Raising the Image of Nutritional Supplements with Packaging

Supplement manufacturers are attempting to improve the image of their products through sophisticated packaging and labeling and controlled packaging processes.

by Greg Erickson

You probably wouldn't expect to hear the term snake oil used by professionals in the nutritional supplements business today. No marketer of supplements would admit to product misrepresentation, and no supplier of packaging materials would make such an accusation of potential customers. Yet there is an underlying sense within the supplements community that insupportable claims made by a few purveyors of these preparations are giving the whole business a bad name. Adding insult to injury is the consumer confusion caused by labeling information—or the lack thereof—or by the grandiose promises printed on some packages. In response, supplement marketers are upping their image, in great part by moving into increasingly sophisticated packaging and by controlling and monitoring packaging processes to ensure packaging quality.

STANDARDS AND REGULATIONS

FDA most certainly has regulatory control over dietary supplements. But because the agency regulates them as foods rather than as drugs, manufacturers do not have to subject their products to administrative review. FDA can run spot checks on selected products but is not required to test them all. As a result, some products may contain far less of the active ingredient than is listed on the FDA-required label. Claims of product effectiveness are another big issue.

Many small manufacturers, laboratories, and compounding pharmacists rely on the MF-30 manual capsule filler that quickly fills 300 capsules at one time.
 

In January, FDA issued its final rule on what can and cannot be claimed by supplement manufacturers. In essence, the rule clarifies and differentiates the definitions of a permissible "structure/function" claim and a prohibited "disease-related" claim. FDA has chosen to use the preexisting definition of disease in 21 CFR 101.14. That definition is:

damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease, hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.

The rule is intended to halt marketers of supplements from touting or even hinting at their product's ability to prevent, treat, or cure a disease without subjecting the product to FDA review. For example, since claims of aiding weight loss or alleviating minor pain are not related to what FDA defines as disease, these claims among others are allowed.

Along with the federal government, a number of trade associations are trying to raise the real and perceived quality of nutritional supplements. They are attempting to stop marketers of these products from using packaging to spread exaggerated, incorrect, purposefully incomplete, or downright untrue information. Even Good Housekeeping magazine, whose seal of approval can dramatically boost sales of an endorsed product, has announced new standards for accepting advertising from dietary supplement manufacturers. Up to now, the magazine has been hesitant to carry such ads because it couldn't be sure the statements made in them were true. Now the publication is requiring supplement makers to substantiate their claims through double-blind studies.

Last year, R. William Soller, PhD, senior vice president and director of science and technology at the Consumer Healthcare Products Association (Washington, DC), wrote to FDA in support of regulation. "Negative media coverage portraying the dietary supplement industry as 'unregulated' erodes [consumer] confidence," he wrote. Even though "section 402(g) of the [Food, Drug, and Cosmetic Act] does not require that the secretary (and by delegation, FDA) adopt regulations that prescribe GMPs, the dietary supplement industry has maintained that such regulations would be helpful for ensuring that dietary supplements are safe and not adulterated or misbranded; have the identity and provide the quantity of dietary ingredients declared in labeling; and meet the quality specifications that the supplement is represented to meet." Soller points out that the Dietary Supplement Health and Education Act of 1994 (DSHEA) authorizes FDA to establish GMP regulations governing the preparation, packing, and holding of dietary supplements under conditions that ensure their safety. FDA is currently in the process of drafting such GMPs.

Label Express's Reveal Estate resealable label can be run on traditional pressure-sensitive machinery.
 

Many in the industry support some sort of regulation. Says Jeff Robinson, market development leader of Flexcon's Packaging Business Team (Spencer, MA): "It is only natural that over-the-counter (OTC) labeling regulations be applied to nutraceutical products. Nutraceuticals today are being perceived in much the same way as vitamins once were. That is, they are not seen as a drug per se, but people take them in the same manner as they take medicine. As a result, nutraceutical companies are striving to connect to the consumer as a bona fide medical product. That, combined with the fact that nutraceuticals represent one of the fastest-growing retail segments in the packaging industry, has fueled an aggressive campaign for shelf presence."

Phillip W. Harvey, director of science and quality assurance of National Nutritional Foods Association (Newport Beach, CA), says his trade group has developed a good manufacturing practices program and a system of testing that attempts to ensure that product labels and product content agree. However, most efforts target manufacturing, not packaging. Says Harvey: "Packaging may be an issue that will be addressed in our GMP standards eventually, but there aren't specific how-tos affecting packaging now. We don't know when the FDA's GMPs will come out and whether they will require expiration dates. If they do, they could make for a change in packaging. A manufacturer would have to be able to prove that the packaging does not cause oxidation, allow water in, and so on during the period of shelf life."

