WASHINGTON — One of the nation's top safety officials is delivering a stern warning to the makers of toys, cribs and other children's products, telling them to put safety first — or face potential fines, lawsuits or other actions.
"If you resist our efforts to recall children's products, be forewarned: This commission stands ready to be creative in the use of our enforcement authorities," Consumer Product Safety Commission Chairwoman Inez Tenenbaum said Wednesday.
It was her sharpest admonition to industry officials since taking over as chairman eight months ago. It follows pointed questions from Congress about the months-long lag time to tell the public about recalls of defective products.
In a speech to the International Consumer Product Health and Safety Organization, Tenenbaum said safety legislation passed in 2008 gives the commission new powers, "and we are not afraid to use them."
The product safety bill set strict limits on lead paint, lead and chemicals called phthalates that are used to soften plastics. It also called for new rules governing cribs, ATVs and other products.
At a crib safety hearing last month, House lawmakers wanted to know why it took CPSC more than six months to negotiate a record recall in November of more than 2 million Stork Craft drop-side cribs. The suffocation deaths of four infants were linked to the cribs.
Tenenbaum said at the time that CPSC and manufacturers need to investigate allegations of defects and then work together on the exact wording of the announcement to the public — a process that can take months. The alternative could be litigation, which might take even longer.
Several lawmakers appeared skeptical, but Tenenbaum pledged to renew efforts to hasten safety recalls.
On Wednesday, Tenenbaum also promised new safety rules for cribs, expected at the end of this year. Since 2007, about 7 million cribs have been recalled — cribs tied to a dozen deaths of infants.
The commission's mandatory standards governing cribs haven't been updated since 1982
Thursday, February 18, 2010
FDA Urges Safe Use of Certain Inhaled Asthma Medicines
FDA Urges Safe Use of Certain Inhaled Asthma Medicine
The Food and Drug Administration (FDA) has issued recommendations on how inhaled medications called Long-Acting Beta-Agonists (LABAs) should be used to treat asthma.
On Feb. 18, 2010, the agency said
LABAs should never be used alone in the treatment of asthma in children or adults
when LABAs are needed, they be used for the shortest time possible to achieve asthma control. They are then to be discontinued, if possible, to limit the long-term use
FDA's actions are based on agency analyses of studies showing an increased risk of severe worsening of asthma symptoms, leading to hospitalization in pediatric and adult patients—as well as death in some patients—using the treatment for asthma.
LABAs are available as single ingredient products, or in combination with a corticosteroid medication. (The reason that some LABAs are offered as single-ingredient products is that not all asthma controller medicines are able to be made into a combination product.)
The drugs affected by FDA's announcement include
the single-ingredient products Serevent (generic name: salmeterol) and Foradil (formoterol)
the combination medications Advair (salmeterol and fluticasone) and Symbicort (formoterol and budesonide)
How LABAs Work
LABAs help people with asthma or a lung condition called chronic obstructive pulmonary disease (COPD) breathe easier. They are also used for exercise-induced bronchospasm, which is asthma that is triggered by vigorous physical activity.
Taken through the mouth using an inhaler or a nebulizer, LABAs relax the muscles of the airways to allow more air to flow into and out of the lungs. Their effects last for at least 12 hours.
FDA's recommendations only apply to the use of LABAs in the treatment of asthma.
“Although these medicines play an important role in helping some patients control asthma symptoms, our review of the available clinical trials determined that their use should be limited, whenever possible, due to an increased risk of serious asthma exacerbations and death,” says Badrul Chowdhury, M.D., director of FDA's Division of Pulmonary and Allergy Products.
“The risks of hospitalization and poor outcomes are of particular concern for children," says Dianne Murphy, director of FDA’s Office of Pediatric Therapeutics. "Parents need to know that their child should not be on a LABA alone.”
