FDA WARNING_LETTER - Teeter Creek Herbs Company - March 11, 2008

This FDA Warning Letter, Ref. KAN 2008-08, was issued to Teeter Creek Herbs Company following a March 11, 2008 inspection. The letter identifies serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR, based on product labels and promotional claims on the firm's website (http://www.teetercreekherbs.com).

The products "Hrt-Tone," "Immunaid," "St. John's Wort Oil," "St. John's Wort," "Sugarease," "Lvr-Tone," and "Echinacea/Goldenseal" are deemed unapproved new drugs under sections 201(g)(1)(B) and 201(p) of the Act. This is due to therapeutic claims on the website, such as "Prevent high blood pressure" for Hrt-Tone, "aid in cancer, HIV" for Immunaid, and "Aids in nerve pain" for St. John's Wort Oil, which establish their intent for disease treatment or prevention. Marketing these products without FDA-approved applications violates sections 301(d) and 505(a) of the Act.

Furthermore, "Hrt-Tone," "Immunaid," "St. John's Wort Oil," "St. John's Wort," "Sug