Who Will Regulate the Regulators?

ON THE morning of December 13, 1991, teams of agents representing the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA), accompanied by armed U.S. marshals, arrived unannounced at the Rockville, Maryland, offices of Sporicidin Inc. and simultaneously at its contract manufacturing facility in Jonesboro, Tennessee. The agents seized products, ordered a stop to sales and shipments, and filed a formal complaint alleging the products were “adulterated and misbranded.” They demanded that the company recall all its products, and began searching and copying its records.

Sporicidin is one of several manufacturers of spore-killing products based on the chemical glutaraldehyde, which are used by hospitals, clinics, physicians, and dentists for disinfecting sensitive instruments and keeping tables and other surfaces clear of germs. Until 1977 the dominant disinfectant was Cidex, a Johnson & Johnson product that is mainly composed of glu-taraldehyde. However, plain glutaral-dehyde has several drawbacks: it is bulky to store, for many uses it has to be heated to work properly, and it gives off vapors that sting the eyes and nose and cause skin rashes. Robert Schattner, a dentist in the Washington, D.C., area, who had already invented the well-known throat spray Chloraseptic, experimented with ways of overcoming these drawbacks. He mixed the glutaraldehyde with phenol, the main ingredient in Chlo-raseptic. The two turned out to have a synergistic effect, resulting in a disinfectant that was able to kill germs, viruses, and spores more quickly than plain glutaraldehyde, and that was much easier to use.

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Peter Samuel

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ON THE morning of December 13, 1991, teams of agents representing the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA), accompanied by armed U.S. marshals, arrived unannounced at the Rockville, Maryland, offices of Sporicidin Inc. and simultaneously at its contract manufacturing facility in Jonesboro, Tennessee. The agents seized products, ordered a stop to sales and shipments, and filed a formal complaint alleging the products were “adulterated and misbranded.” They demanded that the company recall all its products, and began searching and copying its records.

Sporicidin is one of several manufacturers of spore-killing products based on the chemical glutaraldehyde, which are used by hospitals, clinics, physicians, and dentists for disinfecting sensitive instruments and keeping tables and other surfaces clear of germs. Until 1977 the dominant disinfectant was Cidex, a Johnson & Johnson product that is mainly composed of glu-taraldehyde. However, plain glutaral-dehyde has several drawbacks: it is bulky to store, for many uses it has to be heated to work properly, and it gives off vapors that sting the eyes and nose and cause skin rashes. Robert Schattner, a dentist in the Washington, D.C., area, who had already invented the well-known throat spray Chloraseptic, experimented with ways of overcoming these drawbacks. He mixed the glutaraldehyde with phenol, the main ingredient in Chlo-raseptic. The two turned out to have a synergistic effect, resulting in a disinfectant that was able to kill germs, viruses, and spores more quickly than plain glutaraldehyde, and that was much easier to use.