CPSC Urges Consumers to Replace Batteries in Smoke Alarms This Weekend
WASHINGTON, D. C. – Change your clocks. Replace your smoke alarm batteries. Both are important this weekend as Daylight Saving Time ends on Sunday, November 2.
While changing your clock can keep you on time for work on Monday, the U.S. Consumer Product Safety Commission (CPSC) advises consumers that putting fresh batteries in your smoke alarms can save your life.
In recent years, an estimated annual average of 378,700 fires, 2,740 deaths, 13,090 injuries and $5.6 billion in property losses associated with residential fires have been reported by fire departments.
“Smoke alarms save lives. That’s a fact,” said CPSC Acting Chairman Nancy Nord. “Working smoke alarms buy you valuable time to get out of your home when there’s a fire.”
CPSC urges consumers to install smoke alarms on every level of their home, outside sleeping areas, and inside each bedroom. To minimize nuisance alarms, install smoke alarms at least 10 feet from the stove and oven.
CPSC staff recommends installing both ionization and photoelectric type smoke alarms. Ionization type smoke alarms typically detect flaming fires more quickly, while photoelectric
type smoke alarms typically detect smoldering fires sooner.
In addition to replacing smoke alarm batteries, consumers should test their smoke alarms every month to make sure they are operating properly – and never disable a smoke alarm. Long life smoke alarms with 10-year batteries are also available to consumers.
Thursday, October 30, 2008
Wednesday, October 29, 2008
FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report
FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report
We appreciate the hard work and long hours the subcommittee has invested in scientific peer review of the FDA’s draft safety assessment of the use of BPA in food contact applications. The FDA requested this peer review to provide additional insight into this complex issue. This group of distinguished scientists has devoted their considerable knowledge and experience to this effort.
The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct 31.
The FDA agrees that, due to the uncertainties raised in some studies relating to the potential effects of low dose exposure to bisphenol A, additional research would be valuable. The FDA is already moving forward with planned research to address the potential low dose effects of bisphenol A, and we will carefully evaluate the findings of these studies.
Consumers should know that, based on all available evidence, the present consensus among regulatory agencies in the United States, Canada, Europe, and Japan is that current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies.
Regarding Canada, the FDA notes that Health Canada’s assessment of bisphenol A on newborns and infants up to 18 months of age concludes that exposure levels are below the levels that could cause health effects. Out of an abundance of caution, the Government of Canada has taken steps to restrict the use of BPA.
Parents who, as a precaution, wish to use alternatives for their bottle-fed babies can use glass and other substitutes for polycarbonate plastic bottles; avoid heating formula in polycarbonate plastic bottles; and consult their pediatrician about switching to powdered infant formula.
For a copy of the Subcommittee Report, go to: http://www.fda.gov/oc/advisory/scienceboard/meeting103108.html.
Statement of the Acting Surgeon General, Rear Admiral Steven K. Galson, M.D., M.P.H."The most important thing parents can do for their babies is ensure that they receive adequate nutrition. While the best source of nutrition for babies is the mother's breast milk, infant formula remains the recommended alternative when breast milk is not an option"
We appreciate the hard work and long hours the subcommittee has invested in scientific peer review of the FDA’s draft safety assessment of the use of BPA in food contact applications. The FDA requested this peer review to provide additional insight into this complex issue. This group of distinguished scientists has devoted their considerable knowledge and experience to this effort.
The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct 31.
The FDA agrees that, due to the uncertainties raised in some studies relating to the potential effects of low dose exposure to bisphenol A, additional research would be valuable. The FDA is already moving forward with planned research to address the potential low dose effects of bisphenol A, and we will carefully evaluate the findings of these studies.
Consumers should know that, based on all available evidence, the present consensus among regulatory agencies in the United States, Canada, Europe, and Japan is that current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies.
Regarding Canada, the FDA notes that Health Canada’s assessment of bisphenol A on newborns and infants up to 18 months of age concludes that exposure levels are below the levels that could cause health effects. Out of an abundance of caution, the Government of Canada has taken steps to restrict the use of BPA.
Parents who, as a precaution, wish to use alternatives for their bottle-fed babies can use glass and other substitutes for polycarbonate plastic bottles; avoid heating formula in polycarbonate plastic bottles; and consult their pediatrician about switching to powdered infant formula.
For a copy of the Subcommittee Report, go to: http://www.fda.gov/oc/advisory/scienceboard/meeting103108.html.
Statement of the Acting Surgeon General, Rear Admiral Steven K. Galson, M.D., M.P.H."The most important thing parents can do for their babies is ensure that they receive adequate nutrition. While the best source of nutrition for babies is the mother's breast milk, infant formula remains the recommended alternative when breast milk is not an option"
Tuesday, October 28, 2008
FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved Drugs
FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved Drugs
Action involves Bayer Aspirin with Heart Advantage and Bayer Women’s Low Dose Aspirin + Calcium
The U.S. Food and Drug Administration today sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products — Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).
