Regulations Spark Package Redesign

Few industries welcome regulation, and the over-the-counter (OTC) pharmaceutical industry is no different. Two years ago drug manufacturers cringed at the thought of changes to requirements for OTC drug labeling, which demand the significant rework of most OTC packages. Such regulatory changes, however, may benefit those drug makers who take advantage of the change to liven up their packaging with color, graphics, and specialized printing.

FDA's final rule, published March 17, 1999, in the Federal Register (64 FR:13253–13303), requires OTC drug companies to standardize their presentation of such information as active ingredients, directions, uses, warnings, and other data. Labeling must include a "Drug Facts" panel and adhere to specific minimum size requirements for type, headings, and leading. The information must be boxed and cannot include logos, graphics, or bar codes. The regulation will go into effect April 2002.

Because such requirements demand much more space than ever before to convey the facts about the drug, this regulatory requirement is decreasing space for brand identity, says Dick DeWiggins of Mebane Packaging of Westvaco (Mebane, NC), a major converter of OTC packaging for analgesics, cough and cold remedies, and eye care products with seven locations across the country. Drug companies and their package designers are therefore challenged to present clear, easy-to-read, and consistent package instructions in a manner that still grabs consumers' attention.

"We are seeing a dramatic increase in the redesign of OTC packaging as a result of the FDA rule on labeling OTC products," DeWiggins explains. "Mebane is pulling together comprehensive packaging redesign programs for their major accounts. In fact, we've created several unique designs that we call Extended Content Cartons specifically to meet the new regulation requirements."

Since OTC drug makers are spending the money to update their packaging, many are using the opportunity to conduct a whole redesign. "As long as they have to change the package for this requirement, our customers are increasing the number of colors and adding other specialized effects like hot stamping or embossing to increase the impact on the shelf," says Gary Walters, vice president of sales at Mebane.

Adds Tim Freeze of Mebane, "These changes often involve complete structural changes to the packaging. In order to accommodate these new requirements, we may change graphics, as well as add foldout panels and other extended content features."

To help drug manufacturers execute the redesign properly, many packaging suppliers are offering guidance. Lisa Palvino, director of marketing for Diamond Packaging (Rochester, NY), says her firm has put on seminars to educate key customers on FDA's new regulations. "Last fall, we ran a seminar on these new OTC regulations and had a great turnout—about 50 customers," Palvino says. The company is also developing prototype packaging to present to their branded OTC customers, anticipating their need for better graphics and added content.

Because many OTC drug makers use cartons to communicate product and brand information, carton manufacturers like Mebane are being bombarded with redesign requests. Explains Randy Lindert of Beck Carton (Milwaukee), "The most graphic intensity is on the carton. Right now, we are running seven- and eight-color cartons with embossing, debossing, and hot stamping." Beck Carton, The Flottman Co. (Crestview Hills, KY), and Pharmalabel (Greensboro, NC) make up RxPerts, an alliance that offers cartons, labels, and inserts and outserts.

Manufacturers of private-label OTC products like Automatic Liquid Packaging (ALP; Woodstock, IL) are seeing their clients start redesign projects with the carton. "This year, we have seen a lot of graphic enhancement being specified because of a regulatory change on the horizon from the FDA," says Kevin Skalecki, purchasing manager for ALP, which specializes in eye care solutions. "Our customers want more eye-catching packaging, usually on the carton first. In our case, that means an upgrade from a one- or two-color carton to a four- or five-color carton."

ALP's customers have been preparing for this change for the last year. "We are asking our suppliers like RxPerts to help increase the shelf impact of our products because retailers are demanding it," Skalecki says.

However, more than just cartons are being redesigned. "The change in instructional labeling is causing the rework of the complete package," says Lindert. "Even labels and inserts are undergoing graphic upgrade."

Beyond the shelf impact of the carton, the primary identifying label on OTC products is being redesigned as well. According to Des Laffan, general manager of Pharmalabel, OTC marketers want to make sure that once the carton is thrown away, the use instructions and the brand identity still remain.

"We have seen a tremendous shift toward enhanced graphics on labels," says Laffan, whose customers are primarily private-label OTC manufacturers of analgesics and cough and cold medications. "The carton is thrown away in many cases, and the label is the primary means of communicating with the consumer," he says.

"When we work on those package redesigns, which may eliminate the carton, we must ensure that the printing method that we employ can duplicate the graphics as they are now presented via the carton," explains Neil Sellars, director of product development and marketing for National Label (Lafayette Hill, PA), a printer of primary OTC drug labels. "Our primary objective still remains trying to organize a variety of multi-panel label designs that convey the information required by FDA."

