Tamper

Aerosol products are hermetically sealed, ensuring that the contents caimot leak, spill, or be contaminated. The packages can be considered to be tamper-proof. They deUver the product in an efficient manner generating Httie waste, often to sites of difficult access. By control of particle size, spray pattern, and volume deUvered per second, the product can be appHed directiy without contact by the user. For example, use of aerosol pesticides can minimize user exposure and aerosol first-aid products can soothe without applying painful pressure to a wound. Spray contact lens solutions can be appHed directiy and aerosol lubricants (qv) can be used on machinery in operation. Some preparations, such as stable foams, can only be packaged as aerosols. 

In 1982, seven people died from consuming cyanide-laced Tylenol capsules. The incident resulted in a total product recall, massive negative pubHcity for the product, new requirements for safe packaging, and a federal statute making product tampering a crime (2). Since that time, the packaging industry has become visible to most consumers. This awareness has benefited the consumer by a reduction in loss of life due to consumption of adulterated products from tampering. Never before has an industry reacted so swiftly to resolve a problem. 

Every developed nation has experienced product tampering incidents. The principal difference between domestic and foreign incidents is the motive of the tamperers. In the United States, typically random tampering without prior threat occurs whereas outside the United States, extortion prior to injury occurs, with money appearing to be the primary motive. Most developed nations are either implementing or modifying their rules on the use of tamper-evident packaging. Some features as they are used in the United States would have to be modified or the use of a secondary feature required to meet the standards of various other countries. 

The FDA has passed a rule (21 CFR 211.132) (3) requiring the use of tamper-evident packaging on all over-the-counter (OTC) dmgs and some cosmetics (qv), while ignoring other products they regulate (2). Table 1 offers examples of such packaging forms. 

Table 1. FDA Examples of Tamper-Resistant Package Forms ...

Product tampering may be a foreseeable possibility and manufacturers have a responsibility to protect consumers against such possible acts. If a product iu an adulterated form could harm a consumer, manufacturers have the responsibiUty of protecting the product and consumer against such acts, meaning the use of tamper-evident packaging transcends FDA regulations. 

Consumer Preferences. Studies into consumer preferences for tamper-evident (TE) packaging have consistentiy revealed that consumers prefer products that are resistant to tampering and have shelf-visible features. The same studies have indicated that a consumer is willing to pay slightly more than a competing brand that is not TE, indicating consumer awareness of packaging. 

Cost to the Industry. When compared to the potential expense for defending a single claim of tampering, the cost of effective tamper-evident packaging becomes insignificant. Many firms simply caimot afford the cost of responding to product tampering claims, especially if the firm is a small one with a limited or totally related product line where the reputation of the entire product line can be affected by adverse pubHcity on one item. LiabiUty insurance caimot return lost customer confidence. 

J. L. Rosette, "Development of an Index For Rating the Effectiveness of Tamper-Evident Packaging Eeatures," Masters Thesis, California Coast University, Santa Ana, Calif., 1985. 

J. L. Rosette, Improving Tamper-Evident Packaging Technomic Publishing Co., Inc., Lancaster, Pa., 1992. 

J. L. Rosette, Product Tampering Detection Eorensic Packaging Concepts, Inc., Atianta, Ga., 1993. 

D. Lowe, "Crisis Management Marketing, Tampering Strategies for International and Domestic Marketplace Terrorism," San Fran. St. Univ. J. 1, (1990). 

Product Tampering in the Markeplace, Eoundation for American Communications, 1993. 

J. Sneden, H. Lockhart, and M. Richmond, Tamper-Resistant Packaging, Michigan State University, East Lansing, 1983. 

Trends in Product Tampering, EDA EBI data on product tampering, 1990. 

Y. P. Konttiaen, Fibrinolysis—Chemisty, Physiology, Pathology, Oystar Ah Pubhshers, Tampere, Einland, 1968, pp. 1—643. 

Glass or plastic bottles that have plastic or aluminum closures are tested for removal torque. The removal torque represents the force required to remove the closure from the bottle. Closures are also evaluated to ensure that they have been properly appHed and that they are tamper evident. Crown closures are also evaluated to ensure proper appHcation. 

General Safety Aspects. Whereas cyanides have become infamous as poisons in part because of the use in prison execution chambers, Na2i death camps, and in over-the-counter dmg tampering cases, there is worldwide safe production of nearly one million t annually. 

E. Rhode, H. Bechon, and M. Me2ger, Scandinavian Rubber Conference, SCR]89, Tampere, Einland, 1989. 

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