Reasonable Rascal
04-16-08, 10:00
TOXIC ELEMENTS, DIETARY SUPPLEMENTS - USA: ALERT
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A ProMED-mail post
******
[1]
Date: 15 Apr 2008
Source: KALB.com [edited]
<http://www.kalb.com/index.php/news/article/cdc-alert-on-consuming/6241/>
The Centers for Disease Control and Prevention (CDC) in Atlanta, GA, 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 the 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 9 Apr 2008 detailed information regarding the level of selenium in the product (<http://www.fda.gov/bbs/topics/NEWS/2008/NEW01818.html>). The 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 8-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 11 Apr 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 2 or more of the following symptoms that occurred within 2 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.
The 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>.
--
Communicated by:
ProMED-mail Rapporteur Brent Barrett
******
[2]
Date: 9 Apr 2008
Source: FDA website press release [edited]
<http://www.fda.gov/bbs/topics/NEWS/2008/NEW01818.html>
The U.S. Food and Drug Administration (FDA) announced today that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products "Total Body Formula" and "Total Body Mega Formula." The FDA has received 43 reports of persons from 9 states who experienced serious adverse reactions using these products.
On 27 Mar 2008, the FDA warned consumers not to purchase or use "Total Body Formula" in flavors Tropical Orange and Peach Nectar and "Total Body Mega Formula" in the Orange/Tangerine flavor of these products after receiving reports of adverse reactions in users in Florida and Tennessee (http://www.fda.gov/bbs/topics/NEWS/2008/NEW01812.html). The adverse reactions generally occurred after 5 to 10 days of daily ingestion of the product, and included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue.
Selenium, a naturally occurring mineral, is needed only in very small amounts for good health. Selenium can boost the immune system. Generally, normal consumption of food and water provides adequate selenium to support good health. Excessive intake of selenium is known to cause symptoms to include significant hair loss, muscle cramps, diarrhea, joint pain, fatigue, loss of finger nails and blistering skin.
Presently, the FDA has 43 reports of adverse reactions including cases from Alabama, Florida, Georgia, Kentucky, Michigan, New Jersey, North Carolina, Tennessee, and Texas.
Analyses of samples of the products by FDA laboratories have now found most of the samples contain extremely high levels of selenium -- up to 40 800 micrograms per recommended serving, or more than 200 times the amount of selenium per serving (i.e., 200 micrograms) indicated on the labels of the products. The FDA continues to investigate the matter to determine how excessive amounts of selenium were added to the products.
The 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 8-ounce and 32-ounce plastic bottles. "Total Body Mega Formula" is sold in 32-ounce plastic bottles. Both product lines are distributed by Total Body Essential Nutrition of Atlanta, which is listed on the products' labels.
Consumers who have been taking the products and have experienced adverse reactions should consult their health care professional. Consumers and health care professionals are 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>.
The sole distributor of the "Total Body Formula" and "Total Body Mega Formula" products has voluntarily recalled the affected products. According to the company, the products were distributed nationwide.
More information about selenium and its toxic effects is available at this link to the Centers for Disease Control and Prevention's Agency for Toxic Substances and Disease Registry: <http://www.atsdr.cdc.gov/tfacts92.html>.
--
Communicated by:
ProMED-mail
[The FDA metals lab identifies selenium and chromium as toxic elements.
Selenium is a trace mineral essential to good health but is required only in small amounts. High blood levels of selenium (greater than 100 ug/dL) can result in a condition called selenosis [1]. Symptoms of selenosis include gastrointestinal upsets, hair loss, white blotchy nails, garlic breath odor, fatigue, irritability, and mild nerve damage [2].
Selenium toxicity is rare in the U.S. The few reported cases have been associated with industrial accidents and a manufacturing error that led to an excessively high dose of selenium in a supplement [3,4]. The Institute of Medicine of the National Academy of Sciences has set a tolerable upper intake level (UL) for selenium at 400 micrograms per day for adults to prevent the risk of developing selenosis [5].
Chromium is a mineral that humans require in trace amounts, although its mechanisms of action in the body and the amounts needed for optimal health are not well defined. It is found primarily in 2 forms: 1) trivalent (chromium 3+), which is biologically active and found in food, and 2) hexavalent (chromium 6+), a toxic form that results from industrial pollution.
1. Koller LD and Exon JH. The 2 faces of selenium-deficiency and toxicity are similar in animals and man. Can J Vet Res 1986;50:297-306
2. Goldhaber SB. Trace element risk assessment: essentiality vs. toxicity. Regulatory Toxicology and Pharmacology. 2003;38:232-42.
3. Hathcock J. Vitamins and minerals: Efficacy and safety. Am J Clin Nutr 1997;66:427-37.
4 Raisbeck MF, Dahl ER, Sanchez DA, Belden EL, O'Toole D. Naturally occurring selenosis in Wyoming. J Vet Diagn Invest 1993;5:84-7.
5. Institute of Medicine, Food and Nutrition Board. Dietary Reference Intakes: Vitamin C, Vitamin E, Selenium, and Carotenoids. National Academy Press, Washington, DC, 2000.
Portions of this have been extracted from the fact sheets on Selenium and Chromium supplied by the office of Dietary Supplements, a portion of the National Insitutes of Health.
