The Food and Drug Administration routinely approves medications that are barely effective. That’s because a drug company only has to prove its product is better than an inactive placebo.
Some medicines approved by the FDA can cause serious side effects, including permanent disability or death. The heartburn drug metoclopramide, for example, can cause irreversible brain damage resulting in uncontrollable muscle twitches and facial grimaces.
The FDA assumes that such complications are an acceptable risk of pharmaceutical treatment, requiring a warning on the label. Anyone who watches television is familiar with the long list of grave side effects, including death, that frequently accompanies TV drug commercials.
With millions of people harmed every year from medicines, you might think that the FDA would focus most of its attention on really serious drug problems or disease-causing food contamination. That’s why consumers are astonished that the agency spends time and scarce resources going after cherry, pomegranate and walnut growers over their marketing claims.
Two years ago, for example, the FDA sent a warning letter to Diamond Foods, a farmer cooperative owned by 1,800 walnut growers. The letter called the growers on the carpet for claims such as, “Every time you munch a few walnuts, you’re doing your body a big favor.” The website pointed out that omega 3 fatty acids (found in walnuts) may help lower cholesterol, protect against heart disease and alleviate depression. FDA’s letter concludes, “Because of these intended uses, your walnut products are drugs …Your walnut products are also new drugs…because they are not generally recognized as safe and effective for the above referenced conditions…Thus, your walnut products are also misbranded…in that the labeling for these drugs fails to bear adequate directions for use…”
Consumers have responded to this regulatory action with amazement. As one reader put it, “Who knew you had to have directions to eat walnuts?”
The FDA has also issued a permanent injunction against a company selling cherry juice and concentrate. The agency objected to unauthorized health claims. Readers of this column, however, have reported that tart cherries can be helpful for the joint pain of arthritis or gout and for restless legs.
There are hundreds of articles in the medical literature about the effects of pomegranates for health. A recent review points out that “Promising results against cardiovascular disease, diabetes, and prostate cancer have been reported from human clinical trials” (Annual Review of Food Science and Technology, 2011).
Despite such evidence, the FDA wrote to the makers of POM Wonderful that “your…Pomegranate Juice product is promoted for conditions that cause the product to be a drug…the labeling for these drugs fails to bear adequate directions for use.”
Consumers are not mistaking walnuts, cherries and pomegranates for drugs. They don’t need instructions on how to drink juice or munch nuts.
Compared to pharmaceuticals, such foods are far less likely to cause adverse reactions and might even do a body good. After all, nutrition experts urge us to eat more fruits and vegetables and less junk food.
