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In addition to its shrink-sleeved canister format launched in early 2007 and sold at Costco, San Francisco, CA-based Bevology also developed a tube format for its effervescent Zenergize supplements. Introduced in September 2007 and sold in cartons, the products retail in seven varieties at Whole Foods, Walgreens, and Vitamin Shoppe stores nationally and in Los Angeles-area Longs and Ralphs stores. Each is priced at $6.99 for one variety of 10 all-natural servings.
Health Resources LLC of Hueytown, AL, was established in 1995 as a manufacturer of natural health supplements available by mail order. Today, the company offers more than 400 different SKUs, with products that promote a range of health solutions, including joint relief, heart health, reduced inflammation, and better digestion, among many others. In March, the company began running six AirPouch™ Express 3 air-pouch void-fill systems from Automated Packaging Systems to protect its bottles of product during shipment. The switch to air-pouch void-fill systems from loose-fill peanuts increases productivity, lessens mess, and reduces costs.
If you are a packager of dietary supplements, you may have a strong reaction to the new Food and Drug Administration regulations setting current Good Manufacturing Practices (cGMP) requirements for these products. These regulations were announced by the FDA in late June and can be found in 21 CFR Part 111.1 – 111.610. As a maker of these products, you might welcome the level playing field among supplement companies that these new manufacturing controls can bring, as well as the higher consumer confidence in products of this type that may follow from more consistent quality. Or, you may resent the rules’ irritating new burdens in procedures and record keeping.
The Food & Drug Administration’s new current good manufacturing practices (CGMPs) for dietary supplements are rich in requirements related to packaging and labeling. A decade in the making, the CGMP rule, compliance with which will be phased in according to size of company, sets minimum standards for assembly-line contact surfaces, packaging and labeling equipment, inspection of packaging received from suppliers, relations with third-party packagers, personnel hygiene on the packaging line and much more, all within the context of forcing the industry—some of which may already be in compliance—to adopt the kind of CGMPs that the FDA has prescribed for food and drugs.
When Sageant, LLC, Bozeman, MT, a health supplement and vitamin producer, wanted to re-brand and refresh its product image, the company sought the assistance of branding and design agency Maddocks & Co. In the process of designing new labels and recommending PVC shrink-sleeve label materials for the various liquid and solid Sageant products in assorted container sizes and shapes, Maddocks also enlisted the digital printing expertise of CL&D Digital to execute the shrink-sleeve label printing. The 2-mil PVC shrink-sleeve label material, manufactured by Klockner Pentaplast , is digitally printed by CL&D using a four-color process.
Aluminum can lends shelf appeal for New Sun Nutrition's reformulated Free Radical Scavenging (FRS) beverages. In February, New Sun Nutrition's CEO Richard Lamb announced, "Since the launch of FRS in 2004, we have continued to fine-tune the product and are proud to introduce a great-tasting, improved formula in addition to an eye-catching new recyclable can for the ready-to-drink format." The aluminum can with pull tab from Rexam (www.rexam.com) offers a one-year shelf life for the beverage that requires no refrigeration. New Sun Nutrition says the shelf life exceeds that of the plastic bottle that this can replaced.
A PET bottle and shrink-sleeve label help start-up company DTK launch a relief drink for “the day after” called AH+. AH+ (After Hours+) is an appropriate name for a vitamin-fortified water designed to help relieve hangover symptoms associated with drinking too much alcohol. Introduced last July, the three 16.9-oz AH+ varieties are filled into 23-g injection-blown PET bottles provided by O.Berk.
The packagers of over-the-counter drugs (OTC) and dietary supplements will soon need to label their products with contact information to allow consumers to report possible injuries or illnesses. The packagers, in turn, will have to report serious adverse events to the Food and Drug Administration, and keep records of the events. The law goes into effect December 22, 2007.
FDA pushes gently to achieve more accurate information on dietary supplement product labels
After taking essentially a hands-off approach to dietary supplement labeling during President Bush’s first term, the Food and Drug Administration is suddenly all over the industry like an octopus. In November, the agency published an overall regulatory strategy that included some controversial initiatives in the area of labeling.
For the first time since the passage of the Dietary Supplement Health and Education Act of 1994, the agency published a draft guidance document including the kind of scientific substantiation—“competent and reliable scientific evidence”—a company should have for the “structure/function” claims on product packages. No evidence standard had ever been spelled out before, though companies are supposed to have substantiation for the claims they make.
Hot on the heels of the Food and Drug Administration’s efforts to ensure truthful label claims for dietary supplements, the Institute of Medicine has expressed its concern about both the safety and efficacy of the products.
Saying “There is little product reliability,” the institute called for tougher regulations of dietary supplement products on January 12. At a briefing that day, Dr. Stuart Bondurant, chairman of the committee that prepared the institute’s report, said: “Reliable and standardized products are needed.”
Dietary supplements, the report points out, need not be proven safe before they can be sold; sale can only be prohibited if the FDA can prove they are harmful. Also, unlike regulated drugs, companies are not required to report adverse reactions.
