DNC News

Cherry Juice Busted by the FDA

September 26, 2006

 

Jacob Schor, ND

 

Subject: Cherry Juice's effectiveness as an anti-inflammatory led sellers to make health claims which irked the FDA.

 

My early morning jog with our dog Poppy across City Park 's golf course was diverted the other day by a uniformed police officer on a bicycle. While this encounter left me pondering whether Denver police might have anything better to do than enforce leash laws before sunrise, it also brought to mind the FDA's crack down on the “cherry people.”

 

Last year during all the uproar over Vioxx, the FDA found the time and energy to threaten twenty nine companies selling cherry juice concentrates for statements in their advertising. By and large, these were mom and pop operations, family farms and orchards who were selling their cherry crop in the form of juice concentrates.

 

In recent years, orchard owners have found new ways to market tart cherries. Back when Americans baked and ate pies, many people kept a stock of pie cherries in their home freezers (ok, I still do). Recently cherry juice and especially a concentrate of cherry juice has turned into a very marketable commodity. Almost all the fruit juices you see sold in retail stores are diluted from concentrates. Concentrates keep better, are easier to ship and take up less storage room. For people who like fruit juice, buying concentrate is cheaper than buying juice. Why pay someone else bottle juice when you can dilute it at home to ‘make' your own? Where these fruit growers got into trouble was that they mentioned juice is good for you.

 

The health benefits of cherry juice concentrates are especially appealing and make a good way to increase sales. We've been following the research on cherries for years. Even before there was science to tell us so, most doctors, well at least naturopathic doctors, knew that cherries were good for treating gout. Scientific studies are not required to know some things, take prunes for example. Everyone knows what prunes do.

 

In recent years scientists have been published studies that confirm what we already knew. For example:

 

Eating cherries decreases the level of inflammatory markers inside the body. C- reactive protein and nitric oxide production decreases. One study concluded, “Such anti-inflammatory effects may be beneficial for the management and prevention of inflammatory diseases.” [i]

 

Eating cherries decreases circulating levels of uric acid, that nasty little chemical that triggers gout. [ii]

 

Cherries contain the highest concentrations of melatonin found in plants. Yet the amounts are in nanograms per gram, a quantity so small that they probably will not put you to sleep. [iii]

 

In an experiment in which scientists injected the paws of poor rats with some nasty concoction that causes pain, cherries decreased, pain, inflammation and tenderness in a dose dependent manner. At the higher doses of cherry, the pain relieving effect was equivalent to the drug indomethacin. [iv] A couple of ounces of cherries provided equivalent pain relief to a 50 mg dose of the drug, without the side effects.

 

As much as most of us like cherries, eating a bowl of them every day might get old. This is why those cherry juice concentrates are exciting. Two tablespoons of concentrate can be watered down to make an 8 ounce glass of juice. One quart of concentrate makes two gallons of juice. Those two tablespoons of concentrate are the chemical equivalent of 100 cherries. In other words those two tablespoons of concentrate have a very significant anti inflammatory and anti gout effect in the body. You might think twice about swallowing a handful of pain killers day in and day out. But cherry juice? No problem. Now do you understand why these cherry growers were tempted to talk about arthritis on their websites?

 

And that's what got all these little family owned orchards in trouble. They told people about this. No matter that all of this data can be found on PubMed at the National Library of Medicine or that the US Department of Agriculture Research Service posted its own May 2004 newsletter about sweet bing cherries and gout at: http://www.ars.usda.gov/is/AR/archive/may04/cherry0504.htm

 

The problem was that these companies suggested that cherry juice concentrate might be useful at treating disease. That would make cherries a drug and the FDA felt necessary to step in.

 

On October 15, 2004 , the FDA sent out letters of warning to twenty-nine separate fruit growers, most of them family orchards in Michigan and Washington who had made health claims for cherry juice either on their websites or on product labels.

 

The warning letters were all very similar. They pointed out either labels or website advertisements that violated the Federal Food, Drug and Cosmetic Act.


“Under the act, articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man are drugs,” the letters said.

The FDA doesn't want these guys to say things like: “Try our cherry concentrate, an all natural alternative to Vioxx!”

Nor can they use customer testimonials, including: “I have arthritis and gout. I've been taking two separate prescriptions for these afflictions. I have been using tart cherry juice for about four weeks and I stopped taking the medicine.”

These kinds of health claims make the products drugs. You cannot market drugs in the United States without FDA approval. In order to get approval, drugs must go through the proper application process, according to the FDA. This process costs millions of dollars.