UPGRADING PACKAGING APPEARANCE

Packaging itself is changing, but not only for reasons of product protection. Paulette Carnes, vice president of sales and marketing at Ampersand Label Inc. (Garden Grove, CA), puts it this way: "FDA is concerned about people buying snake oil. And manufacturers are frustrated with how long it's taking to get label approval, so they are moving forward, dramatically changing the industry." In order to provide consumers with more product information, nutritional supplement manufacturers are putting more information on labels, including that which DSHEA and FDA require. "In addition, the industry is trying to get more information on the label, such as product history, source, testing data, and suggested diets and regimens," says Carnes.

Coincidentally, on a parallel track FDA has issued new labeling requirements for OTC medicines, resulting in major formatting and content changes to the label. "Real estate on OTC packages is limited relative to the extensive required label text, causing many companies to totally rethink how they package and label their products," says Soller. "Enter label suppliers who see an opportunity for a reinvigorated market, and we see the reemergence of extended content labeling (e.g., peel-back multipanel labels) as a potential solution. This market change, coupled with a move to greater labeling on dietary supplements, is fueling growth opportunities in the packaging sector of the industry."

The move to accommodate more and more label information in a limited package area has its challenges. Says Todd Rice, sales manager and director of marketing for ISO 9001—registered Best Label Co. (Cerritos, CA), which offers a variety of expanded-content labels, "Nutritional supplement manufacturers are being forced to put more information on their label, and they're running out of real estate."

Mark Roughen, marketing manager at Bert-Co Graphics (Los Angeles), agrees. "What we have seen in the past is, because of increased requirements of product labeling in terms of ingredients, there's very little room on the label for marketing."

Perhaps more important, though, is the move to nontraditional labels. Best Label recognized an opportunity in 1988 when it patented Info + Plus. According to Rice, pharmaceutical manufacturers were running out of space on small vials that needed to provide multilingual dosage directions. "Info + Plus not only enables our customers the ability to print on the backside of their labels, it provides a multiple-wrap capability that almost doubles the space for available print."

Best Label's Info + Plus wraparound label almost doubles copy space.
 

Ampersand markets a labeling line called MultiVision, which is secured to itself with resealable adhesive. The consumer can lift a tab to reveal copy underneath. The label is equipped with a resealing mechanism that enables consumers to peel and reseal without damaging it.

Label Express (Midvale, UT) has also developed an expanded content label called Reveal Estate that peels away from a bottle to reveal additional printing on the backside of the label. Using Primax film from Avery Dennison, Fasson Roll North America (Painesville, OH), the company has created a label that allows supplement packaging to expand their labeling space by a minimum of 66%, says Label Express's product manager Dana Kirk. "We chose the Primax film because it had more strength than paper, and the single-layer label helps keep costs down," he says.

For traditional bottle packaging, there are only three ways to get more information on a label, says Kirk. "Decrease the size of the text, which may not conform to FDA standards; increase the size of the label and bottle, which adds cost and may reduce the number of products you can get on the store shelf; or utilize existing nonprinted surfaces or add more surfaces to the label construction." Typically these come in the form of folded outserts, multiple-layer labels, specialty constructions such as Rexall's Twist 'N Learn, or using the back of the existing prime label, such as Label Express's Reveal Estate.

Another way to increase the amount of space available for product information is to move into folding cartons. Many bottled products are now contained in cartons. Other products are moving out of bottles and into blister packages, with one goal being the use of the outer folding cartons for product information. Shelley Meade, account manager at contract packager Future Pak (Farmington Hills, MI), says: "The nutritionals industry is going toward blisters. A lot of the customers I have talked with have been looking to leave bottles. The blister itself can have information on it, and then the carton can have more."

According to Deborah Pyle, marketing manager at Sharp (Conshohocken, PA), a contract packager, there's an aesthetic component in the move from bottles to blisters. "We're finding nutritionals companies trying to be more pharmaceutical-like. They're looking for a more pharmaceutical look in their packaging in going from bottle to blister. A blister gives the consumer a higher-quality feel." Pyle says blisters are the packages of choice in product sampling. "A lot of the cards are being utilized to get the consumer familiar with the product. There might be just two or three days' worth of product in the blisters, and the carton includes a coupon for another package."