The products, which contain aspirin with either phytosterols or calcium, are unapproved new drugs that require an approved new drug application in order to be legally marketed. In addition to being labeled for use as a pain reliever, both products are labeled for use in reducing the risks of heart disease.
Bayer Women's is also labeled for use in "fighting" osteoporosis. Neither product has been approved by the FDA for such uses. These drug uses require a health care professional's diagnosis and supervision, and therefore these products cannot be labeled for use by consumers and sold over-the-counter (OTC).
"The FDA considers these products new drugs and thus they must undergo the FDA's drug approval process," said Mike Chappell, the FDA's acting associate commissioner for regulatory affairs. "The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process."
Bayer Heart Advantage combines aspirin and phytosterols in a single tablet. Bayer Women's combines aspirin and calcium carbonate in a single tablet. The products are labeled as being a combination of a drug and a dietary supplement, but when a drug and a dietary supplement are combined in a single tablet, the product is regulated by FDA as a drug. According to the labeling, the phytosterols in Bayer Heart Advantage are intended to lower blood cholesterol and the calcium in Bayer Women's is intended to strengthen bones to fight osteoporosis.
Although certain calcium-containing dietary supplements may bear claims to reduce the risk of osteoporosis, products that are labeled to "fight" or otherwise treat osteoporosis are drugs that require FDA approval. Similarly, although certain phytosterol-containing dietary supplements may bear claims to reduce the risk of coronary heart disease, and may note that the mechanism by which phytosterols achieve this effect is through lowering blood cholesterol, direct claims to lower cholesterol are claims to prevent or treat coronary heart disease and hypercholesterolemia, which is also a disease.
Products bearing such claims require an approved new drug application from FDA in order to be legally marketed, and cannot be legally marketed for OTC use.
Under its OTC drug monograph system, FDA allows some drugs to be marketed without first obtaining agency approval. These drugs must comply with applicable monographs, that is, regulations that set requirements for the drugs' labeling and formulation, as well as the indications (uses) for which the drugs can be marketed. OTC drugs that do not meet these requirements and that lack FDA approval are considered illegal, unapproved drugs. Bayer Heart
Advantage and Bayer Women's do not meet the conditions in any applicable OTC monograph, and do not have FDA approval. Therefore, Bayer Heart Advantage and Bayer Women's are unapproved new drugs.
In addition, Bayer Heart Advantage and Bayer Women's are misbranded because their labeling lacks adequate directions for use by consumers. In order for a drug to have adequate directions for use, the directions must be written so that consumers can use the product safely for its intended purpose, without the supervision of a health care professional. The use of these products for treatment of heart disease and osteoporosis requires diagnosis and supervision by a health care professional to ensure safe use. Therefore, it is not possible, in OTC drug product labeling, for these products to have adequate directions for their intended uses. The products also are misbranded because their labeling do not have adequate warnings and are misleading.
Among other things, the labeling for the aspirin in the products includes directions and warnings regarding short term use, but these directions and warnings are contradicted by other directions for the phytosterols and calcium that promote the products' daily use without any time limits.
The result is a mixed message about the products' purposes and the length of time for which the products can be safely used.
"The marketing of these unapproved drugs is troubling," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Because OTC drugs are widely used by consumers, without supervision by a doctor or other health care professional, the overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events. It is essential that companies obtain FDA approval and fully comply with FDA regulations."
Although the FDA is not aware of significant adverse events associated with these products, the agency is concerned because neither product has been approved by FDA for its marketed uses.
Today's actions reaffirm the position taken by FDA in two previously issued Warning Letters - one sent to B.F. Ascher & Co., Inc., Lenexa, KS, regarding Melagesic PM, and the other to Omni Nutraceuticals, Inc., Los Angeles, CA regarding Inholtra Joint Pain products. In those letters, the FDA stated that drug ingredients combined with dietary ingredients in a single dosage form require agency approval to be legally marketed in the United States.
Companies that do not resolve violations in FDA Warning Letters risk enforcement action, such as injunctions and/or seizure of illegal products.
Action involves Bayer Aspirin with Heart Advantage and Bayer Women’s Low Dose Aspirin + Calcium
The U.S. Food and Drug Administration today sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products — Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).
The products, which contain aspirin with either phytosterols or calcium, are unapproved new drugs that require an approved new drug application in order to be legally marketed. In addition to being labeled for use as a pain reliever, both products are labeled for use in reducing the risks of heart disease.