The companies have mostly redesigned their labels. They no longer post scientific articles on their own websites; instead they provide links to other websites that post the research. For example, you can check out the Cherry Marketing Institute http://www.cherrymkt.org/



In the last two weeks, several acquaintances have told me what might be construed as personal testimonials about the amazing benefits they have experienced from taking cherry juice concentrates. This has prompted me to investigate purchasing some of this concentrate to sell at the office. That being the case I suppose I should not even be writing this letter and mentioning the research. It may already be too late. In recent newsletters, we have mentioned a study that stated pomegranate juice increased PSA doubling times in metastatic prostate cancer patients from 15 to 54 months. We have also mentioned the study, which showed three or more glasses of juice in a week, lowered Alzheimer's disease risk by 76%. At least we have not mentioned the lung cancer study yet. If we had, you might mistake these juices for a drug and not simply fruit juice.

 

In the near future, when we announce that we have a freezer filled with fruit juice concentrates at the office, we need to be very clear about one thing. We are in the food business. Cherry juice concentrate is not a drug.

 

Fruit juice concentrates are available by mail from a number of companies, at least 29 by FDA count. These companies are not particularly forthcoming with detailed information about how they make the concentrate or even, in the case of the small orchards, whether they make it themselves. All concentrates are a standard 68 Brix. They can be diluted with 7 parts water to make reconstituted juice. If kept in a freezer the concentrate can be stored for years. Is one seller better than another? At this point, we can't say.

 

However, do stay tuned. More info will be forthcoming. And remember it is a food, not a drug.

 

_______________________________________________________________
References:

 

[i] J Nutr. 2006 Apr;136(4):981-6.

Consumption of Bing sweet cherries lowers circulating concentrations of inflammation markers in healthy men and women.

•  Kelley DS ,

•  Rasooly R ,

•  Jacob RA ,

•  Kader AA ,

•  Mackey BE .

U.S. Department of Agriculture/ARS, Western Regional Research Center, Department of Nutrition, University of California, Davis, CA 95616, USA. dkelley@whnrc.usda.gov

The purpose of this study was to determine the effects of consuming sweet cherries on plasma lipids and markers of inflammation in healthy humans. Healthy men and women (n = 18) supplemented their diets with Bing sweet cherries (280 g/d) for 28 d. After a 12-h fast, blood samples were taken before the start of cherry consumption (study d 0 and 7), 14 and 28 d after the start of cherry supplementation (study d 21 and 35), and 28 d after the discontinuation (study d 64) of cherry consumption. After cherries were consumed for 28 d, circulating concentrations of C-reactive protein (CRP), regulated upon activation, normal T-cell expressed, and secreted (RANTES), and NO decreased by 25 (P < 0.05), 21 (P < 0.05), and 18% (P = 0.07) respectively. After the discontinuation of cherry consumption for 28 d (d 64), concentrations of RANTES continued to decrease (P = 0.001), whereas those of CRP and NO did not differ from either d 7 (pre-cherries) or d 35 (post-cherries). Plasma concentrations of IL-6 and its soluble receptor, intercellular adhesion molecule-1, and tissue inhibitor of metalloproteinases-2 did not change during the study. Cherry consumption did not affect the plasma concentrations of total-, HDL-, LDL-, and VLDL- cholesterol, triglycerides, subfractions of HDL, LDL, VLDL, and their particle sizes and numbers. It also did not affect fasting blood glucose or insulin concentrations or a number of other chemical and hematological variables. Results of the present study suggest a selective modulatory effect of sweet cherries on CRP, NO, and RANTES. Such anti-inflammatory effects may be beneficial for the management and prevention of inflammatory diseases.

PMID: 16549461 [PubMed - indexed for MEDLINE]

 

[ii] J Nutr. 2003 Jun;133(6):1826-9. Click here to read 

Consumption of cherries lowers plasma urate in healthy women.

•  Jacob RA ,

•  Spinozzi GM ,

•  Simon VA ,

•  Kelley DS ,

•  Prior RL ,

•  Hess-Pierce B ,

•  Kader AA .

