GAO Says FDA Needs to Crack Down on Food Ingredients

A just-released Government Accountability Office (GAO) report says that the U.S. Food and Drug Administration (FDA) needs to increase its focus on safety for some specific <"http://www.yourlawyer.com/practice_areas/food_poisoning">food ingredients, especially following the broad recall of potentially Salmonella-contaminated hydrolyzed vegetable protein (HVP), said the Associated Press.

The report noted that some ingredients, including spices and artificial flavors—are not subject to ongoing and routine FDA safety reviews because the products are, said the AP, believed to be “generally recognized as safe.” Also according to the GAO, the agency is not doing all it could and it should mandate companies that manufacture or use these products to provide the government with better information, said the AP.

Salt, trans fats, spices, artificial flavorings, emulsifiers, binders, vitamins, minerals, and preservatives, said the AP, which are “generally recognized as safe” and which are used to improve the food taste, consistency, longevity, and nutritional content. The agency agreed—”agrees broadly,” as a matter-of-fact—that its oversight could be better, according to a statement issued by FDA spokeswoman Rita Chappelle Friday.

Meanwhile, the HVP recall is expected to expand beyond the over 50 products recalled thus far, said the AP. Included in the recalls are “four dip, gravy, and stuffing mixes” that are manufactured by McCormick & Company, added the AP.

Most recently we wrote that the FDA announced—in part responding to the GAO investigation—that it plans on stepping up its prosecutions of pharmaceutical and food industry executives as part of its work to revamp the agency’s criminal division said the Wall Street Journal. In addition to being condemned in a government report, the division was derided by Congress, added the Journal.

The FDA recently wrote to Senator Chuck Grassley (Republican-Iowa), saying that an internal committee recommended that the agency and its Office of Criminal Investigations (OCI) “increase the appropriate use of misdemeanor prosecutions, which allows responsible corporate officials to be held accountable and is a valuable enforcement tool,” quoted the Journal. According to the FDA, it has authority to “prosecute corporate executives for criminal actions” under a provision entitled “strict liability.” Although not enacted to a great extent in recent years, the FDA spokesman said that the government is not required to prove intent to defraud in order to convict.

The GAO report said the OCI has operated relatively separate from the FDA with no minimal accountability and no requirement to explain its investigations or use of funds, explained the Journal. The GAO is a so-called “watchdog arm” of Congress.

According to FDA Commissioner Dr. Margaret A. Hamburg, said Thompson Publications, the misdemeanor prosecutions are “a valuable enforcement tool” and the agency came up with criteria for consideration in its choice of misdemeanor prosecution cases. Dr. Hamburg added that, the criteria “will be incorporated into the revised policies and procedures that cover appropriate use of misdemeanor prosecutions,” quoted Thompson. Dr. Hamburg also told Grassley, in a letter, that the agency “is developing meaningful performance measures for OCI, as part of an agency-wide initiative,” adding that it is also “implementing other significant efforts” to address the issues identified by the GAO, reported Thompson.

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