HHS NEWS

U.S. Department of Health and Human Services
Food and Drug Administration
Consumer Hotline: (301) 532-4440

P97-14

May 16, 1997

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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