NEWS
04/22/1994

<TITLE>STATEMENT:  HEALTH WARNING ON BIO-GENESIS PRODUCTS</TITLE>








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<PRE>
April 22, 1994                                     Betsy Adams
                                                   (301) 443-4177

       STATEMENT:  HEALTH WARNING ON BIO-GENESIS PRODUCTS
     The Food and Drug Administration today warned consumers not to
take the liquid form of two unapproved drug products -- Latero-
Flora and Flora-Balance, manufactured by Bio-Genesis Inc. -- 
because they have been found to be contaminated with bacteria. 
These bacteria can cause severe or fatal infections in people with
weakened immune systems, for whom the products are being promoted.
     These products are marketed by Bio-Genesis to aid "in
resolving many immuno suppressed conditions" and improve symptoms
of chronic fatigue syndrome, hay fever, athlete's foot and
tonsillitis.  They are marketed especially to patients undergoing
chemotherapy, organ transplant patients, AIDS patients and patients
on long-term antibiotic therapy.
     Federal search warrants were executed yesterday at Bio-
Genesis' office in San Marcos, Calif., and a manufacturing site in
San Bernardino, in cooperation with the United States Attorney's
office and U.S. Postal inspectors.  Business records, unapproved
drug products and production equipment and materials were seized by
FDA in conformance with the warrants.
     Although only the liquid products have been found to be
contaminated, the capsule form of the products also has not been
shown to be safe and effective.  The contaminating organisms are
forms of Pseudomonas, Flavobacterium and Bacillus bacteria that can
be especially hazardous to people with weakened immune systems.   
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</PRE>





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