/USNewswire/ -- The U.S. Food and Drug Administration today warned consumers about a potentially harmful product represented as "Generic Tamiflu" sold over the Internet. FDA tests revealed that the fraudulent product does not contain Tamiflu's active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin.
The agency reminds patients who are allergic to or may have experienced adverse reactions from penicillin products that they are at risk of experiencing similar reactions from cloxacillin. This includes a sudden, potentially life-threatening reaction called anaphylaxis, with symptoms that include difficulty breathing, chest tightness, swelling of the throat or tongue, hives, dizziness, loss of consciousness, or a rapid or weak pulse. To date, the FDA is not aware of any reports of adverse reactions.
There is no FDA-approved generic drug for the prescription product Tamiflu.
The FDA bought the fraudulent "Generic Tamiflu" without a prescription from a website claiming to be an online drugstore that is no longer operational. The fraudulent version is likely to be found for sale on other websites, however.
"A rogue Internet website marketing drug products may look like a professional and legitimate website, but may actually be an illegal operation," said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. "Medicines purchased from websites operating outside the law put consumers at increased risk due to a higher potential that the products will be counterfeit, impure, contaminated, or have too little or too much of the active ingredient."
The FDA-purchased product arrived in an envelope postmarked from India, containing two foil-backed blister packages each with 15 yellow and tan capsules containing white powder (see photos below). The foil backing is printed, and labeled in part, "Oseltamivir Phosphate 75mg. Capsules TM-FLU Capsules" and "Manufactured by: TRYDRUGS Pharmaceuticals PVT. LTD."
Although the FDA actively monitors the Internet and when appropriate purchases and analyzes drug products, consumers who purchase drugs using an online pharmacy can protect themselves by knowing how to recognize a legitimate Internet pharmacy and how to buy medicines safely online. Legitimate internet pharmacies are licensed by the appropriate U.S. Board of Pharmacy and follow the applicable laws and regulations.
Consumers can also be confident that the National Association of Boards of Pharmacy Verified Internet Pharmacy Sites Seal, also known as VIPPS Seal, gives a seal of approval to pharmacy sites that apply and meet state licensure requirements. Legitimate pharmacies that carry the VIPPS seal are listed at www.vipps.info
The FDA advises anyone possessing or encountering any of these fraudulent Tamiflu drugs not to use them and to contact the FDA's Office of Criminal Investigations by calling 800-551-3989, or by visiting the OCI website (http://www.fda.gov/OCI).
Health care professionals and consumers are encouraged to report adverse events that may be related to the use of these fraudulent products to the FDA's MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, or by mail at: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
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Showing posts with label dumps. toxic waste. Show all posts
Showing posts with label dumps. toxic waste. Show all posts
Thursday, June 17, 2010
Monday, May 03, 2010
FDA Warns Consumers to Avoid Vita Breath Dietary Supplement
The U.S. Food and Drug Administration is advising consumers not to purchase nor consume Vita Breath, a dietary supplement manufactured by American Herbal Lab Inc. of Rosemead, Calif., and marketed at health fairs and on the Internet, because the product may contain hazardous levels of lead.
The FDA was notified by the New York City Department of Health and Mental Hygiene about a patient with lead poisoning who reported taking Vita Breath and two other herbal products. The department analyzed a sample of Vita Breath and reported it contained 1,100 parts per million of lead. This level is more than 10,000 times higher than FDA’s maximum recommended level for lead in candy.
The FDA has collected and is currently analyzing its own samples of Vita Breath.
People with high blood levels of lead may show no symptoms, but the condition may cause damage to the nervous system and internal organs. Acute lead poisoning may cause a wide range of symptoms, including abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Children are particularly vulnerable to lead poisoning. Lead poisoning can be diagnosed through clinical testing, and individuals who have taken Vita Breath should talk to their health care providers about testing.
The FDA is working with state officials in New York and California to further investigate Vita Breath.
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The FDA was notified by the New York City Department of Health and Mental Hygiene about a patient with lead poisoning who reported taking Vita Breath and two other herbal products. The department analyzed a sample of Vita Breath and reported it contained 1,100 parts per million of lead. This level is more than 10,000 times higher than FDA’s maximum recommended level for lead in candy.
The FDA has collected and is currently analyzing its own samples of Vita Breath.
