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Executive Summary

FDA FY 1985 RECALLS INCREASED 48.1% FROM THE PREVIOUS YEAR to a total of 2,085, the agency reported in a Jan. 2 "Talk Paper." FDA noted that almost one-third of that amount is due to recalls of products with undeclared sulfites (169 recalls) and products with undeclared FD&C Yellow No. 5 (467 recalls). Even excluding recalls related to sulfites and Yellow No. 5, the increase represents a record high number of recalls since the agency began tracking enforcement actions in the early 1970s. Recalls have continued to increase since 1981 when the number of actions dipped to 658. In fiscal 1984, ended Sept. 30, there were 1,408 recalls issued, a 53.9% increase over the FY 1983 figure of 915. Seizure actions by FDA also were up, ahead 10.8%, from 213 seizures in fiscal 1984 to 236 seizures in fiscal 1985. The figure is down, however, from a 1980 high of 539 seizures. Other FDA enforcement actions declined from 1984 levels. There were 501 regulatory letters issued in 1985, down from 721 issued in 1984; 24,164 inspections, compared to 27,128 the year before; 21 injunctions, versus 23 in 1984; and 18 prosecutions in 1985, three less than in 1984. By comparison, FDA noted that voluntary corrections undertaken by industry rose 16.4%, from 3,467 to 4,036 in 1985. The agency added that "in 746 cases in 1984 and 751 cases in 1985, these voluntary corrections involved destruction of products, making FDA action to seize or enjoin unnecessary." FDA may be changing its attitude toward, as well as its methods of, enforcement. At a recent Food and Drug Law Institute conference, FDA Associate Commissioner for Regulatory Affairs Joseph Hile, in a speech entitled "New Theories of Enforcement," asserted that FDA "is prepared to do what is necessary to assure a cost-effective operation." Hile stated: "If the agency can operate effectively with fewer field offices, we are prepared to recommend change. If fewer and more specialized field laboratories are appropriate, that will be recommended as well." Hile commented that "one of the most difficult tasks for the agency is to face up to those activities that must be curtailed severely or even, perhaps, eliminated entirely." He added that the agency is "fortunate that the majority of food- and drug-related firms conduct their affairs in a responsible way," responding "promptly to recommendations for change when violative or questionable practices are encountered."

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