This approach, sometimes called “graded security,” would define the extent of security measures needed, with the severity increasing in proportion to the risk. It might be conceptually similar to the classification system created by NIH for laboratories working with biohazardous agents.

Recommendation 4.12: The FDA should convene panels of experts in major areas of food production to assess vulnerabilities and recommend corrective actions. This effort should be pursued with as much cooperation as possible from industry, but it should not be left to industry alone.

Protecting the Pharmaceuticals System: Excipients and Unregulated Diet Supplements

Following the 1982 poisoning incidents in which cyanide-laced Tylenol was placed in retail stores in the Chicago area, tamper-evident packaging became required for all over-the-counter medications. As a result, deliberate contamination of distributed nonprescription drugs has become far more difficult. Similarly, to successfully tamper with FDA-approved drugs before distribution, a terrorist would have to defeat the relatively rigorous controls established for routine drug production.

A greater risk, however, is contamination of the vast array of vitamins, health supplements, and “natural” remedies, which do not need FDA approval. The chance prevention, in 1998, of a mailing in which sodium cyanide was deliberately sent packaged as a free sample of a nutritional supplement (Canto, 1998) underscores the vulnerability of these products.

The manufacturers of pharmaceutical products are required by law (21CFR211) to establish and maintain controls over personnel, facilities, and materials (including all raw materials, intermediates, and final products). Such controls are also mandated for producers of active agents subsequently compounded into medications and, to a limited degree, for the producers of excipients.10 Controls include physical management of material movement and use, especially inventory reconciliation; worker training and qualification for assigned tasks; and strict monitoring of water and air systems within production environments.

The ability of such controls to protect products against deliberate contamination before distribution is clearly dependent on the nature and concentration of the contaminant. Acute poisoning of consumers requires materials and doses different from cumulative or delayed-effect toxins or from radioisotopic substitutions, all of which present more insidious threats. Excipients in particular often

10  

Excipients are the salts, sugars, polymers, and binding agents that are compounded with the active ingredients to produce the final tablet, capsule, or solution.



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