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Article: FDA clamps down on 29 firms for unauthorized health claims.(Food and Drug Administration)
- Article from:
- The Food Institute Report
- Article date:
- October 31, 2005
CopyrightCOPYRIGHT 2005 The Food Institute. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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FDA issued Warning Letters to 29 companies that manufacture, market, or distribute fruit products because of unauthorized claims that such products treat or prevent disease. A list of the companies and products can be found below.
The Warning Letters object to the products in question, because they make claims to treat or prevent diseases (i.e., health claims) that have not been authorized by FDA. These unauthorized health claims cause the products to be drugs and new drugs may not be legally marketed in the U.S. without a New Drug Application approved by FDA. Therefore, FDA considers these products to be unapproved drugs according to Food Institute counsel, ...