Additional Advice
In addition to following the recommendations issued on Feb. 18, FDA advises patients to
know that LABAs do not relieve sudden-onset asthma symptoms. Patients should always have a rescue inhaler, such as an albuterol inhaler, to treat sudden-onset asthma symptoms
know that, if they need a LABA plus an asthma controller medication that is not available as a combination product, they should work with their health care professionals to ensure that each individual medication is taken correctly
read the Medication Guide included in each LABA
talk with their health care professionals to learn the warning signs of worsening asthma, and to discuss any questions they have about the use of LABAs
Other FDA Actions
On Feb. 18, FDA also required that the product labels for LABAs reflect the agency's recommendations
called on manufacturers of LABAs to conduct additional studies to further evaluate the safety of these medicines when used in combination with inhaled corticosteroids
said it will work with public and private partners under the agency’s ongoing Safe Use Initiative to study LABA prescribing practices
required a risk management program—called a Risk Evaluation and Mitigation Strategy (REMS)—to help ensure the safe use of these products. The program requires the manufacturers to better inform health care professionals and patients about the risk of LABAs for patients with asthma and ways to decrease that risk while maintaining the benefits of the drug
This article appears on FDA's Consumer Updates page1, which features the latest on all FDA-regulated products.
The Food and Drug Administration (FDA) has issued recommendations on how inhaled medications called Long-Acting Beta-Agonists (LABAs) should be used to treat asthma.
On Feb. 18, 2010, the agency said
LABAs should never be used alone in the treatment of asthma in children or adults
when LABAs are needed, they be used for the shortest time possible to achieve asthma control. They are then to be discontinued, if possible, to limit the long-term use
FDA's actions are based on agency analyses of studies showing an increased risk of severe worsening of asthma symptoms, leading to hospitalization in pediatric and adult patients—as well as death in some patients—using the treatment for asthma.
LABAs are available as single ingredient products, or in combination with a corticosteroid medication. (The reason that some LABAs are offered as single-ingredient products is that not all asthma controller medicines are able to be made into a combination product.)
The drugs affected by FDA's announcement include
the single-ingredient products Serevent (generic name: salmeterol) and Foradil (formoterol)
the combination medications Advair (salmeterol and fluticasone) and Symbicort (formoterol and budesonide)
How LABAs Work
LABAs help people with asthma or a lung condition called chronic obstructive pulmonary disease (COPD) breathe easier. They are also used for exercise-induced bronchospasm, which is asthma that is triggered by vigorous physical activity.
Taken through the mouth using an inhaler or a nebulizer, LABAs relax the muscles of the airways to allow more air to flow into and out of the lungs. Their effects last for at least 12 hours.
FDA's recommendations only apply to the use of LABAs in the treatment of asthma.
“Although these medicines play an important role in helping some patients control asthma symptoms, our review of the available clinical trials determined that their use should be limited, whenever possible, due to an increased risk of serious asthma exacerbations and death,” says Badrul Chowdhury, M.D., director of FDA's Division of Pulmonary and Allergy Products.
“The risks of hospitalization and poor outcomes are of particular concern for children," says Dianne Murphy, director of FDA’s Office of Pediatric Therapeutics. "Parents need to know that their child should not be on a LABA alone.”
Additional Advice
In addition to following the recommendations issued on Feb. 18, FDA advises patients to
know that LABAs do not relieve sudden-onset asthma symptoms. Patients should always have a rescue inhaler, such as an albuterol inhaler, to treat sudden-onset asthma symptoms
know that, if they need a LABA plus an asthma controller medication that is not available as a combination product, they should work with their health care professionals to ensure that each individual medication is taken correctly
read the Medication Guide included in each LABA
talk with their health care professionals to learn the warning signs of worsening asthma, and to discuss any questions they have about the use of LABAs
Other FDA Actions
On Feb. 18, FDA also required that the product labels for LABAs reflect the agency's recommendations
called on manufacturers of LABAs to conduct additional studies to further evaluate the safety of these medicines when used in combination with inhaled corticosteroids
said it will work with public and private partners under the agency’s ongoing Safe Use Initiative to study LABA prescribing practices
required a risk management program—called a Risk Evaluation and Mitigation Strategy (REMS)—to help ensure the safe use of these products. The program requires the manufacturers to better inform health care professionals and patients about the risk of LABAs for patients with asthma and ways to decrease that risk while maintaining the benefits of the drug
This article appears on FDA's Consumer Updates page1, which features the latest on all FDA-regulated products.
