Medical Device Link.

Originally Published PMPN September 2004

Nutritionals

Daphne Allen

To catch the eyes of nutritional supplement shoppers, manufacturers can turn to color. Photo of bottles, including those for nutritional supplements, courtesy Alpha Packaging (St. Louis, MO).

Worldwide demand for nutritional supplements remains strong. Global demand will grow 6.1% each year through 2008, reported The Freedonia Group (Cleveland) in July 2004. This rate has wavered little from the firm’s predictions back in June 2002, when demand was predicted to grow 6.2% through 2005. Freedonia currently values the world market at $7.1 billion, expecting it to reach $9.6 billion in 2008. Others estimate the market value to be much greater.

While certain products are driving growth (chitosan, gingko biloba, glucosamine, omega-3 fatty acids, and soy isoflavones are among Freedonia’s favorites), FDA’s proposed GMPs may also have an effect on the legitimacy of the industry. Speaking before the Association of Food and Drug Officials in June 2004, FDA’s acting commissioner Lester M. Crawford said that the agency is “pushing hard on finalizing the first GMP guidelines for dietary supplement manufacturers.” 

These guidelines include strict standards for manufacturing, packaging, and labeling to ensure consistency and potency. “In short, the dietary supplement GMPs will eliminate the ‘buyer beware’ situation Americans now commonly face when they purchase these types of health products,” Crawford continued. 

Packaging suppliers report that nutritional supplement manufacturers appear to be taking the proposal seriously, asking for supplies and services that will best preserve their products. Material quality is a priority. In many cases, though, suppliers are being asked by manufacturers to use common materials rather than find new ones that may meet unique product requirements. 

In addition, product makers are requesting upscale packaging and labeling supplies that help promote product benefits. 

However, suppliers interviewed for this article also report that they are being asked to deliver high-end solutions at low-end prices. As a result, many suppliers are adopting lean manufacturing to help nutritional supplement makers on a budget meet FDA’s upcoming requirements. 

HIGH-QUALITY PACKAGING

FDA’s proposed GMPs require that manufacturers select packaging containers that do not “contaminate dietary ingredients or dietary supplements nor cause them to deteriorate.” Quite simply and logically, the packaging must be appropriate for the product. 

Industry advocates largely support this requirement. The American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), and the National Nutritional Foods Association (NNFA) responded in January 2004 to the proposal, asking only that the rule not require the inspection of “each” container. 

Gary Bobko, vice president of sales and marketing for flexible packaging supplier Glenroy Inc. (Menomonee Falls, WI), says that the nutritional firms he has worked with are taking this requirement seriously. “We know that customers require the benefits of high-quality flexible packaging, particularly in the areas of light and moisture transmission rates,” he says. 

Bob Crossno, director of sales and marketing for the Americas at Süd-Chemie Performance Packaging (Belen, NM), reports that the firm’s nutritional customers are increasing their use of desiccant canisters to preserve their products. 

The evaluations necessary for selecting appropriate materials are routine. “Supplement companies do evaluate and test packaging and labeling and do conduct stability studies to support appropriate expiration dating,” says Annette Dickinson, CRN’s president.

To locate the appropriate supplier partners, many firms may look to those with experience in pharmaceutical packaging. Howell Packaging (Elmira, NY), whose folding carton and contract packaging business has been concentrated in the pharmaceutical market for decades, has recently helped several dietary and nutritional supplement clients. “Our work with the nutritional supplement market has emerged within the past few years,” says Joe Lally, marketing manager, packaging for pharmaceuticals, at Howell. “It was during this period that a number of nutritional supplement firms choose to align their package production and packaging operations more closely with pharmaceutical GMPs.” 

MORE SUPPLIER HELP

Dave Spence, president of Alpha Packaging (St. Louis, MO), agrees that nutritional firms are more concerned than ever about packaging quality. But he says that firms are asking suppliers to provide the assurances. “As a result of the GMP proposal, firms are asking more of suppliers. They want more documentation, materials traceability, and materials with drug master files (DMFs) on record with FDA.”

Mahesh Gupta’s clients are asking to inspect his packaging operation, Nutra-Med Packaging Inc. (Rockaway, NJ). “They want to audit our facilities, look at our standard operating procedures, and view our latest FDA inspection records,” says Gupta, president of Nutra-Med. FDA last inspected his firm, which provides both blister and bottle packaging, in 2003.

Gupta credits the scrutiny to the fact that he is dealing more with larger nutritional supplement manufacturers. “We are seeing more large corporations with packaging professionals who are highly educated on QA/QC issues,” he explains. “The small companies with small orders are disappearing.” He suspects they are leaving the market because of FDA’s proposed GMPs.

INTEREST IN STABILITY? 

Still, Gupta says that his company hasn’t been asked to assist in any stability studies. “No U.S.-based nutritional firms have asked us to handle stability. So, to meet FDA’s requirements, we require certificates of analysis to support the stated expiration dates. These days, we are being asked to package products with shelf lives of 24 months or less.” 

