Pharmaceutical and Medical Packaging News
Magazine
PMPN Article Index
Originally Published January 2000
SPOTLIGHT
Expanding Labeling Space
Labeling technologies are helping OTC drug and nutritional supplement makers tackle the problem of meeting government requirements while creating brand presence.by Sally Lane
Take one capsule three times daily as needed." It used to be that drug labels were simple. Government regulations concerning over-the-counter (OTC) drugs and nutraceuticals combined with marketing demands, however, have changed healthcare package labeling forever.
Legislation under the Dietary Supplement Health and Education Act (DSHEA) of 1994 requires that any nutraceutical product containing vitamins, minerals, herbs, or amino acids must be labeled as a "dietary supplement" and carry a list of data.
Photo by Roni Ramos/Product courtesy CCL Label AND Rexall Sundown.
This includes a "Supplement Facts" panel and appropriate or dosing information. Also, the label must indicate the presence of 14 specific nutrients when included at significant levels, the presence of other vitamins and minerals, dietary ingredients for which no recommended daily intakes have been set, and the identity of (but not the concentration of) each dietary ingredient in a proprietary blend.
Also, manufacturers of OTC drugs face an April 16, 2001, deadline for compliance with FDA's new labeling requirements. All OTC drug labels must include a boxed "Drug Facts" panel similar to the "Nutrition Facts" panel found on most food items. The box must include a heading, warnings, directions, active ingredients and their purpose, inactive ingredients, intended uses of the drug, and other information. The labels must be printed in 6-point type. Such rules leave little space for drug product and marketing information.
"It's a Catch-22," says Paul Mangano, executive vice president at Quality Packaging Systems (Colonial Heights, VA), a contract packaging firm. "To meet the regulations, you need more labeling, but you need to keep the same package size to keep costs down." He says that many of his customers are especially struggling to meet the 6-point type requirement.
MEETING THE CHALLENGE
Thankfully, suppliers offer alternatives to package redesign, including peel-away wraparound labels, multiple-panel labels, booklet labels, and two-layer rotating labels. Suppliers promise these systems can be implemented easily with little or no capital investment.
"I think our customers are looking for suppliers to solve real estate issues in a concise and equitable manner," says John Pacific, vice president of sales for Pharmagraphics (Greensboro, NC). "They want something that can be applied easily without too much hassle," he says.
Before determining which expanded-content label is right for a particular application, however, packagers must decide precisely what they want the label to accomplish. The solutions all come with specific benefits and costs.
WRAPAROUND LABELS
Wraparound labels are single-ply pressure-sensitive labels that can be produced in one printing process. According to some sources, a one-step printing-and-die-cutting process keeps manufacturing time and costs down. Perhaps the only real difference between traditional labels and these wraparound labels is that the wraparound label must be specifically engineered so that it can wrap around itself, be lifted, and be resealed to itself without damage. Their resealability ensures that the text always stays with the product.
Dennis Tursso, owner and CEO of Tursso Cos. (St. Paul, MN), anticipated the need for expanded-content labeling as product distribution moved swiftly into foreign markets. In 1994, Tursso developed and patented the X-panda- Label wraparound label. The label nearly doubles available copy area by wrapping around the product container twice. The top layer, immediately visible to shopping consumers, can carry the FDA-required boxed information, while the layer underneath can carry additional product information. To access this hidden panel, consumers just need to pull back a corner of the label.
Challenge Printing Co. (Wallington, NJ, and Broadway, NC) has also introduced products to expand packaging real estate. "We've been working diligently to meet our customers' need for more label real estate without compromising quality," says Margaret Polt, Challenge's marketing manager. "Part of the problem we've seen with the versions of expanded-content labels currently on the market is that they are not true 'pharmaceutical' versions. Instead, they are based on designs that existed for couponing applications, and therefore, they haven't been widely adopted," Polt says. Challenge's solution is the ReSealaTab, which can be peeled open to reveal product information on the reverse side of the label and then resealed. It also comes in an extended version that wraps around the bottle.
H.S. Crocker (Philadelphia) helped American Home Products develop such a label for its Centrum 15 line of vitamins. "We took regular label stock and used a special deadening agent on the adhesive that allows the label to wrap more than 360° around the bottle," explains Mike Sauter, a sales representative for Crocker. "There were no special materials or equipment involved, and the advantages to the customer are minimal added costs and no packaging changes."
J R Cole Industries (JRCI; Charlotte, NC) also offers a similar construction. "Our wraparound label is made from a single web of film. One end of the label overlaps the other end. Because the adhesive has been killed on one end of the label, users are able to peel that end back and see two additional panels—one underneath and one on the other side of the label, explains JRCI's special projects manager Hollis Cobb.
