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Somewhere, over-the-counter, the FDA waits for drug packers

OTC drug makers will have to become packaging 'wizards' to fit new Drug Facts information on cartons, containers, tubes and bottles.

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Over-the-counter (OTC) drug packagers might want to tell their label and package design experts to get their heels moving. Many packagers will be required to use new packaging graphics by April 16, 2001. The two-year race to develop the new "Drug Facts" label mandated by the U.S. Food & Drug Administration is underway.

Developing the labels won't be cheap, particularly if packages have to be resized. A packaging engineer at Whitehall-Robins, Inc., Madison, NJ, who asks not to be identified, says there is no question that packages for many of that company's 400 to 500 SKUs will have to be upsized.

That is because one of the requirements for the new "Drug Facts" label is that body type be a minimum of 6 points in size. The current minimum is 41/2 points. There just isn't enough room on many of the Whitehall product labels for putting the existing copy in 6-point type. "We could downsize the name of the product, or cut some of the promotional copy," says this executive wryly, "but the marketing people aren't too thrilled about that possibility."

WR is looking at creating a fifth panel for its packages. The problem, Packaging World is told, is that the company's cartoning machines cannot be adapted to make a five-panel carton. So WR would have to buy new equipment. Moreover, cartoning machines that erect and fill the five-panel cartons typically run more slowly than conventional cartoners.

Many other OTC companies will have to get out the magic packaging wand. After the FDA proposed this rule and asked for public comments, the Consumer Healthcare Products Assn. (formerly the Non-prescription Drug Manufacturers Assn.), which represents the major OTC manufacturers, estimated that 33% of brand-name products and 95% of private-label products would have to revamp packaging in some way.

One company suggested that a new packaging line to accommodate a label change for just one product line would result in a one-time equipment expenditure of about $2.5 million (including equipment, installation, validation, depreciation of old equipment, facility renovation and inventory loss). Plus, they also estimate recurring costs of almost $500ꯠ for more expensive labeling.

The FDA apparently took those estimates as seriously as a Jay Leno joke. The agency had a consultant do a study of about 2꺜 SKUs in three Boston retail outlets. The consultant concluded only 6.4% of the SKUs would have to be repackaged.

Many packaging professionals are reaching for OTC antacids as they begin to digest the FDA final rule that was published on March 17. So no one knows whether the FDA's or the CHPA's estimate on packaging changes is closer to the truth.

Y2K again?

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