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OTC TAMPER-RESISTANT PACKAGING: CANS MAY BE ACCEPTABLE, FDA

Executive Summary

OTC TAMPER-RESISTANT PACKAGING: CANS MAY BE ACCEPTABLE, FDA Commissioner Young said in a recent speech to a Center for Professional Advancement Seminar sponsored by McGraw-Hill in New York. "Cans were not included in the original list of acceptable technologies because they were rarely used for over-the-counter drug products, [but] FDA now recognizes that cans do have the potential to meet the requirements in the regulation," Young stated. Cans are one packaging technology that Young said FDA is considering including in revisions to the 1982 tamper-resistant packaging regulations. Young added that if cans are used, the manufacturers "should consider directly printing the label onto the can by a process such as lithographing, rather than attaching a separate label that could be reapplied to cover a hole made by a tamperer." Another acceptable technology is bottle mouth inner seals applied by heat induction, which "appear to offer a higher degree of tamper resistance than those that depend on adhesive to create the bond," Young said. Also, the use of perforated tear strips with heat shrink bands "could enhance tamper resistance," the commissioner remarked. He said that sealed paperboard cartons are unacceptable, but "future technological advances" may produce new paperboard packages that meet the regulation requirements. The commissioner noted the importance of labeling in educating the consumer about tamper-resistant packaging. "Labeling is like a blackboard for educating consumers about what to look for to ensure that tampering has not occurred," Young stated. He also encouraged the food industry to voluntarily use such labeling when applicable. "As new packages and materials are developed, we need to keep consumers aware of new tamper-evident features so that they can protect themselves," Young said. He noted that such consumer awareness is possible through labeling and the media. Young said that FDA, the Proprietary Association and the Council on Family Health had recently recorded and mailed out copies of a 30-second public service announcement about product tampering to more than 8,400 radio stations. The commissioner mentioned that a public education campaign, which sends out the message that tampering or even the threat of tampering is considered a federal crime, is scheduled for nationwide distribution this summer. The campaign was developed by FDA, the J. Walter Thompson ad agency and the project's sponsors: the Food Marketing Institute, the National Advertising Council and the Grocery Manufacturers of America. "Prevention also includes industry education about the importance of product integrity during production, distribution and sale," Young stated. He said that packages damaged in shipping are often found on store shelves and that "for the consumer, there is no way to tell whether this kind of damage occurred in shipping and handling or through tampering." Young mentioned that the agency has determined that one way government and industry can work together to prevent tampering is that "each processor, distributor, and retailer should have a crisis management team, a clear plan of action, and a spokesperson who will communicate with FDA."
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