GMPs and Nutritional Packaging
Companies already following GMPs can expect minor changes to their packaging operations. Others should take heed and follow their example.
Hard-hit by recent bad press concerning the dangers of products containing ephedra, dietary supplement companies should receive a much-needed boost as a result of FDA’s proposed rule on good manufacturing practices (GMPs). The proposal, which was published on March 13, 2003, would require nutritional companies to take responsibility for manufacturing, packaging, and holding dietary ingredients or dietary supplements in a manner that will not adulterate them.
While large nutritional manufacturers are likely to be following GMPs already, the industry is made up mostly of smaller companies, many of which do not have GMPs in place. These companies may have up to three years to comply with the new rule after it is finalized. “[The industry] needs the GMPs,” says Jim Wagner, editor of Nutritional Outlook magazine. “Supplement companies are struggling, and GMPs are needed to restore consumer confidence. Sales that once averaged 15 to 20% growth now average 2 to 5% growth annually.” FDA’s GMPs will help raise the quality of nutritional supplements, protect the public health, and restore the public’s faith in the industry.
The GMPs will require quality control in manufacturing, packaging, and labeling operations and the maintenance of records related to packaging, although they need not be as extensive as those for pharmaceuticals. For some nutritional companies, such as Pharmavite (Northridge, CA), the GMPs will not result in significant changes to packaging operations. “We found that the aspects related to packaging and labeling were not that controversial,” says Paul Bolar, vice president of regulatory and legal affairs. “The packaging requirements seem to be fairly standard in that they reflect what I believe most responsible companies do already.”
Demian Rose, West Coast sales rep for Hueck Foils (Wall, NJ), agrees: “I don’t think [GMPs] will affect the packaging much,” he says. “There will probably be more in-depth proclamations on each package by manufacturers saying ‘this has been tested,’ so there will be more integral designs and more text on each package.”
In terms of labels, Randy Lindert, manager of new business development, Rxperts Printing Alliance (Crestview Hills, KY), has found that many of his customers have already made changes, primarily to comply with the pharmaceutical GMPs. These companies have included nutritional supplement facts on their labels, changed fonts to comply with FDA regulations, and set up quality systems, he relates.
One thing that Bolar finds surprising is that the proposal requires full reconciliation of labels to verify that the correct number of labels are used, without allowing an alternative, such as electronic checking on-line. “For drugs, [electronic verification] eliminates the need for 100% reconciliation of label usage,” he says. “We feel that the same latitude or means of ensuring that proper labels are used should be allowed for dietary supplements as for drug products.”
On the Record
The proposal calls for recordkeeping of lot or batch numbers, which may require some companies to make changes to packaging operations. “[Recording lot numbers] is a procedure that’s probably standard with many companies,” says Bolar. “But those companies that do not use it will have to institute new procedures whereby they record the lot numbers that are issued to a packaging run.”
FDA is not proposing requirements for written procedures; however, the agency is seeking comments on whether such practices should be included in the final rule. According to Bolar, written procedures for packaging operations are essential for consistent and controllable operations, as well as training purposes.
“Companies in the nutrition industry have spent a lot of time and effort to upgrade their internal standards as well as the standards for their outside vendors, whether that’s the manufacturer or the packager of the product,” says Howard Thau, president of Sonic Packaging Industries Inc. (Westwood, NJ), a contract packaging company. “Many of them are pushing toward a pharmaceutical GMP standard—everything from testing of incoming raw materials and ingredients to finished goods testing. The amount of documentation being requested has increased so much that outside vendors are forced to upgrade their staff and capabilities to be in accordance with customer and government requirements.”
Expiration Dating, Stability, and Shelf Life
FDA’s proposed GMPs do not require expiration dating or stability studies. According to Bolar, expiration dating on products is standard in the industry, but what may be treated more inconsistently is the manner in which companies substantiate their expiration dates. “Some companies have very extensive stability programs. There may be others that use a more wishful approach when they put dating on a label.” He feels that the GMPs should require nutritional companies to have a stability program in place.
Thau has also found that a lot of products now have expiration dates, and this is pushing the industry to use a higher grade of packaging material to ensure longer product packaging. “With some pouches, for example, companies were using a non-foil-based lamination, and today they’re running foil-based lamination to extend shelf life. In some cases, with capsules they were using an uncoated PVC and today they’re using coated PVC or blister materials that provide additional moisture barrier.”
Currently, FDA is conducting a pilot program to determine whether nutritional packaging should comply with U.S. Pharmacopeia standards for light transmission, which state that to ensure the integrity, purity, and strength of a product, the package shall not allow greater than 10% light transmission. “Nutritional packaging has been outside these parameters,” says David Gotler, director of technical services, O. Berk Co. (Union, NJ). “Mostly, [nutraceuticals] have been packaged in green glass, a lot of styrene, and PET on the vitamin side, all of which do not comply with USP light-transmission standards.” Should the industry need to comply with USP standards, the range of colors would be restricted. “Companies that are not in compliance will have to have their suppliers test the colorants that they presently use and have UV inhibitors added to meet the criteria for light transmission,” says Gotler. “Some of the colors would become unusable. The companies using them would have to make changes in the bottle-making process or the choice of resin.”
Hueck Foils’ Rose feels that although the GMPs are “a little vague, having a regulation that requires an increase in testing and backup material is better in the long run,” and will give the industry credibility. Although it is still too soon to say what the impact of the regulation will be, many in the industry agree the proposed GMPs are necessary and can only serve to benefit nutritional companies in the long run.