Label Remedies Space ProblemsNew government copy requirements have created tremendous packaging challenges for nutraceutical and pharmaceutical manufacturers. "We looked at going to a larger bottle to accommodate the additional information required by DSHEA," says David Wagner, chief operating officer of Pharmacist's Ultimate Health Corp., a Minnesota-based manufacturer and distributor of herbal medicinals and dietary supplements. Wagner says that the company also researched the possibility of putting its containers into a box in order to create an additional copy vehicle. However, "we received negative feedback from pharmacies about putting the product in a box because of theft concerns," Wagner says. The concern is that a person could open the box, remove the product, and put the box back on the shelf without the store officials noticing. Increasing the size of the bottle also proved to be an undesirable idea for Pharmacist's Ultimate Health. Wagner notes, "We have numerous retail displays in the marketplace that are custom designed to fit our bottles." Moving to larger bottles would not only have included a costly redesign of the product container but the displays as well. And further, selling the same volume of product in a larger bottle could be perceived by the consumer as deceptive marketing. Realizing that neither introducing a carton nor increasing the container size were ideal options, Wagner began to explore other possibilities. Luther Galchutt, a sales representative for Tursso Cos., approached Pharmacist's Ultimate Health with what proved to be an ideal solution—the X-pandaLabel. This unique wraparound label nearly doubles the available copy area by wrapping around the container twice, easily allowing for the addition of DSHEA- and FDA-mandated text. With the addition of a second layer, Pharmacist's Ultimate Health did not have to sacrifice important product information or graphics. Because the movement to X-pandaLabel did not require radical packaging or graphic changes or additional packaging components, it proved to be a cost-effective label solution for Pharmacist's Ultimate Health Corp. Galchutt further identified X-pandaLabel as a consumer-friendly option because all of the product information remains with the product until its disposal, offering greater safety and optimal product performance. To access the information on the second layer of the label, the consumer simply pulls back the corner of the label to reveal the additional text. The label can then be resealed back down onto the container. There was initial skepticism about the difficulty of applying this type of label to the bottles. However, Wagner explains that "the X-pandaLabel actually comes in the same size roll—it's just a matter of threading them through the label applicator, as with any other kind of adhesive label." Pharmacist's Ultimate Health is now exploring the possibility of using the X-pandaLabel technology to create multilingual labels because they distribute products throughout the United States as well as in Puerto Rico. |
MULTIPLE-PAGE LABELS
Intended to hold more information than wraparound labels, multiple-panel and booklet labels often contain more than a dozen pages. Label design varies: the multiple-page labels can be held together either in a book or in a fan-folded construction and can be designed to tear open for one-time use or to reseal for continual use. They can contain detailed product descriptions and history, schedules and calendars, cross promotions, coupons, reminder stickers, diets, regimens, and other text and graphics. In some instances, these labels can replace the need for a separate insert and eliminate the need for cartons. The top portion of the booklet label often mirrors the bottom or prime label in case the booklet is removed.
Sauter says that many of his clients have had to move toward the booklet-style label in order to meet the new OTC labeling regulations. "Customers were giving up all their labeling panels to meet the regulations. The booklet gave them more space for other information," he says.
Pharmagraphics and JRCI both offer multiple-panel labels. Pharmagraphics's solution is the Hitch:Hiker, a product that combines both a label and an insert. Opened by tearing a perforation on the right, the label reveals multiple panels that stay with the bottle. Made of paper, the Hitch:Hiker's panels are laminated to the base pressure-sensitive paper label.
JRCI's product includes pages that are arranged in a booklike format, which can be made resealable. The booklet label contains panels that are constructed of paper, printed off-line, and then dropped and laminated onto the base pressure-sensitive film label. Says Cobb, "An eight-page booklet is most desirable because the pages can be bound together with an adhesive rather than by a staple, which can affect how flat the label lies on the web during lamination."
After developing X-pandaLabel for smaller cylindrical bottles and vials, Tursso later developed InfoPac as an additional expanded-content labeling option for a variety of other uses, including medical instruments, cartons, and flexible packaging. Copy can be presented in either a leaflet or booklet format. "Since many of our clients require a minimum of six language translations, InfoPac's vast copy area is often the most viable solution when the addition of a carton or separate printed insert is cost prohibitive," says Bruce Rankin, vice president of sales and marketing for Tursso.
Labelad (Markham, ON, Canada) produces InfoPlus Multipanel labels that consist of a snug cover label that peels away to reveal up to 13 folded panels containing product information. Available in a wide range of materials and eight constructions, InfoPlus can be designed so specific panels remain on the package after opening. Because expanded-content labels such as the InfoPlus allow manufacturers to use less packaging, there is a savings involved, explains Leonard Rudner, vice president of sales and marketing.
Lance VandenBrook, sales and marketing manager for New Jersey Packaging (Fairfield, NJ), says his company has developed a more cost-effective way for expanding label space than using the booklet labels. "Cost is an issue with these expanded-text labels—they are cost prohibitive to some companies because they can involve a two-step printing process," he explains. As an alternative, "we take a traditional patient insert and marry it to a pressure-sensitive label. It is not cost prohibitive because we aren't printing high-end graphics. The label is just intended to get product information to the customer without all the bells and whistles." Costs for the product, called Booklet Plus, are higher than for traditional labels and inserts or outserts, but users can make up costs by a reduction in incoming inspections and by an increase in packaging line speeds, says VandenBrook.
