Foreign Foods Evade FDA's Watch

The ability of the U.S. Food and Drug Administration (FDA) to monitor and police imported foods is once again under scrutiny. A public health crisis originally thought to be limited to China crept into the U.S. when FDA announced recalls of products tainted by melamine, a dangerous chemical.

The FDA has announced recalls for beverage products imported from China and contaminated with melamine. On Sept. 26, FDA announced the recall of Mr. Brown instant coffee and milk tea products. On Oct. 6, FDA recalled Blue Cat Flavor Drink. California has recalled Chinese-made candies as well. No illnesses have been reported, according to FDA.

FDA announced Oct. 3 a new standard for melamine. Rather than banning the nonfood item completely, FDA released an interim assessment that determines melamine to be safe in food at levels of 2.5 parts per million or lower.

The current melamine contamination controversy began in September when contaminated infant formula was linked to thousands of illnesses and at least four infant deaths in China. The Chinese dairies producing the contaminated formula cut their milk with melamine to create the appearance of increased nutrient content. Unlike water, melamine can fool devices that test milk for purity. However, melamine is toxic and more commonly used in industrial manufacturing to produce glue and concrete, among other items.

FDA's new interim assessment also says that no amount of melamine in baby formula is safe. According to FDA, the agency is "currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns." FDA adds, "There is too much uncertainty to set a level in infant formula…" In September, FDA advised consumers not to purchase infant formula manufactured in China from Internet sites or other sources.

The recalls have reignited concern over FDA's ability to adequately police the rising tide of imported food reaching American consumers. From 2002 to 2007, food imports increased 84 percent, according to the Government Accountability Office (GAO).

GAO released a report Sept. 26 analyzing FDA's practices for ensuring the safety of the nation's fresh produce supply. The report comes on the heels of this summer's Salmonella Saintpaul outbreak, which sickened 1,442 people in 43 states, Washington D.C., and Canada. After a three-month investigation focusing mainly on tomatoes, FDA traced the contamination to serrano and jalapeño peppers imported from Mexico.

GAO found that FDA is unable to examine the vast majority of fresh produce imports. FDA samples less than one quarter of one percent of imported produce shipments, according to GAO. "[W]hile FDA has allocated additional resources to import oversight, it has not been able to inspect a larger percentage of imported fresh produce items," the report says.

FDA conducts fewer than 20,000 inspections of all imported foods, GAO found. Batches of imported foods, which FDA calls "entry lines," numbered 9.6 million in 2007. Based on those figures, FDA inspects less than 0.21 percent of all import entry lines.

Controversy has surrounded FDA for the past few years. In addition to numerous imported food recalls, the agency's drug safety program has been under scrutiny. FDA's approval of Vioxx, which killed thousands of people suffering heart disease, piqued public awareness of the flaws in FDA's drug approval process. Later controversies over pharmaceuticals, such as the diabetes drug Avandia, fanned the flames.

FDA officials decided to begin a public relations campaign to improve the agency's image. However, even that was not immune from controversy. A Washington Post investigation, published Oct. 2, found the agency sidestepped contracting requirements when it awarded a $300,000 contract to a public relations firm.

FDA awarded the business to Alaska Newspapers Inc., which does not have to compete for federal contracts because the company is considered an Alaska Native corporation. The government exempts Alaska Native corporations from competition requirements in order to promote native-owned business.

However, the Post investigation shows that FDA's intent all along was to subcontract the public relations work to Qorvis Communications, a major Washington-based consulting firm. Internal e-mails uncovered by the Post show FDA knowingly circumvented contracting rules in order to award the contract to Qorvis without opening up the work to competition. Although the FDA suspended the contract, Congress has started an investigation.

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