U.S. Department of Agriculture/ARS Western Human Nutrition Research Center, University of California at Davis, Davis , CA 95616 , USA . rjacob@whnrc.usda.gov

To assess the physiologic effects of cherry consumption, we measured plasma urate, antioxidant and inflammatory markers in 10 healthy women who consumed Bing sweet cherries. The women, age 22-40 y, consumed two servings (280 g) of cherries after an overnight fast. Blood and urine samples were taken before the cherry dose, and at 1.5, 3 and 5 h postdose. Plasma urate decreased 5 h postdose, mean +/- SEM = 183 +/- 15 micro mol/L compared with predose baseline of 214 +/- 13 micro mol/L (P < 0.05). Urinary urate increased postdose, with peak excretion of 350 +/- 33 micro mol/mmol creatinine 3 h postdose compared with 202 +/- 13 at baseline (P < 0.01). Plasma C-reactive protein (CRP) and nitric oxide (NO) concentrations had decreased marginally 3 h postdose (P < 0.1), whereas plasma albumin and tumor necrosis factor-alpha were unchanged. The vitamin C content of the cherries was solely as dehydroascorbic acid, but postdose increases in plasma ascorbic acid indicated that dehydroascorbic acid in fruits is bioavailable as vitamin C. The decrease in plasma urate after cherry consumption supports the reputed anti-gout efficacy of cherries. The trend toward decreased inflammatory indices (CRP and NO) adds to the in vitro evidence that compounds in cherries may inhibit inflammatory pathways.

PMID: 12771324 [PubMed - indexed for MEDLINE]

 

[iii] J Agric Food Chem. 2001 Oct;49(10):4898-902.

Detection and quantification of the antioxidant melatonin in Montmorency and Balaton tart cherries (Prunus cerasus).

•  Burkhardt S ,

•  Tan DX ,

•  Manchester LC ,

•  Hardeland R ,

•  Reiter RJ .

Department of Cellular and Structural Biology, University of Texas Health Science Center , Mail Code 7762, 7703 Floyd Curl Drive, San Antonio , Texas 78229-3900 , USA .

The antioxidant melatonin was recently identified in a variety of edible plants and seeds in high concentrations. In plants, as in animals, melatonin is believed to function as a free radical scavenger and possibly in photoperiodism. In this study, melatonin was detected and quantified in fresh-frozen Balaton and Montmorency tart cherries (Prunus cerasus) using high-performance liquid chromatography. Both cherry species contain high levels of melatonin compared to the melatonin concentrations in the blood of mammals. Montmorency cherries (13.46 +/- 1.10 ng/g) contain approximately 6 times more melatonin than do Balaton cherries (2.06 +/- 0.17 ng/g). Neither the orchard of origin nor the time of harvest influenced the amount of melatonin in fresh cherries. The implication of the current findings is that consuming cherries could be an important source of dietary melatonin inasmuch as melatonin is readily absorbed when taken orally. Also, previously published data and the results presented here show that melatonin is not only endogenously produced but also present in the diet.

PMID: 11600041 [PubMed - indexed for MEDLINE]

 

[iv] Behav Brain Res. 2004 Aug 12;153(1):181-8.

Tart cherry anthocyanins suppress inflammation-induced pain behavior in rat.

•  Tall JM ,

•  Seeram NP ,

•  Zhao C ,

•  Nair MG ,

•  Meyer RA ,

•  Raja SN .

Department of Anesthesiology and Critical Care Medicine, The Johns Hopkins Hospital, 600 North Wolfe Street, Osler 292, Baltimore, MD 21287, USA.

The use of complementary and alternative medicine ( CAM ) has increased in the United States and more patients are seeking CAM therapies for control of pain. The present investigation tested the efficacy of orally administered anthocyanins extracted from tart cherries on inflammation-induced pain behavior in rats. Paw withdrawal latency to radiant heat and paw withdrawal threshold to von Frey probes were measured. The first set of experiments examined the effects of tart cherry anthocyanins (400 mg/kg) on the nociceptive behaviors and edema associated with inflammation induced by intraplantar injection of 1% carrageenan. These studies also included tests of motor coordination. The second set of experiments determined if tart cherry anthocyanins (15, 85, and 400 mg/kg) dose-dependently affected the inflammation induced by intraplantar injection of 25% complete Freund's adjuvant. We found that tart cherry extracts reduce inflammation-induced thermal hyperalgesia, mechanical hyperalgesia and paw edema. The suppression of thermal hyperalgesia was dose-dependent and the efficacy of highest dose (400 mg/kg) was similar to indomethacin (5 mg/kg). The highest dose anthocyanin (400 mg/kg) had no effects on motor function. These data suggest that tart cherry anthocyanins may have a beneficial role in the treatment of inflammatory pain. The antihyperalgesic effects may be related to the anti-inflammatory and antioxidant properties of anthocyanins. A better understanding of the modulatory role of dietary constituents and phytonutrients on pain will offer further therapeutic options for treating patients with persistent and chronic pain conditions.

PMID: 15219719 [PubMed - indexed for MEDLINE]

 


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