A Sticky SituationIndustry expected that complying with FDA's new over-the-counter (OTC) regulations would be difficult. That certainly has been the case for Wyeth-Ayerst Laboratories (St. Davids, PA), a company official told the audience at a recent conference in Philadelphia. Wyeth-Ayerst has found that the new labeling format does not fit on its smaller existing packages, said Debi Cometa-Schimpf, associate director for desktop publishing and formerly manager of packaging for the company's OTC/Biologicals division. During her presentation at Barnett International's Pharmaceutical Labeling conference held during November, Cometa-Schimpf showed what smaller packages of products like Advil and ChapStick would look like with the new format. A significant portion of the product labeling could not fit on the package. "We may have to increase bottle sizes," she said. "We looked at wraparound labels, but there are cost issues there." Cometa-Schimpf was also concerned that browsing shoppers who unwrap leaflets and wraparound labels in stores may not resecure them if they decide not to purchase the product. This may affect the shelf presence. Even if the information was only needed on an outer carton, if the carton had to increase in size, the bottle would also need to increase in order to comply with laws against deceptive packaging, she said. So far, the company has found that in order to fit all of the necessary information on a carton, it would need to spread it over two or three panels and put the bar code on the end flap. Brand names, which traditionally have been printed on three face panels, would be confined to one or two, she said.
If package sizes need to be changed, that raises the possibility of buying and validating new equipment, a process that would be difficult to complete by FDA's April 16, 2001, deadline. Industry has asked for a two-year extension of that deadline. |
EQUIPMENT CHANGES?
As mentioned before, suppliers claim that the expanded-content labels do not require pharmaceutical and nutritional supplement makers to purchase any special machinery or to slow down label application. In fact, with the help of equipment from On Serts Systems Inc. (Toronto), many labeling printers are able to produce expanded-content labels with multiple pages, coupons, and even promotional items like magnets that are supplied on the same type of rolls that traditional labels are, says president Kevin Quinn. For example, the lamination that attaches the booklet labels to their carrier labels holds the booklet in place on the roll and through the bends and curves of the applicator.
Using expanded-content labels may indeed eliminate the need for some machinery. Because some label products incorporate patient inserts, packaging lines won't need stations for inserting them into cartons. And, in some cases where the label replaces the carton altogether, the line won't even need a cartoner.
ANOTHER SOLUTION
One of the more novel approaches to expanding label space has been the Spinformation rotating label. The label, manufactured by CCL Label (Rosemont, IL), is a two-ply label. The top label contains an information window that can be turned to reveal product information on the label below.
New Jersey Packaging's Booklet Plus, shown here for the prescription product Floxin, can be used for OTC drugs.
"The concept is very popular with customers," says Tom Ventrudo, regional vice president of pharmaceutical sales for CCL. "The production line is truly efficient. Spinformation labels are applied in the same traditional method as pressure-sensitive labels."
According to Rexall Sundown (Boca Raton, FL), who is using the label and has dubbed it "Twist 'N Learn" for its line of Sundown Herbals, the label allows the firm to include up to 75% more product information than a traditional label. In addition to displaying the "Supplement Facts" box, the label includes facts about the product's origin, active ingredients, potential benefits, and suggestions for other herbs that can be used along with the product.
The label has pleased consumers and may have contributed to an increased market share. According to Staci Glorsky, director of marketing, herbal and diet brands, for Rexall Sundown, consumers have reacted positively to the Twist 'N Learn label. Also, by the end of the company's fiscal year in August 1999, Sundown Herbals had achieved a 24.3% market share, up two share points during a period in which herbal segment sales declined by 10%.
The new label has also received industry accolades. Last September at WestPack '99 in Anaheim, CA, Rexall Sundown, CCL Label, and Avery Dennison (Philadelphia) were recognized by Mobil Chemical Co. (Pittsford, NY) for the Twist 'N Learn label. The packaging team used two of Mobil's films: a white biaxially oriented polypropylene film served as the bottom layer and a clear film with consistent slip properties as the top layer. Mobil called Twist 'N Learn a "truly solutions-oriented label" and presented the three companies with a 1999 Pyramid Award.
THE FUTURE OF LABELING
Whatever labeling challenges the new millennium may bring, key to overcoming them is communication. Challenge was able to tailor its expanded-content labels exclusively to the nutraceutical and pharmaceutical industries by conducting extensive research, including sending questionnaires to pharmaceutical executives and conducting in-depth interviews with package development professionals. Such exchanges led Challenge to purchase a wide press (more than 42 in.) for the production of booklets and to invest in eight-color UV printing equipment to provide vibrant, eye-catching labels. Because Challenge listened to its clients' comments, drug and supplement packagers should feel free to share their needs and frustrations with their own label suppliers. It could lead to the next Spinformation.
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