Health Canada proposes LABELLING changes
Health Canada is launching a consultation with stakeholders and the Canadian public on proposed changes to improve the labelling requirements for food colours in Canada.
The consultation, which will be posted on the Health Canada website and open for comments from February 18th until May 4th, is intended to seek input on several options for future labelling requirements.
The Canadian Food and Drug Regulations currently allow manufacturers to use the general term “colour” to specify one or more food colours. For the majority of prepackaged foods, manufacturers may voluntarily declare individual colours by name at their own discretion.
However, there is some evidence suggesting a link between consumption of certain food colours and adverse reactions in sensitive individuals. More recently, certain food colour mixtures have been associated with behavioural effects in children. For these reasons, Health Canada considers it prudent to improve labelling requirements for food colours.
Health Canada's proposed changes would eliminate the option of using the general term "colour" and require that individual colours be identified on food ingredient labels for many, if not all, colours. By improving food colour labelling requirements, Health Canada's goal is to enable consumers to make more informed choices which could contribute to the reduction of adverse reactions.
Health Canada will continue to update Canadians on the progress of this issue once the consultation period has concluded. Please visit the Health Canada website for more information on the proposal to improve the food colour labelling requirements in Canada.
In addition, please visit Health Canada's Allergen Labelling Page for information on another recent Health Canada initiative to improve prepackaged food labels,
The consultation, which will be posted on the Health Canada website and open for comments from February 18th until May 4th, is intended to seek input on several options for future labelling requirements.
The Canadian Food and Drug Regulations currently allow manufacturers to use the general term “colour” to specify one or more food colours. For the majority of prepackaged foods, manufacturers may voluntarily declare individual colours by name at their own discretion.
However, there is some evidence suggesting a link between consumption of certain food colours and adverse reactions in sensitive individuals. More recently, certain food colour mixtures have been associated with behavioural effects in children. For these reasons, Health Canada considers it prudent to improve labelling requirements for food colours.
Health Canada's proposed changes would eliminate the option of using the general term "colour" and require that individual colours be identified on food ingredient labels for many, if not all, colours. By improving food colour labelling requirements, Health Canada's goal is to enable consumers to make more informed choices which could contribute to the reduction of adverse reactions.
Health Canada will continue to update Canadians on the progress of this issue once the consultation period has concluded. Please visit the Health Canada website for more information on the proposal to improve the food colour labelling requirements in Canada.
In addition, please visit Health Canada's Allergen Labelling Page for information on another recent Health Canada initiative to improve prepackaged food labels,
Wednesday, February 10, 2010
National Institutes of Health discuss Long-lasting LEAD DAMAGE
Long-lasting lead damage
From the U.S. Department of Health and Human Services.
A study indicates people may never outgrow the damage that lead does to the brain. At Cincinnati Children’s Hospital Medical Center, Kim Cecil saw that in brain imaging of adults who were exposed to high levels of lead when they were children.
Cecil says adults who had higher lead exposure as children were more likely to have decreased activity in parts of the brain associated with attention and controlling impulses.
``What our study is showing is that, long after this exposure is over, the effects are irreversible.’’
Cecil says it’s another reason to keep kids free of things like lead-based paint.
The research, which was supported by the National Institutes of Health, was presented at a meeting of the Radiological Society of North America.
From the U.S. Department of Health and Human Services.
A study indicates people may never outgrow the damage that lead does to the brain. At Cincinnati Children’s Hospital Medical Center, Kim Cecil saw that in brain imaging of adults who were exposed to high levels of lead when they were children.
Cecil says adults who had higher lead exposure as children were more likely to have decreased activity in parts of the brain associated with attention and controlling impulses.
``What our study is showing is that, long after this exposure is over, the effects are irreversible.’’
Cecil says it’s another reason to keep kids free of things like lead-based paint.
