FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers to Help Consumers Use Products Safely
The Food and Drug Administration issued a final rule today that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these popular drugs.
Products covered by the FDA action include acetaminophen, and a class of drugs known as the nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs include aspirin, ibuprofen, naproxen, and ketoprofen. Acetaminophen is in a class by itself. The revised labeling applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with other ingredients, such as in cold medicines containing pain relievers or fever reducers.
“Acetaminophen and NSAIDs are commonly used drugs for both children and adults because they are effective in reducing fevers and relieving minor aches and pain, such as headaches and muscle aches, “ said Charles Ganley, M.D., director, FDA’s Office of Nonprescription Drugs in the Center for Drug Evaluation and Research. “However, the risks associated with their use, need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause. It is important that they know how to take these medications safely to reduce their risk.”
Under the final rule, manufacturers must ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both the packages and bottles. The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen.
Since 2006, some manufacturers have voluntarily revised their product labeling to identify these potential safety concerns. However, the voluntary changes to labeling do not address all of the labeling requirements in the new rule. For example, the new rule includes a warning on products containing acetaminophen that instructs consumers to ask a doctor before they are taking the blood thinning drug warfarin. The new rule requires all manufacturers to relabel their products within one year of today’s date.
Safety data reported in medical literature indicate that people sometimes take more acetaminophen than the labeling recommends. Others unknowingly take multiple products containing acetaminophen at the same time. Exceeding the recommended dosage of acetaminophen may increase the risks for severe liver damage. Alcohol use can also increase the risk of liver damage with acetaminophen.
The risk for stomach bleeding may increase in people who use NSAIDs and who are taking blood-thinning drugs (anticoagulants) or steroids. Stomach bleeding risks also increase for people who take multiple NSAIDs at the same time, or in people who take them longer than directed. Alcohol use can increase the risk for stomach bleeding with NSAIDs use.
An FDA Advisory Committee meeting will be convened on June 29 & 30, 2009, to discuss further steps the FDA could take to reduce the risk of liver damage associated with acetaminophen overdoses.
To read the final rule on the relabeling of OTC pain relievers and fever reducers, go tohttp://www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm
To read the FR Notice announcing the FDA Advisory Committee meeting, see link below:http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-9380.pdf
OTC Pain Relievers
Acetaminophen: Tylenol & other Brands
NSAIDS
Aspirin: Bayer & other brands
Ibuprofen: Advil, Motrin & other brands
Naproxen: Aleve & other brands
Wednesday, April 29, 2009
Monday, April 27, 2009
Ford Replacing Defective Tire Valve Stems, But Issues No Recall
Ford Replacing Defective Tire Valve Stems, But Issues No Recall
Ford Motor Company’s recent decision to send letters to customers warning them that tire valve stems on 26 different Ford models could be defective has come under criticism. According to thebostonchannel.com, at least one car safety expert contends that Ford should have issued a recall over the potentially deadly valve stems.
The Ford tire valve stems have the potential to crack. In such a case, they could cause a tire to deflate or rupture, resulting in a crash. According to thebostonchannel.com, the National Highway Transportation Safety Administration (NHTSA) investigated the faulty Ford valves last year.
The valves in question were made by a Chinese company, Topseal Automotive. The NHTSA launched its investigation after it received 37 complaints of faulty valve stems. At least 23 of those reports involved one valve that was “severely cracked or cracked and leaking” according to NHTSA. In 11 of the complaints, the tire lost inflation and had to be replaced after being damaged. Several accidents, including some that resulted in fatalities, were blamed on valve stem failures.
The NHTSA closed its probe earlier this month. However, the agency said in a statement that “the closing of this investigation does not constitute a finding by NHTSA that a safety-related defect does not exist”. According to the NHTSA, owners of affected Ford vehicles are eligible for a free dealer inspection. Any valve showing evidence of cracking will be replaced free of charge.
Ford will send letters to more than 1 million vehicle owners informing them of the free inspection and replacement program. The letters should go out in May, thebostonchannel.com said.
According to the report, vehicles eligible for valve inspection and replacement include: some 2007-2008 model year MKZs, Escapes, Mariners, Expeditions, F150s, Montegos, Sables, Focus, Crown Victorias, Grand Marquis, Rangers, Edges, MKXs, Navigators, Fusions, Milans, Mark LTs, Five Hundreds, Taurus, Mustangs, Sport Tracs, Mountaineers and Explorers; some 2007 model year Freestars and Freestyles; and some 2008 Ford Taurus Xs.
Ford is also warning vehicle owners to maintain proper air pressure in their tires and examine the valve stems for any sign of fatigue or damage, the bostonchannel.com said. The company has also added valve stem inspection to its recommended tire maintenance suggestions and to its “Multi-Point Inspections” performed by dealers.
But one tire expert told thebostonchannel.com that Ford’s actions are inadequate. “This is a problem that should have ultimately led to a recall,” auto safety expert Sean Kane said. “Ford should have stepped up and issued a formal recall to replace these valve stems because it is a safety-related hazard.”
Kane pointed out that under normal circumstances, valve stems don’t fail for many years. “These are not old cars. That is what is so unusual,” he said.
Ford Motor Company’s recent decision to send letters to customers warning them that tire valve stems on 26 different Ford models could be defective has come under criticism. According to thebostonchannel.com, at least one car safety expert contends that Ford should have issued a recall over the potentially deadly valve stems.
The Ford tire valve stems have the potential to crack. In such a case, they could cause a tire to deflate or rupture, resulting in a crash. According to thebostonchannel.com, the National Highway Transportation Safety Administration (NHTSA) investigated the faulty Ford valves last year.
The valves in question were made by a Chinese company, Topseal Automotive. The NHTSA launched its investigation after it received 37 complaints of faulty valve stems. At least 23 of those reports involved one valve that was “severely cracked or cracked and leaking” according to NHTSA. In 11 of the complaints, the tire lost inflation and had to be replaced after being damaged. Several accidents, including some that resulted in fatalities, were blamed on valve stem failures.
The NHTSA closed its probe earlier this month. However, the agency said in a statement that “the closing of this investigation does not constitute a finding by NHTSA that a safety-related defect does not exist”. According to the NHTSA, owners of affected Ford vehicles are eligible for a free dealer inspection. Any valve showing evidence of cracking will be replaced free of charge.
Ford will send letters to more than 1 million vehicle owners informing them of the free inspection and replacement program. The letters should go out in May, thebostonchannel.com said.
According to the report, vehicles eligible for valve inspection and replacement include: some 2007-2008 model year MKZs, Escapes, Mariners, Expeditions, F150s, Montegos, Sables, Focus, Crown Victorias, Grand Marquis, Rangers, Edges, MKXs, Navigators, Fusions, Milans, Mark LTs, Five Hundreds, Taurus, Mustangs, Sport Tracs, Mountaineers and Explorers; some 2007 model year Freestars and Freestyles; and some 2008 Ford Taurus Xs.
Ford is also warning vehicle owners to maintain proper air pressure in their tires and examine the valve stems for any sign of fatigue or damage, the bostonchannel.com said. The company has also added valve stem inspection to its recommended tire maintenance suggestions and to its “Multi-Point Inspections” performed by dealers.
But one tire expert told thebostonchannel.com that Ford’s actions are inadequate. “This is a problem that should have ultimately led to a recall,” auto safety expert Sean Kane said. “Ford should have stepped up and issued a formal recall to replace these valve stems because it is a safety-related hazard.”
Kane pointed out that under normal circumstances, valve stems don’t fail for many years. “These are not old cars. That is what is so unusual,” he said.
Thursday, April 23, 2009
Philips Debates Recall Of Defective Coffee Makers In China
Philips Debates Recall Of Defective Coffee Makers In China
(OUR MEMBERS KNOW !)
Dutch electronics giant Royal Philips Electronics is recalling seven million Senseo coffee makers due to a safety defect, but it has yet to make the recall in China.
Joon Knapen, a spokesperson for Royal Philips, told Chinese media that 25 million Senseo coffee makers have been sold worldwide, but about seven million of them, which were mainly made between July 2006 and November 2008, have safety problems.
At present, Philips is said to be calling back the defective coffee machines in the Netherlands, Belgium, Britain, Austria, Denmark, France, Germany, and the United States. Knapen said they have not started the recall in China and other countries where the products may have been sold as they still need to consult with the relevant departments of these countries before deciding what kind of action should be taken.
It is learned that in the event of a heavy calcium build-up combined with a safety catch failure, the boilers of the coffee makers in question may burst under pressure when the flow of air through a valve is blocked. According to Knapen, there have been several injuries caused by this defect, but there has been no injuries reported in China. Knapen stressed that the company is
launching the recall as a "voluntary step".
(OUR MEMBERS KNOW !)
Dutch electronics giant Royal Philips Electronics is recalling seven million Senseo coffee makers due to a safety defect, but it has yet to make the recall in China.
Joon Knapen, a spokesperson for Royal Philips, told Chinese media that 25 million Senseo coffee makers have been sold worldwide, but about seven million of them, which were mainly made between July 2006 and November 2008, have safety problems.
At present, Philips is said to be calling back the defective coffee machines in the Netherlands, Belgium, Britain, Austria, Denmark, France, Germany, and the United States. Knapen said they have not started the recall in China and other countries where the products may have been sold as they still need to consult with the relevant departments of these countries before deciding what kind of action should be taken.
It is learned that in the event of a heavy calcium build-up combined with a safety catch failure, the boilers of the coffee makers in question may burst under pressure when the flow of air through a valve is blocked. According to Knapen, there have been several injuries caused by this defect, but there has been no injuries reported in China. Knapen stressed that the company is
launching the recall as a "voluntary step".
Wednesday, April 22, 2009
Delays in product recalls tempt tragedy
Delays in product recalls tempt tragedy
Regulators may know about safety issues, but getting the information out of them is difficult.
Canada's Mega Brands Inc., maker of Mega Blox and other popular playthings, agreed to pay a civil penalty of $1.1 million last week in connection with a defective toy that caused the death of a toddler in November 2005 and intestinal injuries in 25 others.
MagnetixMega Brands didn't actually own the company that made the toy until after the toddler was killed, yet it was legally on the hook for some of the problems.
The case highlights the difficulty that companies and consumers face in obtaining accurate and up-to-date safety data from federal regulators.
Simply put, it's too hard to find out in a timely manner whether a product poses a danger to users. And, shamefully, it's often not until someone dies before steps are taken to remove that product from store shelves -- a process that can take months.
The Mega Brands settlement centered on Magnetix play sets. The sets had powerful magnets that, if ingested, could tear through a child's intestines.
