CDC Alert on Adverse
Effects Associated with Consuming “Total Body Formula” and “Total Body Mega
Formula”
The Centers for Disease Control and Prevention
is working collaboratively with state health departments, the American Association
of Poison Control Centers, and the U.S. Food and Drug Administration (FDA) on
reports of adverse health effects following consumption of the dietary
supplement “Total Body Formula,” and “Total Body Mega Formula” manufactured in
the USA exclusively for
Total Body Essential Nutrition, Inc. This
dietary supplement has been found by FDA to contain hazardous levels of
selenium (up to 200 times the label value) and chromium (up to 17 times
the label value).
An FDA press release on April 9, 2008 detailed
information regarding the level of selenium in the product (http://www.fda.gov/bbs/topics/NEWS/2008/NEW01818.html). FDA is advising consumers to stop using “Total
Body Formula” in flavors Tropical Orange and Peach Nectar and “Total Body Mega
Formula” in the Orange/Tangerine flavor and discard them by placing them in a
trash receptacle outside of the home. “Total Body Formula” products are sold in
eight-ounce and 32-ounce plastic bottles. “Total Body Mega Formula” is sold in 32-ounce plastic
bottles. Products with the following lot numbers should be discarded: Total Body Tropical Orange with lot numbers 4016801, 4024801 and
4031801; Total Body Peach Nectar with lot numbers 4016802 and 4031802; and
Total Body Mega Orange/Tangerine with lot number 4031803.
As of April 11, 2008, 91 adverse reactions have been
reported from Florida, Georgia, Kentucky,
Pennsylvania, Tennessee, and Virginia health departments. The American
Association of Poison Control Centers and the FDA report additional exposures
in other states.
Total Body Essential Nutrition, Inc reportedly
distributed this product to 16 states (Alabama, California, Florida, Georgia,
Kentucky, Louisiana, Michigan, Missouri, New Jersey, North Carolina, Ohio,
Pennsylvania, South Carolina, Tennessee, Texas, and Virginia), and also sells
its products over the Internet.
Clinical description of selenium toxicity
Excessive intake of selenium is known to cause
the following symptoms: significant hair loss, muscle cramps, diarrhea, joint
pain, fatigue, loss of finger nails and blistering skin.
Clinical description of chromium toxicity
Excessive intake of chromium may result in the
following symptoms: renal failure, elevated hepatic enzymes,
thrombocytopenia, hemolysis, changes in thought processes, gastrointestinal
disorders, chest pain, erythema/flushing/rash, dizziness, headache, agitation,
and rhabdomyolysis.
Case definition
Individuals presenting with two or more of the following
symptoms that occurred within two weeks of ingesting a dietary supplement
manufactured in the USA exclusively for Total Body Essential Nutrition,
Inc: hair loss, muscle or joint pains, fingernail discoloration or
changes, headache, foul breath, weakness, gastrointestinal symptoms (such as
nausea, vomiting, diarrhea or abdominal pain), rash, oliguria/anuria or
abnormal renal function tests, jaundice or abnormal liver function tests,
anemia or hematological changes.
CDC requests that consumers and clinicians who encounter
patients with symptoms consistent with selenium and/or chromium poisoning
report these cases to their local poison control center (PCC) at
1-800-222-1222. Medical personnel are available at PCCs to provide
specific medical management advice and will make appropriate referral to state
and local health authorities.
Health care professionals and consumers are also
encouraged to report adverse events to the FDA's MedWatch program at
800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.