People with high blood levels of lead may show no symptoms, but the condition may cause damage to the nervous system and internal organs. Acute lead poisoning may cause a wide range of symptoms, including abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Children are particularly vulnerable to lead poisoning. Lead poisoning can be diagnosed through clinical testing, and individuals who have taken Vita Breath should talk to their health care providers about testing.
The FDA is working with state officials in New York and California to further investigate Vita Breath.
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Monday, December 14, 2009
Toxic Chemical bisphenol A Still Not Banned By FDA; Schumer, Gillibrand Call for Ban; Govt Official Warns Public
/PRNewswire/ -- Environmental health advocates hope that U.S. FDA will make its promised announcement about health hazards of bisphenol A (BPA), a synthetic sex hormone linked to cancer, behavioral changes, reproductive harm and other illnesses, in time for Christmas.
Sarah Janssen, MD, PhD, staff scientist, Natural Resources Defense Council: "Just as you rely on your doctor for medical advice, FDA must rely on the advice of scientific experts. Dozens of independent scientists, including the Director of NIEHS, have recommended avoiding BPA exposure. FDA should heed their guidance and ban BPA in food packaging."
Janet Nudelman, Breast Cancer Fund: "Scientific evidence shows there's no safe level of BPA exposure. The FDA should immediately ban BPA in polycarbonate food containers and require labeling of cans containing BPA."
Urvashi Rangan, PhD, toxicologist with Consumers Union, whose recent study revealing BPA in canned foods was cited by Senators Schumer and Gillibrand: "Consumers can't know how much BPA is in any can of food. The current safety limit for BPA is outdated, using traditional toxicology that doesn't apply to BPA and other endocrine disruptors. BPA has demonstrated adverse effects at very low doses."
"Restrictions on BPA are in place in Connecticut, Minnesota, Chicago, three New York counties, and legislation has been introduced in 21 states," according to Sarah Uhl from Coalition for a Safe and Healthy Connecticut.
Bobbi Chase Wilding of Clean New York is pregnant: "Women of child bearing age and babies are put in danger because this toxic chemical is in products we use. Recent studies find BPA in the bodies of pregnant women and health care providers. FDA must protect us and not delay."
Mike Schade, Center for Health, Environment & Justice. says, "Some local and state governments have banned sales of BPA-contaminated products, and retailers are taking them off their shelves. The FDA needs to act now."
"As we celebrate the Christmas season, we are reminded of Jesus' commitment to those in poverty. We hope that the FDA will take measures to ensure that canned food is BPA-free through the use of safe alternatives in the future," says Chloe Schwabe from the National Council of Churches.
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Sarah Janssen, MD, PhD, staff scientist, Natural Resources Defense Council: "Just as you rely on your doctor for medical advice, FDA must rely on the advice of scientific experts. Dozens of independent scientists, including the Director of NIEHS, have recommended avoiding BPA exposure. FDA should heed their guidance and ban BPA in food packaging."
Janet Nudelman, Breast Cancer Fund: "Scientific evidence shows there's no safe level of BPA exposure. The FDA should immediately ban BPA in polycarbonate food containers and require labeling of cans containing BPA."
Urvashi Rangan, PhD, toxicologist with Consumers Union, whose recent study revealing BPA in canned foods was cited by Senators Schumer and Gillibrand: "Consumers can't know how much BPA is in any can of food. The current safety limit for BPA is outdated, using traditional toxicology that doesn't apply to BPA and other endocrine disruptors. BPA has demonstrated adverse effects at very low doses."
"Restrictions on BPA are in place in Connecticut, Minnesota, Chicago, three New York counties, and legislation has been introduced in 21 states," according to Sarah Uhl from Coalition for a Safe and Healthy Connecticut.
Bobbi Chase Wilding of Clean New York is pregnant: "Women of child bearing age and babies are put in danger because this toxic chemical is in products we use. Recent studies find BPA in the bodies of pregnant women and health care providers. FDA must protect us and not delay."
Mike Schade, Center for Health, Environment & Justice. says, "Some local and state governments have banned sales of BPA-contaminated products, and retailers are taking them off their shelves. The FDA needs to act now."
"As we celebrate the Christmas season, we are reminded of Jesus' commitment to those in poverty. We hope that the FDA will take measures to ensure that canned food is BPA-free through the use of safe alternatives in the future," says Chloe Schwabe from the National Council of Churches.