Yet another desirable feature of blisters is their ability to accommodate several different products on a single card. Says Pyle: "We've had requests for packages that can hold three tablets for the morning and two for the afternoon, with different combinations of ingredients. The manufacturers are looking at these as being convenient, so the consumer can carry a whole day's dosage around with them." Like the compliance packaging used for pharmaceuticals, these coded, multiple-ingredient blister cards encourage consumers to adhere to daily regimens.

Tom Grinnan, director of marketing and strategy at folding-carton specialist Mebane Packaging Group (Mebane, NC), says that blisters go a long way toward regimen compliance even if supplement manufacturers don't choose blisters exactly for that reason. Grinnan even wonders whether some day blister use will be a requirement. "I wonder, from a legal point of view, whether blisters might be pushed by FDA. The Consumer Product Safety Commission seems to be pushing blisters for certain pharmaceuticals."

Many marketers of supplements, while trying to determine what should be done to meet new standards of product quality, are also moving ahead with improvements in package graphics. The better looking the package, they know, the higher the perceived value and quality of the product inside.

Ampersand's Carnes says that seven or eight colors of ink used on product labels are becoming the norm. Rice adds: "The customer is saying, 'The more colors the better.'" In addition to 10-color labels, Best has seen an increase in requests for foil stamping, a high-end look designed to give products more shelf appeal.

Grinnan says packaging imagery is changing, too. "There's a move away from fitness—flexing muscles and all that—and what you see now is a lot more focus on being very natural. Marketers are using light pastel colors. They're bringing in innovative printing, graphic design, structural design, unique coatings, metallic inks, matte finishes. They are trying to shed their image as a garage or cottage industry but don't want to look as sterile as pharmaceuticals. As they have moved into the Wal-Marts and so on, they have had to really change their image on the shelf in terms of promotion."

Another way supplement manufacturers can promote their products is through samples. "By inserting sample packages of either solid- or liquid-dose supplements into packages of other products, manufacturers can cross-promote new products," says Howard Thau, president of Sonic Packaging Industries Inc. (Hillsdale, NJ). For instance, Sonic has been supplying foil sachets with multiple-layer laminates for sample packages of some of the latest nutritional supplements to hit the market, like MSM cream.

PACKAGING PROCESSES

While showcasing products in sophisticated packaging with detailed labeling can do a lot to elevate the reputation of a particular nutritional supplement, manufacturers must also ensure that the packaging process itself is trustworthy. To do so, some nutritional product makers are purchasing the same packaging equipment that pharmaceutical product makers use.

One piece of machinery that has jumped product lines is the capsule filler. "One year, we sold more of our capsule fillers to nutritional supplement companies than to pharmaceutical companies," says Bill Arden, marketing manager for Bosch—TL Systems (Minneapolis), a manufacturer of high-speed capsule-filling machines for powders, pellets, and tablets. For instance, Bosch—TL installed six machines at Rexall Sundown (Boca Raton, FL). The supplement maker's main concern was high output. "The firm is currently producing one million capsules per machine per shift," he says. In addition, "Rexall was concerned about possible machine downtime, so we also offer service and support."

Even the smaller supplement makers are looking for pharmaceutical-grade equipment. "We have customers ranging from doctors to nutritionists to compounding pharmacists making unique formulations who buy our tabletop capsule filler," says Rebecca Blum, marketing and sales representative for Encap Systems Inc. (Carlsbad, CA), a provider of manual to semiautomatic systems. "Filling capsules by hand, which is what a lot of these makers start out doing, isn't accurate and is time-consuming. They switch to gain accuracy and increase volume." Encap's model can produce up to 8000 capsules per hour with an accuracy of ±2%.

Claudio Radossi, director of sales for MG America (Fairfield, NJ), a provider of high-speed capsule fillers that can output up to 140,000 capsules per hour, sees another reason behind the nutritional supplement maker's search for pharmaceutical-grade equipment. "Pharmaceutical companies are moving into the nutritional supplement industry, and they have established quality control procedures. The newer, strictly nutritional supplement companies are having to raise their product and packaging quality to compete."

LOOKING AHEAD

With observers reporting a continued increase in sales of nutritional supplements, we can expect to see more advances in the way marketers use packaging to keep the customer informed and coming back for more.

Photo By Roni Ramos; Capsule Filler Courtesy of Encap Systems Inc.

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