Business Beat
The Drug Facts panel like the one seen on Bare Escentuals' i.d. Soy Mocha lip balm container will soon be required for most OTC drug-cosmetics. Photo courtesy of Ampersand Label.ICMAD and FDA Give Crash Course in OTC Drug Facts Labeling
Over-the-counter (OTC) drug labeling regulations and how they apply to the cosmetic and personal care industry were the main focus at the 24th annual ICMAD/FDA Cosmetic Workshop. Hosted by FDA and the Independent Cosmetic Manufacturers and Distributors (ICMAD; Palatine, IL) association, the seminar took place February 12 at the DoubleTree Guest Suites in Santa Monica, CA. The workshop also covered other hot topics such as international regulatory developments.
The Drug Facts Labeling segment was timely, as the deadline for FDA's final monograph for OTC drug labeling approaches. By May 16, 2005, all OTC drug labels must include FDA's standardized Drug Facts panel. While this rule focuses on drug products, FDA also considers cosmetic products that make claims to physiologically alter the body's structure to be OTC drugs. Thus, the packaging for such cosmetic products must include the Drug Facts panel.
Often, whether a product is categorized as an OTC drug depends on the claims that the brand makes about it. FDA defines an OTC drug as a product that physiologically affects the body's structure. By contrast, cosmetics are defined as products that clean, beautify, promote the attractiveness of, or alter the appearance of the body. If, for instance, a company states that a facial product "removes fine lines," it would be considered an OTC drug. Conversely, if it were described as "diminishing the appearance of fine lines," it could be classified as a cosmetic. Marketers should be aware that FDA can check brands' Web sites and marketing materials to ensure that claims are consistent with packaging.
FDA announced that it has stayed the final monograph deadlines for some products. Robert Eshelman of the OTC Drugs Team at FDA's Center for Drug Evaluation and Research said that those products include products for which annual sales are less than $25,000; packages that contain no more than two doses of an OTC drug; and packages so small that the Drug Facts panel would occupy more than 60% of the package's total available surface area for labeling.
Allen Halper of the Office of Cosmetics and Colors, Center for Food Safety and Applied Nutrition, gave a presentation on what information the Drug Facts panels should contain.
According to the final monograph, the panel must include a detailed list of active ingredients, a description of the product's uses, warnings, directions, and a list of inactive ingredients. The panel must be visible on packaging to consumers at the point of retail. In addition, the panel's format, font style, and type size must be standardized. For some ingredients, FDA specifies special warnings. For instance, it suggests a specific sunburn alert statement that should appear on packaging for products containing alpha hydroxy acids.
ICMAD/FDA workshop attendees design their own Drug Facts labels. For marketers concerned with how the Drug Facts panel will interfere with their labels' decoration, FDA has made some adjustments to its ruling. FDA announced that the Drug Facts panel doesn't need to appear on a plain white background, as previously stated. Companies can choose whatever background color they want, as long as the color contrasts with the required black-ink text.
At the workshop, FDA's representatives organized an exercise during which groups of attendees were charged with designing a mock Drug Facts label according to the monograph's regulations. Based on the ingredients of the product assigned, each group had to decide whether to market its product as an OTC drug or a cosmetic product.
For more information on FDA's OTC drug labeling requirements, visit www.fda.gov/cder/offices/otc/drugfacts.htm.
The other workshop speakers provided valuable information on a host of topics. Carl Geffken, ICMAD's technical committee chair and president of Carl Geffken Consultants, advised attendees on the latest in international regulations. Geffken's presentation paid special attention to the European Union's changes in labeling and other regulations. For instance, animal testing for finished products will be banned within the European Union as of September 11, 2004. Animal testing will also be banned for ingredients by September 11, 2009.
Geffken announced that countries joining the EU in 2004 are Cyprus, Malta, Hungary, Slovenia, Latvia, Estonia, Slovakia, Czech Republic, Poland, and Lithuania. Bulgaria and Romania will join in 2007. He also touched on regulatory updates in the Asian, Latin America, and Canadian markets.
Jack Bierig, ICMAD legal counsel and a partner for Sidley Austin Brown and Wood, briefed attendees on legal issues involved in manufacturing and distributing cosmetics. Among the topics he covered, he warned companies about what claims to avoid so that a cosmetic will not be regulated as a drug. "Drugs in this country are highly regulated; cosmetics are not," he stated. "The claims that you make about your product will affect the way that they are classified. When deciding what claims to make about your product, consider what kind of litigation those claims could spawn from consumers and competitors."
He also cautioned marketers about making organic claims about their products. For instance, California governs such claims and requires that certified organic products contain 70% organically grown ingredients.
Judith Praitis, a partner for Sidley Austin Brown and Wood, explained what marketers need to do to comply with California's Proposition 65. The proposition prohibits companies "from knowingly and intentionally exposing any individual to a chemical known to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such an individual." Praitis emphasized that by the act of marketing a product, companies are assumed by the law to know whether their products fall into the harmful category. Praitis also warned that suing in the name of the proposition is extremely popular and urged companies to take preventative measures.