They were originally manufactured by Rose Art Industries Inc., which was acquired by Mega Brands for $315 million in early 2006.
While Mega Brands says it didn't know about problems with Magnetix sets while it was vetting Rose Art for purchase in 2005, Rose Art says it disclosed all relevant information. The two companies are duking it out in court over who knew what and when.
Regardless of which side is telling the truth, the bottom line is that it should be easier for interested parties to find out whether there are safety issues with a firm's products.
It's not clear whether Mega Brands sought to independently check out Rose Art's safety track record by getting in touch with the Consumer Product Safety Commission; neither the company nor the commission kept full records of every contact.
But even if the firm had made a point of seeking federal safety data, Mega Brands would have had a tough time prying information from the commission.
It turns out that a company or consumer can't just call up and ask the agency to search its database for a specific product or manufacturer. Rather, a request would have to be filed under the Freedom of Information Act and months could pass before a response might be offered.
Joe Martyak, the commission's chief of staff, acknowledged that this isn't the most efficient way of providing access to the agency's vast storehouse of safety data. "Our databases aren't set up for doing it any other way," he said.
But still, what if Mega Brands had followed that procedure?
According to Martyak, the company would have learned that the commission had received at least two complaints from consumers -- in 2004 and early 2005 -- about magnets becoming dislodged from Magnetix sets.
Because magnets are known to pose a safety threat to youngsters if swallowed, this would have been an immediate red flag for Mega Brands.
More important, the company would have learned that in May 2005, an Indiana preschool teacher reported that a 5-year-old child had required emergency surgery after swallowing a Magnetix magnet.
The Mega Brands-Rose Art merger was still about two months from being finalized when, shortly before Thanksgiving Day in 2005, Kenny Sweet Jr. swallowed a Magnetix magnet at his home in suburban Seattle.
The magnet tangled the child's intestines and ultimately killed him, as depicted in a Pulitzer Prize-winning 2007 story in the Chicago Tribune.
Would the knowledge of this have been sufficiently troubling to Mega Brands to compel the company to abandon the Rose Art acquisition? Could Mega Brands have exerted pressure on Rose Art to recall the product? We'll never know.
FULL STORY: http://www.latimes.com/business/la-fi-lazarus222009apr22,0,4943888.column
Regulators may know about safety issues, but getting the information out of them is difficult.
Canada's Mega Brands Inc., maker of Mega Blox and other popular playthings, agreed to pay a civil penalty of $1.1 million last week in connection with a defective toy that caused the death of a toddler in November 2005 and intestinal injuries in 25 others.
MagnetixMega Brands didn't actually own the company that made the toy until after the toddler was killed, yet it was legally on the hook for some of the problems.
The case highlights the difficulty that companies and consumers face in obtaining accurate and up-to-date safety data from federal regulators.
Simply put, it's too hard to find out in a timely manner whether a product poses a danger to users. And, shamefully, it's often not until someone dies before steps are taken to remove that product from store shelves -- a process that can take months.
The Mega Brands settlement centered on Magnetix play sets. The sets had powerful magnets that, if ingested, could tear through a child's intestines.
They were originally manufactured by Rose Art Industries Inc., which was acquired by Mega Brands for $315 million in early 2006.
While Mega Brands says it didn't know about problems with Magnetix sets while it was vetting Rose Art for purchase in 2005, Rose Art says it disclosed all relevant information. The two companies are duking it out in court over who knew what and when.
Regardless of which side is telling the truth, the bottom line is that it should be easier for interested parties to find out whether there are safety issues with a firm's products.
It's not clear whether Mega Brands sought to independently check out Rose Art's safety track record by getting in touch with the Consumer Product Safety Commission; neither the company nor the commission kept full records of every contact.
But even if the firm had made a point of seeking federal safety data, Mega Brands would have had a tough time prying information from the commission.
It turns out that a company or consumer can't just call up and ask the agency to search its database for a specific product or manufacturer. Rather, a request would have to be filed under the Freedom of Information Act and months could pass before a response might be offered.
Joe Martyak, the commission's chief of staff, acknowledged that this isn't the most efficient way of providing access to the agency's vast storehouse of safety data. "Our databases aren't set up for doing it any other way," he said.
But still, what if Mega Brands had followed that procedure?
According to Martyak, the company would have learned that the commission had received at least two complaints from consumers -- in 2004 and early 2005 -- about magnets becoming dislodged from Magnetix sets.
Because magnets are known to pose a safety threat to youngsters if swallowed, this would have been an immediate red flag for Mega Brands.
More important, the company would have learned that in May 2005, an Indiana preschool teacher reported that a 5-year-old child had required emergency surgery after swallowing a Magnetix magnet.
The Mega Brands-Rose Art merger was still about two months from being finalized when, shortly before Thanksgiving Day in 2005, Kenny Sweet Jr. swallowed a Magnetix magnet at his home in suburban Seattle.
The magnet tangled the child's intestines and ultimately killed him, as depicted in a Pulitzer Prize-winning 2007 story in the Chicago Tribune.
Would the knowledge of this have been sufficiently troubling to Mega Brands to compel the company to abandon the Rose Art acquisition? Could Mega Brands have exerted pressure on Rose Art to recall the product? We'll never know.
FULL STORY: http://www.latimes.com/business/la-fi-lazarus222009apr22,0,4943888.column
Tuesday, April 21, 2009
FDA is investigating Nutro pet food products following consumer allegations
On April 20, 2009 The U.S. Food and Drug Administration (FDA) confirmed that it is investigating Nutro® pet food products following consumer allegations that Nutro® food products have caused pets to become sick or die.
The consumer complaints began over 2 years ago. Some of the symptoms reported include gastrointestinal problems, difficulty in urination, and lethargy.
Nutro®, which is owned by Mars Inc., has denied that its food is to blame for these pets’ illnesses. For concerned customers, the company can be reached at 1-800-833-5330.
Consumeraffairs.com, an independent online consumer news and resource center, also asked Dr. Steven Hansen, a veterinary toxicologist with the American Society for the Prevention of Cruelty to Animals (ASPCA), to review some of the Nutro complaints.
Dr. Hansen stated that the cases of alleged Nutro illnesses and deaths are “not consistent and appear to be anecdotal with no real definitive diagnostic findings.” Dr. Hansen then added, “This does appear to us to be a situation where bad things happen, but they are not likely food-related.”
While no conclusions can be drawn at this point, if you are feeding your dog Nutro products, please use caution and stay informed about the latest updates as the FDA’s investigation continues.
The consumer complaints began over 2 years ago. Some of the symptoms reported include gastrointestinal problems, difficulty in urination, and lethargy.
Nutro®, which is owned by Mars Inc., has denied that its food is to blame for these pets’ illnesses. For concerned customers, the company can be reached at 1-800-833-5330.
Consumeraffairs.com, an independent online consumer news and resource center, also asked Dr. Steven Hansen, a veterinary toxicologist with the American Society for the Prevention of Cruelty to Animals (ASPCA), to review some of the Nutro complaints.
Dr. Hansen stated that the cases of alleged Nutro illnesses and deaths are “not consistent and appear to be anecdotal with no real definitive diagnostic findings.” Dr. Hansen then added, “This does appear to us to be a situation where bad things happen, but they are not likely food-related.”
While no conclusions can be drawn at this point, if you are feeding your dog Nutro products, please use caution and stay informed about the latest updates as the FDA’s investigation continues.
Thursday, April 16, 2009
Consumers Left to Sweep Up as Martha Stewart Tables Shatter
Consumers Left to Sweep Up as Martha Stewart Tables Shatter
Courts, feds, the press, Kmart and Martha turn their backs on consumers
As winter turns to spring, consumers across the country are once again waking up to the sounds of their Martha Stewart Everyday glass tabletops exploding into thousands of tiny pieces. The tables, sold at Kmart, have a long history of spontaneously shattering, and they don’t show signs of stopping anytime soon, not that anyone in authority seems to care.
Months after a federal court dismissed a class action lawsuit alleging that the tabletops are defectively manufactured, owners of the product remain without recourse and several hundred dollars poorer, as they are left to clean the glass off of their patios and sometimes dig it out of their skin.
Late last year, a federal court in Illinois rejected class certification in the action, ruling that the court would have to decide individual issues of causation for each plaintiff, making a class action impracticable.
The suit, originally filed in 2005 on behalf of lead plaintiff Michelle Ronat, alleged that Kmart refused to give aggrieved customers refunds or replacements, since the tabletops weren’t covered under warranty. Martha Stewart Living Omnimedia (MSLO) — named after convicted felon and media darling Martha Stewart — when confronted by consumers, passed the buck to JRA Manufacturing, the Chinese company that produced the tables. The manufacturer, in turn, said the problem lay in a design defect attributable to MSLO’s designers.
The suit, prosecuted by Horwitz, Horwitz & Paradis, a New York class action firm, sought replacement tabletops for an estimated 300,000 consumers. With tabletops potentially costing as much as $500 apiece, the action threatened to leave MSLO liable for up to $150 million.
The glass replacements cost so much because JRA, the manufacturer, declared bankruptcy in 2007, leaving consumers unable to obtain factory replacements. Instead, they have been forced to have glass custom-made to fit their tables. In some cases, individuals could end up paying more for the replacement top than they did for the entire table set in the first place.
Although MSLO contends that a relatively small number of consumers were affected,
ConsumerAffairs.com has received hundreds of complaints over the past five years, as have other Internet sites. Like the swallows returning to Capistrano, the complaints increase predictably each spring, as tables are brought back outside and exposed to the sun's rays.
Additionally, according to the lawsuit, because the tabletops weren’t covered under warranty, Kmart didn’t keep records of most complaints. As a result, the complaints Kmart does have on file likely represent only a fraction of actual incidents.
Similar complaintsAffected consumers’ experiences are strikingly similar, and the most common – and disturbing – thread is that there is no way to know when a table is about to explode.
“My Martha Stewart Glass topped patio table exploded after only one year of use,” writes Marylou of Brockton, Ma. “I am left with a set of six chairs and no table to use. I received minor cuts from cleaning up all of the exploded glass which is fine but emotionally I was very upset after spending all that money on something that is now useless to us.”
In a similar vein, Judy of Unionville, Oh., writes, “Table shattered into a million pieces. Paid good money for poor quality. It is so sad especially with the economy like it is. Who can afford this[?]”.
A considerable number of consumers have had more than one table shatter. Some bought a set and ended up having several shatter over time, as happened to Lisa of Austintown, Oh.
A considerable number of consumers have had more than one table shatter. Some bought a set and ended up having several shatter over time, as happened to Lisa of Austintown, Oh.
