also claims of extended protection or immediate action are not permitted for products marketed under the OTC Sunscreen Monograph. A separate NDA has to be obtained for these claims.

The FDA rules and draft Guidances can be found at the following web addresses:http://www.gpo.gov/fdsys/pkg/FR-2011-06-17/pdf/2011- 14766.pdfhttp://www.gpo.gov/fdsys/pkg/FR-2011-06-17/pdf/2011-14769.pdfhttp://www.gpo.gov/fdsys/pkg/FR-2011-06-17/pdf/2011-14767.pdfhttp://www.gpo.gov/fdsys/pkg/FR-2011-06-17/pdf/2011-14768.pdf

[email protected] for additional details or referral to a regula-tory specialist.

U.S. FDA New Sunscreen Regulations

12 June 2012

Page 13: June 2012 ICMAD Makes a Name at Cosmoprof North … ICMAD June...Cosmoprof North America will take place July 22 – 24, ... BIR Discount to Members ... experts on FDA and FTC rulings

JOB MARTReplies will be forwarded to you or you may be contacted directly. Address your reply to ICMAD, c/o Job Mart, 1220 W. Northwest Highway, Palatine, IL 60067. Job seekers in the cosmetic industry are invited to submit their notice of availability (in 50 words or less).

Practical Modern Hair Science is the defi nitive guide for translating hair sci-ence into practical application. This is a book you will use and not watch collect dust on your shelf. The book includes the fundamental science of hair while recognizing the need to create success-ful products and meet the needs of con-sumers. You can order the book at www.AlluredBooks.com.

Cosmoprof North America, July 22–July 24, Las Vegas—This show facilitates one-on-one introductions between man-ufacturers and distributors. There are four pavilions and hundreds of resources in one venue. There is an international fl air and wide range of products show-cased including Spotlights, which will highlight smaller companies and their products that are big on creativity, but tight on budget. For registration informa-tion, contact www.cosmoprofnorthamer-ica.com. Use 12ICMAD to receive a 50 percent discount.

Spa & Beauty Expo, August 11–12, Sydney, Australia—This is the largest event for the spa and beauty industries in Australia. Professionals at all levels have a unique opportunity to source and experience the latest beauty products, treatments, ideas and equipment from the country’s leading brands and suppli-ers. For more information, go to www.internationalbeautyexpo.com.au.

Beyond Beauty Paris, September 10–12, Paris—To refl ect a professional’s need as closely as possible, the program features three specialized exhibitions: Cosmeeting, Creative and Spa. Every year, new and emerging organic brands, the latest sustainable innovations and important trends are showcased. There are also 50 keynotes from which to choose. For information, go to www.be-yondbeautyparis.com.

International Beauty Show, June 9– 11, Las Vegas—This tradeshow is for members of the professional beauty industry. IBS is packed with education and opportunities and off ers more than 150 classes, 300 exhibitors, nail competi-tions and barber cutting competitions. Information on registration is located at www.ibslasvegas.com

HBA Global Expo, June 19–21, New York—Whether you are looking to add new products to an existing line or launch your own beauty company, HBA Global Expo provides attendees with resources, techniques and skills that will assist you in your day-to-day job. The show off ers a new product zone, a trend spot theater, case histories and in-dustry panels and new this year Splash, an invitation only program that serves as a springboard for emerging compa-nies. You can register for this event at www.hbaexpo.com. Use ICMAD code ICMADSAVE to save on your admission.

Propack China 2011, July 18–20, Shanghai— This is China’s leading processing and packaging technology trade show. It is going to be held at the Shanghai New International Expo Centre. ProPak showcases processing and packaging solutions for all indus-tries, including cosmetics. For more in-formation, go to www.propakchina.com.

y

ak

June 2012 13

Digest Advertising & Information Services

Trade Shows

Trade Shows

Resources

USA Pfeiffer Consulting LLC 1101 Sweetwater Lane #1204 Naples, FL 34110 - USA Europe/Asia Pfeiffer Consulting GmbH Im Brünnlislehen 18 75180 Pforzheim - GermanyContact: [email protected]

As one of the leading European training companies, Pfeiffer Consulting trains and educates your staff in:

Cosmetic-GMP ISO 22716 R&D Preservatives EU-Regulations

Public and inhouse seminars.ICMAD members receive special conditions.