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Monday, August 03, 2009
Electronic Cigarette Company (eCigarettesChoice.com) Claims FDA Study Proves E-Cigarettes Are Safer Than Tobacco Cigarettes
TT Note: While I don't smoke, I have still been following this issue. My dad was a smoker and I wonder if he would have tried the electronic cigarette. What I don't have to wonder about is the lack of evidence the FDA presented in their recent release on the safety of cigarettes. Their report did seem a bit skewed in the direction of tobacco.
I had planned to ask a smoker what they thought about this whole debate, but they are hard to find in my area.
/24-7/ -- The study by the FDA released July 22, 2009 may actually prove what e-cigarette aficionados have been shouting on the rooftops from day one: that electronic cigarettes are actually much safer than tobacco cigarettes. Within the last year at least three independent labs have given the green light to electronic cigarettes and the FDA pretends they do not exist.
In the recent FDA study, trace amounts of tobacco-specific nitrosamines and tobacco specific impurities were reportedly found in a limited test of two brands of e-cigarettes. Nitrosamines may also be found in consumer foods such bacon and beer. Trace amounts of carcinogens may also be found in nicotine replacement products such as NicoDerm CQ and Nicorette gum which are FDA approved. The list of hazardous chemicals found in tobacco cigarettes is somewhere around 4,000 according to the CDC
The FDA claimed their analysis detected diethylene glycol, a chemical used in antifreeze which is toxic to humans was present in only one of the samples. They failed to qualify at what level is it harmful or how much was in the sample. This misleads the public to believe that antifreeze is in their e-cigarettes. Diethylene glycol is not an ingredient used to make electronic cigarettes and how it came to be in the sample should raise an eyebrow. But the FDA sounded an alarm even though the test was done months before.
With as many toxic chemicals found in tobacco smoke in comparison to electronic cigarettes, the alarm the FDA is sounding about a less hazardous product is both suspicious and negligent. One might be left to believe that the real FDA agenda may not be to protect the publics' health, but to aggressively protect the bottom line of the makers of smoking cessation products as well as the loss of tax revenue from the sale of tobacco cigarettes. The pressure the FDA is under from health groups and special interest groups is certainly noticeable. It is public record where these organizations receive their funding from and to who they owe their allegiance.
"In effect, the FDA news release was telling the public go smoke tobacco cigarettes, cancer sticks, which are known to kill millions of people while not one death has been recorded as a result of using electronic cigarettes," says Kyle Newton, owner of eCigarettesChoice.com. "It does not make sense." eCigarettesChoice.com is an online Super Store that manufactures the SS Choice No 7 brand along with the new No 7 Stealth electronic cigarette for military use in combat environments. This brand was not part of the FDA test.
The FDA scare resulted in several customers canceling orders. However, on Monday morning they were calling back to order again. "It was educational," says Kyle, "after our customers did their homework, they determined the benefits of the electronic cigarettes far out-weighed the risks. Almost everything consumers come in contact with has traces of hazardous chemicals. Nothing is 100% safe. I lost my mom, who was a smoker, to cancer in 2005, so we do our best to protect our customers and our reputation.
Several prominent doctors and tobacco researchers, including Dr. Michael Siegel at the Boston University School of Public Health, Dr. Joel Nitzkin of the AAPHP Tobacco Control Task Force, and Dr. Brad Rodu, Endowed Chair, Tobacco Harm Reduction Research University of Louisville, has chastised the FDA and requested that they justify their warning about electronic cigarettes with qualified scientific proof.
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I had planned to ask a smoker what they thought about this whole debate, but they are hard to find in my area.
/24-7/ -- The study by the FDA released July 22, 2009 may actually prove what e-cigarette aficionados have been shouting on the rooftops from day one: that electronic cigarettes are actually much safer than tobacco cigarettes. Within the last year at least three independent labs have given the green light to electronic cigarettes and the FDA pretends they do not exist.
In the recent FDA study, trace amounts of tobacco-specific nitrosamines and tobacco specific impurities were reportedly found in a limited test of two brands of e-cigarettes. Nitrosamines may also be found in consumer foods such bacon and beer. Trace amounts of carcinogens may also be found in nicotine replacement products such as NicoDerm CQ and Nicorette gum which are FDA approved. The list of hazardous chemicals found in tobacco cigarettes is somewhere around 4,000 according to the CDC
The FDA claimed their analysis detected diethylene glycol, a chemical used in antifreeze which is toxic to humans was present in only one of the samples. They failed to qualify at what level is it harmful or how much was in the sample. This misleads the public to believe that antifreeze is in their e-cigarettes. Diethylene glycol is not an ingredient used to make electronic cigarettes and how it came to be in the sample should raise an eyebrow. But the FDA sounded an alarm even though the test was done months before.