Wednesday, April 15, 2009
Many Americans ignore food recalls: survey
Many Americans ignore food recalls: survey
Only about 60 percent of Americans search their homes for foods recalled because of contamination, researchers reported on Tuesday.
The United States has had several major food recalls in recent years, including a Salmonella outbreak that sickened 700 people and was linked to the deaths of nine this year and an ongoing recall of pistachios contaminated with the bacteria.
But a survey by Rutgers University in New Jersey showed that many Americans believe they are less likely than others to have bought recalled products.
"Getting consumers to pay attention to news about recalls isn't the hard part. It's getting them to take the step of actually looking for recalled food products in their homes," said William Hallman, a professor of human ecology who led the study.
The Rutgers team surveyed 1,101 Americans in August and September of last year.
"Most Americans (84 percent) say that they pay close attention to news reports about food recalls and 81 percent say that when they hear about a food recall, they tell others about it," the report said.
In 2006, there were 34 recalls of meat and poultry products and 65 recalls of other foods.
The survey, found at www.foodpolicy.rutgers.edu, found that 80 percent correctly said that recalls of food were more frequent lately than in past years.
FULL STORY: http://uk.reuters.com/article/usTopNews/idUKTRE53D33E20090414
Only about 60 percent of Americans search their homes for foods recalled because of contamination, researchers reported on Tuesday.
The United States has had several major food recalls in recent years, including a Salmonella outbreak that sickened 700 people and was linked to the deaths of nine this year and an ongoing recall of pistachios contaminated with the bacteria.
But a survey by Rutgers University in New Jersey showed that many Americans believe they are less likely than others to have bought recalled products.
"Getting consumers to pay attention to news about recalls isn't the hard part. It's getting them to take the step of actually looking for recalled food products in their homes," said William Hallman, a professor of human ecology who led the study.
The Rutgers team surveyed 1,101 Americans in August and September of last year.
"Most Americans (84 percent) say that they pay close attention to news reports about food recalls and 81 percent say that when they hear about a food recall, they tell others about it," the report said.
In 2006, there were 34 recalls of meat and poultry products and 65 recalls of other foods.
The survey, found at www.foodpolicy.rutgers.edu, found that 80 percent correctly said that recalls of food were more frequent lately than in past years.
FULL STORY: http://uk.reuters.com/article/usTopNews/idUKTRE53D33E20090414
FDA Imposes Restrictions on Coast IRB due to Violations
FDA Imposes Restrictions on Coast IRB due to Violations
The U.S Food and Drug Administration today announced that Coast IRB, LLC of Colorado Springs, Colo., has agreed to voluntarily halt some aspects of its clinical trial oversight operations due to serious concerns about the company's ability to protect human subjects participating in clinical trials.
According to the company's records, these actions may involve approximately 300 active human research studies conducted by some 3,000 clinical investigators.
Until further notice, Coast IRB has agreed to stop reviewing new FDA-regulated studies. Also, Coast IRB will direct clinical investigators in on-going FDA-regulated studies approved by Coast IRB to halt new subject enrollment. FDA has issued a Warning Letter to Coast IRB outlining its concerns and FDA will continue to actively monitor the company and take appropriate action as necessary. These restrictions will remain in effect until the FDA is satisfied that Coast IRB has taken necessary corrective actions that bring it into compliance with FDA regulations designed to protect human research subjects.
Under current federal law, clinical research involving human subjects and FDA-regulated products, such as drugs, biologics or medical devices, must have the review and approval of an “institutional review board” (IRB). An IRB is a panel of doctors, scientists and non-scientists charged with reviewing the clinical research to protect the rights and welfare of the subjects participating in the study.
Today's actions follow a recent undercover operation by the U.S. Government Accountability Office (GAO). The GAO submitted to Coast IRB for review a fictitious research study involving a purportedly FDA-cleared medical device. Although no human subjects were involved, the GAO operation heightened FDA's concerns about Coast IRB's ability to protect the rights and welfare of human research subjects.
In evaluating the information provided by the GAO investigators, FDA determined that Coast IRB committed several violations of the laws and regulations intended to protect the rights and welfare of human research subjects in clinical trials and that the company failed to perform the robust review needed to approve a study.
The FDA's action is precautionary. Because of the potential risk to enrolled subjects and disruption to the research if on-going studies were abruptly terminated, studies that Coast IRB has already approved will be permitted to continue. However, no new subjects will be permitted to enroll in these studies until there is assurance that the research has undergone adequate review. Coast IRB continues to be obligated to receive and respond to reports of unexpected and serious adverse events as well as to review progress reports submitted by clinical investigators.
The U.S Food and Drug Administration today announced that Coast IRB, LLC of Colorado Springs, Colo., has agreed to voluntarily halt some aspects of its clinical trial oversight operations due to serious concerns about the company's ability to protect human subjects participating in clinical trials.
According to the company's records, these actions may involve approximately 300 active human research studies conducted by some 3,000 clinical investigators.
Until further notice, Coast IRB has agreed to stop reviewing new FDA-regulated studies. Also, Coast IRB will direct clinical investigators in on-going FDA-regulated studies approved by Coast IRB to halt new subject enrollment. FDA has issued a Warning Letter to Coast IRB outlining its concerns and FDA will continue to actively monitor the company and take appropriate action as necessary. These restrictions will remain in effect until the FDA is satisfied that Coast IRB has taken necessary corrective actions that bring it into compliance with FDA regulations designed to protect human research subjects.
Under current federal law, clinical research involving human subjects and FDA-regulated products, such as drugs, biologics or medical devices, must have the review and approval of an “institutional review board” (IRB). An IRB is a panel of doctors, scientists and non-scientists charged with reviewing the clinical research to protect the rights and welfare of the subjects participating in the study.
Today's actions follow a recent undercover operation by the U.S. Government Accountability Office (GAO). The GAO submitted to Coast IRB for review a fictitious research study involving a purportedly FDA-cleared medical device. Although no human subjects were involved, the GAO operation heightened FDA's concerns about Coast IRB's ability to protect the rights and welfare of human research subjects.
In evaluating the information provided by the GAO investigators, FDA determined that Coast IRB committed several violations of the laws and regulations intended to protect the rights and welfare of human research subjects in clinical trials and that the company failed to perform the robust review needed to approve a study.
The FDA's action is precautionary. Because of the potential risk to enrolled subjects and disruption to the research if on-going studies were abruptly terminated, studies that Coast IRB has already approved will be permitted to continue. However, no new subjects will be permitted to enroll in these studies until there is assurance that the research has undergone adequate review. Coast IRB continues to be obligated to receive and respond to reports of unexpected and serious adverse events as well as to review progress reports submitted by clinical investigators.
Mega Brands America To Pay $1.1 Million Civil Penalty For Reporting Violations With Popular Magnetic Building Sets
Mega Brands America To Pay $1.1 Million Civil Penalty For Reporting Violations With Popular Magnetic Building Sets
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) announced today that Mega Brands America Inc., of Livingston, N.J., formerly Rose Art Industries Inc., has agreed (PDF) to pay a $1.1 million civil penalty. The penalty, which the Commission has provisionally accepted, settles allegations that Mega Brands America and Rose Art failed to provide the government with timely information about dangers to children with Magnetix magnetic building sets, as required under federal law.
In December of 2005, Rose Art filed an “initial report” with CPSC that a 22-month-old child from Washington state had died, due to ingesting multiple magnets that fell out of pieces from a Magnetix set. The report contained no other product or incident information and Rose Art attributed the magnets falling out to unusually abusive play by the toddler’s older siblings. On February 1, 2006, Rose Art submitted a Full Report which again lacked incident and product information. Rose Art stated that it did not retain any complaint or incident records. On March 31, 2006, Rose Art voluntarily recalled nearly 4 million Magnetix sets for users under the age of 6.
After discovering documents which led CPSC staff to believe Rose Art had compiled incident information, a subpoena was issued to the firm (which had been renamed Mega Brands America and was under new ownership and control) to obtain product and incident information. CPSC learned through the subpoena that at the time Rose Art filed its “initial report” in December 2005, it had received over 1,100 consumer complaints that magnets had fallen out of plastic pieces from dozens of different Magnetix models. Additionally, the subpoena revealed that Rose Art had received at least one report of an injury due to magnet ingestion, prior to the toddler’s death in Washington state.
By the time Rose Art agreed to the recall of Magnetix in March 2006, the firm had received more than 1,500 complaints of magnets falling out of plastic pieces in more than 65 different models of Magnetix. In April 2007, Mega Brands America expanded the recall of Magnetix sets for users of any age, after more than 25 children suffered intestinal injuries that required surgery to remove the magnets.
Federal law requires firms to report to CPSC immediately (within 24 hours) after obtaining information reasonably supporting the conclusion that a product contains a defect which could create a substantial product hazard, creates an unreasonable risk of serious injury or death, or violates any consumer product safety rule, or any other rule, regulation, standard, or ban enforced by CPSC.
In agreeing to settle this matter, Mega Brands America and its parent, Mega Brands Inc., of Montreal, Canada contend that 1) Mega Brands Inc. did not know of the Magnetix defect at the time it acquired Rose Art and 2) Rose Art’s prior owners never advised Mega Brands Inc. of the problems of associated with Magnetix.
CPSC strongly encourages consumers to check (PDF) to see if they have any of the recalled building sets and return them to Mega Brands for a free replacement toy - potentially millions of recalled units remain in homes today and accessible to young children.
Tuesday, April 14, 2009
Many Americans ignore food recalls: survey
Many Americans ignore food recalls: survey
Only about 60 percent of Americans search their homes for foods recalled because of contamination, researchers reported on Tuesday.
The United States has had several major food recalls in recent years, including a Salmonella outbreak that sickened 700 people and was linked to the deaths of nine this year and an ongoing recall of pistachios contaminated with the bacteria.
But a survey by Rutgers University in New Jersey showed that many Americans believe they are less likely than others to have bought recalled products.
"Getting consumers to pay attention to news about recalls isn't the hard part. It's getting them to take the step of actually looking for recalled food products in their homes," said William Hallman, a professor of human ecology who led the study.
The Rutgers team surveyed 1,101 Americans in August and September of last year.
"Most Americans (84 percent) say that they pay close attention to news reports about food recalls and 81 percent say that when they hear about a food recall, they tell others about it," the report said.
In 2006, there were 34 recalls of meat and poultry products and 65 recalls of other foods.
The survey, found at www.foodpolicy.rutgers.edu, found that 80 percent correctly said that recalls of food were more frequent lately than in past years.
