P97-14 Food and Drug Administration
FOR IMMEDIATE RELEASE Larry Bachorik (301) 827-6242
May 16, 1997
Consumer Hotline: (800) 532-4440
FDA WARNS AGAINST CONSUMING THE ARISE & SHINE PRODUCT "CHOMPER"
The Food and Drug Administration is warning consumers not to
purchase or consume "CHOMPER," one of a line of dietary
supplement products distributed by "Arise & Shine" of Mount
Shasta, California. FDA has determined that this product has
been associated with a severe injury and that it may contain
substances that may result in an abnormal heart rate and rhythm,
and could potentially cause cardiac arrest.
FDA has learned of a recent case where the consumption of
this product as part of Arise & Shine "The Cleanse Thyself"
program by a young woman apparently resulted in abnormal heart
rate with heartblock, a potentially life-threatening condition.
The agency is also investigating if other injuries have been
associated with this product.
The "Chomper" product is promoted as an "herbal laxative"
and "cleansing" agent to be used as part of a regimen of dietary
products distributed by this company. Laboratory analyses of the
product revealed that it contains substances similar to those
that affect the heart. Use of these powerful substances, which
are found in a number of poisonous plants, may result in a
severe, potentially fatal heartblock, even in otherwise healthy
individuals. The agency has found that "Chomper" poses a
potentially significant and unreasonable risk to public health.
FDA urges all individuals who may have this product to avoid
consuming it and to immediately consult their health care
professional if they are experiencing any adverse effects
associated with use of the product. These effects may include
nausea, vomiting, dizziness, headache, confusion, hypotension
(low blood pressure), vision disturbances and abnormal heart rate
and rhythm.
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This is a mirror of the page at http://www.fda.gov/bbs/topics/NEWS/NEW00567.html
To Report Adverse Events Associated With This Product Call 1-800-FDA-1088