Even the firms that Gupta has helped switch from bottles to blisters haven’t asked him to perform stability studies to support these changes. Instead, firms are choosing commonly used materials. “Most of our blister packaging for U.S. firms uses 10-mil PVC with 1-mil foil lidding,” he says. “Some companies coming from Europe, however, are asking for PVdC materials.”

Spence, too, says that he hasn’t had many questions surrounding shelf life and stability. “There is an established track record of success when it comes to packaging nutritionals in PET bottles, so firms stick with what works,” he says. Nonetheless, Alpha has expanded its offerings to increase barrier by combining PET with other barrier materials, treating bottles after molding with proprietary coatings, custom formulating bottle materials, and adding ultraviolet light inhibitors. 

The Healthcare Packaging Group, a division of O.Berk Co. (Union, NJ), has also added new barrier options to its line of bottles for nutritionals and other products. This year the company introduced a line of thick-walled HDPE pharmaceutical rounds. According to the firm, these containers have a minimum wall thickness of 0.050 in., more than double the thickness of standard bottles. USP testing proves a significant reduction in moisture permeability with these bottles, thus increasing product shelf life. 

But Spence says new barrier package options haven’t taken off, at least for Alpha, mainly because of economics. Instead, he sees the industry asking for tried-and-true materials, with more supplier assurances.

Manufacturers have asked FDA to officially recognize current procedures for establishing expiration dates. In one of the proposed changes that AHPA, CRN, and NNFA requested, the group suggested that manufacturers be required to use a “statement of product shelf life, which may be expressed as a retest date for dietary ingredients or an expiration date for dietary supplements.”

According to Dickinson, “The industry believes expiration dating is essential and is in fact a precondition for acceptance of products marketed in some large retail chains. Expiration dating is virtually universal, and CRN’s comments on the GMP proposal urged inclusion of language about this. We believe that most companies already have procedures in place upon which they base their selection of expiration dates, so we do not believe such a requirement would impose a major new burden.” 

HIGH-IMPACT PACKAGING

Manufacturers are hoping that high-quality packaging combined with a high-impact shelf presence will help them secure loyal consumers.
“Sophisticated packaging and labeling are important elements in identifying a supplement product as a scientifically based formulation meeting specific consumer needs,” says Dickinson.

Packaging suppliers continue to see increased interest in eye-catching packaging. “Firms are looking for ways to differentiate their products from competitors on the shelf,” says Spence. “The gloss levels and shine of PET bottles, for instance, really pop. We are seeing more demand for greens, lavenders, and blues.”

Providers of secondary packaging, which is usually employed for marketing space, are also seeing increased investments.

“Our most recent experience tells us that nutritional supplement manufacturers are rapidly moving toward higher-quality packaging, using substrates such as polyester, metal, and holographic lamination, just to name a few,” says Jeff Nykerk, marketing manager for Rex Corp. (Jacksonville, FL). “Additionally we’ve seen a wide-scale increase in value-added processes such as foil stamping, hybrid ink printing, embossing, debossing, and UV coating. Using specialty materials and coatings produces the same eye-catching results or shelf-popping typically associated with hair-care packaging and other health and beauty products.”

But all the sophistication isn’t just for flash. It may also be needed to bring attention to distinguishing product attributes. “Ethical pharmaceuticals require a prescription. A physician or medical professional may very well recommend a particular OTC product,” says Lally. However, he says, “Nutritional supplements are much more of a self-directed purchase. It is no surprise that packaging and graphic presentations have become more elegant and complex.” 

ON A BUDGET?

Suppliers report that they are being asked to provide high-quality, high-impact materials as economically as possible. As a result, some firms have turned to lean manufacturing.

Manufacturers may be keeping an eye on costs because of constant package updates. “Manufacturers are moving toward a modified just-in-time ordering philosophy due to the continuous labeling changes and other printing requirements. Since our organization offers direct-to-plate printing, which is an electronic workflow process, and lean thinking, it is not an issue to meet our customer’s demanding production schedule,” says Nykerk. 

Others may just have short-lived product life cycles, says Nutra-Med’s Gupta. “I have seen as little as six months,” he says.

Whatever the reason, suppliers are responding. Glenroy stocks 50-in. master rolls of polyester/foil/seal layer laminations that can be custom slit to narrow-web printer specifications. “We can deliver a very high-quality, economically priced, unprinted lamination to a narrow web printer within a week of a placed order. Our narrow- web-printer customers have much lower minimum production requirements compared with wide-web printers. This is due in part to the smaller and versatile printing presses that can produce high-quality printing with a very fast turnaround.”

Adds Lally of Howell Packaging: “We can bundle our cartoning products and services to offer efficiencies not only with respect to cost but also compress speed-to-market, which in today’s retail world can make all the difference.” 

Copyright ©2004 Pharmaceutical & Medical Packaging News