FULL STORY: http://uk.reuters.com/article/usTopNews/idUKTRE53D33E20090414
Only about 60 percent of Americans search their homes for foods recalled because of contamination, researchers reported on Tuesday.
The United States has had several major food recalls in recent years, including a Salmonella outbreak that sickened 700 people and was linked to the deaths of nine this year and an ongoing recall of pistachios contaminated with the bacteria.
But a survey by Rutgers University in New Jersey showed that many Americans believe they are less likely than others to have bought recalled products.
"Getting consumers to pay attention to news about recalls isn't the hard part. It's getting them to take the step of actually looking for recalled food products in their homes," said William Hallman, a professor of human ecology who led the study.
The Rutgers team surveyed 1,101 Americans in August and September of last year.
"Most Americans (84 percent) say that they pay close attention to news reports about food recalls and 81 percent say that when they hear about a food recall, they tell others about it," the report said.
In 2006, there were 34 recalls of meat and poultry products and 65 recalls of other foods.
The survey, found at www.foodpolicy.rutgers.edu, found that 80 percent correctly said that recalls of food were more frequent lately than in past years.
FULL STORY: http://uk.reuters.com/article/usTopNews/idUKTRE53D33E20090414
Monday, April 13, 2009
Consumers must remain diligent to track all recalls
Consumers must remain diligent to track all recalls
From toys to meat to automobiles, it's almost too much to keep up with the defects
Darrell Bellaart, The Daily News
Published: Saturday, March 28, 2009
A young mother wants to know if the toy manufacturer's safety recall includes her child's favourite rattle. A man eyes ground beef suspiciously after hearing of an E. coli scare. A driver calls the dealership to see if his car is affected by a braking system recall.
Recalls have been making headlines frequently in the past year. Melamine contamination of baby formula led to numerous food recalls after it was learned some unscrupulous Chinese manufacturers use the kidney-damaging product as a food additive. Maple Leaf Foods issued a massive recall of its products because of listeriosis contamination that ultimately contributed to the deaths of 20 Canadians. In January, a mass peanut butter recall jumped the border into Canada after a salmonella outbreak sickened 453 people and contributed to five deaths in 43 states. Products are still being recalled as a result of that investigation.
Distributing recall information, especially when health is at stake, is essential, but with so many recalls and advisories issued every week, how does a consumer stay on top of it all?
In the digital age, consumers have an advantage their parents lacked: The Internet. But in the vast reaches of the World Wide Web, information can easily get lost. Manufacturers and consumers notify government agencies when they become aware of a concern. If the concern is serious, the media is usually contacted to get the word out.
But not all alerts receive the kind of attention as last year's listeriosis scare or toy recall. Some product recalls aren't serious enough to warrant media notification, or may include so many different products it's too much for media outlets to list every item or product code.
Public notification can be a challenge for the people who issue recalls.
"There's no national system in place for recalls," says Anthony Toderian, spokesman for the Canadian Standards Association, which tests products for safety. When manufacturing defects pose safety hazards, CSA can issue a recall.
FULL STORYl: http://www2.canada.com/nanaimodailynews/story.html?id=857e0d8c-a0f7-40e1-9ace-d8aafcd11af2
From toys to meat to automobiles, it's almost too much to keep up with the defects
Darrell Bellaart, The Daily News
Published: Saturday, March 28, 2009
A young mother wants to know if the toy manufacturer's safety recall includes her child's favourite rattle. A man eyes ground beef suspiciously after hearing of an E. coli scare. A driver calls the dealership to see if his car is affected by a braking system recall.
Recalls have been making headlines frequently in the past year. Melamine contamination of baby formula led to numerous food recalls after it was learned some unscrupulous Chinese manufacturers use the kidney-damaging product as a food additive. Maple Leaf Foods issued a massive recall of its products because of listeriosis contamination that ultimately contributed to the deaths of 20 Canadians. In January, a mass peanut butter recall jumped the border into Canada after a salmonella outbreak sickened 453 people and contributed to five deaths in 43 states. Products are still being recalled as a result of that investigation.
Distributing recall information, especially when health is at stake, is essential, but with so many recalls and advisories issued every week, how does a consumer stay on top of it all?
In the digital age, consumers have an advantage their parents lacked: The Internet. But in the vast reaches of the World Wide Web, information can easily get lost. Manufacturers and consumers notify government agencies when they become aware of a concern. If the concern is serious, the media is usually contacted to get the word out.
But not all alerts receive the kind of attention as last year's listeriosis scare or toy recall. Some product recalls aren't serious enough to warrant media notification, or may include so many different products it's too much for media outlets to list every item or product code.
Public notification can be a challenge for the people who issue recalls.
"There's no national system in place for recalls," says Anthony Toderian, spokesman for the Canadian Standards Association, which tests products for safety. When manufacturing defects pose safety hazards, CSA can issue a recall.
FULL STORYl: http://www2.canada.com/nanaimodailynews/story.html?id=857e0d8c-a0f7-40e1-9ace-d8aafcd11af2
Federal health minister wants tougher product recall laws.
Federal health minister wants tougher product recall laws.
By Sarah Schmidt, Canwest News Service April 13, 2009
OTTAWA - When Health Canada wasn't satisfied with the way a Quebec company publicized its recall of baby slippers after a serious choking incident, a senior investigator in the consumer-products branch made some pointed suggestions.
The poster alerting customers about the defective product posted at stores was ``too vague, given the risk,'' he told executives at Souris Mini, which sold the slippers. He also ``suggested'' the company post the recall information on its website ``to reach as many people as possible.''
Souris Mini didn't take the advice and followed its own strategy to reach out to customers, according to internal documents released under the Access to Information Act.
Other Health Canada documents about consumer complaints and voluntary product recalls appear to reveal the dynamic in this case is more the norm than the exception. And in the absence of legislation empowering Health Canada to initiate recalls and to roll them out as the federal government sees fit, companies call the shots from start to finish.
When voluntary recalls are initiated, followup action on the part of the companies is optional.
This means Health Canada inspectors can't gauge the effectiveness of recalls because companies are not required to provide statistics about how many defective items have been returned.
Conceding government inspectors feel ``frustration'' by the current state of affairs, Health Minister Leona Aglukkaq is banking on the quick passage of the Consumer Product Safety Act to give Health Canada the power to recall products. Debate on the bill could begin as early as next week, and the opposition parties have indicated they like the broad strokes.
Bill Huzar, president and founding member of the Consumers Council of Canada, says giving Health Canada this kind of clout is something that can't come soon enough.
``The fact that we've left to industry the sole ability to recall product is unacceptable. We need to have the ability for government, when they see that there's a threat to health or safety, that they need to have the authority to take action,'' he said, praising the government for identifying the need to act in the face of a growing number of dubious imports finding their way into store
shelves in Canada.
``That's the positive aspect (of) it. The government has responded to the number of incidents that have occurred in the last few years that have indicated that these products have gotten into the marketplace and are not controlled,'' said Huzar.
In the case last spring of a voluntary recall of a teether rattle manufactured in China, Health Canada's product-safety branch opened a file four months earlier after a mother complained about the structural integrity of the Manhattan Toy Company's Tumble Tower, internal documents show.
The Toronto mother of a six-month-old thought the newly purchased toy should have stayed intact after being dropped from approximately two-feet from the floor. She returned the rattle to her baby after wiping it clean, and that's when trouble began.
``A minute later, the child began gagging/choking and then vomited. The mother then found the rattle with a piece missing from it and then found the broken piece in the child's vomit,'' the product safety officer's report, dated Jan. 9, 2008, states.
After receiving confirmation from the company later in the month that it was ``investigating this complaint,'' the file at HealthCanada remained dormant until the end of April, according to internal records released to Canwest News Service.
FULL STORY: http://www.canada.com/Federal+health+minister+wants+tougher+product+recall+laws/1491960/story.html
By Sarah Schmidt, Canwest News Service April 13, 2009
OTTAWA - When Health Canada wasn't satisfied with the way a Quebec company publicized its recall of baby slippers after a serious choking incident, a senior investigator in the consumer-products branch made some pointed suggestions.
The poster alerting customers about the defective product posted at stores was ``too vague, given the risk,'' he told executives at Souris Mini, which sold the slippers. He also ``suggested'' the company post the recall information on its website ``to reach as many people as possible.''
Souris Mini didn't take the advice and followed its own strategy to reach out to customers, according to internal documents released under the Access to Information Act.
Other Health Canada documents about consumer complaints and voluntary product recalls appear to reveal the dynamic in this case is more the norm than the exception. And in the absence of legislation empowering Health Canada to initiate recalls and to roll them out as the federal government sees fit, companies call the shots from start to finish.
When voluntary recalls are initiated, followup action on the part of the companies is optional.
This means Health Canada inspectors can't gauge the effectiveness of recalls because companies are not required to provide statistics about how many defective items have been returned.
Conceding government inspectors feel ``frustration'' by the current state of affairs, Health Minister Leona Aglukkaq is banking on the quick passage of the Consumer Product Safety Act to give Health Canada the power to recall products. Debate on the bill could begin as early as next week, and the opposition parties have indicated they like the broad strokes.
Bill Huzar, president and founding member of the Consumers Council of Canada, says giving Health Canada this kind of clout is something that can't come soon enough.
``The fact that we've left to industry the sole ability to recall product is unacceptable. We need to have the ability for government, when they see that there's a threat to health or safety, that they need to have the authority to take action,'' he said, praising the government for identifying the need to act in the face of a growing number of dubious imports finding their way into store
shelves in Canada.
``That's the positive aspect (of) it. The government has responded to the number of incidents that have occurred in the last few years that have indicated that these products have gotten into the marketplace and are not controlled,'' said Huzar.
In the case last spring of a voluntary recall of a teether rattle manufactured in China, Health Canada's product-safety branch opened a file four months earlier after a mother complained about the structural integrity of the Manhattan Toy Company's Tumble Tower, internal documents show.
The Toronto mother of a six-month-old thought the newly purchased toy should have stayed intact after being dropped from approximately two-feet from the floor. She returned the rattle to her baby after wiping it clean, and that's when trouble began.
``A minute later, the child began gagging/choking and then vomited. The mother then found the rattle with a piece missing from it and then found the broken piece in the child's vomit,'' the product safety officer's report, dated Jan. 9, 2008, states.
After receiving confirmation from the company later in the month that it was ``investigating this complaint,'' the file at HealthCanada remained dormant until the end of April, according to internal records released to Canwest News Service.
