Business Beat
Robert Eshelman of FDA's OTC Compliance Team discusses the final rule's effect on cosmetics classified as OTC drugs. Workshop Addresses OTC Labeling Final Rule
By Jennifer KwokPackagers got a crash course in FDA labeling regulations at a workshop held February 7 in Marina del Rey, CA. How the over-the-counter (OTC) labeling final rule is affecting label and product design was a key topic of discussion at the session, sponsored by FDA and the Independent Cosmetic Manufacturers and Distributors Inc. (ICMAD; Palatine, IL).
Speakers from FDA's OTC Compliance Team stressed that most OTC drug packages must display a standard Drug Facts label, similar in design to FDA's Nutritional Facts label, by the effective date of May 16, 2002. The Drug Facts label must appear on a product's outermost package and list in a standardized format such information as active ingredient(s), purpose, uses, warnings, directions, and inactive ingredients. The active ingredient(s) and warnings must also be included on the primary package's label. Regulations for graphics include a standard font style and a minimum type size.
Cosmetic products classified as OTC drugs and subject to regulation include antiperspirant, fluoride toothpaste, and antidandruff shampoo. The effective date of the final monograph for OTC products containing sunscreen has been stayed indefinitely and is not expected before January 1, 2005.
Speakers and attendees acknowledged that the standardized Drug Facts label—intended to help consumers choose and use products more safely—means many manufacturers will face redesigns for their OTC packages.
Manufacturers of packages too small to fit the standard Drug Facts label can apply for an exemption or for a deferred format with reduced font size. However, FDA cautions that such exceptions, granted on a case-by-case basis, will be rare. More likely, manufacturers of small products will be forced to explore other packaging options, such as expanded-content labels and cartons with foldout panels that provide extra space for printing.
"We're getting a lot of calls from manufacturers who are rushing to meet the May 2002 deadline," says workshop attendee James McKinney, marketing and sales manager for Ampersand Label Inc. (Garden Grove, CA). Companies, McKinney says, are seeking the most desirable packaging solution possible to preserve the look of their products.
"The cosmetics market is used to a more glamorous look," says Bruce Albert, director of validation for Merle Norman Cosmetics (Los Angeles), who also attended the workshop. "Having to put, for instance, a high-end looking [OTC] lipstick in a blister pack to accommodate the Drug Facts label will be a big change."
Neutrogena also understands the imminent changes. For example, the company realizes that if the entire Drug Facts label doesn't fit on one side of a package, the printed panel can continue on an adjacent side. "It doesn't look as nice, but it works," says attendee Michael Hernandez, regulatory affairs assistant for Neutrogena (Los Angeles).
FDA encourages manufacturers of OTC drugs to start revising their packages now if they haven't already. Though the effective date for the sunscreen monograph has been stayed, manufacturers of such products may begin relabeling their packages using the guidelines provided in the final monograph, according to Crystal Rice, trade media liaison for FDA's Center for Drug Evaluation and Research.
Manufacturers are not required to submit their revised packages to FDA for prior approval. However, if packages are found to violate the regulation after the effective date, regulatory action may be taken. Manufacturers are encouraged to familiarize themselves with the new format and to contact the agency with questions.
The new Drug Facts label will save consumers unnecessary healthcare costs associated with erroneous product usage, according to FDA. While manufacturers support protecting consumers, "designing packages to be as aesthetically pleasing as they were before the inclusion of the Drug Facts label will be a challenge," says McKinney.
For more information on FDA's OTC drug labeling regulations, visit http://www.fda.gov/cder/otc/label/default.htm. To find out more about the FDA/ ICMAD workshop, contact ICMAD at info@icmad.org. And for more on how manufacturers of cosmetics and personal care products can revise their packages to meet the new requirements, see the article "Labels That Fit The Bill" in this issue.
Sephora's First Factice Auction Supports the Annette Green Museum
Whether a cosmetic is sold at mass outlets or in fine department stores, its overall look has to be quality. Today's shoppers, even those not paying for a truly high-end product, expect a quality package. They want a look that is polished, elegant. And "anything elegant is trendy" when it comes to cosmetics packaging, says Anja Mansdoerfer, sales and marketing manager for cosmetic-pencil manufacturer Weckerle Cosmetics (Torrance, CA).
