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On May 9, 2006 the US Food and Drug Administration (FDA) rejected a petition for a qualified health claim for green tea (Camellia sinensis) that sought permission to allow manufacturers to claim cardiovascular benefits on product labels associated with green tea as a beverage (i.e., as a conventional food) or as a dietary supplement.1
The Japanese company Ito En, Ltd. and its U.S. subsidiary Ito En, Inc., which produces and markets green tea, filed the petition a year earlier on June 9, 2005.2 The petition sought a qualified health claim indicating that daily consumption of at least 5 fluid ounces of green tea as a source of catechins (flavonoids with antioxidant capabilities) may reduce a number of risks associated with cardiovascular disease (CVD). In a letter from Barbara Schneeman, PhD, director of the Office of Nutritional Products, Labeling, and Dietary Supplements of the FDA’s Center for Food Safety and Applied Nutrition, the FDA claimed to have reviewed the scientific literature and concluded “that there is no credible evidence to support a relationship between consumption of green tea or green tea extract and a reduced risk of CVD.”1
Although Ito En’s petition cited 105 publications as evidence to support the health claim for green tea, the FDA argued that many of the documents (i.e., review articles, meta-analyses, book chapters, letters, government reports, and animal and in vitro studies) were not appropriate for drawing scientific conclusions to support a health claim.1 After discounting what FDA deemed inappropriate, the agency was left with 29 intervention studies on green tea or green tea extract and 10 observational studies. The majority of these were considered insufficient for drawing scientific conclusions, due to poor study design or reporting. According to Dr. Schneeman, the remaining available scientific and clinical evidence was 4 observational studies on green tea (3 of which reported a correlation between green tea and reduced risk of CVD), 3 observational studies on green tea extract (all of which found no evidence of an effect), and 4 intervention studies on green tea (all of which established no evidence of an effect).1
“The biggest problem with this FDA action is the misinterpretation of the decision by the media, and the resulting potential confusion among consumers,” said Mark Blumenthal, Founder and Executive Director of the American Botanical Council. “The way it has been reported in the press suggests that FDA has conducted an evaluation on the efficacy of tea and has found it to be ineffective,” he said. “This is simply not the case,” he added. “What we have here is a regulatory process whereby a company has applied for FDA review and approval of a proposed health claim, and FDA has concluded that not enough clinical data are available to support the proposed health claim to the FDA’s satisfaction.”
Blumenthal explained that health claims are disease risk reduction statements authorized by the Nutrition Labeling and Education Act of 1990 (NLEA) and as such, are a separate regulatory category distinct from the so-called structure/function claims authorized by the Dietary Supplement Health and Education Act of 1994 (DSHEA). Health claims pertain to both conventional foods and dietary supplements, and are based on the correlation of a nutrient and the reduction of risk of a disease and must be pre-approved by FDA. Structure/function claims pertain mainly to dietary supplements and can be made if the manufacturer believes it has reasonable scientific evidence to support the claim. Structure/function claims do not require FDA pre-approval but the manufacturer must notify FDA within 30 days after introducing the claim into the market.
Although FDA refused to allow a health claim regarding green tea and reduced risk of CVD, its decision has no bearing on green tea’s general benefits. The variety of health benefits of green tea were recently reviewed in a 2-part article in the Journal of Alternative & Complementary Medicine (which was summarized in a 2-part HerbClip in June of 2006).3,4 According to one of the articles’ co-authors, Ray Cooper, PhD, of PhytoScience Inc., such benefits include the following properties for which there is some degree of scientific evidence to support: antiviral and anticancer properties (catechins); anticariogenic (prevention of tooth cavities) effects; potential benefits for weight loss (catechins and caffeine); cardiac health (black tea theaflavins); and arthritis, bone density, and stress reduction (theanine).
According to Dr. Cooper, “Numerous scientific publications now attest to the health benefits of both black and green teas including clinical and epidemiological studies. Firstly, consumption of green tea is generally recognized as safe over a wide therapeutic range (up to 10 cups of green tea per day). Much attention to tea catechins and health has focused on cancer, and drinking tea has been regarded traditionally in Asia, for example, as a generally healthful practice” (Cooper R, e-mail to M. Blumenthal, May 11, 2006).
Notwithstanding the FDA’s position on denying cardio health claims, Dr. Cooper states that there is overwhelming evidence from epidemiological and animal studies to attest to the health benefits of green tea in cancer protection.
The overall health benefits of green tea are understandably supported by members of the tea industry. “While the rejection of the Ito En petition has stirred some confusing if not mildly negative media about tea, the fact remains that nutritional experts still consider tea one of the most healthy beverage options on the planet, with its plentiful antioxidants, various minerals and lack of sugar (brewed tea), etc.,” said Brian Keating, founder of Sage Group International and publisher of the Specialty Tea is ‘Hot’ Report (e-mail to M. Blumenthal, May 11, 2006). He added, “Consumers and media must understand that tea remains a safe, nutritious and friendly consumer beverage and rejection of one claim filing is not catastrophic.”
-Courtney Cavaliere and Mark Blumenthal
References
1. B. Schneeman. Qualified health claims: letter of denial-green tea and reduced risk of cardiovascular disease. U.S. Food and Drug Administration Web site. Available at: http://www.cfsan.fda.gov/~dms/qhcgtea2.html. Accessed July 7, 2006.
2. FDA rejects green tea health claims: no credible evidence that drinking it reduces heart disease risk. Associated Press. May 10, 2006. MSNBC Web site. Available at: http://www.msnbc.msn.com/id/12718769/. Accessed July 7, 2006.
3. Cooper R, Morre J, Morre D. Medicinal benefits of green tea: part I. Review of noncancer health benefits. J Altern Complement Med. 2005;11(3):521-528.
4. Cooper R, Morre J, Morre D. Medicinal benefits of green tea: part II. Review of anticancer properties. J Altern Complement Med. 2005;11(4):639-652.
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