FULL STORY: http://www.canada.com/Federal+health+minister+wants+tougher+product+recall+laws/1491960/story.html
Saturday, April 11, 2009
Protein linked to wasting disease found in elk antler velvet
Protein linked to wasting disease found in elk antler velvet Consumers of health supplement may be at risk, study says
Research shows that protein associated with chronic wasting disease can be found in antler velvet, a substance used to make nutritional supplements.
The discovery is prompting one organization to demand an emergency recall of the products, but the Canadian Food Inspection Agency says there is no reason to worry.
Chronic wasting disease, or CWD, is a fatal disease that spreads among species in the deer family. Like mad cow disease, the killer involved is a prion. It is a tiny infectious agent that, unlike a virus or bacterium, is made up entirely of protein and contains no nucleic acid.
The discovery of prions in antler velvet of CWD-affected elk suggests that this tissue may play a role in disease transmission among members of the deer family, including elk, said the study, which will be published in the May issue of Emerging Infectious Diseases Journal.
"Humans who consume antler velvet as a nutritional supplement are at risk for exposure to prions," the study said.
The Canadian Food Inspection Agency collaborated on the study with scientists from the University of Kentucky Medical Center, Colorado State University, and the U.S. Department of Agriculture.
The results of the study are not surprising, given that the prions have been found in blood and nerve tissue and antler velvet is rich in nerves and blood, said Dr. Cornelius Kiley, senior staff veterinarian with the Canadian Food Inspection Agency.
But Kiley said people who consume nutritional supplements made from antler velvet don't need to worry.
"Based upon the scientific evidence at this time, they should not be concerned." There is no scientific evidence that CWD is transmissible to humans, he added.
In Alberta and Saskatchewan, all elk over 12 months of age that go to slaughter must be tested for CWD, he explained. Currently, there are no tests for live animals and velvet comes from live animals.
These farms have a number of years of history of not having problems with chronic wasting disease. Farmers are also aware of the clinical signs of the disease in elk, such as depression, difficulty swallowing, lack of co-ordination, and paralysis, Kiley said.
"It's only out of an abundance of caution because of the international experience, primarily U.K., with BSE that these particular measures are in place." But Darrel Rowledge, director of the Calgary-based Alliance for Public Wildlife, is convinced these measures aren't enough.
Rowledge, who has followed the CWD issue for 20 years, said his organization is drafting a letter to Prime Minister Stephen Harper asking him to start an emergency recall of all velvet products, both for humans and animals.
Rowledge said it's irresponsible to say there's no evidence that CWD can infect humans. "An absence of evidence is not evidence of absence. So we can't prove that it has happened, but that doesn't indicate that it can't happen." Rowledge said that the prions would not be destroyed in the process used to create the nutritional supplements. One study showed that prions could survive being cooked at 600 C.
Kiley said there are two ongoing studies seeking to get closer to that question of whether or not people can be infected by CWD. The tests are being done on primates. It will take three to five years before the results are known because the disease has a long incubation period, he said.
"There is no evidence, but it's only by doing the research and doing it extensively where you can start to speak in absolute terms. And the world's not there yet with CWD." In the meantime, governments should be using the precautionary principle, Rowledge said.
"The bottom line question is not just what if this jumps to people. The nightmare question is what if this jumps to people and it behaves in us like it does in deer where it's highly contagious. Mad cow, yeah, people started dying from it, but it was never contagious, even amongst cattle.
The only way you could give cattle, herbivores, the disease was to not just turn them into carnivores and feed them meat, you had to turn them into cannibals and feed them into cannibals." The local game farm industry is not concerned about the study.
"First of all, you need to understand that we take very seriously the care of our animals and our consumers," said Glenda Elkow, chairwoman of the Alberta Elk Commission. "Because of that commitment, we have a number of different, what I like to call, firewalls in place, like surveillance and testing. We have annual veterinarian inspections of our herds. We also have inspections from Alberta Agriculture." There has only been one positive case of CWD in a farmed elk in Alberta, she added.
The alternative health industry is also standing firm.
The capsules at the Optimum Health Centre in Edmonton are produced in Alberta and are used mostly by men to boost testosterone levels, said Elaine Doucette, the store's manager.
They've been sold for decades with positive results and no negative feedback, she said.
"We're not at this point going to pull it off the shelf because we haven't seen a reason to do that."
If Health Canada decides to ban it, though, the store would comply, she added.
Research shows that protein associated with chronic wasting disease can be found in antler velvet, a substance used to make nutritional supplements.
The discovery is prompting one organization to demand an emergency recall of the products, but the Canadian Food Inspection Agency says there is no reason to worry.
Chronic wasting disease, or CWD, is a fatal disease that spreads among species in the deer family. Like mad cow disease, the killer involved is a prion. It is a tiny infectious agent that, unlike a virus or bacterium, is made up entirely of protein and contains no nucleic acid.
The discovery of prions in antler velvet of CWD-affected elk suggests that this tissue may play a role in disease transmission among members of the deer family, including elk, said the study, which will be published in the May issue of Emerging Infectious Diseases Journal.
"Humans who consume antler velvet as a nutritional supplement are at risk for exposure to prions," the study said.
The Canadian Food Inspection Agency collaborated on the study with scientists from the University of Kentucky Medical Center, Colorado State University, and the U.S. Department of Agriculture.
The results of the study are not surprising, given that the prions have been found in blood and nerve tissue and antler velvet is rich in nerves and blood, said Dr. Cornelius Kiley, senior staff veterinarian with the Canadian Food Inspection Agency.
But Kiley said people who consume nutritional supplements made from antler velvet don't need to worry.
"Based upon the scientific evidence at this time, they should not be concerned." There is no scientific evidence that CWD is transmissible to humans, he added.
In Alberta and Saskatchewan, all elk over 12 months of age that go to slaughter must be tested for CWD, he explained. Currently, there are no tests for live animals and velvet comes from live animals.
These farms have a number of years of history of not having problems with chronic wasting disease. Farmers are also aware of the clinical signs of the disease in elk, such as depression, difficulty swallowing, lack of co-ordination, and paralysis, Kiley said.
"It's only out of an abundance of caution because of the international experience, primarily U.K., with BSE that these particular measures are in place." But Darrel Rowledge, director of the Calgary-based Alliance for Public Wildlife, is convinced these measures aren't enough.
Rowledge, who has followed the CWD issue for 20 years, said his organization is drafting a letter to Prime Minister Stephen Harper asking him to start an emergency recall of all velvet products, both for humans and animals.
Rowledge said it's irresponsible to say there's no evidence that CWD can infect humans. "An absence of evidence is not evidence of absence. So we can't prove that it has happened, but that doesn't indicate that it can't happen." Rowledge said that the prions would not be destroyed in the process used to create the nutritional supplements. One study showed that prions could survive being cooked at 600 C.
Kiley said there are two ongoing studies seeking to get closer to that question of whether or not people can be infected by CWD. The tests are being done on primates. It will take three to five years before the results are known because the disease has a long incubation period, he said.
"There is no evidence, but it's only by doing the research and doing it extensively where you can start to speak in absolute terms. And the world's not there yet with CWD." In the meantime, governments should be using the precautionary principle, Rowledge said.
"The bottom line question is not just what if this jumps to people. The nightmare question is what if this jumps to people and it behaves in us like it does in deer where it's highly contagious. Mad cow, yeah, people started dying from it, but it was never contagious, even amongst cattle.
The only way you could give cattle, herbivores, the disease was to not just turn them into carnivores and feed them meat, you had to turn them into cannibals and feed them into cannibals." The local game farm industry is not concerned about the study.
"First of all, you need to understand that we take very seriously the care of our animals and our consumers," said Glenda Elkow, chairwoman of the Alberta Elk Commission. "Because of that commitment, we have a number of different, what I like to call, firewalls in place, like surveillance and testing. We have annual veterinarian inspections of our herds. We also have inspections from Alberta Agriculture." There has only been one positive case of CWD in a farmed elk in Alberta, she added.
The alternative health industry is also standing firm.
The capsules at the Optimum Health Centre in Edmonton are produced in Alberta and are used mostly by men to boost testosterone levels, said Elaine Doucette, the store's manager.
They've been sold for decades with positive results and no negative feedback, she said.
"We're not at this point going to pull it off the shelf because we haven't seen a reason to do that."
If Health Canada decides to ban it, though, the store would comply, she added.
Friday, April 10, 2009
FDA Obtains Permanent Injunction Barring Two Companies from Manufacturing and Distributing Unapproved Drugs
FDA Obtains Permanent Injunction Barring Two Companies from Manufacturing and Distributing Unapproved Drugs
Companies made and distributed adulterated, misbranded and unapproved drugs
The U.S. Food and Drug Administration today announced that it had obtained a permanent injunction barring Neilgen Pharmaceuticals Inc. of Westminster, Md., its parent company, Advent Pharmaceuticals, Inc. (Advent), of East Windsor, N.J., and two of their officers, Bharat Patel and Pragna Patel, from manufacturing and distributing any unapproved, adulterated or misbranded drugs.
Both Neilgen, which does business as Unigen Pharmaceuticals Inc. (Unigen), and Advent are contract manufacturers and distributors of more than 25 different unapproved drug products each. The more than 50 unapproved drug products primarily include prescription cough and cold products. The unapproved drugs manufactured by Unigen and/or Advent include, but are not limited to:
RE All 12 Suspension; BP Allergy Junior Suspension; PE Tann 20 mg/CP Tann 4 mg Suspension; BP New Allergy DM Suspension; D-Tann CT Tablets; B-Vex D Suspension; Histex SR; and Chlorpheniramine Maleate 12 mg/Pseudoephedrine HCl 120 mg LA Tablets.
The unapproved drugs manufactured by these companies have not undergone the FDA's drug approval process, so their safety and effectiveness have not been established and the FDA has not reviewed the adequacy and accuracy of the directions for use and warnings on the labeling.
Consumers in possession of any of these products should discontinue using them and discuss FDA-approved treatments with their health care professional. Pharmacists should discontinue dispensing these products.
The defendants signed a consent decree that orders them to destroy their existing drug supply, and prohibits them from commercially manufacturing and distributing any new drugs without the FDA's approval. Further, the firms must retain outside experts who will advise them on appropriate compliance standards with U.S. current Good Manufacturing Practice (cGMP) requirements for drugs, and obtain written authorization from FDA to resume operations. The consent decree also authorizes the FDA to order the defendants to cease operations or take other corrective action in the event of future violations and further subjects the defendants to liquidated damages of $1,000 for each violation. An additional $5,000 per day, up to $1 million per year, can be levied for each violation, if the defendants fail to comply with any of the provisions of the decree. The consent decree was entered by Chief Judge Benson E. Legg in the U.S. District Court of Maryland on April 9, 2009.
