Q: What guidance does FDA have for manufacturers of Tea?


 A: Tea (Thea sinensis) is not only subject to the Federal Food, Drug, and Cosmetic Act, but also to the Tea Importation Act. Under the latter law, tea offered for entry must meet the standards of purity, quality, and fitness for consumption prescribed under 21 CFR 1220.

Beverages brewed from the leaves of other plants may be labeled as "____ tea" as long as the blank is filled in with the name of a specific plant material. The name placed in the blank must clearly differentiate the product from traditional "tea", or "flavored tea" (e.g., "lemon tea" or "raspberry tea") both of which contain Thea sinensis. Beverages such as "ginseng tea" should not be represented as capable of producing health, energy, endurance, or other physiological effects. Otherwise such teas may be subject to regulation as drugs requiring, among other things, to be proven safe and effective for their intended uses.


-Access the Code of Federal Regulations for the provisions mentioned above.
-For additional information see Information Materials for the Food and Cosmetics Industries.

 

Source: Excerpted from Requirements of Laws and Regulations Enforced by the U.S. Food and Drug Administration (1997).

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