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Why Is the FDA Picking On Cherries?

(Author's name withheld due to the controversial nature of this article.)

March 2006

George Washington cut down one tree. Bureaucrats in Washington, DC, are trying to pull up the whole orchard. On October 17, 2005, letters went out from the Food and Drug Administration warning cherry purveyors that they had better quit telling people that cherries have health benefits or dire things are going to happen. The lucky recipients were warned that it's illegal to say things like, "The same chemicals that give tart cherries their color may relieve pain better than aspirin and ibuprofen." estimonials such as "I no longer take any drugs!" had better cease-or else.

Although most of the 29 letters were aimed at Michigan cherry growers, some were fired off to growers of other berries in other states. What prompted the berry attack is still at large. Inquiries to the office of Judith Putz, compliance officer for the FDA's Detroit district office, didn't yield answers beyond that the FDA had become aware that people were "making claims." The action is not unprecedented, however. Back in 2001, somebody at Food and Drug got bugged about a different berry-the cranberry.

At that time, a letter was fired off to the king of cranberries, Ocean Spray, telling the company that, despite recommendations of the Surgeon General and the National Research Council, it had better quit repeating the story that eating foods high in plant nutrients may protect against some types of cancer and strokes. The alleged criminal acts had occurred on Ocean Spray's website. Normally, the FDA has no authority over websites, but the company had put its website address on its products, and the agency does have authority over labels. On the theory that the website was now part of the label, the agency moved to censor what Ocean Spray was saying. In response, the company moved its health and anti-aging data to the Cranberry Institute's site, thus separating product from information. Today, however, the site contains a lot of scientific data about how the proanthocyanidins in cranberries prevent bacteria from sticking to the urinary tract.

Unlike the cranberry situation, however, the recent attack on cherries is aimed at statements made on websites not linked to labels. Since the FDA has no authority to dictate website content-which is regulated by the Federal Trade Commission-I asked the agency by what authority it was threatening to seize property and stop people from selling cherry products. The agency responded that websites are part of the legal definition of "label." A reading of the legal definition, however, reveals that a label is, well, a label-something stuck to a product or its package. The definition also allows Food and Drug to regulate things that come with the product, such as a package insert. But no mention is made of websites.*


* The definition of label and labeling (21CFR1.3): (a) Labeling includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce. (b) Label means any display of written, printed, or graphic matter on the immediate container of any article, or any such matter affixed to any consumer commodity or affixed to or appearing upon a package containing any consumer commodity. Source: Code of Federal Regulations, Title 21, Section 1.3.

What the Supreme Court Says

Not surprisingly, some in the cherry industry are talking about their First Amendment rights. "Tart is smart," according to King Orchards, and it's not rolling over. Neither, apparently, is the Supreme Court. In sharply worded opinions, the Court has repeatedly rebuked the FDA's "highly paternalistic approach" to keeping information from people for their own good. When the FDA tried to keep compounding pharmacies from advertising, the Court warned the agency that whether a person wants alternative choices is not the government's decision to make. The searing verdict: Bans against truthful, nonmisleading commercial speech . . . usually rest solely on the offensive assumption that the public will respond "irrationally" to the truth. The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good.1 The Court further admonished the agency to quit trying to protect favored markets by suppressing information. According to these and other Court opinions, the FDA appears to have more bureaucratic bark than legal bite.

Government Studies

Incredible as it seems, part of the information on cherries that the FDA wants to censor was funded by a different governmental agency. The US Department of Agriculture (USDA) gave the cherry industry a $141,210 grant to investigate the health benefits of cherries so the industry could increase its sales. Tom Dorr, special assistant to the Secretary of the USDA, had high hopes when he handed over the funds that were used to explore the nutritional and nutraceutical aspects of the berry, enthusing that cherry growers "know how to best develop new markets for the cherry industry."

The FDA does not want the cherry industry to tell people that recent studies show that cherries contain substances that are potentially 10 times stronger than aspirin or ibuprofen for relieving pain. It does not want the public to know that substances in cherries may kill cancer cells and prevent cancer. It makes no difference whether these statements are true. What's important is that the public not be told that a natural substance (cherries) has been shown to work as well as or better than an unnatural one (ibuprofen). Only drugs, according to the FDA's legal doctrine, can prevent, treat, mitigate, or cure disease. If something does those things, it's a drug. And if it's a drug, it has to be tested for its ability to do those things. In this double-speak world, no natural substance can do anything significant against disease-that is, unless it undergoes testing as a drug. Attempts at slaying this many-headed monster of convoluted truths have only made it grow new heads.

For example, when backed into a corner over whether the public can be told of scientific studies showing the benefits of folic acid, fiber, omega-3 fatty acids, and antioxidants, the agency grew four new heads, each looking into the validity of the data for each of the four products. Should people selling cherry concentrate want to say something like, "Cherries may protect your brain from Alzheimer's disease," the agency will grow another new head to determine whether it's legal to say that.

Allowing "claims," as the agency calls them, is a tortuous process. First, somebody at the agency pulls all the scientific studies. (We don't know who, since my request to Barbara Schneeman, director of the Office of Nutritional Products, Labeling and Dietary Supplements at the Center for Food Safety and Applied Nutrition, went unanswered.) Then each study is rated according to criteria created by the agency (good study, bad study, etc.). Then all of the data are taken together and given an FDA "grade" (A, B, C, etc.). How "good" the studies are determines whether or not the public is allowed to hear things such as cherries may help prevent type II diabetes.2-4 Only data from large, controlled studies with findings that are "not likely to be changed by new and evolving science" will receive the FDA's highest "A" rating and be unleashed on the public.5,6 It's hard to resist saying that most drugs would fail this test, since evolving "post-marketing surveillance" is exactly what the Food and Drug Administration relies on to pull killer drugs off the market. Without updated data, the FDA couldn't act to protect the public.

It might be quicker and cheaper for the cherry industry to file "new drug applications" than to deal with a new monster head every time someone in industry wants to inform the public about a potential health benefit. Although Food and Drug told me that it "supports giving consumers as much information as possible to make the best dietary choices," its "warning letters" to the cherry industry make clear it wants the opposite