“The FDA's key enforcement priorities include shutting down manufacturers and distributors of unapproved drugs. Drugs not in compliance with cGMP cause great risk to public health,” said Michael Chappell, acting associate commissioner for the FDA's Office of Regulatory Affairs.
The FDA sought an injunction after the defendants failed to comply with previous warnings and continued to manufacture drugs in violation of federal law. Multiple FDA inspections of both the Unigen and Advent facilities found that the companies continued to manufacture unapproved new drugs. FDA inspections also revealed numerous and recurring violations of the cGMP requirements for drugs in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Both Unigen and Advent failed to respond adequately to issues raised by the FDA's inspection findings.
“To protect the American public, companies that continue to market unapproved drugs must be required to cease that illegal activity,” said Janet Woodcock, M.D., director, the FDA's Center for Drug Evaluation and Research. “It is critical that only drugs that are safe, effective and manufactured in accordance with good manufacturing practices be allowed into the U.S. marketplace.”
In June 2006, the FDA issued a guidance document titled, “Marketed Unapproved Drugs - Compliance Policy Guide” (CPG). The CPG makes clear that companies may not market drugs that require approval without first establishing in applications that the products are safe and effective. Among priorities in the CPG are enforcement actions against manufacturers that violate provisions of the FD&C Act.
For more information: www.fda.gov/cder/drug/unapproved_drugswww.fda.gov/cder/dmpq/
Companies made and distributed adulterated, misbranded and unapproved drugs
The U.S. Food and Drug Administration today announced that it had obtained a permanent injunction barring Neilgen Pharmaceuticals Inc. of Westminster, Md., its parent company, Advent Pharmaceuticals, Inc. (Advent), of East Windsor, N.J., and two of their officers, Bharat Patel and Pragna Patel, from manufacturing and distributing any unapproved, adulterated or misbranded drugs.
Both Neilgen, which does business as Unigen Pharmaceuticals Inc. (Unigen), and Advent are contract manufacturers and distributors of more than 25 different unapproved drug products each. The more than 50 unapproved drug products primarily include prescription cough and cold products. The unapproved drugs manufactured by Unigen and/or Advent include, but are not limited to:
RE All 12 Suspension; BP Allergy Junior Suspension; PE Tann 20 mg/CP Tann 4 mg Suspension; BP New Allergy DM Suspension; D-Tann CT Tablets; B-Vex D Suspension; Histex SR; and Chlorpheniramine Maleate 12 mg/Pseudoephedrine HCl 120 mg LA Tablets.
The unapproved drugs manufactured by these companies have not undergone the FDA's drug approval process, so their safety and effectiveness have not been established and the FDA has not reviewed the adequacy and accuracy of the directions for use and warnings on the labeling.
Consumers in possession of any of these products should discontinue using them and discuss FDA-approved treatments with their health care professional. Pharmacists should discontinue dispensing these products.
The defendants signed a consent decree that orders them to destroy their existing drug supply, and prohibits them from commercially manufacturing and distributing any new drugs without the FDA's approval. Further, the firms must retain outside experts who will advise them on appropriate compliance standards with U.S. current Good Manufacturing Practice (cGMP) requirements for drugs, and obtain written authorization from FDA to resume operations. The consent decree also authorizes the FDA to order the defendants to cease operations or take other corrective action in the event of future violations and further subjects the defendants to liquidated damages of $1,000 for each violation. An additional $5,000 per day, up to $1 million per year, can be levied for each violation, if the defendants fail to comply with any of the provisions of the decree. The consent decree was entered by Chief Judge Benson E. Legg in the U.S. District Court of Maryland on April 9, 2009.
“The FDA's key enforcement priorities include shutting down manufacturers and distributors of unapproved drugs. Drugs not in compliance with cGMP cause great risk to public health,” said Michael Chappell, acting associate commissioner for the FDA's Office of Regulatory Affairs.
The FDA sought an injunction after the defendants failed to comply with previous warnings and continued to manufacture drugs in violation of federal law. Multiple FDA inspections of both the Unigen and Advent facilities found that the companies continued to manufacture unapproved new drugs. FDA inspections also revealed numerous and recurring violations of the cGMP requirements for drugs in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Both Unigen and Advent failed to respond adequately to issues raised by the FDA's inspection findings.
“To protect the American public, companies that continue to market unapproved drugs must be required to cease that illegal activity,” said Janet Woodcock, M.D., director, the FDA's Center for Drug Evaluation and Research. “It is critical that only drugs that are safe, effective and manufactured in accordance with good manufacturing practices be allowed into the U.S. marketplace.”
In June 2006, the FDA issued a guidance document titled, “Marketed Unapproved Drugs - Compliance Policy Guide” (CPG). The CPG makes clear that companies may not market drugs that require approval without first establishing in applications that the products are safe and effective. Among priorities in the CPG are enforcement actions against manufacturers that violate provisions of the FD&C Act.
For more information: www.fda.gov/cder/drug/unapproved_drugswww.fda.gov/cder/dmpq/
Wednesday, April 8, 2009
FDA Statement on the Voluntary Withdrawal of Raptiva From the U.S. Market
FDA Statement on the Voluntary Withdrawal of Raptiva From the U.S. Market
Today, Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market. The company is taking this action because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. By June 8, 2009, Raptiva will no longer be available in the United States.
Prescribers are being asked not to initiate Raptiva treatment for any new patients. Prescribers should immediately begin discussing with patients currently using Raptiva on how to transition to alternative therapies. The FDA strongly recommends that patients work with their health care professional to transition to other alternative therapies for psoriasis.
The risk that an individual patient taking Raptiva will develop PML is rare and is generally associated with long-term use. Generally, PML occurs in people whose immune systems have been severely weakened and often leads to an irreversible decline in neurologic function and death. There is no known effective treatment for PML. On Oct. 16, 2008, FDA updated the FDA-approved labeling for Raptiva to warn of the risk of life-threatening infections, including PML. On Feb. 19, 2009, the FDA issued a Public Health Advisory informing patients and prescribers of the risk of PML in patients taking Raptiva, after receiving reports of four patients with PML, three of whom died. On March 13, 2009, the FDA approved a Medication Guide for Raptiva and included additional information in Raptiva's labeling regarding PML.
Raptiva was approved by the FDA in 2003. It is a once-weekly injection for adults with moderate to severe plaque psoriasis.
Prescribers should continue to monitor patients on Raptiva for neurologic symptoms that might represent PML. Prescribers and patients may report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch/report.htm.
More information about the withdrawal of Raptiva is available on the Genentech Web site: www.gene.com/gene/products. Prescribers with questions about Raptiva may contact Genentech Medical Communications at (800) 821-8590.
Today, Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market. The company is taking this action because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. By June 8, 2009, Raptiva will no longer be available in the United States.
Prescribers are being asked not to initiate Raptiva treatment for any new patients. Prescribers should immediately begin discussing with patients currently using Raptiva on how to transition to alternative therapies. The FDA strongly recommends that patients work with their health care professional to transition to other alternative therapies for psoriasis.
The risk that an individual patient taking Raptiva will develop PML is rare and is generally associated with long-term use. Generally, PML occurs in people whose immune systems have been severely weakened and often leads to an irreversible decline in neurologic function and death. There is no known effective treatment for PML. On Oct. 16, 2008, FDA updated the FDA-approved labeling for Raptiva to warn of the risk of life-threatening infections, including PML. On Feb. 19, 2009, the FDA issued a Public Health Advisory informing patients and prescribers of the risk of PML in patients taking Raptiva, after receiving reports of four patients with PML, three of whom died. On March 13, 2009, the FDA approved a Medication Guide for Raptiva and included additional information in Raptiva's labeling regarding PML.
Raptiva was approved by the FDA in 2003. It is a once-weekly injection for adults with moderate to severe plaque psoriasis.
Prescribers should continue to monitor patients on Raptiva for neurologic symptoms that might represent PML. Prescribers and patients may report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch/report.htm.
More information about the withdrawal of Raptiva is available on the Genentech Web site: www.gene.com/gene/products. Prescribers with questions about Raptiva may contact Genentech Medical Communications at (800) 821-8590.
Tuesday, April 7, 2009
Fourteen Firms Agree to Pay More than $1 Million in Civil Penalties for Failing to Report Drawstrings in Children’s Outerwear
Fourteen Firms Agree to Pay More than $1 Million in Civil Penalties for Failing to Report Drawstrings in Children’s Outerwear
The U.S. Consumer Product Safety Commission (CPSC) announced today that 14 firms have agreed to pay a total of $1,055,000 in civil penalties.
The penalties settle allegations that the firms knowingly failed to report to the CPSC immediately, as required by federal law, that children’s hooded sweatshirts or jackets they sold had drawstrings at the hood and/or neck. Children’s upper outerwear with drawstrings, including sweatshirts or jackets, pose a strangulation hazard that can cause death to children.
The garments were eventually recalled as appropriate. The settlements have been provisionally accepted by the Commission.
CPSC has ordered the following firms to pay civil penalties to the U.S. Treasury:
The TJX Companies Inc., d/b/a T.J. Maxx, of Framingham, Mass.
Recalls: #09-083, #08-266, #08-121
Marshalls of MA Inc., of Framingham, Mass.
Recalls: #08-357, #08-356, #08-207, #08-192, #08-177, #08-146, #08-121
Concord Buying Group Inc., d/b/a A.J. Wright, of Framingham, Mass.
Recalls: #08-358, #08-234, #08-121
Bob’s Stores Corp., of Meriden, Conn.
Recalls: #08-288, #08-121
Kidz World Inc., d/b/a High Energy USA, of New York City, N.Y.
Recall: #08-234
The Bon-Ton Stores Inc., of York, Pa.
Recall: #08-103
Coolibar Inc., of St. Louis Park, Minn.
Recall: #08-316
Brents-Riordan Co. LLC, of Shreveport, La.
Recall: #08-238
Forman Mills Inc., of Pennsauken, N.J.
Recall: #08-192
Urgent Gear Inc., of Los Angeles, Calif.
Recall: #08-217
Seventy Two Inc., of La Puenta, Calif.
Recall: #08-185
Orioxi International Corp., of Brea, Calif.
Recall: #08-379
Outfitter Trading Co. LLC, of Littleton, Colo.
Recall: #08-379
Retco Inc., of Breckenridge, Colo.