Bidders raised more than $10,000 for The Fragrance Foundation's Annette Green Museum. Giant perfume bottles were auctioned off at Sephora, Rockefeller Center, in New York City on January 23, raising more than $10,000 for The Fragrance Foundation's Annette Green Museum. Perfume Giants on the Auction Block was host to package designers, as well as foundation and museum members, private collectors, and celebrities. They bid on factices donated by foundation members and collectors.
"Factices create a public awareness of fragrance package design," says Annette Green, president of The Fragrance Foundation. "These bottles are such artistic creations that people just want to own them."
Among the factices up for bid were Yves Saint Laurent Parfums' Baby Doll (1999), Christian Dior's J'Adore (2000), Parfums Givenchy's Marc Jacobs, and Jean-Paul Gaultier's Fragile. The event's highest bid was $550, for Fragile.
An evening of music, champagne, and hors d'oeuvres for the fragrance industry and museum members followed the daylong auction.
The Annette Green Museum is dedicated to the procurement, study, and display of fragrance. For more information, visit The Fragrance Foundation on-line at http://www.fragrance.org.
P&G Recognizes Marietta for Quality
Marietta Corp. (Cortland, NY), a contract manufacturer of personal care products, has received a perfect score from Procter & Gamble's (P&G; Cincinnati) Beauty-Care Contract Manufacturing Quality Assurance Group during its most recent quality audit. Marietta is the only contract primary pack site to have received this award and earned a perfect score. The award is the highest quality award that P&G issues to its suppliers.
P&G's quality audit includes examination of a supplier's laboratory systems, overall regulatory compliance, materials management, documentation, process controls, accountability, validation, leadership and commitment to quality, and establishment of and compliance with standards and procedures.
Before this year's audit, Marietta received P&G's Bronze Pinnacle Award for surpassing the required quality audit score during each of the past three years. The supplier produces sample-sized and unit-of-use products for cosmetic, household, personal care, and consumer product companies. The firm also manufactures retail-sized soap bars and guest amenities, including personal care products primarily for the hospitality industry.
Airspray, TricorBraun Strike Distribution Deal
Dispenser supplier Airspray N.V. (Alkmaar, Netherlands) has reached a distribution agreement with U.S. packaging design and distribution organization TricorBraun (St. Louis). TricorBraun will increase Airspray's market presence, particularly for small and midsized sales accounts, say representatives at Airspray. Airspray's sales force will continue serving the existing customer base, and will work with TricorBraun to increase penetration. The agreement makes Airspray the sole supplier of foaming pumps to the U.S. distributor, and contains sales targets outside Airspray's customer base. TricorBraun will provide the complete Airspray product line.
Airspray operates worldwide, selling its dispensing technologies to such personal care product manufacturers as Johnson & Johnson, Unilever, and Wella.
TricorBraun has more than 25 offices throughout North America. The firm is the largest packaging distributor in the United States, and is reportedly more than twice as big as the second-largest U.S. distributor.
CTFA Publishes 2002 Dictionary, CD-ROM
The Cosmetic, Toiletry, and Fragrance Association (CTFA; Washington DC) has published its ninth edition of the International Cosmetic Ingredient Dictionary and Handbook and the 2002 Scientific/Regulatory Reference CD-ROM. Featured are current regulatory data and a comprehensive listing of ingredients used in cosmetics and personal care products.
Companies that formulate, label, or market personal care products can use the Dictionary and Handbook to source more than 1700 new International Nomenclature Cosmetic Ingredient (INCI) labeling names and 10,000 new trade and technical names. Expanded to four volumes, the reference lists approximately 12,000 INCI names and 55,000 trade and technical names, making it the most complete list of ingredients used in cosmetics and personal care products globally, says CTFA.
The 2002 CD-ROM contains 11 infobases, including CD-ROM versions of seven of CTFA's major publications, a compilation of CIR Reports, and three sections of the U.S. Code of Federal Regulations of relevance to the cosmetic industry.
