by
Barbara Kram, Editor | October 28, 2008
Today's actions reaffirm the position taken by FDA in two previously issued Warning Letters - one sent to B.F. Ascher & Co., Inc., Lenexa, KS, regarding Melagesic PM, and the other to Omni Nutraceuticals, Inc., Los Angeles, CA regarding Inholtra Joint Pain products. In those letters, the FDA stated that drug ingredients combined with dietary ingredients in a single dosage form require agency approval to be legally marketed in the United States.
Companies that do not resolve violations in FDA Warning Letters risk enforcement action, such as injunctions and/or seizure of illegal products.
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Read the warning letters:
http://www.fda.gov/foi/warning_letters/s6991c.htm
http://www.fda.gov/foi/warning_letters/s6990c.htm
Get FAQs:
http://www.fda.gov/consumer/updates/bayer102808.html
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