Recall: #08-379
In February 1996, CPSC issued drawstring guidelines (pdf) to help prevent children from strangling or getting entangled on the neck and waist drawstrings in upper outerwear, such as jackets and sweatshirts. In May 2006, CPSC’s Office of Compliance announced (pdf) that children’s upper outerwear with drawstrings at the hood or neck would be regarded as defective and a substantial risk of injury to young children.
Federal law requires manufacturers, distributors, and retailers to report to CPSC immediately (within 24 hours) after obtaining information reasonably supporting the conclusion that a product contains a defect which could create a substantial product hazard, presents an unreasonable risk of serious injury or death, or violates any consumer product safety rule or any other rule, regulation, standard, or ban enforced by the CPSC.
In agreeing to settle the matters, the firms deny CPSC’s allegations that they knowingly violated the law.
The U.S. Consumer Product Safety Commission (CPSC) announced today that 14 firms have agreed to pay a total of $1,055,000 in civil penalties.
The penalties settle allegations that the firms knowingly failed to report to the CPSC immediately, as required by federal law, that children’s hooded sweatshirts or jackets they sold had drawstrings at the hood and/or neck. Children’s upper outerwear with drawstrings, including sweatshirts or jackets, pose a strangulation hazard that can cause death to children.
The garments were eventually recalled as appropriate. The settlements have been provisionally accepted by the Commission.
CPSC has ordered the following firms to pay civil penalties to the U.S. Treasury:
The TJX Companies Inc., d/b/a T.J. Maxx, of Framingham, Mass.
Recalls: #09-083, #08-266, #08-121
Marshalls of MA Inc., of Framingham, Mass.
Recalls: #08-357, #08-356, #08-207, #08-192, #08-177, #08-146, #08-121
Concord Buying Group Inc., d/b/a A.J. Wright, of Framingham, Mass.
Recalls: #08-358, #08-234, #08-121
Bob’s Stores Corp., of Meriden, Conn.
Recalls: #08-288, #08-121
Kidz World Inc., d/b/a High Energy USA, of New York City, N.Y.
Recall: #08-234
The Bon-Ton Stores Inc., of York, Pa.
Recall: #08-103
Coolibar Inc., of St. Louis Park, Minn.
Recall: #08-316
Brents-Riordan Co. LLC, of Shreveport, La.
Recall: #08-238
Forman Mills Inc., of Pennsauken, N.J.
Recall: #08-192
Urgent Gear Inc., of Los Angeles, Calif.
Recall: #08-217
Seventy Two Inc., of La Puenta, Calif.
Recall: #08-185
Orioxi International Corp., of Brea, Calif.
Recall: #08-379
Outfitter Trading Co. LLC, of Littleton, Colo.
Recall: #08-379
Retco Inc., of Breckenridge, Colo.
Recall: #08-379
In February 1996, CPSC issued drawstring guidelines (pdf) to help prevent children from strangling or getting entangled on the neck and waist drawstrings in upper outerwear, such as jackets and sweatshirts. In May 2006, CPSC’s Office of Compliance announced (pdf) that children’s upper outerwear with drawstrings at the hood or neck would be regarded as defective and a substantial risk of injury to young children.
Federal law requires manufacturers, distributors, and retailers to report to CPSC immediately (within 24 hours) after obtaining information reasonably supporting the conclusion that a product contains a defect which could create a substantial product hazard, presents an unreasonable risk of serious injury or death, or violates any consumer product safety rule or any other rule, regulation, standard, or ban enforced by the CPSC.
In agreeing to settle the matters, the firms deny CPSC’s allegations that they knowingly violated the law.
FSA to grill Talley's about poisonous berry---New Zealand
FSA to grill Talley's about poisonous berry
The New Zealand Food Safety Authority (NZFSA) plans to call South Island food company Talley's today after a man found a bag of frozen peas he said was made up of nearly 50 per cent poisonous black nightshade berries.
It is one of several reported case of contamination of Talley's products.
Humphrey Elton, a father of preschoolers, said he complained to Talley's six months ago after finding the berries in a bag of peas.
The company had simply sent him a $5 cheque to replace the peas and a letter saying the berries were not toxic, Mr Elton said.
NZFSA director of compliance and investigation, Geoff Allen, said today almost 50 per cent contamination was unacceptable.
"If the contamination is at that level Talley's need to up their game significantly," he told Radio New Zealand.
"We need to be talking to Talley's and actually checking what their quality systems are and what ways that they are looking at to improve their performance."
Talley's should be stipulating maximum levels of weeds and contaminants for the peas which were mostly grown by contractors, Mr Allen said.
Another customer, Anne Anderson, found more than a tablespoon of the berries per cup of Talley's vegetables as she was boiling some frozen peas and corn last week.
And Christchurch man Scott Barnard contacted the NZFSA after finding the berries in a packet of frozen beans he was about to serve his 19-month-old son several weeks ago.
National Poisons Centre spokesman Leo Schep said the black nightshade berries did not kill but were dangerous in large quantities and could cause fever, nausea, diarrhoea, vomiting and abdominal pain.
Talley's said last week the company was starting an immediate review of its processes.
The New Zealand Food Safety Authority (NZFSA) plans to call South Island food company Talley's today after a man found a bag of frozen peas he said was made up of nearly 50 per cent poisonous black nightshade berries.
It is one of several reported case of contamination of Talley's products.
Humphrey Elton, a father of preschoolers, said he complained to Talley's six months ago after finding the berries in a bag of peas.
The company had simply sent him a $5 cheque to replace the peas and a letter saying the berries were not toxic, Mr Elton said.
NZFSA director of compliance and investigation, Geoff Allen, said today almost 50 per cent contamination was unacceptable.
"If the contamination is at that level Talley's need to up their game significantly," he told Radio New Zealand.
"We need to be talking to Talley's and actually checking what their quality systems are and what ways that they are looking at to improve their performance."
Talley's should be stipulating maximum levels of weeds and contaminants for the peas which were mostly grown by contractors, Mr Allen said.
Another customer, Anne Anderson, found more than a tablespoon of the berries per cup of Talley's vegetables as she was boiling some frozen peas and corn last week.
And Christchurch man Scott Barnard contacted the NZFSA after finding the berries in a packet of frozen beans he was about to serve his 19-month-old son several weeks ago.
National Poisons Centre spokesman Leo Schep said the black nightshade berries did not kill but were dangerous in large quantities and could cause fever, nausea, diarrhoea, vomiting and abdominal pain.
Talley's said last week the company was starting an immediate review of its processes.
Florida senators seek Chinese drywall recall
Florida senators seek Chinese drywall recall
The Federal government should order a recall of potentially defective Chinese drywall and ban its importation until safety standards are established, two U.S. senators said Monday.
Sens. Bill Nelson, D-Fla., and Mary Landrieu, D-La., filed a nonbinding resolution Monday urging the Consumer Product Safety Commission to issue the recall. The senators also filed a bill that would require the consumer agency to do a more thorough drywall investigation and consider establishing product-safety standards for drywall.
“This Chinese drywall represents an attack on our homeowners, a defrauding of our homebuilders and another obstacle on our road to recovery,” Landrieu said. “The Consumer Product Safety Commission should have been the first line of defense in preventing this inferior product from entering the U.S. market in the first place.” Homeowners in Manatee County, across Florida and in at least three other states have complained that Chinese-made drywall in their homes has emitted a "rotten eggs" odor, corroded metal jewelry and air-conditioning parts, and caused headaches, breathing difficulty and other health problems. Those complaints have prompted several lawsuits, as well as state and federal investigations.
The Federal government should order a recall of potentially defective Chinese drywall and ban its importation until safety standards are established, two U.S. senators said Monday.
Sens. Bill Nelson, D-Fla., and Mary Landrieu, D-La., filed a nonbinding resolution Monday urging the Consumer Product Safety Commission to issue the recall. The senators also filed a bill that would require the consumer agency to do a more thorough drywall investigation and consider establishing product-safety standards for drywall.
“This Chinese drywall represents an attack on our homeowners, a defrauding of our homebuilders and another obstacle on our road to recovery,” Landrieu said. “The Consumer Product Safety Commission should have been the first line of defense in preventing this inferior product from entering the U.S. market in the first place.” Homeowners in Manatee County, across Florida and in at least three other states have complained that Chinese-made drywall in their homes has emitted a "rotten eggs" odor, corroded metal jewelry and air-conditioning parts, and caused headaches, breathing difficulty and other health problems. Those complaints have prompted several lawsuits, as well as state and federal investigations.
Sunday, April 5, 2009
Rocket fuel chemical found in baby formula
Traces of a chemical used in rocket fuel were found in samples of powdered baby formula, and could exceed what's considered a safe dose for adults if mixed with water also contaminated with the ingredient, a government study has found.
The study by scientists at the U.S. Centers for Disease Control and Prevention looked for the chemical, perchlorate, in different brands of powdered baby formula. It was published last month, but the Environmental Working Group issued a press release Thursday drawing attention to it.
The chemical has turned up in several cities' drinking water supplies. It can occur naturally, but most perchlorate contamination has been tied to defense and aerospace sites.
No tests have ever shown the chemical caused health problems, but scientists have said significant amounts of perchlorate can affect thyroid function. The thyroid helps set the body's metabolism. Thyroid problems can impact fetal and infant brain development.
However, the extent of the risk is hard to assess. The government requires that formula contain iodine, which counteracts perchlorate's effects. The size of the infant and how much formula they consume are other factors that can influence risk.
The study itself sheds little light on how dangerous the perchlorate in baby formula is. "This
wasn't a study of health effects," said Dr. Joshua Schier, one of the authors.
The largest amounts of the chemical were in formulas derived from cow's milk, the study said.
The researchers would not disclose the brands of formula they studied. Only a few samples were studied, so it's hard to know if the perchlorate levels would be found in all containers of those brands, a CDC spokesman said.
Earlier this year, the U.S. Environmental Protection Agency said it was considering setting new limits on the amount of perchlorate that would be acceptable in drinking water. A few states have already set their own limits.
The EPA has checked nearly 4,000 public water supplies serving 10,000 people or more. About 160 of the water systems had detectable levels of perchlorate, and 31 had levels high enough to exceed a new safety level the EPA is considering.
The study by scientists at the U.S. Centers for Disease Control and Prevention looked for the chemical, perchlorate, in different brands of powdered baby formula. It was published last month, but the Environmental Working Group issued a press release Thursday drawing attention to it.
The chemical has turned up in several cities' drinking water supplies. It can occur naturally, but most perchlorate contamination has been tied to defense and aerospace sites.
No tests have ever shown the chemical caused health problems, but scientists have said significant amounts of perchlorate can affect thyroid function. The thyroid helps set the body's metabolism. Thyroid problems can impact fetal and infant brain development.