Bayer Women's is also labeled for use in "fighting" osteoporosis. Neither product has been approved by the FDA for such uses. These drug uses require a health care professional's diagnosis and supervision, and therefore these products cannot be labeled for use by consumers and sold over-the-counter (OTC).
"The FDA considers these products new drugs and thus they must undergo the FDA's drug approval process," said Mike Chappell, the FDA's acting associate commissioner for regulatory affairs. "The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process."
Bayer Heart Advantage combines aspirin and phytosterols in a single tablet. Bayer Women's combines aspirin and calcium carbonate in a single tablet. The products are labeled as being a combination of a drug and a dietary supplement, but when a drug and a dietary supplement are combined in a single tablet, the product is regulated by FDA as a drug. According to the labeling, the phytosterols in Bayer Heart Advantage are intended to lower blood cholesterol and the calcium in Bayer Women's is intended to strengthen bones to fight osteoporosis.
Although certain calcium-containing dietary supplements may bear claims to reduce the risk of osteoporosis, products that are labeled to "fight" or otherwise treat osteoporosis are drugs that require FDA approval. Similarly, although certain phytosterol-containing dietary supplements may bear claims to reduce the risk of coronary heart disease, and may note that the mechanism by which phytosterols achieve this effect is through lowering blood cholesterol, direct claims to lower cholesterol are claims to prevent or treat coronary heart disease and hypercholesterolemia, which is also a disease.
Products bearing such claims require an approved new drug application from FDA in order to be legally marketed, and cannot be legally marketed for OTC use.
Under its OTC drug monograph system, FDA allows some drugs to be marketed without first obtaining agency approval. These drugs must comply with applicable monographs, that is, regulations that set requirements for the drugs' labeling and formulation, as well as the indications (uses) for which the drugs can be marketed. OTC drugs that do not meet these requirements and that lack FDA approval are considered illegal, unapproved drugs. Bayer Heart
Advantage and Bayer Women's do not meet the conditions in any applicable OTC monograph, and do not have FDA approval. Therefore, Bayer Heart Advantage and Bayer Women's are unapproved new drugs.
In addition, Bayer Heart Advantage and Bayer Women's are misbranded because their labeling lacks adequate directions for use by consumers. In order for a drug to have adequate directions for use, the directions must be written so that consumers can use the product safely for its intended purpose, without the supervision of a health care professional. The use of these products for treatment of heart disease and osteoporosis requires diagnosis and supervision by a health care professional to ensure safe use. Therefore, it is not possible, in OTC drug product labeling, for these products to have adequate directions for their intended uses. The products also are misbranded because their labeling do not have adequate warnings and are misleading.
Among other things, the labeling for the aspirin in the products includes directions and warnings regarding short term use, but these directions and warnings are contradicted by other directions for the phytosterols and calcium that promote the products' daily use without any time limits.
The result is a mixed message about the products' purposes and the length of time for which the products can be safely used.
"The marketing of these unapproved drugs is troubling," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Because OTC drugs are widely used by consumers, without supervision by a doctor or other health care professional, the overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events. It is essential that companies obtain FDA approval and fully comply with FDA regulations."
Although the FDA is not aware of significant adverse events associated with these products, the agency is concerned because neither product has been approved by FDA for its marketed uses.
Today's actions reaffirm the position taken by FDA in two previously issued Warning Letters - one sent to B.F. Ascher & Co., Inc., Lenexa, KS, regarding Melagesic PM, and the other to Omni Nutraceuticals, Inc., Los Angeles, CA regarding Inholtra Joint Pain products. In those letters, the FDA stated that drug ingredients combined with dietary ingredients in a single dosage form require agency approval to be legally marketed in the United States.
Companies that do not resolve violations in FDA Warning Letters risk enforcement action, such as injunctions and/or seizure of illegal products.
Friday, October 24, 2008
Soon-To-Be-Banned Plastic Toys Flooding the Market
Soon-To-Be-Banned Plastic Toys Flooding the Market
Toymakers mount 'fire sale' of phthalate-laden children's products
There was a festive feeling among consumer advocates when Congress passed legislation over the summer that outlaws the use of phthalates -- chemicals some fear may cause reproductive defects -- in toys. But ever-inventive toymakers have a holiday surprise: a flood of phthalate-ridden toys hitting stores just in time for holiday shopping.
The ban enacted by Congress doesn't take effect until Feb. 10, so toymakers and distributors have their elves working overtime to clear out their backlog of toys containing the chemical additives that make hard plastics more flexible.
Consumer advocates and some members of Congress are outraged that toymakers and retailers are rushing to sell the contaminated toys rather than destroy them. Congress never meant to "encourage fire sales in toy stores," Rep. Janice Schakowsky (D-Ill.) told The Wall Street Journal.