<http://ods.od.nih.gov/factsheets/chromium.asp#h8>
<http://ods.od.nih.gov/factsheets/selenium.asp#h7> - Mod.TG]
************************************************
A ProMED-mail post
******
[1]
Date: 15 Apr 2008
Source: KALB.com [edited]
<http://www.kalb.com/index.php/news/article/cdc-alert-on-consuming/6241/>
The Centers for Disease Control and Prevention (CDC) in Atlanta, GA, 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 the 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 9 Apr 2008 detailed information regarding the level of selenium in the product (<http://www.fda.gov/bbs/topics/NEWS/2008/NEW01818.html>). The 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 8-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 11 Apr 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 2 or more of the following symptoms that occurred within 2 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.
The 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>.
--
Communicated by:
ProMED-mail Rapporteur Brent Barrett
******
[2]
Date: 9 Apr 2008
Source: FDA website press release [edited]
<http://www.fda.gov/bbs/topics/NEWS/2008/NEW01818.html>
The U.S. Food and Drug Administration (FDA) announced today that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products "Total Body Formula" and "Total Body Mega Formula." The FDA has received 43 reports of persons from 9 states who experienced serious adverse reactions using these products.
On 27 Mar 2008, the FDA warned consumers not to purchase or use "Total Body Formula" in flavors Tropical Orange and Peach Nectar and "Total Body Mega Formula" in the Orange/Tangerine flavor of these products after receiving reports of adverse reactions in users in Florida and Tennessee (http://www.fda.gov/bbs/topics/NEWS/2008/NEW01812.html). The adverse reactions generally occurred after 5 to 10 days of daily ingestion of the product, and included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue.
Selenium, a naturally occurring mineral, is needed only in very small amounts for good health. Selenium can boost the immune system. Generally, normal consumption of food and water provides adequate selenium to support good health. Excessive intake of selenium is known to cause symptoms to include significant hair loss, muscle cramps, diarrhea, joint pain, fatigue, loss of finger nails and blistering skin.
Presently, the FDA has 43 reports of adverse reactions including cases from Alabama, Florida, Georgia, Kentucky, Michigan, New Jersey, North Carolina, Tennessee, and Texas.
Analyses of samples of the products by FDA laboratories have now found most of the samples contain extremely high levels of selenium -- up to 40 800 micrograms per recommended serving, or more than 200 times the amount of selenium per serving (i.e., 200 micrograms) indicated on the labels of the products. The FDA continues to investigate the matter to determine how excessive amounts of selenium were added to the products.
The 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 8-ounce and 32-ounce plastic bottles. "Total Body Mega Formula" is sold in 32-ounce plastic bottles. Both product lines are distributed by Total Body Essential Nutrition of Atlanta, which is listed on the products' labels.
Consumers who have been taking the products and have experienced adverse reactions should consult their health care professional. Consumers and health care professionals are 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>.
The sole distributor of the "Total Body Formula" and "Total Body Mega Formula" products has voluntarily recalled the affected products. According to the company, the products were distributed nationwide.
More information about selenium and its toxic effects is available at this link to the Centers for Disease Control and Prevention's Agency for Toxic Substances and Disease Registry: <http://www.atsdr.cdc.gov/tfacts92.html>.
--
Communicated by:
ProMED-mail
[The FDA metals lab identifies selenium and chromium as toxic elements.
Selenium is a trace mineral essential to good health but is required only in small amounts. High blood levels of selenium (greater than 100 ug/dL) can result in a condition called selenosis [1]. Symptoms of selenosis include gastrointestinal upsets, hair loss, white blotchy nails, garlic breath odor, fatigue, irritability, and mild nerve damage [2].
Selenium toxicity is rare in the U.S. The few reported cases have been associated with industrial accidents and a manufacturing error that led to an excessively high dose of selenium in a supplement [3,4]. The Institute of Medicine of the National Academy of Sciences has set a tolerable upper intake level (UL) for selenium at 400 micrograms per day for adults to prevent the risk of developing selenosis [5].
Chromium is a mineral that humans require in trace amounts, although its mechanisms of action in the body and the amounts needed for optimal health are not well defined. It is found primarily in 2 forms: 1) trivalent (chromium 3+), which is biologically active and found in food, and 2) hexavalent (chromium 6+), a toxic form that results from industrial pollution.
1. Koller LD and Exon JH. The 2 faces of selenium-deficiency and toxicity are similar in animals and man. Can J Vet Res 1986;50:297-306
2. Goldhaber SB. Trace element risk assessment: essentiality vs. toxicity. Regulatory Toxicology and Pharmacology. 2003;38:232-42.
3. Hathcock J. Vitamins and minerals: Efficacy and safety. Am J Clin Nutr 1997;66:427-37.
4 Raisbeck MF, Dahl ER, Sanchez DA, Belden EL, O'Toole D. Naturally occurring selenosis in Wyoming. J Vet Diagn Invest 1993;5:84-7.
5. Institute of Medicine, Food and Nutrition Board. Dietary Reference Intakes: Vitamin C, Vitamin E, Selenium, and Carotenoids. National Academy Press, Washington, DC, 2000.
Portions of this have been extracted from the fact sheets on Selenium and Chromium supplied by the office of Dietary Supplements, a portion of the National Insitutes of Health.
<http://ods.od.nih.gov/factsheets/chromium.asp#h8>
<http://ods.od.nih.gov/factsheets/selenium.asp#h7> - Mod.TG]