Training ofemployees

We qualify your staff! campusc o s m e t i c

Page 14: June 2012 ICMAD Makes a Name at Cosmoprof North … ICMAD June...Cosmoprof North America will take place July 22 – 24, ... BIR Discount to Members ... experts on FDA and FTC rulings

Shipping Program

*Includes a bonus 5% online processing discount. Full details available at www.PartnerShip.com/08icmad/FedExdiscounts. For full FedEx® offer terms, contact your association or PartnerShip. All FedEx shipments are subject to the applicable FedEx Service Guide at fedex.com. FedEx service marks used by permission.PartnerShip LLC, an independent transportation broker, produced this ad.

Enroll online today at

or call 800-599-2902PartnerShip.com/08ICMAD

for more information.

Managed by

Freight

SAVE ATLEAST 70%

Small Package

SAVEUP TO29%*

14 June 2012

Digest Advertising & Information Services

USA Pfeiffer Consulting LLC 1101 Sweetwater Lane #1204 Naples, FL 34110 - USA

Europe/Asia Pfeiffer Consulting GmbH Im Brünnlislehen 18 75180 Pforzheim - Germany

Contact: [email protected]

As an internationally known consulting company we make your products marketable for the EU. Our services:

Cosmetic-GMP Audits Implementation of the standard Staff education

ICMAD members receive special conditions.

Cosmetic-GMPISO 22716:2007

We implement it!

Page 15: June 2012 ICMAD Makes a Name at Cosmoprof North … ICMAD June...Cosmoprof North America will take place July 22 – 24, ... BIR Discount to Members ... experts on FDA and FTC rulings

June 2012 15

Digest Advertising & Information Services

Making the case for beauty...

7 Columbia TurnpikeFlorham Park, NJ 07932

Tel: 800.950.0390Email: [email protected]: www.wwpinc.com

Page 16: June 2012 ICMAD Makes a Name at Cosmoprof North … ICMAD June...Cosmoprof North America will take place July 22 – 24, ... BIR Discount to Members ... experts on FDA and FTC rulings

16 June 2012

Digest Advertising & Information Services

USA Pfeiffer Consulting LLC 1101 Sweetwater Lane #1204 Naples, FL 34110 - USA

Europe/Asia Pfeiffer Consulting GmbH Im Brünnlislehen 18 75180 Pforzheim - Germany

Contact: [email protected]

NATRUEOrganic Cosmetic

As an internationally known consulting company, we are also NATRUE accredited to certify your organic cosmetic products.

ICMAD members receive special conditions.

We certify your products!

Page 17: June 2012 ICMAD Makes a Name at Cosmoprof North … ICMAD June...Cosmoprof North America will take place July 22 – 24, ... BIR Discount to Members ... experts on FDA and FTC rulings

Masterpiece International Ltd is the official freight forwarder & on-site handling agent for USA exhibitors attending Cosmetic & Beauty Trade Shows Worldwide.

Masterpiece offers a discounted rate on domestic shipping charges for trade show or commercial shipments and FREE storage in between trade shows for all ICMAD members. For more information please contact Masterpiece International. T: 847-806-9595 E: [email protected]

W: www.masterpieceintl.com

June 2012 17

Digest Advertising & Information Services

Whereverthe beautyindustry is

For enquiry please contact:[email protected]@mteedizioni.it

EXPORT MAGAZINEis there too

Page 18: June 2012 ICMAD Makes a Name at Cosmoprof North … ICMAD June...Cosmoprof North America will take place July 22 – 24, ... BIR Discount to Members ... experts on FDA and FTC rulings

USA Pfeiffer Consulting LLC 1101 Sweetwater Lane #1204 Naples, FL 34110 - USA

Europe/Asia Pfeiffer Consulting GmbH Im Brünnlislehen 18 75180 Pforzheim - Germany

Contact: [email protected]

As an internationally known consulting company we make your products marketable for the EU. Our services:

Preparing safety reports Structuring and administering PIFs Cosmetic GMP audits Providing the responsible person

ICMAD members receive special conditions.

European RegulationEC/1223/2009

We prepare you!

