OT: CDC Alert on Consuming “Total Body Formula” and “Total Body Mega Formula”

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CDC Alert on Consuming " Total Body Formula " and " Total Body Mega

Formula "

By Michele Godard - News Director

April 15 2008

KALB-TV Newschannel 5 - andria,LA*

This is an official

CDC Health Advisory

Distributed via Health Alert Network

http://www.kalb.com/index.php/news/article/cdc-alert-on-

consuming/6241/

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 > http://www.fda.gov/medwatch/how.htm.