Full Story: http://www.consumeraffairs.com/news04/2008/10/plastic_toys_xmas.html
Toymakers mount 'fire sale' of phthalate-laden children's products
There was a festive feeling among consumer advocates when Congress passed legislation over the summer that outlaws the use of phthalates -- chemicals some fear may cause reproductive defects -- in toys. But ever-inventive toymakers have a holiday surprise: a flood of phthalate-ridden toys hitting stores just in time for holiday shopping.
The ban enacted by Congress doesn't take effect until Feb. 10, so toymakers and distributors have their elves working overtime to clear out their backlog of toys containing the chemical additives that make hard plastics more flexible.
Consumer advocates and some members of Congress are outraged that toymakers and retailers are rushing to sell the contaminated toys rather than destroy them. Congress never meant to "encourage fire sales in toy stores," Rep. Janice Schakowsky (D-Ill.) told The Wall Street Journal.
Full Story: http://www.consumeraffairs.com/news04/2008/10/plastic_toys_xmas.html
CPSC and Carter’s Advise Parents of Rashes Associated with Heat Transferred, or “Tag-less,” Labels
CPSC and Carter’s Advise Parents of Rashes Associated with Heat Transferred, or “Tag-less,” Labels
WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission (CPSC) and Carter’s, Inc., of Atlanta, Georgia, are advising parents and caregivers that they have received reports that a small percentage of babies and infants have developed rashes on the upper back after wearing Carter’s clothing with heat-transferred, or “tag-less,” labels.
This advisory applies to Carter’s Fall 2007 product line. The Fall 2007 line utilizes a label on the inside back of the garment that has a raised surface with a solid, rather than a stenciled, background. This advisory does not apply to previous and current product lines, which utilize labels with stenciled backgrounds.
The garments, which were made in various countries, were sold at Carter’s own retail stores and at department and national chain stores.
If your child develops a rash on the upper back after wearing garments that have a “tag-less” label with a solid background, you should stop using these garments. If the rash persists or worsens, you should contact your pediatrician. For additional information, visit Carter’s website at http://www.carters.com/corporate/tagless_message.aspx, contact Carter’s toll free at 1-888-282-4674 or by email at contactus@carters.com
WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission (CPSC) and Carter’s, Inc., of Atlanta, Georgia, are advising parents and caregivers that they have received reports that a small percentage of babies and infants have developed rashes on the upper back after wearing Carter’s clothing with heat-transferred, or “tag-less,” labels.
This advisory applies to Carter’s Fall 2007 product line. The Fall 2007 line utilizes a label on the inside back of the garment that has a raised surface with a solid, rather than a stenciled, background. This advisory does not apply to previous and current product lines, which utilize labels with stenciled backgrounds.
The garments, which were made in various countries, were sold at Carter’s own retail stores and at department and national chain stores.
If your child develops a rash on the upper back after wearing garments that have a “tag-less” label with a solid background, you should stop using these garments. If the rash persists or worsens, you should contact your pediatrician. For additional information, visit Carter’s website at http://www.carters.com/corporate/tagless_message.aspx, contact Carter’s toll free at 1-888-282-4674 or by email at contactus@carters.com
Wednesday, October 22, 2008
Using Over-the-Counter Cough and Cold Products in Children
Using Over-the-Counter Cough and Cold Products in Children
Tips for Parents and Caregivers
On Oct. 8, 2008, the Food and Drug Administration (FDA) released a statement that supports recent voluntary actions by many drug manufacturers regarding the use of nonprescription, over-the-counter (OTC) cough and cold products in children.
The voluntary actions announced by the Consumer Healthcare Products Association (CHPA) are intended to help prevent and reduce the misuse of these products in children and to better inform consumers about their safe and effective use. CHPA represents most of the manufacturers of these products.
Members of CHPA have volunteered to modify the product labels of OTC cough and cold medicines to state "do not use" in children under 4 years of age. (Many of the products currently state "do not use" in children under 2 years of age.) Additionally, the manufacturers are introducing new child-resistant packaging and new measuring devices for use with the products.
CHPA's voluntary actions will not affect the availability of the medicines, but will result in a transition period where the instructions for using some OTC cough and cold medicines in children will be different from others. Some product instructions will state "do not use" in children under 4 years of age, while others will instruct not to use in children under 2 years of age.
FDA does not typically request that OTC products with previous labeling be removed from the shelves during a voluntary label change such as this one. The agency recommends following the dosage instructions and warnings on the label that accompanies the medication if you have or buy a product that does not have the voluntarily modified labeling.