—Jennifer Kwok
BIW Shines Spotlight on Packaging
Beauty Industry West (BIW) turned its eye toward packaging at the association's January lunch meeting. Three Southern Californian suppliers—House of Packaging, Tubepack, and Westlake Packaging--presented their latest packaging technology at the event, held January 13 at the Crowne Plaza hotel in Los Angeles.
During lunch, the suppliers gave company presentations. Westlake Packaging's (Agoura Hills, CA) president, Dan Thompson, talked about the packaging distributor's newest injection molding technology, which was developed to add sensory appeal to packaging. He added that Westlake's new developments include making compacts from injection-molded rubber and adding scents to resin during injection molding.
Gloria Dunlap, North American sales manager for New Zealand tube supplier Tubepack, emphasized that Tubepack offers its clients the option of ordering smaller packaging runs. Dunlap also showed Tubepack's latest projects, which include a roller tube for body shimmer lotion for Gap.
Finally, John Davis spoke about the latest news from House of Packaging, a secondary packaging supplier. Davis said that many of the brand-name cartons the company had recently created featured highly reflective paper as well as pearlescent effects. He also said that plastic has become popular in secondary packaging.
Companies Renamed
Two premier beauty packaging suppliers recently announced that they have changed their names:
Rexam Beauty & Closures (Suresnes, France) has changed its name to Rexam Beauty & Pharma. The worldwide packaging company recently acquired two phamaceutical packaging plants. Business units within Rexam Beauty & Pharma, such as Rexam Dispensing Systems, will retain their names.
Risdon-AMS (Watertown, CT), a leading supplier of cosmetic components, will now operate under the name CROWN Risdon. The change reflects a new global branding strategy by its parent company, Crown Holdings Inc. CROWN Risdon will retain its current organizational structure and facilities.
EastPack To Hit New York City
EastPack, the East Coast's largest annual packaging show, returns to New York City on June 15–17. To be held at the Jacob K. Javits Convention Center, the trade show is a premier event dedicated to cosmetic packaging.
Exhibitors in the show's Cosmetic/Personal Care Packaging Pavilion, cosponsored by CPC Packaging, will showcase the latest packaging components including bottles, tottles, jars, tubes, secondary containers, sample packaging, and closures, including child-resistant, senior-friendly designs. Exhibitors include The Cosmetic Packaging Group, Rexam Closures & Containers, Qosmedix, Cleartec Packaging, HandsFree Applicators, Imex Vinyl Packaging, and Airopak/Novapak, a PVC Container Co.
For more information on attending EastPack, visit www.eastpackshow.com or contact Canon Communications LLC, trade show department, at 310/445-4200.
HBA, PCITX Plan Ingredients for Conference
The Personal Care Ingredients & Technology Exposition (PCITX) division of the Health & Beauty America (HBA) trade show will host a two-day conference focusing on product formulation. Called The Advanced Technical Conference, the event will take place April 13–14 at the New York Sheraton Hotel & Towers in New York City.
The conference is divided into three symposiums: high-performance ingredients, high-function colors, and high-function naturals. Attendees have the option of attending different sections in the three symposiums.
The high-performance ingredients symposium will address the industry's newest ingredients and technologies. It is headed by William Schmitt, former head of Unilever HPC's (Greenwich, CT) R&D department. Topics will include How to Increase the Efficacy of OTC Drugs and Cosmeceutical Ingredients; Chemotaxis & Wrinkle Repair; Cell-Energizing Active Ingredients in Modern Cosmetics; A Vegetable-Derived Topical Alternative to Botox; and Repeat-Sequence Proteins.
The High-Impact Colors Symposium will be headed by Julio Russ, senior vice president, R&D, for Revlon Inc. Color Products & Skin Care. The forum's sessions will cover Color Measurement: Theory and Techniques; Color Matching: The Art and Science; Colorants: Safety and Regulation; The Basics of Color as Appearance; Inorganic Colorants: Properties and Applications; Organic Colorants: Properties and Applications; Composite Pigments; and Future Color Trends.
The High-Function Naturals portion will explore the use of natural ingredients in product development. It will examine new trends in this area for cosmetics, personal care products, and fragrances; regulatory issues; and specific applications for ingredients and aroma chemicals.
Attendees will also be able to view select exhibits from presenting and other companies. A tabletop exhibition on Tuesday night will let attendees get in-depth information from specific industry suppliers. For more information on the event, call 609/452-2800 or visit www.hbaexpo.com.
On May 4–5, HBA will also present a midyear conference on innovative packaging at the Westin Hotel in Times Square, New York City. Attendees will learn how to use packaging and design to strengthen their brands' impact. Speakers will include packaging experts from companies such as Estée Lauder, Cosmopak, Sleever, AGI/Klearfold, Engelhard Corp., Ampersand Label, and Owen-Illinois.
