Green Tea and Cancer: A Qualified Health Claim Case Study

Abstract

In 2005, the Food and Drug Administration (FDA) released an enforcement letter for qualified health claims (QHC) about the ingestion of green tea (food and supplement forms) and the reduced risk of breast cancer or prostate cancer. The QHCs for green tea were enforced shortly after the FDA release of the Consumer Health Information for Better Nutrition Initiative (CHIBN), which expanded the enforcement of QHCs from dietary supplements to conventional foods. Green tea and breast/prostate cancer was identified as a case study to assess the progression of QHCs since the CHIBN expansion. An in‐depth review of court cases, FDA enforcement letters, and correspondence between FDA and green tea manufacturers was conducted. The investigation demonstrated that QHC statements about green tea and breast/prostate cancer have undergone multiple iterations and as a result, are a potential source of confusion for food and supplement designers and manufacturers. The progression of QHC statements for green tea and breast/prostate cancer reflects other enforced QHC diet‐disease categories. The evidence suggests that current FDA enforcement of QHCs is ineffective and in need of repair.Grant Funding Source: Robert Wood Johnson Foundation Investigator Awards in Health Policy Research