However, the extent of the risk is hard to assess. The government requires that formula contain iodine, which counteracts perchlorate's effects. The size of the infant and how much formula they consume are other factors that can influence risk.
The study itself sheds little light on how dangerous the perchlorate in baby formula is. "This
wasn't a study of health effects," said Dr. Joshua Schier, one of the authors.
The largest amounts of the chemical were in formulas derived from cow's milk, the study said.
The researchers would not disclose the brands of formula they studied. Only a few samples were studied, so it's hard to know if the perchlorate levels would be found in all containers of those brands, a CDC spokesman said.
Earlier this year, the U.S. Environmental Protection Agency said it was considering setting new limits on the amount of perchlorate that would be acceptable in drinking water. A few states have already set their own limits.
The EPA has checked nearly 4,000 public water supplies serving 10,000 people or more. About 160 of the water systems had detectable levels of perchlorate, and 31 had levels high enough to exceed a new safety level the EPA is considering.
Friday, April 3, 2009
U.S. Food and Drug Administration warned nine companies to stop manufacturing 14 unapproved narcotic drugs
The U.S. Food and Drug Administration warned nine companies to stop manufacturing 14 unapproved narcotic drugs that are marketed in several dosage forms and are widely used to treat pain.
The FDA's warning letters notified the companies they may be subject to enforcement action if they do not stop manufacturing and distributing prescription unapproved products that include high concentrate morphine sulfate oral solutions and immediate release tablets containing morphine sulfate, hydromorphone or oxycodone. This action does not include oxycodone capsules.
Those companies receiving warning letters are Boehringer Ingelheim Roxane, Inc., Columbus, Ohio; Cody Laboratories, Inc., Cody, Wyoming; Glenmark Pharmaceuticals Inc., Mahwah, N.J.; Lannett Company, Inc., Philadelphia; Lehigh Valley Technologies, Inc., Allentown, Pa.; Mallinckrodt Inc. Pharmaceuticals Group, St. Louis; Physicians Total Care Inc., Tulsa, Okla.; Roxane Laboratories Inc., Columbus, Ohio; and Xanodyne Pharmaceuticals Inc., Newport, Ky.
The warning letters are part of the FDA's initiative on marketed unapproved drugs announced in June 2006. At that time, the agency published a compliance policy guide describing its risk-based enforcement approach against illegally marketed unapproved drugs.
"Consumers have a right to expect that their drugs meet the FDA's safety and effectiveness standards," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research (CDER). "Doctors and patients are often unaware that not all drugs on the market are backed by FDA approval. It is a high priority for the FDA to remove these products from the market because they may be unsafe, ineffective, inappropriately labeled, or of poor quality."
Consumers who rely on narcotics for pain relief continue to have access to narcotic products that the agency has evaluated and determined to be safe and effective. The FDA has determined that removal of the unapproved narcotic products will not create a shortage for consumers.
For more information, please visit: http://www.fda.gov/bbs/topics/NEWS/2009/NEW01983.html
The FDA's warning letters notified the companies they may be subject to enforcement action if they do not stop manufacturing and distributing prescription unapproved products that include high concentrate morphine sulfate oral solutions and immediate release tablets containing morphine sulfate, hydromorphone or oxycodone. This action does not include oxycodone capsules.
Those companies receiving warning letters are Boehringer Ingelheim Roxane, Inc., Columbus, Ohio; Cody Laboratories, Inc., Cody, Wyoming; Glenmark Pharmaceuticals Inc., Mahwah, N.J.; Lannett Company, Inc., Philadelphia; Lehigh Valley Technologies, Inc., Allentown, Pa.; Mallinckrodt Inc. Pharmaceuticals Group, St. Louis; Physicians Total Care Inc., Tulsa, Okla.; Roxane Laboratories Inc., Columbus, Ohio; and Xanodyne Pharmaceuticals Inc., Newport, Ky.
The warning letters are part of the FDA's initiative on marketed unapproved drugs announced in June 2006. At that time, the agency published a compliance policy guide describing its risk-based enforcement approach against illegally marketed unapproved drugs.
"Consumers have a right to expect that their drugs meet the FDA's safety and effectiveness standards," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research (CDER). "Doctors and patients are often unaware that not all drugs on the market are backed by FDA approval. It is a high priority for the FDA to remove these products from the market because they may be unsafe, ineffective, inappropriately labeled, or of poor quality."
Consumers who rely on narcotics for pain relief continue to have access to narcotic products that the agency has evaluated and determined to be safe and effective. The FDA has determined that removal of the unapproved narcotic products will not create a shortage for consumers.
For more information, please visit: http://www.fda.gov/bbs/topics/NEWS/2009/NEW01983.html
Thursday, April 2, 2009
Standards for Improved Fire Safety of Mattresses
Subject: Standards for Improved Fire Safety of Mattresses
In July, 2007, the United States Consumer Product Safety Commission (CPSC) implemented a new standard for open flame testing of mattresses that is mandatory for all mattresses manufactured, renovated or imported into the United States1.
The open flame test requirements of the US CPSC standard are widely regarded as an effective additional fire safety specification to make mattresses and box springs (mattress sets) safer in case of a fire. The goal of the standard is to minimize flammability when a mattress is ignited in a fire. Mattresses that meet the standard will make only a limited contribution to a fire, especially in the early stages of the fire. This will allow occupants more time to discover the fire and escape.
Underwriters' Laboratories of Canada (ULC) has published a new voluntary standard, CAN/ULC-S137, titled Standard Method of Test for Fire Growth of Mattresses (Open Flame Test)2, which is harmonized with the US CPSC standard. Some Canadian mattress manufacturers who export their products to the US are already in compliance with the US CPSC standard.
Hospital Beds
Mattresses designed expressly for hospital beds are deemed to be medical devices. There are no standards in Canada for flammability of hospital bed mattresses. However, the Medical Devices Bureau of Health Canada believes that conformance with the US CPSC standard and/or CAN/ULC-S137 will provide improved assurance of fire safety for hospital bed mattresses as well.
Recommendation
Health Canada recommends that when purchasing new mattresses, health care facilities consider those that comply with flammability standards CAN/ULC-S137 Standard method of test for fire growth of mattresses (open flame test) and/or the US CPSC Standard for the Flammability (Open Flame) of Mattress Sets.
Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse incidents in patients using hospital bed mattresses and other medical devices should be reported to market authorization holder or to Health Canada at the following address:
Any suspected adverse reaction can also be reported to:Health Products and Food Branch InspectorateHealth Canada Address Locator: 2003DOttawa, Ontario K1A 0K9Telephone: The Inspectorate Hotline 1-800-267-9675
The Reporting Form and Guidelines can be obtained from the Health Canada web site.
For other inquiries related to this communication, please contact Health Canada at:Marketed Health Products Directorate (MHPD)E-mail: MHPD_DPSC@hc-sc.gc.ca Telephone: 613-954-6522Fax: 613-952-7738
In July, 2007, the United States Consumer Product Safety Commission (CPSC) implemented a new standard for open flame testing of mattresses that is mandatory for all mattresses manufactured, renovated or imported into the United States1.
The open flame test requirements of the US CPSC standard are widely regarded as an effective additional fire safety specification to make mattresses and box springs (mattress sets) safer in case of a fire. The goal of the standard is to minimize flammability when a mattress is ignited in a fire. Mattresses that meet the standard will make only a limited contribution to a fire, especially in the early stages of the fire. This will allow occupants more time to discover the fire and escape.
Underwriters' Laboratories of Canada (ULC) has published a new voluntary standard, CAN/ULC-S137, titled Standard Method of Test for Fire Growth of Mattresses (Open Flame Test)2, which is harmonized with the US CPSC standard. Some Canadian mattress manufacturers who export their products to the US are already in compliance with the US CPSC standard.
Hospital Beds
Mattresses designed expressly for hospital beds are deemed to be medical devices. There are no standards in Canada for flammability of hospital bed mattresses. However, the Medical Devices Bureau of Health Canada believes that conformance with the US CPSC standard and/or CAN/ULC-S137 will provide improved assurance of fire safety for hospital bed mattresses as well.
Recommendation
Health Canada recommends that when purchasing new mattresses, health care facilities consider those that comply with flammability standards CAN/ULC-S137 Standard method of test for fire growth of mattresses (open flame test) and/or the US CPSC Standard for the Flammability (Open Flame) of Mattress Sets.
Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse incidents in patients using hospital bed mattresses and other medical devices should be reported to market authorization holder or to Health Canada at the following address:
Any suspected adverse reaction can also be reported to:Health Products and Food Branch InspectorateHealth Canada Address Locator: 2003DOttawa, Ontario K1A 0K9Telephone: The Inspectorate Hotline 1-800-267-9675
The Reporting Form and Guidelines can be obtained from the Health Canada web site.
For other inquiries related to this communication, please contact Health Canada at:Marketed Health Products Directorate (MHPD)E-mail: MHPD_DPSC@hc-sc.gc.ca Telephone: 613-954-6522Fax: 613-952-7738
Consumers Urged to Replace Dangerous Home Heating Vent Pipes
May 1, 2009 Deadline Approaching for Remedy Change in Recall Program; Consumers Urged to Replace Dangerous Home Heating Vent Pipes
The U.S. Consumer Product Safety Commission (CPSC) and various home heating furnace, boiler, and high-temperature plastic vent pipe (HTPV) manufacturers are urging home owners who have not yet responded to the previously-announced 1998 recall, to do so immediately. After May 1, 2009, the remedy consumers receive will change.
The recall originally included about 250,000 Plexvent and Ultravent HTPV pipe systems attached to gas or propane mid-efficiency furnaces and boilers in homes. The HTPV pipes can crack or separate at the joints and leak deadly carbon monoxide (CO) gas. After checking the vent pipes, consumers should call (800) 758-3688 between 8 a.m. and 7 p.m. ET Monday through Friday to sign up for HTPV pipe system replacement.
The U.S. Consumer Product Safety Commission (CPSC) and various home heating furnace, boiler, and high-temperature plastic vent pipe (HTPV) manufacturers are urging home owners who have not yet responded to the previously-announced 1998 recall, to do so immediately. After May 1, 2009, the remedy consumers receive will change.
The recall originally included about 250,000 Plexvent and Ultravent HTPV pipe systems attached to gas or propane mid-efficiency furnaces and boilers in homes. The HTPV pipes can crack or separate at the joints and leak deadly carbon monoxide (CO) gas. After checking the vent pipes, consumers should call (800) 758-3688 between 8 a.m. and 7 p.m. ET Monday through Friday to sign up for HTPV pipe system replacement.
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