HHS NEWS

U.S. Department of Health and Human Services 
FDA Press Release
February 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
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.
                            ####
FDA Press Release
February 28, 1995
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