With as many toxic chemicals found in tobacco smoke in comparison to electronic cigarettes, the alarm the FDA is sounding about a less hazardous product is both suspicious and negligent. One might be left to believe that the real FDA agenda may not be to protect the publics' health, but to aggressively protect the bottom line of the makers of smoking cessation products as well as the loss of tax revenue from the sale of tobacco cigarettes. The pressure the FDA is under from health groups and special interest groups is certainly noticeable. It is public record where these organizations receive their funding from and to who they owe their allegiance.
"In effect, the FDA news release was telling the public go smoke tobacco cigarettes, cancer sticks, which are known to kill millions of people while not one death has been recorded as a result of using electronic cigarettes," says Kyle Newton, owner of eCigarettesChoice.com. "It does not make sense." eCigarettesChoice.com is an online Super Store that manufactures the SS Choice No 7 brand along with the new No 7 Stealth electronic cigarette for military use in combat environments. This brand was not part of the FDA test.
The FDA scare resulted in several customers canceling orders. However, on Monday morning they were calling back to order again. "It was educational," says Kyle, "after our customers did their homework, they determined the benefits of the electronic cigarettes far out-weighed the risks. Almost everything consumers come in contact with has traces of hazardous chemicals. Nothing is 100% safe. I lost my mom, who was a smoker, to cancer in 2005, so we do our best to protect our customers and our reputation.
Several prominent doctors and tobacco researchers, including Dr. Michael Siegel at the Boston University School of Public Health, Dr. Joel Nitzkin of the AAPHP Tobacco Control Task Force, and Dr. Brad Rodu, Endowed Chair, Tobacco Harm Reduction Research University of Louisville, has chastised the FDA and requested that they justify their warning about electronic cigarettes with qualified scientific proof.
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Saturday, January 10, 2009
EIP: Latest TVA Ash Spill Site in Alabama Contains Even More Toxic Metals Than Harriman, Tennessee Spill Site From December
/PRNewswire-USNewswire/ -- The Tennessee Valley Authority (TVA) apparently has reported a new spill at the Widows Creek Fossil Plant in northeast Alabama. According to TVA's own data, the Widows Creek plant disposed of even more toxic metals in its coal ash ponds than the TVA Kingston plant, which was the site of a widely publicized pre-Christmas coal ash spill.
A comparison of Kingston and Widows Creek toxic metal pollution -- based on industry reports to the USEPA's Toxics Release Inventory -- can be found in a detailed analysis released by the Environmental Integrity Project on January 7, 2009. The full EIP report is available online at http://www.environmentalintegrity.org/. A new chart focusing specifically on the Kingston and Widows Creek pollution data is available online at http://www.environmentalintegrity.org/pub590.cfm.
The EIP's report from earlier this week warned that nearly 100 largely unregulated "wet dumps" across the United States comparable to the TVA's breached site in Harriman, Tennessee for the storage of toxic pollution from coal-fired power plants have a place on one or more of the "worst site" lists for six toxic metals, including arsenic and lead.
The Tennessee TVA site was on the "worst site" list for five of the six toxic metals. The site of today's spill -- TVA Widows Creek Fossil Plant, Jackson, AL -- was one of five toxic coal pollution storage sites that showed up on all six of the six worst-site lists for toxic metals. The other four sites are: Duke Energy Gibson Generating Station, Gibson, IN; Georgia Power Scherer Steam Electric Generating Plant, Juliette, GA; Kentucky Utilities Co Ghent Station, Ghent, KY.; and Louisville Gas & Electric Co. -- Mill Creek Station, Louisville, KY.
Using industry-reported data collected by the Environmental Protection Agency (EPA) Toxic Reporting Inventory (TRI) data system for 2000-2006 (the latter being the most recent year for which complete data is available), EIP looked at the presence of arsenic, chromium, lead, nickel, selenium and thallium in the waste at Tennessee-style pollution dumping sites across the nation. The EPA has determined that these "surface impoundment" ponds (also known as "wet dumps") are the most likely storage sites to leak pollution into groundwater and surface water, even without a catastrophic failure such as the one before Christmas at the TVA's Kingston Steam Plant coal ash retention pond, which burst and covered the nearby area with more than a billion gallons of toxic-laden sludge.