The research, which was supported by the National Institutes of Health, was presented at a meeting of the Radiological Society of North America.
Tuesday, February 9, 2010
The science behind the SULPHITES story
The science behind the story
Sulphites are used as preservatives in a wide range of foods, in particular soft drinks, sausages, burgers, and dried fruit and vegetables. These additives maintain food colour and prolong shelf-life by preventing the growth of micro-organisms.
When the gas sulphur dioxide is dissolved in a liquid, such as wine, it is known as a sulphite.
Sulphur dioxide is produced naturally when wine and beer are made and it is often added to wine to stop it from continuing to ferment in the bottle. Usually, most of the ‘head space’ in a bottle of wine (the part of the bottle not filled with wine) is sulphur dioxide.
Some people who have asthma may react to inhaling sulphur dioxide. A very few people with asthma have had an attack after drinking acidic drinks (such as fruit-based drinks) containing sulphites, but this is not thought to be very common.
Read more about intolerance to sulphites and other additives at eatwell.gov.uk/healthissues/foodintolerance/foodintolerancetypes/foodadditiv/.
Sulphites are used as preservatives in a wide range of foods, in particular soft drinks, sausages, burgers, and dried fruit and vegetables. These additives maintain food colour and prolong shelf-life by preventing the growth of micro-organisms.
When the gas sulphur dioxide is dissolved in a liquid, such as wine, it is known as a sulphite.
Sulphur dioxide is produced naturally when wine and beer are made and it is often added to wine to stop it from continuing to ferment in the bottle. Usually, most of the ‘head space’ in a bottle of wine (the part of the bottle not filled with wine) is sulphur dioxide.
Some people who have asthma may react to inhaling sulphur dioxide. A very few people with asthma have had an attack after drinking acidic drinks (such as fruit-based drinks) containing sulphites, but this is not thought to be very common.
Read more about intolerance to sulphites and other additives at eatwell.gov.uk/healthissues/foodintolerance/foodintolerancetypes/foodadditiv/.
Thursday, February 4, 2010
United States Seizes more than 1,500 Cases of Food from Wisconsin Distribution Warehouse
Media Inquiries: Tom Gasparoli, 301-796-4737, thomas.gasparoli@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
United States Seizes more than 1,500 Cases of Food from Wisconsin Distribution Warehouse
FDA acts after inspections reveal filthy, rodent-infested facility
At the request of the U.S. Food and Drug Administration, U.S. Marshals on Tuesday seized a wide range of human and animal food products stored under insanitary conditions at Mid-States Closeouts, a distribution warehouse in Ellsworth, Wis. The products were seized under a warrant issued by the U.S. District Court for the Western District of Wisconsin.
U.S. Marshals seized all FDA-regulated human and animal food susceptible to rodent and pest contamination or other filth. The products are adulterated under the Federal Food, Drug, and Cosmetic Act (the Act) because they have been held under insanitary conditions whereby they may have become contaminated with filth.
During an FDA inspection of Mid-States Closeouts conducted in November and December 2009, the agency found widespread and active rodent infestation, numerous gnawed packages of human and animal food, rodent excreta pellets on, in, and around food packages and rodent nesting material. The facility also had structural defects permitting easy pest access to the entire facility, and rodent harborage areas near the warehouse.
"The violations at Mid-States Closeouts are widespread and significant,” said Michael Chappell, the FDA’s acting associate commissioner, Office of Regulatory Affairs. “The FDA took this action because the company failed to provide adequate safeguards to ensure that products they hold for sale remain free of contamination.”
The FDA has not received any reports of human or pet illness or death associated with consumption of food distributed by Mid-States Closeouts. However, the seized products were in permeable packages and held under conditions that could compromise the food’s quality.
Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator. Contact information for coordinators is located at http://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators.
Consumer Inquiries: 888-INFO-FDA
United States Seizes more than 1,500 Cases of Food from Wisconsin Distribution Warehouse
FDA acts after inspections reveal filthy, rodent-infested facility
At the request of the U.S. Food and Drug Administration, U.S. Marshals on Tuesday seized a wide range of human and animal food products stored under insanitary conditions at Mid-States Closeouts, a distribution warehouse in Ellsworth, Wis. The products were seized under a warrant issued by the U.S. District Court for the Western District of Wisconsin.
