Why is the FDA Picking on Cherry Growers?
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 tart cherry purveyors that they had better quit telling people that tart 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." Testimonials such as, "I no longer take any drugs!" had better cease - or else. Although most of the 29 letters were aimed at Michigan tart 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 office 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 tart 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 - we asked the agency by what authority it was threatening to seize property and stop people from selling tart 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.
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, non-misleading 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. 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.
Incredible as it seems, part of the information on cherries that the FDA wants to censor was funded by a difference governmental agency. The US Department of Agriculture (USDA) gave the cherry industry a $141,120 grant to investigate the health benefits of tart 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 tart cherry, enthusing that tart cherry growers "know how to best develop new markets for the cherry industry." Apparently not.
The FDA does not want the cherry industry to tell people that recent studies show that tart 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 tart 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 (tart 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 doublespeak 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 and 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 tart cherry products. Should people selling tart cherry concentrate want to say something like, "Tart 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 our 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 tart cherries may help prevent type II diabetes. 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. 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 us 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.
The Truth About Tart Cherries
Let's slice through the cobbler and look at some cherry science. First the USDA-funded studies determined that:
* Tart cherries have a low glycemic index;
* Tart cherries are fat-free, sodium-free, and high in vitamins C, B6, E and folic acid;
* Tart cherries rate high on the ORAC antioxidant scale (128 units per gram).
The sellers of tart cherry products would also like people to know that tart cherries can relieve arthritis pain and may be good for blood sugar. Are these statements true?
In 2004, researchers from Johns Hopkins Hospital reported that phytocompounds in tart cherries suppress pain caused by inflammation about as well as the drug Indocin (indomethacin). Indocin is a powerful nonsteroidal anti-inflammatory drug (NSAID) that can cause many side effects. The Hopkins report on tart cherries confirms reports from other countries that the same substance that makes tart cherries red makes inflammation subside. That substance is called anthocyanins. Anthocyanins are related to proanthocyanidins found in grapes and other berries, but they're not the same thing. Anthocyanins are the red pigment in berries. They also make blueberries purple and blue corn blue. Anthocyanins (and there are many) compare favorably to ibuprofen and naproxen for pain relief. Except for the Johns Hopkins study, which was done on rodents, most studies show the effects of anthocyanins in cells, not clinical effects in people. Do they work in humans as well as they do in rats?
The cherry growers get letters saying things like, "I have been using the tart cherry concentrate for my extremely debilitating fibromyalgia pain for about three weeks and have noticed a significant difference." Is it true? Is it false? Who should be the judge? The FDA says it, the agency, should be the judge of the validity of such statements - that it will decide what's healthy and what's not healthy, not the consumer. We asked the Food and Drug Administration if it could tell us about any adverse reactions being reported for tart cherry products. We were instructed to file a request for that information under the Freedom of Information Act.
Tart Cherries and Melatonin
In 2001, a leading researcher reported that tart cherries contain relatively high levels of melatonin, a natural facto previously associated with sleep but now know to be a factor in immunity and much more. A recent study shows how important melatonin is to health. For the first time ever, researchers report that people who have heart attacks have very low levels of melatonin. At the same time, they have very high levels of oxidized low-density lipoprotein (LDL) when measured at night. Eating tart cherries increases levels of melatonin. Researchers in Spain, China, and other countries have documented that melatonin suppresses cyclooxygenase-2 (COX-2) which plays a role in conditions such as Alzheimer's disease where it does damage, yet augments COX-2 in situation where it's needed, such as healing stomach ulcers. In other words, melatonin is a "smart" compound in tart cherries.
Fast-acting Phytochemicals in Tart Cherries
Anthocyanins, in cabernet sauvignon grapes reach the brain within minutes of ingestion. Anthocyanins are powerful antioxidants. Could this be why people of Bordeaux, France, who drink three to four glasses of wine a day can reduce their risk of Alzheimer's disease by 70%. Yes, says another study - flavonoids slash the risk of dementia by half (tart cherry anthocyanins are a type of flavonoid). And by accident, another potential benefit has been discovered. While looking for something that might cause Parkinson's disease, researchers in New Jersey instead found that eating plums may prevent it - reducing risk by 76%. Is it the anthocyanins again? USDA researchers at Tufts University confirm that anthocyanins cross the blood-brain barrier. They fed them to aging rodents and were able to track exactly which part of the brain the anthocyanins ended up in. Further, they showed that animals that were given anthocyanins in their diet could get out of water faster and better than those that were not given anthocyanins. When the animals were tricked by the exit ramp being moved, anthocyanins reduced confusion and slowness. It's believed that anthocyanins actually make the brain work better. This government-sponsored research documents that factors in tart cherries go far beyond simply protecting against free radicals.
Anthocyanins protect against free radicals related to proteins as well as those related to lipids. This means that tart cherries can protect heart muscle, skin, arteries, the fluid in joints, and more. "It's noteworthy" that although tomatoes are also red, their color comes from a different source. Their pigment is lycopene, a type of carotenoid. Lycopene blocks fat-related free radicals such as those that damage LDL.
The FDA has a legitimate interest in protecting the public from dangerous drugs and adulterated food. On any given day, it might decide, for example, that the danger of developing life-threatening liver failure from use of an attention-deficit/hyperactivity disorder called Cyclert outweighs the benefits (as it recently did). Or it might get a mislabeled anticoagulant monitoring unit off the shelves called VeriCal Calibrator Set, as it also recently did. The mistakes and potential disasters are many - antibiotics put into the wrong capsules, asthma inhalants containing nothing but air - these and more have been intercepted by the agency.
But tart cherries? Given their potential benefits and lack of toxicity, it's reasonable to ask why the agency is spending enormous public resources threatening Michigan's cherry growers. the recent explosion of FDA-approved killer drugs suggests that the agency's overzealous approach to tart cherry products might be better directed at pharmaceutical manufacturers whose products are one of the leading causes of death in America. Adverse drug reactions cause more than 100,000 fatalities each year and send a million and a half people to the hospital annually. Those are the documented cases; the actual number of people who become sick, hospitalized, or die from drugs is unknown. Resources might be better spent requiring that drug manufacturers warn people that statin drugs deplete coenzyme Q10, which can cause deadly complications - something that the agency refused to do.
At the same time the agency sent warning letters to people selling tart cherry products, it was poised to approve another new, potentially dangerous drug called Pargluva. That approval has been suspended because concerned researchers at the Cleveland Clinic reevaluated the manufacturer's data and found that it increased the risk of dying 300%, and the Journal of American Medical Association had the fortitude to publish those findings. A committee that reports to the House of Commons in Britain recently advised that the drug industry's stranglehold on research, doctors, disease support groups, journals, regulators, and others should be curtailed. Whether Britain's version of Congress will act or not remains to be seen, but in the meantime, it's fair to ask if the FDA's attack on tart cherry products is an effort to protect the profits of the pharmaceutical industry. Or is the agency protecting the interests of certain conglomerates like Coca-Cola's "Minute Maid," which puts "unapproved health claims" boldly across its labels? Nature Made's berry products have claims on the labels, but it appears to be exempt from warnings. Its parent company, Otsuka Pharmaceuticals, is a multinational corporation with US revenue in excess of $4 billion. Its US headquarters are in Rockville, MD, 15 minutes away from the FDA.
What's going on here? Given what's at stake, the public has a right to know.