Food Dish — Where food, science and regulation meet

In addition to the above, there is an approved Natural Health Product (NHP) Monograph for green tea extract which provides it is a source of antioxidants for the maintenance of good health, and can be used with a program of reduced dietary intake of calories and increased physical activity to help in weight management. This means that applicants for products containing green tea extracts for the uses specified in the Monograph can reference the Monograph and speed up the approval process. The NHPD will not evaluate the safety and efficacy of NHP ingredients that are already known to be safe and efficacious when used under the conditions specified in the Monograph.

Permitted label claims in the U.S.

In the U.S., the FDA has not yet approved any health claims for use on the labels of green tea foods or dietary supplements. Health claims in the U.S. describe a relationship between a food, food component, or dietary supplement, and a reduced risk of a disease or health-related condition. Health claims must be pre-approved by the FDA following review of scientific evidence.

In the case of green tea, the FDA has allowed the use of qualified health claims. Qualified health claims are permitted when there is emerging evidence of a relationship between a food, food component, or dietary supplement and reduced risk of a disease or health-related condition. In this case, the evidence is not well enough established to meet the significant scientific standard for a bona fide health claim, and qualifying language is included as part of the claim to indicate that the evidence supporting the claim is limited.

The qualified health claim for green tea was approved in February 2011 and provides: “Drinking green tea may reduce the risk of breast or prostate cancer. FDA does not agree that green tea may reduce that risk because there is very little scientific evidence for the claim.” This claim is eligible for inclusion on green tea and conventional foods and dietary supplements that contain green tea.

The FDA’s decision to permit the qualified health claim was based on a review of 92 observational studies that evaluated the general category of tea, and 39 observational studies that specifically evaluated the relationship between green tea and one or more cancers. These studies consisted of seven prospective cohort studies, one nested case-control study, and 31 case-control studies. The types of cancer included breast, prostate, gastric, lung, colon/rectal, esophageal, pancreatic, ovarian, liver, bladder and skin.

In addition to the qualified health claim, in the U.S. green tea can be labelled with structure/function claims. These claims describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans, may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, or may describe general well-being from consumption of a nutrient or dietary ingredient. Structure/function claims must be truthful and not misleading, but do not require pre-approval by the FDA.

The future for green tea?

While there may not be enough evidence to satisfy regulators that consumption of green tea can prevent or cure cancer, improve cardiovascular or neurological health, or help us to lose weight, the food industry is certainly abuzz with the promise of green tea. A simple Google search turns up literally hundreds of hits espousing the multitude of beneficial effects of green tea. In addition, green tea is often used in “alternative medicine” practices to promote well-being.