Why Is the FDA Picking On Cherries?

[Guest guest]

Why Is the FDA Picking On Cherries?

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

article.)

http://www.lef.org/magazine/mag2006/mar2006_cover_cherries_01.htm

 

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 LEGAL DEFINITION OF LABEL

* 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

 

The Truth About Cherries

Let's slice through the cobbler and look at some cherry science.

First, the USDA-funded studies determined that:

 

cherries have a low glycemic index;

cherries are fat-free, sodium-free, and high in vitamins C, B6, E,

and folic acid;

cherries rate high on the ORAC antioxidant scale (128 units per

gram).

The sellers of cherry products would also like people to know that

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).7 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 showing that the same substance that

makes cherries red makes inflammation subside.8-13 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.12,13 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 industry gets letters saying things like, " I have been

using the 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. I asked the Food and Drug

Administration if it could tell us about any adverse reactions being

reported for cherry products. I was instructed to file a request for

that information under the Freedom of Information Act.

 

 

Cherries and Melatonin

In 2001, a leading researcher reported that tart cherries contain

relatively high levels of melatonin, a natural factor previously

associated with sleep but now known to be a factor in immunity and

much more.14-17 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.18

 

Eating 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

situations where it's needed, such as healing stomach ulcers.19-22

In other words, melatonin is a " smart " compound in cherries.

 

Fast-Acting Phytochemicals in Cherries

Anthocyanins in cabernet sauvignon grapes reach the brain within

minutes of ingestion.23 Anthocyanins are powerful antioxidants.

Could this be why people in Bordeaux, France, who drink three to

four glasses of wine a day can reduce their risk of Alzheimer's

disease by 70%?24 Yes, says another study-flavonoids slash the risk

of dementia by half (cherry anthocyanins are a type of flavonoid).25

 

And by accident, another potential benefit has been discovered.

While looking for something in seeds that might cause Parkinson's

disease, researchers in New Jersey instead found that eating plums

may prevent it-reducing risk by 76%.26 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.27 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.27 When the animals were

tricked by the exit ramp being moved, anthocyanins reduced confusion

and slowness. It's believed that anthocyanins actually made the

brain work better. This government-sponsored research documents that

factors in cherries go far beyond simply protecting against free

radicals.

 

Anthocyanins protect against free radicals related to proteins as

well as those related to lipids.28 This means that 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.29

 

Unhealthy Politics

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 drug called Cylert® outweighs the benefits (as it recently

did). Or it might get a mislabeled anticoagulant monitoring unit

called VeriCal® Calibrator Set off the shelves, 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 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 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.30 Those are the documented cases; the actual

number of people who become sick, hospitalized, or die from drugs is

unknown.31 Resources might be better spent requiring that drug

manufacturers warn people that statin drugs deplete coenzyme Q10,

which can cause deadly complications-something the agency recently

refused to do.

 

At the same time the agency sent warning letters to people selling

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 the American Medical Association had

the fortitude to publish those findings.32,33

 

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Accessed December 5, 2005

_________________

JoAnn Guest

mrsjoguest

www.geocities.com/mrsjoguest/Diets