The EIP analysis shows that a total of 13 states were found to have at least three coal-fired power plant "surface impoundment" dumping sites on the six 50-worst toxic chemical lists: Indiana, 11 dumps; Ohio, eight dumps; Kentucky, seven dumps; Alabama, seven dumps; Georgia, six dumps; North Carolina, six dumps; West Virginia, four dumps; Tennessee, four dumps; Illinois, three dumps; Michigan, three dumps; Pennsylvania, three dumps; Florida, three dumps; and Wyoming, three dumps.
Eric Schaeffer, director, Environmental Integrity Project, said: "The Tennessee eco-disaster and now the Alabama coal spill have cast a spotlight on what is a very serious national problem -- the existence of under-regulated toxic pollution coal dump sites near coal-fired power plants that pose a serious threat to drinking water supplies, rivers and streams. Our analysis confirms that this problem is truly national in scope and that Tennessee may end up only being a warning sign of much more trouble to come. In addition to so-called 'surface impoundments' in ponds, we need to be concerned about inadequate oversight and monitoring of land-based disposal and other 'storage' of these toxic wastes. We can no longer afford to ignore this problem and we certainly can't be content to just sit around and wait for the next Tennessee-style disaster to happen."
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A comparison of Kingston and Widows Creek toxic metal pollution -- based on industry reports to the USEPA's Toxics Release Inventory -- can be found in a detailed analysis released by the Environmental Integrity Project on January 7, 2009. The full EIP report is available online at http://www.environmentalintegrity.org/. A new chart focusing specifically on the Kingston and Widows Creek pollution data is available online at http://www.environmentalintegrity.org/pub590.cfm.
The EIP's report from earlier this week warned that nearly 100 largely unregulated "wet dumps" across the United States comparable to the TVA's breached site in Harriman, Tennessee for the storage of toxic pollution from coal-fired power plants have a place on one or more of the "worst site" lists for six toxic metals, including arsenic and lead.
The Tennessee TVA site was on the "worst site" list for five of the six toxic metals. The site of today's spill -- TVA Widows Creek Fossil Plant, Jackson, AL -- was one of five toxic coal pollution storage sites that showed up on all six of the six worst-site lists for toxic metals. The other four sites are: Duke Energy Gibson Generating Station, Gibson, IN; Georgia Power Scherer Steam Electric Generating Plant, Juliette, GA; Kentucky Utilities Co Ghent Station, Ghent, KY.; and Louisville Gas & Electric Co. -- Mill Creek Station, Louisville, KY.
Using industry-reported data collected by the Environmental Protection Agency (EPA) Toxic Reporting Inventory (TRI) data system for 2000-2006 (the latter being the most recent year for which complete data is available), EIP looked at the presence of arsenic, chromium, lead, nickel, selenium and thallium in the waste at Tennessee-style pollution dumping sites across the nation. The EPA has determined that these "surface impoundment" ponds (also known as "wet dumps") are the most likely storage sites to leak pollution into groundwater and surface water, even without a catastrophic failure such as the one before Christmas at the TVA's Kingston Steam Plant coal ash retention pond, which burst and covered the nearby area with more than a billion gallons of toxic-laden sludge.
The EIP analysis shows that a total of 13 states were found to have at least three coal-fired power plant "surface impoundment" dumping sites on the six 50-worst toxic chemical lists: Indiana, 11 dumps; Ohio, eight dumps; Kentucky, seven dumps; Alabama, seven dumps; Georgia, six dumps; North Carolina, six dumps; West Virginia, four dumps; Tennessee, four dumps; Illinois, three dumps; Michigan, three dumps; Pennsylvania, three dumps; Florida, three dumps; and Wyoming, three dumps.
Eric Schaeffer, director, Environmental Integrity Project, said: "The Tennessee eco-disaster and now the Alabama coal spill have cast a spotlight on what is a very serious national problem -- the existence of under-regulated toxic pollution coal dump sites near coal-fired power plants that pose a serious threat to drinking water supplies, rivers and streams. Our analysis confirms that this problem is truly national in scope and that Tennessee may end up only being a warning sign of much more trouble to come. In addition to so-called 'surface impoundments' in ponds, we need to be concerned about inadequate oversight and monitoring of land-based disposal and other 'storage' of these toxic wastes. We can no longer afford to ignore this problem and we certainly can't be content to just sit around and wait for the next Tennessee-style disaster to happen."
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