FDA WARNING_LETTER - www.ayurvediccure.com - January 20, 2010

The FDA issued a Warning Letter to Emmbros Overseas (www.ayurvediccure.com) on January 26, 2010, following a website review on January 20, 2010. The FDA determined the firm was illegally marketing unapproved, uncleared, or unauthorized products intended to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus in people. The specific products cited were Guduchi Satya (Tinospora Cordifolia) Capsules, Tulasi (Holy Basil) Capsules, and Sunthi (Ginger) Capsules. The letter detailed various violative claims on the website, such as "Herbs for swine flu treatment" and "Holy Basil is also recommended as a Remedy for Swine Flu," which render the products unapproved new drugs. This marketing violates the Federal Food, Drug, and Cosmetic Act (FFDC Act), specifically 21 U.S.C. §§ 331, 351, 352, and/or 355. Given the H1N1 Flu Virus public health emergency, the FDA considers the sale of such unauthorized products a significant public health threat. Emmbros Overseas was instructed to immediately cease marketing these unapproved H1N1-related products and to email the FDA within 48 hours detailing corrective actions. Failure to comply could lead to enforcement actions, including seizure, injunction, criminal prosecution, and inclusion on a public FDA warning list. The FDA also warned that unapproved products offered for importation into the U.S. are subject to detention.