Recent FDA ActionsFDA has held two public meetings over the past year on the safe use of nonprescription OTC cough and cold medicines in children. The most recent meeting on Oct. 2, 2008, focused on labeling of these products. FDA issued a nationwide Public Health Advisory in January 2008 recommending that these products not be used in children under the age of 2 because of the risk of serious and potentially life-threatening side effects. FDA continues to reach out to other public health agencies, consumer and patient groups, drug manufacturers, CHPA, and the scientific community. As it obtains more up-to-date information and scientific data about the safety and effectiveness of these products in children, FDA can take the appropriate regulatory steps moving forward.
Tips for Parents and CaregiversDo not give children medications labeled only for adults. Talk to your health care professional, such as your doctor or pharmacist, if you have any questions about using cough or cold medicines in children. Choose OTC cough and cold medicines with child-resistant safety caps, when available. After each use, make sure to close the cap tightly and store the medicines out of the sight and reach of children. Check the "active ingredients" section of the "Drug Facts" label of the medicines that you choose. This section will help you understand what symptoms the active ingredients in the medicine are intended to treat. Cough and cold medicines often have more than one active ingredient, such as an antihistamine, a decongestant, a cough suppressant, an expectorant, or a pain reliever and fever reducer. Be very careful if you are giving more than one medicine to a child. Make sure the medicines do not have the same type of active ingredients. For example, do not give a child more than one medicine that has a decongestant. If you use two medicines that have the same or similar active ingredients, your child could be harmed by getting too much of an ingredient. Carefully follow the directions for how to use the medicine in the "Drug Facts" part of the label. These directions tell you how much medicine to give and how often you can give it. If you have a question about how to use the medicine, ask your pharmacist or other health care professional. Overuse or misuse of these products can lead to serious and potentially life-threatening side effects, such as rapid heartbeat, drowsiness, breathing problems, and seizures. Only use measuring devices that come with the medicine or those specially made for measuring drugs. Do not use household spoons to measure medicines for children because household spoons come in different sizes and are not meant for measuring medicines. Understand that using OTC cough and cold medicines does not cure the cold or cough. These medicines only treat your child's symptoms, such as runny nose, congestion, fever, and aches. They do not shorten the length of time your child is sick.
This article appears on FDA's Consumer Health Information Web page
(www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
For More InformationSafe Use of Over-the-Counter Drug
Productswww.fda.gov/cder/offices/otc/consumer.htm
FDA 101: How to Use the Consumer Complaint System and MedWatchwww.fda.gov/consumer/updates/reporting061008.html
Your Guide to Reporting Problems to FDAwww.fda.gov/consumer/updates/reporting_guide061008.html
Improving Medical Products for Children: Q & A with Dianne Murphy, M.D.www.fda.gov/consumer/updates/murphy091407.html
Tips for Parents and Caregivers
On Oct. 8, 2008, the Food and Drug Administration (FDA) released a statement that supports recent voluntary actions by many drug manufacturers regarding the use of nonprescription, over-the-counter (OTC) cough and cold products in children.
The voluntary actions announced by the Consumer Healthcare Products Association (CHPA) are intended to help prevent and reduce the misuse of these products in children and to better inform consumers about their safe and effective use. CHPA represents most of the manufacturers of these products.
Members of CHPA have volunteered to modify the product labels of OTC cough and cold medicines to state "do not use" in children under 4 years of age. (Many of the products currently state "do not use" in children under 2 years of age.) Additionally, the manufacturers are introducing new child-resistant packaging and new measuring devices for use with the products.
CHPA's voluntary actions will not affect the availability of the medicines, but will result in a transition period where the instructions for using some OTC cough and cold medicines in children will be different from others. Some product instructions will state "do not use" in children under 4 years of age, while others will instruct not to use in children under 2 years of age.
FDA does not typically request that OTC products with previous labeling be removed from the shelves during a voluntary label change such as this one. The agency recommends following the dosage instructions and warnings on the label that accompanies the medication if you have or buy a product that does not have the voluntarily modified labeling.
Recent FDA ActionsFDA has held two public meetings over the past year on the safe use of nonprescription OTC cough and cold medicines in children. The most recent meeting on Oct. 2, 2008, focused on labeling of these products. FDA issued a nationwide Public Health Advisory in January 2008 recommending that these products not be used in children under the age of 2 because of the risk of serious and potentially life-threatening side effects. FDA continues to reach out to other public health agencies, consumer and patient groups, drug manufacturers, CHPA, and the scientific community. As it obtains more up-to-date information and scientific data about the safety and effectiveness of these products in children, FDA can take the appropriate regulatory steps moving forward.
