Engineered Food and the FDA

To get bioengineered medicines, grains, vegetables, and animals on the market for human consumption, U.S. biotech companies must pass their products through the Food and Drug Administration (FDA). Recently, the FDA has been in the news because its Prescription Drug User Fee Act of 1992, which forces drug companies to pay in to expedite drug approval, came up for renewal.

That same year, the FDA rejected mandatory labeling of genetically modified organism (GMO) products. How might the FDA affect the future of bioengineered food? The User Fee Act has, in Harvard professor Jerry Avorn's opinion, "pretty much transformed the FDA. The sense now is we report to the industry; they pay our salaries; we had better be quick on these approvals." Some biotech products will zoom through the FDA because they are advances in medical treatment, and, of course, we all want the sick to get the best new therapies.

The problem is that the FDA is underfunded, so most resources are dedicated to medical advances. Thus, according to David Kessler of the FDA, "other parts of the agency - post-market surveillance, food safety, the field resources—those areas of the agency suffer." In addition, the FDA is essentially rubber-stamping the tests performed by each company that has developed a product, and since they're bogged down in analysis of drug tests, they hardly ever follow up on the market to see if bioengineered products are having a negative impact on consumers.

One publicized mishap in 2000 resulted in traces of StarLink Bt10 corn, meant only for industrial purposes, cross-pollinating with conventional corn and winding up in taco shells. We know the FDA isn't catching problems like this one--and that, as yet, consuming products deemed marginally unsafe won't cause an epidemic—but eventually the biotech industry may get consumer backlash for causing a serious problem that could have been avoided if the budget were expanded. I should probably note that the U.S. Department of Agriculture (USDA) oversaw the restrictions on this brand of corn, and the Department of Health and Human Services, of which the FDA is a part, only posts notices for products consumed by humans—so there's a further complication for biologically engineered products.

They may be subject to these two departments as well as the Environmental Protection Agency, and this structural weakness probably doesn't make for excellent communication. One could argue that GMO labeling is only a minor issue in the U.S. and that the average citizen isn't too concerned about the provenance of his or her food. There are at least two problems with this attitude. The first is that U.S. exports will be increasingly suspect to foreign markets, particularly the EU, which require labeling and stringent testing.

The second is that any misstep, such as a genetically engineered product that results in widespread sickness, will create distrust of the FDA and bioengineering in general. Europe's vigorous standards regarding approval, track-back, and isolation for GMO crops may be driving North America out of the market. Agricultural specialists like Dan McGuire are questioning if GMO crops are really to their economic advantage. "I can't recall any foreign or domestic corn customer ever requesting that U.S. farmers start planting and supplying genetically engineered corn.

So the introduction of GMOs was not a response to importers or consumers requesting such a change. Indeed, it's a direct result of biotech companies introducing those products into the domestic and foreign market without market research on consumer acceptance. Indeed, the first I heard about GMOs was from European importers," said McGuire. Leaders in the biotechnology industry need to be activists for their products—labeling their products will bring them one step closer to informing the public and leading us into discussions of benefits like cheaper crop production and less pesticide runoff.

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