Tuesday, March 9, 2010

An apple a day might keep the doctor away - but not the Food and Drug Adminis- tration. In a sign that Big Govern- ment is alive and thriving, FDA chief Dr. Margaret Hamburg last week notified food makers that the government is cracking down on box-front claims it considers misleading and even has threatened to force some products to go through the agency’s drug-approval process.

Foods that promote certain health benefits are now, according to the FDA, “considered to be drugs and must meet the regulatory requirements for drugs.” Cereal maker General Mills got a taste of this treatment last May when the FDA told the company the way it markets Cheerios causes it “to be a drug because the product is intended for use in the prevention, mitigation and treatment of disease.” Pretty soon, Americans with high cholesterol may have to pick up two prescriptions at the pharmacy - one for Lipitor and one for Cheerios.

Long-time critics of the food industry, such as the Center for Science in the Public Interest, hailed the FDA for “not merely firing a shot across the bow” but “declaring war on misleading food labeling.” War metaphors have often accompanied government efforts to rally the nation behind important causes: the War on Poverty, the War on Drugs, the War on Terror. But the War on Wheaties?

Examples of products the FDA deems a threat to public health can be found in 17 separate “warning letters” the agency sent to specific manufacturers last week. While medical experts at the Mayo Clinic trumpet the value of eating walnuts as part of a “heart-healthy diet” and endorse the nuts’ cholesterol-lowering benefits, the FDA informed Diamond Foods that it cannot tell consumers its shelled walnuts can help prevent heart disease. Other miscreants include Beech-Nut for promoting the “low sodium” and “plus vitamins and minerals” in its whole-grain oatmeal mixed with fruit and Nestle’s Juicy Juice apple juice, which includes a “no sugar added” label.

Lest anyone think these warning letters are merely a slap on the wrist, the FDA has told manufactures their labels “are in violation of the law and subject to legal proceedings to remove misbranded products from the marketplace.” Companies have 15 days to report back to the FDA on how they will fix their labels - or risk being dragged into court or having their cereal, juice and nuts banned from the grocery aisle.

On one level, it is amusing to ponder the spectacle of elaborate clinical trials for Cheerios to determine whether the health benefits of toasted whole-grain cereal outweigh the risks, if any. But this sort of endless government intrusion comes at a high cost.

It costs about $1.2 billion and takes 10 to 15 years to bring a new drug from the laboratory through the FDA approval process. Presumably, the government’s scrutiny of the breakfast-cereal market won’t be so costly, but every dollar companies spend to hire lawyers to negotiate with FDA bureaucrats over box labels is a dollar that can’t be spent expanding into new markets, building more efficient plants or hiring new workers.

Expanding the nanny state also provides unneeded grist for America’s litigation mill. Last summer, a U.S. District Court judge had to dispatch a lawsuit filed by a women who sued Quaker Oats because she felt misled into believing the “crunch berries” in Cap’n Crunch’s Crunch Berries were real fruit. Imagine what the trial bar can do when the FDA starts pulling products off the shelves. Every Cheerios-munching heart attack victim becomes a potential plaintiff.

The FDA acknowledged last month that its backlog of pending generic drug applications is nearly 2,000 long. Each approval takes 26.7 months, compared to 16.3 months in 2005. Does this agency really not have more pressing priorities than making the world safe for Juicy Juice?

Dan Pero is president of the American Justice Partnership, which advocates legal reform.

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