U.S. Marshals seized all FDA-regulated human and animal food susceptible to rodent and pest contamination or other filth. The products are adulterated under the Federal Food, Drug, and Cosmetic Act (the Act) because they have been held under insanitary conditions whereby they may have become contaminated with filth.
During an FDA inspection of Mid-States Closeouts conducted in November and December 2009, the agency found widespread and active rodent infestation, numerous gnawed packages of human and animal food, rodent excreta pellets on, in, and around food packages and rodent nesting material. The facility also had structural defects permitting easy pest access to the entire facility, and rodent harborage areas near the warehouse.
"The violations at Mid-States Closeouts are widespread and significant,” said Michael Chappell, the FDA’s acting associate commissioner, Office of Regulatory Affairs. “The FDA took this action because the company failed to provide adequate safeguards to ensure that products they hold for sale remain free of contamination.”
The FDA has not received any reports of human or pet illness or death associated with consumption of food distributed by Mid-States Closeouts. However, the seized products were in permeable packages and held under conditions that could compromise the food’s quality.
Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator. Contact information for coordinators is located at http://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators.
More tainted milk products found in China shops
Melamine-laced milk products have been found on sale in China, state media said on Monday, more than a year after the chemical was blamed for six deaths in a huge scandal over contaminated dairy goods.
Three Chinese companies have been found selling food products tainted with melamine, the chemical blamed for the deaths of six babies in a huge dairy scandal in 2008, state media said Monday.
Authorities in the southwestern province of Guizhou found that products made by three food companies contained illegally high levels of the toxic substance, the China Daily said.
It quoted a former dairy industry official as saying it was likely more tainted goods remained in supermarkets despite a major recall after the 2008 scandal, which highlighted China's persistent product safety problems.
The suspect products in Guizhou have been pulled from stores, the China Daily said, adding that the firms involved blamed milk powder bought from suppliers.
The report illustrated the apparent continued threat from tainted dairy goods long after the 2008 scandal when it was revealed that the industrial chemical -- which can, in large quantities, cause kidney failure and death -- was being abused by food producers.
At that time, melamine was found to have been added to milk to give the appearance of a higher protein content and was blamed for killing six infants and making nearly 300,000 others sick, according to official figures.
The scare led to foodstuffs containing dairy products being taken off shelves around the world. A total of 21 people were reportedly convicted of wrongdoing, with two executed and others sentenced to jail terms.
But other cases have since surfaced.
FULL STORY: http://www.bangkokpost.com/news/health/166430/more-tainted-milk-products-found-in-china-shops
Three Chinese companies have been found selling food products tainted with melamine, the chemical blamed for the deaths of six babies in a huge dairy scandal in 2008, state media said Monday.
Authorities in the southwestern province of Guizhou found that products made by three food companies contained illegally high levels of the toxic substance, the China Daily said.
It quoted a former dairy industry official as saying it was likely more tainted goods remained in supermarkets despite a major recall after the 2008 scandal, which highlighted China's persistent product safety problems.
The suspect products in Guizhou have been pulled from stores, the China Daily said, adding that the firms involved blamed milk powder bought from suppliers.
The report illustrated the apparent continued threat from tainted dairy goods long after the 2008 scandal when it was revealed that the industrial chemical -- which can, in large quantities, cause kidney failure and death -- was being abused by food producers.
At that time, melamine was found to have been added to milk to give the appearance of a higher protein content and was blamed for killing six infants and making nearly 300,000 others sick, according to official figures.
The scare led to foodstuffs containing dairy products being taken off shelves around the world. A total of 21 people were reportedly convicted of wrongdoing, with two executed and others sentenced to jail terms.
But other cases have since surfaced.
FULL STORY: http://www.bangkokpost.com/news/health/166430/more-tainted-milk-products-found-in-china-shops
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