18 June 2012

Digest Advertising & Information Services

COSM

OPRO

FNOR

THAM

ERICA.CO

M

LAS VEGAS - MANDALAY BAY CONVENTION CENTER22ND - 24THJULY 2012

Page 19: June 2012 ICMAD Makes a Name at Cosmoprof North … ICMAD June...Cosmoprof North America will take place July 22 – 24, ... BIR Discount to Members ... experts on FDA and FTC rulings

MGL Associates LLC • www.mglusa.com

BeginningsMGL Associates LLC was founded in 2000 by Michael Long, following a successful 20-year execu ve career with L’Oreal, Bene on, and LVMH. A er managing start-up acquisi ons for LVMH, Michael realized how young companies are especially challenged with not being able to aff ord experienced industry management. Michael’s vision of Integrated Brand Management quickly gained trac on and MGL Associates began providing outsourced turnkey management to some of the most crea ve and exci ng start-ups in the cosme cs industry.

“The most cri cal me for a developing company is during the fi rst two years of opera ons when major decisions and investments set the course for future success or failure. There is a signifi cant need for these companies to have con nuing professional guidance to navigate business decisions and maximize investment dollars.”

Over the last 12 years, MGL Associates has worked with clients in a number of industry sectors including Fragrance and Cosme cs, Well-ness, Personal Care, Fashion and Accessories, and Home and Interior Design. Michael points out that in recent years, there has been a shi in which services are focused on structuring and managing companies for scalable interna onal growth.

MGL Associates works with clients in the United States and overseas. Management services include strategic business development, retail strategy and interna onal expansion for U.S.-based clients, fi nancial and opera onal management, crea ng business plans, procuring asset-based fi nancing, establishing interna onal companies in the U.S. market and guiding start-up opera ons.

Michael a ributes the success of his company to a wealth of knowledge and structure gained through his previous corporate career, a willingness to assist clients at all levels of management, a track record of consistently providing value to clients, and his strong professional network that aff ords clients access to the fi nest industry resources. Michael graduated with a degree in Account-ing & Business from Montclair State University and is a Cer fi ed Public Accountant and Chartered Global Management Accountant.

FutureIn the short-term, MGL Associates will con nue to focus on a number of current priori es ed to some exci ng client ini a ves. Being an ICMAD member since 2000 has provided MGL Associates with many benefi ts that include using ICMAD’s regulatory contacts and its professional network of industry experts.

Long-term planning includes developing a Paris-based prac ce, star ng fi rst quarter 2013, to more easily work with European clients and developing a proprietary business educa on forum. You can reach Michael at [email protected].

Member Spotlight

Would you like your company featured here? Just let us know. Fax your request to 847-991-8161 or write us at: ICMAD, 1220 West Northwest Highway, Palatine, IL 60067.

Selection for the ICMAD Spotlight does not serve as any form of certifi cation or confi rmation that the above mentioned product or service is in compliance with applicable laws or regulations, nor does it constitute an endorsement of the

company or its products.

June 2012 19

Page 20: June 2012 ICMAD Makes a Name at Cosmoprof North … ICMAD June...Cosmoprof North America will take place July 22 – 24, ... BIR Discount to Members ... experts on FDA and FTC rulings

ICMAD represents, educates and fosters the growth and profi tability of entrepreneurial companies in the cosmetic and personal care industries worldwide.

Independent Cosmetic Manufacturers and Distributors, Inc.1220 West Northwest HighwayPalatine, IL 60067-1803847-991-4499 • 800-334-2623847-991-8161 (fax)www.icmad.org • [email protected]

INVITES ALL MEMBERS TO ADVERTISE WITH US!• 3-1/4” X 2” CREDIT CARD SIZED BLACK AND WHITE AD COSTS $600, 4-COLOR COSTS $800• WILL RUN IN 10 DIGESTS (ONE FULL YEAR)• FOR AN ADDITIONAL $150 YOUR AD WILL RUN ON ICMAD’S WEBSITE• CONTACT THE ICMAD OFFICE AT 1-800-334-2623 OR • [email protected] FOR MORE INFORMATION

Rates for black and white credit card sized ads are $600, 4-color ads are $800, payable annually. Nonmembers will be allowed to reach our members by paying $1200 for black and white, $1600 for 4-color. If you do advertise in our newsletter, for an additional $150 your classifi ed ad can be posted on ICMAD’s website. Nonmembers would pay $300. If you have any questions, please call Marilyn at 1-800-334-2623.

ADVERTISE YOUR COMPANY IN THE ICMAD DIGEST