Tips for Parents and CaregiversDo not give children medications labeled only for adults. Talk to your health care professional, such as your doctor or pharmacist, if you have any questions about using cough or cold medicines in children. Choose OTC cough and cold medicines with child-resistant safety caps, when available. After each use, make sure to close the cap tightly and store the medicines out of the sight and reach of children. Check the "active ingredients" section of the "Drug Facts" label of the medicines that you choose. This section will help you understand what symptoms the active ingredients in the medicine are intended to treat. Cough and cold medicines often have more than one active ingredient, such as an antihistamine, a decongestant, a cough suppressant, an expectorant, or a pain reliever and fever reducer. Be very careful if you are giving more than one medicine to a child. Make sure the medicines do not have the same type of active ingredients. For example, do not give a child more than one medicine that has a decongestant. If you use two medicines that have the same or similar active ingredients, your child could be harmed by getting too much of an ingredient. Carefully follow the directions for how to use the medicine in the "Drug Facts" part of the label. These directions tell you how much medicine to give and how often you can give it. If you have a question about how to use the medicine, ask your pharmacist or other health care professional. Overuse or misuse of these products can lead to serious and potentially life-threatening side effects, such as rapid heartbeat, drowsiness, breathing problems, and seizures. Only use measuring devices that come with the medicine or those specially made for measuring drugs. Do not use household spoons to measure medicines for children because household spoons come in different sizes and are not meant for measuring medicines. Understand that using OTC cough and cold medicines does not cure the cold or cough. These medicines only treat your child's symptoms, such as runny nose, congestion, fever, and aches. They do not shorten the length of time your child is sick.
This article appears on FDA's Consumer Health Information Web page
(www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
For More InformationSafe Use of Over-the-Counter Drug
Productswww.fda.gov/cder/offices/otc/consumer.htm
FDA 101: How to Use the Consumer Complaint System and MedWatchwww.fda.gov/consumer/updates/reporting061008.html
Your Guide to Reporting Problems to FDAwww.fda.gov/consumer/updates/reporting_guide061008.html
Improving Medical Products for Children: Q & A with Dianne Murphy, M.D.www.fda.gov/consumer/updates/murphy091407.html
Sunday, October 19, 2008
States Act On BPA in Baby Bottles
States Act On BPA in Baby Bottles
Regulators take harder stance on chemical than Federal counterparts While federal regulators have taken the position that the chemical bisphenol A (BPA) in consumer products like baby bottles poses no risk, three states are taking a harder line.
Officials in Connecticut, New Jersey and Deleware have sent letters to 11 manufacturers, asking them to stop using BPA in baby bottles and baby formula containers in light of recent studies clearly linking the chemical to potential health problems.
The states contend that growing scientific evidence shows that even small amounts of BPA damages infant reproductive, neurological and immune systems.
"Exposure to this dangerous chemical has been linked to a range of illnesses, including cancer and diabetes. For the sake of consumers' safety, and especially the health and safety of our children, we are calling on manufacturers to immediately remove this chemical from the products they produce," said Delaware State Solicitor Lawrence Lewis.
Full Story: http://www.consumeraffairs.com/news04/2008/10/bpa_states.html
Regulators take harder stance on chemical than Federal counterparts While federal regulators have taken the position that the chemical bisphenol A (BPA) in consumer products like baby bottles poses no risk, three states are taking a harder line.
Officials in Connecticut, New Jersey and Deleware have sent letters to 11 manufacturers, asking them to stop using BPA in baby bottles and baby formula containers in light of recent studies clearly linking the chemical to potential health problems.
The states contend that growing scientific evidence shows that even small amounts of BPA damages infant reproductive, neurological and immune systems.
"Exposure to this dangerous chemical has been linked to a range of illnesses, including cancer and diabetes. For the sake of consumers' safety, and especially the health and safety of our children, we are calling on manufacturers to immediately remove this chemical from the products they produce," said Delaware State Solicitor Lawrence Lewis.
Full Story: http://www.consumeraffairs.com/news04/2008/10/bpa_states.html
Friday, October 17, 2008
Pet Owners Eligible For $24 Million in Landmark Melamine Settlement
Pet Owners Eligible For $24 Million in Landmark Melamine Settlement
But many say money is no replacement for loss of beloved animals Pet owners whose dogs or cats became ill or died last year after eating melamine-tainted food are now eligible for a piece of a landmark $24 million settlement. But some pet owners say no amount of money can replace the loss of their best friend.
Full Story: http://www.consumeraffairs.com/news04/2008/10/pet_food_settlement.html
But many say money is no replacement for loss of beloved animals Pet owners whose dogs or cats became ill or died last year after eating melamine-tainted food are now eligible for a piece of a landmark $24 million settlement. But some pet owners say no amount of money can replace the loss of their best friend.
Full Story: http://www.consumeraffairs.com/news04/2008/10/pet_food_settlement.html
Tests Find Bottled Water No Cleaner Than Tap Water
Tests Find Bottled Water No Cleaner Than Tap Water
10 popular brands contain mixtures of bacteria, fertilizer, and chemicals
Looking for ways to cut back in these tough economic times? An environmental group suggests skipping the bottled water and drinking from the tap. It might even be healthier.
