spacer
  Home | About CDC | Press Room | Funding | A-Z Index | Centers, Institute & Offices | Training & Employment | Contact Us
spacer
spacer CDC Centers for Disease Control and Prevention Home Page spacer
CDC en Español
spacer
Search:  
spacer
Health & Safety TopicsPublications & ProductsData & StatisticsConferences & Events
spacer
spacer
spacer
Health Alert Network
spacer
  HAN Menu
space
arrow Home
space
arrow News & Events
space
arrow Training
space
arrow IT Infrastructure
space
arrow HAN/PHIN Jurisdictions
space
arrow Other Jurisdictions
space
arrow Advanced Practice Centers
space
arrow HAN Messages Archive
space
spacer spacer
spacer
Skip Nav spacer
This is an official
CDC HEALTH ADVISORY


Distributed via Health Alert Network
Monday, April 14, 2008, 18:50  EDT (6:50  PM EDT)
CDCHAN-00274-2008-04-14-ADV-N

CDC Alert on Adverse Effects Associated with Consuming “Total Body Formula” and “Total Body Mega Formula”

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.

 

 

##This Message was distributed to State and Local Health Officers, Public Information Officers, Epidemiologists, State Laboratory Directors, PHEP/BT Coordinators and HAN Coordinators, as well as Public Health Associations and Clinician organizations##

Categories of Health Alert Messages:

Health Alert

Conveys the highest level of importance; warrants immediate action or attention.

Health Advisory

Provides important information for a specific incident or situation; may not require immediate action.

Health Update

Provides updated information regarding an incident or situation; unlikely to require immediate action.


You have received this message based upon the information contained within our emergency notification database. If you have a different or additional e-mail or fax address that you would like us to use, please contact the Health Alert Network program at your State or local health department.




This page last reviewed: November 10, 2003
spacer
spacer
spacer
spacer
Home | Policies and Regulations | Disclaimer | e-Government | FOIA | Contact Us
spacer
spacer
spacer Safer, Healthier People
spacer
Centers for Disease Control and Prevention, 1600 Clifton Rd, Atlanta, GA 30333, U.S.A
Tel: (404) 639-3311 / Public Inquiries: (404) 639-3534 / (800) 311-3435
spacer USA.gov: The U.S. Government's Official Web Portal DHHS Department of Health
and Human Services