Brand New CITY Awards Call for Cosmetic Innovators
The Independent Cosmetic Manufacturers and Distributors (ICMAD; Palatine, IL) association has replaced its Cosmetic Entrepreneur awards with a brand new program. Called the CITY, or Cosmetic Innovators of the Year, awards, the new competition will recognize the year's best cosmetic innovations from companies that are ICMAD members.
The awards features three categories: Product Innovation Award for a Branded or Private-Label Cosmetic Product; Product Innovation Award for Packaging Design of a Cosmetic Product; and Marketing, Sales, or Manufacturing Innovation. Two companies will be awarded in each of the three categories, one a company that has been in business for less than five years, and the other more than five years.
To be eligible, products must have been first shipped, and marketing and sales programs must have been initiated, between April 1, 2003 and March 31, 2004. Deadline for entries is April 15. The CITY awards will be presented at ICMAD's annual dinner meeting, to be held June 10 in New York City. For more information on the CITY awards, call 800/334-2623 or visit the association's Web site at www.icmad.org.
Faster Machinery For Thick-Walled Jars
Husky Injection Molding Systems (Bolton, ON, Canada) is offering an attractive alternative to thick-walled glass cosmetic jars commonly used for facial creams. Husky's Index Dual injection molding machine can produce thick-walled plastic jars quickly. Husky's machine is now typically used for molding PET preforms, which are molded, reheated, and then blown into the shape of a soda pop bottle. The company realized that a major advantage of this process was that it allows operators to mold thick parts quickly—which would be a major benefit in the cosmetic jar market.
The thick-walled, plastic jar was designed to replicate the look and feel of glass, "Yet, it won't chip; is shatterproof, easier to fill, and lighter to ship; and offers more design freedom to create unusual shapes," says Bruce Catoen, vice president, automated systems. Probably the most important point is that this machine cuts the production cycle time in half, according to Catoen.
The company already has received 19 inquiries within the past few months from major companies that might be looking into the possibility of having Husky build a machine for them.
"I wouldn't be surprised if we saw a mass conversion from glass to plastic over the next couple of years, once everyone realizes the benefits," says Catoen.
Soon to arrive: Wilco's 40-in. sheet-fed gravure press.New Press Arriving at Wilco
Folding-carton supplier Wilco Inc. (Candiac, QC, Canada) announced that a 40-in. sheet-fed gravure press will soon arrive at its facilities. According to Wilco, the three-color, 40-in. sheet-fed gravure press will be the only one of its kind in North America. Construction and preparations for the press are on schedule. Wilco expects to be using it to produce cartons by the end of spring.
The new press offers exceptional metallic and intense solid colors to enhance graphics on cosmetic packaging. It is fully compatible with Wilco's offset printing, hot-stamping, and embossing equipment.
Monaco Luxe Pack Calls for Entries
The organizers of trade show Luxe Pack Monaco are calling for entries for the show's second annual Monaco Luxe Pack Design Awards. Eligible candidates are junior-level professional designers from all business sectors who have done freelance or full-time work in the business for up to five years.
For this year's competition, candidates must design and submit a retail concept for a powder compact with a mirror and an applicator, and a matching lipstick container. The design theme is Modernity in Monaco.
The deadline to enter the U.S. preliminary competition is May 1. Preliminary competitions will also be held in seven other countries: Japan, Spain, UK, Germany, Brazil, France, and Italy. The U.S. finalist will be announced on June 8 during the Luxe Pack New York trade show in New York City. The grand-prize winner will be awarded at the Luxe Pack Monaco trade show, happening October 20-23.
Trade Show Allies
The organizers of the trade shows Pharmintech and Interphex USA have signed a three-year agreement to endorse and support each other's events.
Pharmintech, happening June 8–11 in Bologna, Italy, will cover the cosmetic, nutritional, and pharmaceutical industries. Exhibition categories include packaging, processing, raw materials, logistics, and marketing services. Interphex USA, held March 16-18 at New York City's Jacob K. Javits Convention Center, covers manufacturing, processing, packaging, outsourcing, information technology, and drug discovery and development.
FACES & PLACES
James H. AdamsCROWN Risdon (Watertown, CT) has named James H. Adams vice president of operations. Adams will be responsible for the manufacturing, quality assurance, purchasing, and related production functions of Risdon's six North American plants. Previously, he had served as Risdon's vice president and general manager, eye-care and metal products.
In other company personnel news, Claire Santopietro and Marjorie Andrews have been named senior account managers for CROWN Risdon's sales and marketing team. CROWN Risdon is a global manufacturer of packaging components for the cosmetic and fragrance industry.
Eric Robbins Eric Robbins has joined Cameo Metal Products Inc. (Brooklyn, NY) as sales manager. Prior to joining Cameo Metal, Robbins served as vice president of DieterBakicEnterprises USA for five years.
Karen Fondu Karen Fondu has been appointed president of Maybelline New York's Garnier U.S. division. Fondu previously served as the division's general manager.