The Environmental Working Group says its tests how 10 popular U.S. bottled water brands contain mixtures of 38 different pollutants, including bacteria, fertilizer, Tylenol and industrial chemicals, some at levels no better than tap water.
Full Story: http://www.consumeraffairs.com/news04/2008/10/polluted_bottled_water.html
10 popular brands contain mixtures of bacteria, fertilizer, and chemicals
Looking for ways to cut back in these tough economic times? An environmental group suggests skipping the bottled water and drinking from the tap. It might even be healthier.
The Environmental Working Group says its tests how 10 popular U.S. bottled water brands contain mixtures of 38 different pollutants, including bacteria, fertilizer, Tylenol and industrial chemicals, some at levels no better than tap water.
Full Story: http://www.consumeraffairs.com/news04/2008/10/polluted_bottled_water.html
Wednesday, October 15, 2008
Maple Leaf to tackle Listeria with newly approved preservative
Maple Leaf to tackle Listeria with newly approved preservative
Canadian meat processor, Maple Leaf Foods, said it plans to use a recently approved preservative that stops the growth of listeria for its meat products, following a listeria-related outbreak attributed to one of its plants and linked to 20 deaths.
In September, Health Canada gave the backing for the use by Canadian food processors of sodium diacetate as a preservative in meat, poultry and fish products. According to the food scientists, the preservative, when used in combination with sodium lactate, can inhibit the growth of Listeria monocytogenes.
The rules allow interim use of such preservatives in preparations of meat, meat byproducts, poultry meat, poultry meat byproducts and prepared and preserved fish products at a maximum level of 0.25 per cent of final product weight.
Last week CEO of Maple Leaf, Michael McCain said that Listeria exists in 100 per cent of all meat processing plants and it is impossible to eliminate it.
L monocytogenes is a pathogenic bacterium causing listeriosis, which is a rare but potentially lethal infection that can kill vulnerable people, such as the elderly and pregnant women, as well as those suffering from immuno-compromising diseases like cancer or HIV.
The pathogen can contaminate ready-to-eat meat and poultry during post-processing steps such as slicing, peeling and packaging.
Maple Leaf said that it identified listeria lurking deep inside two meat-slicing machines as the most likely source of the contamination, which caused it to shut down its Toronto processing plant in August.
The meat processor subsequently sanitized the facility, which led the government to permit the company to resume food production on 17 September. However, products are not allowed to leave the site until the Canadian Food Inspection Agency (CFIA) finishes its testing programme.
Maple Leaf said that since the plant re-opened 841 environmental samples have been taken, with one positive test result for listeria: “This is considerably lower than what normal practice would yield in listeria management programs.”
Officials are taking 60 samples from each production line every day, said McCain.
Maple Leaf said that it has developed a five-point plan for food safety, including a proposal to strengthen Canada's food-inspection system that would involve:
Researchers from the University of Nottingham, in a recent study, claim that meat factories may need to modify their cleaning and disinfecting procedures according to the type of meat product being processed to prevent food poisoning outbreaks.
The team claims that biofilms, which are bacteria that form communities on surfaces, are much more highly resistant to cleaning products and antibiotics.
In their opinion, bacterium such as Listeria's success in persisting in processing environments comes partly from its ability to form resistant biofilms, and partly from its tolerance to drying out, thus enabling it to survive on ‘clean’ surfaces.
The researchers said that they also evaluated the influence of different cooked meat juices including beef, pork, lamb, chicken and duck on the attachment of Listeria to surfaces.
"We found significant differences between the ability of Listeria to stick to stainless steel surfaces at different temperatures, depending upon which meat was used,” said Professor Lisa Dodd. “Cooked duck juices at 25°C allowed the highest levels of Listeria attachment.”
Canadian meat processor, Maple Leaf Foods, said it plans to use a recently approved preservative that stops the growth of listeria for its meat products, following a listeria-related outbreak attributed to one of its plants and linked to 20 deaths.
In September, Health Canada gave the backing for the use by Canadian food processors of sodium diacetate as a preservative in meat, poultry and fish products. According to the food scientists, the preservative, when used in combination with sodium lactate, can inhibit the growth of Listeria monocytogenes.
The rules allow interim use of such preservatives in preparations of meat, meat byproducts, poultry meat, poultry meat byproducts and prepared and preserved fish products at a maximum level of 0.25 per cent of final product weight.
Last week CEO of Maple Leaf, Michael McCain said that Listeria exists in 100 per cent of all meat processing plants and it is impossible to eliminate it.
L monocytogenes is a pathogenic bacterium causing listeriosis, which is a rare but potentially lethal infection that can kill vulnerable people, such as the elderly and pregnant women, as well as those suffering from immuno-compromising diseases like cancer or HIV.