The final impact of package redesign is on the insert. Traditionally used to provide additional instructions for use, marketers see new value to enhancing insert appeal. "With the fight between FDA requirements and marketing information over package space, inserts are slowly beginning to become more colorful," says Tom Flottmann, president of The Flottman Co. "Inserts have typically been pretty simple as far as colors and graphics. But certain types of OTC products have begun to demand more color and more graphics, even on their insert products." Beyond the regulatory factors, Flottman feels there are two additional reasons for this trend. "First of all, manufacturers of products such as eye care solutions want to ensure that the consumer uses the product properly, and that if the irritation worsens, the consumer consults a physician. In addition, Flottman describes the need for brand cross promotions. "OTC products such as cough syrups offer manufacturers tremendous cross product promotional opportunities," he says. "A graphically appealing insert can encourage the consumer to use another product. And manufacturers want to seize that cross marketing opportunity."

To keep pace with the demand for enhanced graphics, packaging suppliers must invest in new technologies and new capital equipment. For printers, this may require changes to the prepress process or new presses.

Explains Lindert, "At Beck, we decided that our prepress area needed expansion. As customers demanded more color, relying on outside vendors to run around prepress work affected our turn around time." Customers are eager to go from two- to six-color cartons, but not willing to see lead times extend, he says. "A few years ago, we might have four to six weeks to turn around an order. Now the graphics are twice as complex, and our customers want orders in a week." To increase color without increasing the wait, Beck is partnering with another company to offer direct-to-plate equipment.

Converters also need new press equipment with more color stations and additional flexibility to produce various print effects. "We have chosen to invest in combination presses to meet our customers' needs," says National Label's Sellars. "Some of the new combination platform style presses allow us to offer a wide variety of printing without extensive setup time," he adds. "To achieve the graphic effects our customers are asking for, we are finding that variable repeat offset stations can produce the soft vignettes that really make a brand stand out." According to Sellars, many OTC drug makers are modeling their redesigns after personal care product packaging. "The packaging managers for OTC products are asking for graphic effects similar to those found on personal care products—everything from matte and gloss varnishes to screen effects that have helped personal care products stand out on the shelf."

Pharmalabel's Laffan says his operation has invested in several eight-color presses in the last two years. "In fact, we have another eight-color press being installed as we speak," he says. Pharmalabel plans to support short-run color for key OTC customers. "Another investment our company has made is in short-run digital color through our parent company, The John Henry Co. (Lansing, MI)," says Laffan. "With digital, you can simulate any color combination, and you can support runs as short as 3000 to 5000 labels."

John Henry configured its business to handle short-run color in order to meet the needs of private-label products. "Private-label OTC applications typically demand smaller runs than national brands," says Mike Longo, vice president of sales and marketing. "But they are still treated like brands by the major retailers. There is a tremendous amount of time, effort, and money going into making OTC private-label products stand out on the shelf." The company's dedicated digital print operation has Indigo, Xeikon, and Heidelberg 9110 equipment along with a proprietary digital print configuration on a eight-color Chromas press. The company offers these short-run capabilities, as well as traditional carton and insert printing, to their customers. "We have to be a one-stop shop to support the package redesigns going on right now," says Longo.

Because converters are printing in more colors, suppliers need to provide materials that can accept color flawlessly. Flexcon (Spencer, MA), a supplier of film label materials, specializes in such offerings. "We have seen a growing demand for polyethylene and polypropylene film label materials for OTC applications," says Rick Harris, sales and marketing manager for Flexcon's packaging business unit. "Printers are investing in equipment to run seven and eight colors for these OTC applications. And customers are combining color with clear, matte, and white films. Using a film that is surface treated and top coated for print receptivity for multiple colors is a must."

Redesign projects are never easy, but OTC drug makers don't have to undertake them alone. Converters are ready to help OTC packagers prepare for the new regulations. Such availability should delight manufacturers. "We are absolutely counting on our key suppliers to support us through this transition," says ALP's Skalecki.

To make the most of a redesign, converters are asking for support from all those involved with any packaging component. Says Mebane's DeWiggins, "We are redesigning the entire package, and we need the support staff who are expert in materials, printing, and equipment. Once the package concept is open to redesign, customers ask for graphics in combination with other package features like anticounterfeiting features or enhanced child-resistant, senior-friendly closures. We have to be prepared to support the entire package transition."

And if the redesign starts to get complicated, drug manufacturers shouldn't give up. "Companies who are ready to rethink the entire package are the clear winners," says Flexcon's Harris. Drug makers who redesign both to meet the OTC labeling requirements and to liven up their cartons and labels will not only better inform their customers, they will attract more of them.