NEWS 02/28/1995 FDA WARNS CONSUMERS AGAINST NATURE'S NUTRITION FORMULA ONE 


Feb. 28, 1995                               Brad Stone        
                                            (202) 205-4144   

   FDA WARNS CONSUMERS AGAINST NATURE'S NUTRITION FORMULA ONE

     The Food and Drug Administration is warning consumers
not to purchase or consume Nature's Nutrition Formula One
products labeled as containing Ma huang (ephedrine) and kola nut
because the product poses a risk to consumers' health.  The
products are sold by Alliance U.S.A. of Richardson, Texas.  
      FDA has determined that the products can cause severe
injury or death in some people who consume them.       
     Nature's Nutrition Formula One is labeled as a dietary
supplement and has been marketed with labeling purporting that it
is useful for weight loss and energy enhancement.  
     The potentially dangerous products can be identified by the
listing of Ma huang and kola nut as ingredients and the
appearance of either of the following usage statements on the
label:  "Adult Food Supplement Take 1 to 3 capsules at 10:00 AM &
3:00 PM," or "Adult food supplement: one to two capsules mid-
morning and mid-afternoon."
     FDA has received more than 100 reports of injuries and
adverse reactions related to the product during the past year. 
Reported reactions range from serious, life-threatening
conditions such as irregular heartbeat, heart attack, stroke, 
seizures, hepatitis and psychosis, to relatively minor and
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 temporary conditions such as dizziness, headache and
gastrointestinal distress.  Several deaths have been associated
with the product.
     FDA and outside medical experts have determined that the
products represent a threat to health because the combination of
Ma huang, a source of ephedrine, and kola nut, a source of
caffeine, can cause severe injury to people even under conditions
of usual or recommended use.  Ephedrine is an amphetamine-like
chemical that acts as a stimulant in the body. 
     In November 1994, FDA informed Alliance that Nature's
Nutrition Formula One posed a potential health hazard and was in
violation of federal laws designed to protect the public health.
After inadequate response from Alliance, the agency asked the
company to recall the products.  Because the company to date has
failed to recall its potentially dangerous products, FDA is
issuing today's warning as a matter of public health protection.  
     At this time, FDA's warning is limited to versions of
Nature's Nutrition Formula One that contain both Ma huang and
kola nut.  The company has advised FDA that it has reformulated
its product to remove the kola nut.  This warning does not apply
to the reformulated version of the product.   The agency is
continuing to evaluate the safety of ephedrine-containing
products produced or distributed by Alliance U.S.A. and other
companies.
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