Despite Sustainability Initiatives, Still More Labeling Space Needed

Hundreds of OTCs are affected by proposed amended labeling rules for OTC products containing analgesics. They require patient safety information and advise on when to consult a doctor. The name of the ingredient has to be prominently shown on the package’s principal display panel. Labeling on nonsteroidal antiinflammatory drugs (NSAIDs), including aspirin and ibuprofen, must warn of the potential risk for stomach bleeding. Acetaminophen warnings advise of the risk of liver damage.

Issued by FDA in December 2006, the labeling also covers antipyretic and antirheumatic OTC drugs (www.fda.gov/OHRMS/DOCKETS/98fr/E6-21855.htm).

The new labeling would be required for OTC drugs marketed under a new drug application (NDA) or an OTC monograph. OTCs are marketed without further FDA clearance if their active ingredients meet specifications set out in drug class monographs that describe safe and effective ingredients, manufacturing, and marketing.

“Most of the OTC pain relievers fall under the monograph system. The agency is in the process of reviewing the comments made on the tentative final monographs,” says Crystal Rice, spokesperson, Center for Drug Evaluation and Research, FDA.

The labeling applies to products such as cold relievers that contain the pain relief actives along with other ingredients.

“[More] label requirements drive packaging costs up. But these costs are heavily outweighed by the benefits of clear, concise information in user-friendly formats, which improves patient compliance. This translates to fewer compliance-related health issues, which in turn, reduces the drug manufacturer’s liability,” says Des Laffan, director, business development for MPS Healthcare, formerly John Henry Packaging (Greensboro, NC).

To help with space needs for branding and labeling of unit-dose OTC pouches, Oracle Packaging (Tulsa, OK) has launched Extend-A-Print Pouchstock. Two panels permanently sealed to the bottom of the pouch may be peeled down to reveal information, in the “pouch-in-a-pouch” system. Panels can be resealed, but not removed, promoting patient safety.

For pouching of products such as analgesics and antacids, the system increases printing space from two to six panels, providing a cost-effective alternative to double pouches or a larger package, say Chris Payne, VP sales and marketing.

“Extend-A-Print [enables] increasing the readable surface area by up to 300%,” Payne adds. “In most cases, customers can use existing form-fill-seal equipment.”

Labeling for OTCs and dietary supplements is addressed on another front in new FDA guidance on meeting the Dietary Supplement and Nonprescription Drug Consumer Protection Act. As of December 2007, companies must implement procedures for reporting serious adverse product events to the agency. For OTCs, the law expands safety reporting requirements that were in place for OTCs approved with a new drug application to include also monographed OTCs (www.fda.gov/cder/guidance/7950dft.pdf and www.cfsan.fda.gov/~dms/dsaergui.html). Package labeling on diet products and OTCs has to feature a U.S. address and phone number to assist in patient reporting.

Focusing additionally on dietary supplements, FDA has published a final rule establishing current good manufacturing practices for the products. The rule sets minimum CGMPs for ensuring supplement quality and that labels accurately reflect product ingredients (www.fda.gov/ohrms/dockets/98fr/cf0441.pdf).

“Our diet supplement and nutraceutical customers are welcoming these changes. They provide legitimacy to the market, and weed out the less sophisticated players,” says Jim Hassenfeld, president, Generic Pharmaceutical Services Inc. (Hauppauge, NY).