For more information, contact CTFA Publications at 301/953-2614 or log on to the CTFA Publications on-line store at http://www.ctfapublications.org.
Ex-Tracts Offers On-Line Registration
Ex-Tracts, a trade show for the aromatherapy, fragrance, and personal care markets, has added free on-line registration for attendees to its Web site, http://www.extractsny.com. Also new to the site is on-line purchasing of tickets to educational programs and special events. On-line registration for Ex-Tracts 2002 begins February 1. For more information on the event, see the Datebook section on page 54 in this issue.
Mary Kay Honors Eyelematic Manufacturing
Eyelematic employees receive Mary Kay's 2001 Supplier of the Year Award. Eyelematic Manufacturing Company, Inc. (Watertown, CT), a metal fabricator, plastics molder, and assembly supplier to the cosmetics industry, received a 2001 Supplier of the Year Award from cosmetics and skin-care company Mary Kay Inc. (Dallas). Mary Kay gave Eyelematic an overall quality rating of 100%, an accuracy rating of 99.3%, and a perfect score of 12 out of 12 points for customer service. The supplier was also commended for its responsiveness to new business development and design requests.
FACES & PLACES
CFC International Inc. (Chicago Heights, IL), a worldwide holographic and specialty coated-film manufacturer, has added two employees to its sales force. Tom Calahan joins the company as account executive. Calahan has more than 20 years of sales experience in the print industry, and will serve CFC's customers on the West Coast. Michael Coffman, who has more than 13 years of experience in sales in the chemical industry, will serve as account manager on a newly aligned territory in the Midwest.
The Institute of Packaging Professionals (IoPP; Naperville, IL) has appointed Suzanne Fisher vice president, chapters, of its council of officers. Fisher is a packaging engineer with Herman Miller Inc. (Zeeland, MI).
John Bailey, former director of FDA's Office of Applied Research and Safety Assessment, has joined the Cosmetic, Toiletry, and Fragrance Association (CTFA; Washington, DC) as director, cosmetic chemistry. Among Bailey's responsibilities will be providing support on cosmetic regulatory matters to CTFA staff and association members.
C-Care LLC (Linthicum Heights, MD) has named Lauren McLaughlin formulation chemist. McLaughlin will assist C-Care's customers in the research, development, and testing of new personal care products. A former employee of Procter & Gamble's Cosmetic Division (Hunt Valley, MD), McLaughlin has a degree in chemical engineering from Rensselaer Polytechnic Institute.
Pump supplier Valois of America has moved its U.S. headquarters and its manufacturing facility to Congers, NY. The plant in Norwalk, CT, will move midyear. Contact the firm at 250 N. Route 303, Congers, NY 10920; phone: 845/639-3700.
Andrea Jung, chairman and CEO of Avon Products Inc., has been reelected chair of the Cosmetic, Toiletry, and Fragrance Association (CTFA; Washington, DC). Jung was renamed to the post during the General Session of the CTFA Annual Meeting in Boca Raton, FL, on March 1.
Hans-Joachim Honigfort has been appointed president of Coty Beauty Europe, the European mass-market fragrance, cosmetics, and toiletries division of Coty Inc. (New York City). Prior to joining the Coty team, Honigfort worked for Procter & Gamble for 27 years.
Carol J. Hamilton has been promoted to president, L'Oreal Paris Brand Division. Most recently, Hamilton served as senior vice president and general manager of the division.
Orlandi Inc. (Farmingdale, NY), a maker of specialty scented products and packaging, has named Patricia Kane quality control and safety manager. Previously Kane spent 22 years at Estée Lauder.
Orlandi also announced plans to add a third manufacturing facility on Long Island, NY. In a transaction expected to close in April, the firm will acquire a 40,000-sq-ft building for manufacturing, warehousing, and offices. The facility will house another printing press and additional contract packaging equipment.
Expac Corp. (Montvale, NJ) has opened a new office in Ontario, Canada, near Toronto. (The supplier of cosmetic and personal care packaging also has an office in Montreal.) Contact information for the new office is 76 Ava Crescent, Richmond Hill, ON, Canada L4B 2X4; phone: 905/770-3557; fax: 905/770-0037.