The Serene Cup
FDA takes steam out of tea’s health claims
by Bruce Richardson
Tea’s claim to a healthy life suffered a setback recently when the Food and Drug Administration rejected the petition of Ito En, a Japanese company and the world’s largest green tea manufacturer. Ito En wanted to claim that drinking five ounces of green tea each day may reduce the risk of cardiovascular disease.
The May announcement by the FDA stated: “Based on FDA’s consideration of the scientific evidence and other information submitted with your petition, and other pertinent scientific evidence and information, FDA concludes that there is no credible evidence to support qualified health claims for green tea or green tea extract and a reduction of a number of risk factors associated with cardiovascular disease.”
The decision comes on the heels of last year’s rejection of a petition by another tea company, Dr. Lee’s Tea for Health, asking that a claim be allowed to state that the consumption of green tea prevents breast and prostate cancer. Dr. Lee’s is owned by Dr. Hang Lee, a practicing pathologist. The desired claim was to be printed directly on Dr. Lee’s bottles of ready-to-drink green tea.
Both of these Asian-based companies appear to have petitioned the FDA before enough controlled studies were documented. These premature attempts to use health claims as marketing strategies threaten the tea industry’s growing appeal to health-conscious consumers.
The petitions did not go unnoticed by the United States Tea Association. They are reasons for concern, according to President Joe Simrany. Knowing the poor reception afforded Dr. Lee’s request, Simrany attempted to postpone Ito En’s requests. “When we first heard of the Ito En petition a year or so ago, we met with senior members of their management team to encourage them to withdraw their petition because, in our opinion, it likely would not be approved by the FDA,” Simrany said. “Obviously, we failed to convince them to do so as they were quite optimistic that their petition would be approved. We were concerned that the industry still lacked critically important human clinical studies, which the FDA weighs very heavily in their decision making process.”
For years, the United States Tea Association and Specialty Tea Institute have cautioned members about getting ahead of the tea and health research studies going on worldwide. Tea is part of a healthy lifestyle, but is it medicine?
Tea & Health Symposium
I remember sitting in the audience at the International Symposium on Tea and Health held in Washington, D.C., in September 2002. The daylong marathon of speakers featured 12 prominent research scientists reading the results of their studies. Approximately 300 international clinicians and a sprinkling of tea industry leaders and journalists filled the Department of Agriculture auditorium. The deluge of medical and scientific jargon taxed my word comprehension and statistical analysis skills.
I might not have been able to understand all that I heard that day, but I did come away with a few important conclusions to share with my tea customers:
• More than 300 research projects were going on worldwide;
• Preliminary studies showed tea consumption appeared to influence some forms of cancer and heart disease;
• We should always temper our excitement about tea’s health benefits by using terms such as “may prevent” and “early studies indicate.”
As exciting as these revelations were, the best result of the symposium was the boost it gave to tea sales. The good news of tea was broadcast that evening on every TV news show, and tea’s healthy reputation was splashed across the front pages of the nation’s newspapers and magazines. It was the beginning of a love affair between the nation’s food and health writers and an ancient beverage. Tea’s dusty Victorian image was infused with new life. And the publicity was free.
That’s why tea industry leaders are concerned about the confusion the recent FDA pronouncements have stirred in the press. Following the Ito En story, one reporter said, “People can still buy green tea, but they will have to face the reality that it does nothing for them.” That is not the kind of news we want to generate.
Asian society views tea as healthy
In defense of Dr. Lee’s and Ito En, tea drinking in Asian society has a healthy reputation that goes back thousands of years. Tea is part of the culture, and consumers—and the domestic trade—are convinced that tea is a healthy beverage.
However, the U.S. government requires more tangible evidence. Tea Association President Simrany said, “Unfortunately, tea consumption is not so deeply enmeshed in the lives of people outside [Asia], and the FDA must be convinced through methodical and consistent scientific studies.”
Ito En North America released a statement in response to the FDA’s decision. Rona Tison, vice president of corporate relations, said: “Although Ito En considers it unfortunate that the green tea health claim petition has been rejected by the FDA, the company will continue its research on green tea. Ito En looks forward to working with the FDA to identify research supporting green tea and a specific benefit to human health. Like many fruits and vegetables, green tea contains important antioxidants, which research has shown can play a significant role in an individual’s well being.”
The tea industry response
Tea Council of the USA Statement in Response to the FDA’s Decline of Green Tea Cardiovascular Health Claim Petition
May 11, 2006
Even though the FDA has denied this health claim, there is a great deal of evidence suggesting that dietary flavonoids, including those found in both green and black tea, contribute to cardiovascular health. What’s missing from the literature right now is epidemiological research on green tea consumption in the U.S. population and clinical human studies showing that drinking green tea reduces the risk of cardiovascular disease by reducing risk of specific measurable endpoints associated with the disease, such as lowering cholesterol or blood pressure.
Governmental health claims communicate information about reduction of disease state. Therefore to
qualify for such a claim, the research must show disease reduction through epidemiological and clinical studies on the disease state.
We have no doubt that drinking tea contributes to overall health on a variety of levels. The research on this subject has been ongoing for decades. But as always, more research needs to be done and is being done now.
We anticipate that the research will evolve to support a health claim in this area in the future, since the anecdotal evidence certainly supports the position. But in the meantime, people should still feel good about drinking tea because it’s an enjoyable beverage and the research to date certainly suggests that it may contribute to overall health.
Why can’t we make absolute claims based on anecdotal evidence or short-term studies? Isn’t the United States Department of Agriculture one of the sponsors of the research into tea’s healthy components?
It can be confusing to read that the USDA is touting the results of preliminary studies on tea’s possible health benefits while down the street, the FDA is denying absolute claims that tea cures cancer and heart disease.
I tell my customers that I take an aspirin each day because some studies indicate it may be good for my cardiovascular health. But, the Bayer Company cannot say on its label that “consuming an aspirin each day will prevent a heart attack.” Ten years worth of controlled studies may someday reveal that to be true. Until then, borrowing a line from Porgy and Bess, “It ain’t necessarily so.”
What does this health claim battle mean to the average tea retailer and the customers you serve? What are we to say when customers ask, “What’s so healthy about green tea?” Is it healthy or not?
Simrany offers some advice: “Tea retailers should reassure their customers that it is not if a health claim will be granted, it is when it will be granted. As more research is conducted, it is only a matter of time until the industry will be able to meet the stringent requirements of the FDA. Also, it is always a good idea for suppliers to stress the other reasons for drinking tea: It tastes good, and it makes you feel good about yourself. If consumers drink tea for this reason, then they will likely consume it on a regular basis, which is a very positive step towards making an intelligent food/beverage choice.”
Why do I drink tea? Tea is a ritual that refreshes my spirit. How do you measure that? How much more fortunate I will be if it turns out to be healthy!
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