The pathogen can contaminate ready-to-eat meat and poultry during post-processing steps such as slicing, peeling and packaging.
Maple Leaf said that it identified listeria lurking deep inside two meat-slicing machines as the most likely source of the contamination, which caused it to shut down its Toronto processing plant in August.
The meat processor subsequently sanitized the facility, which led the government to permit the company to resume food production on 17 September. However, products are not allowed to leave the site until the Canadian Food Inspection Agency (CFIA) finishes its testing programme.
Maple Leaf said that since the plant re-opened 841 environmental samples have been taken, with one positive test result for listeria: “This is considerably lower than what normal practice would yield in listeria management programs.”
Officials are taking 60 samples from each production line every day, said McCain.
Maple Leaf said that it has developed a five-point plan for food safety, including a proposal to strengthen Canada's food-inspection system that would involve:
Researchers from the University of Nottingham, in a recent study, claim that meat factories may need to modify their cleaning and disinfecting procedures according to the type of meat product being processed to prevent food poisoning outbreaks.
The team claims that biofilms, which are bacteria that form communities on surfaces, are much more highly resistant to cleaning products and antibiotics.
In their opinion, bacterium such as Listeria's success in persisting in processing environments comes partly from its ability to form resistant biofilms, and partly from its tolerance to drying out, thus enabling it to survive on ‘clean’ surfaces.
The researchers said that they also evaluated the influence of different cooked meat juices including beef, pork, lamb, chicken and duck on the attachment of Listeria to surfaces.
"We found significant differences between the ability of Listeria to stick to stainless steel surfaces at different temperatures, depending upon which meat was used,” said Professor Lisa Dodd. “Cooked duck juices at 25°C allowed the highest levels of Listeria attachment.”
Melamine update---U.K.
Melamine update
The Food Standards Agency has today written to all UK ports and local authorities after the European Commission refined the measures it has put in place to test for melamine in food products from China.
Melamine is an industrial chemical that should not be present in food. Milk products containing melamine have been at the centre of a major food incident in China.
The European Commission had originally said that any composite products, like biscuits and cakes, from China containing more that 15% milk products (or where the content could not be established) should be tested for melamine. However, some Member States had been reporting difficulties in establishing the exact milk product content of a number of foods targeted by the original decision.
The new requirements that came into effect today now require the testing of all composite foods from China containing milk products. As before, products found to contain more than 2.5mg/kg melamine have to be withdrawn from the market and destroyed.
UK ports and local authorities are being advised to start implementing this new testing regime.
The revised measures continue the prohibition of imports into the European Community of infant formula from China and other composite products containing milk or milk products intended for infant and young children’s nutrition.
Feed and food business operators also need to provide prior notification, to the relevant port, of consignments from China of products covered by the Commission Decision.
The Food Standards Agency has today written to all UK ports and local authorities after the European Commission refined the measures it has put in place to test for melamine in food products from China.
Melamine is an industrial chemical that should not be present in food. Milk products containing melamine have been at the centre of a major food incident in China.
The European Commission had originally said that any composite products, like biscuits and cakes, from China containing more that 15% milk products (or where the content could not be established) should be tested for melamine. However, some Member States had been reporting difficulties in establishing the exact milk product content of a number of foods targeted by the original decision.
The new requirements that came into effect today now require the testing of all composite foods from China containing milk products. As before, products found to contain more than 2.5mg/kg melamine have to be withdrawn from the market and destroyed.
UK ports and local authorities are being advised to start implementing this new testing regime.
The revised measures continue the prohibition of imports into the European Community of infant formula from China and other composite products containing milk or milk products intended for infant and young children’s nutrition.
Feed and food business operators also need to provide prior notification, to the relevant port, of consignments from China of products covered by the Commission Decision.
Thursday, October 9, 2008
Advisory-Use of Codeine Products by Nursing Mothers
Use of Codeine Products by Nursing Mothers
Advisory2008-164
OTTAWA - Health Canada is advising the public, especially nursing mothers, about the very rare but serious health risk to breastfed babies posed by codeine use in mothers. Once ingested, codeine is converted by the body into morphine. Some people convert codeine into morphine more rapidly and completely than others. The babies of nursing mothers who rapidly metabolize codeine may be at increased risk for morphine overdose due to higher-than-expected morphine levels in breast milk.
Codeine is found in prescription and non-prescription products used to relieve pain or to treat coughs. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, awareness of this new information is important because in severe cases, infant death can occur.
Health Canada recommends nursing mothers take the following precautions to minimize the risk of morphine exposure in breastfed babies:
Consult a physician before taking any codeine-containing products. Read the ingredient list of all over-the-counter medications, especially cough or pain medications, to see if they contain codeine. If treatment with codeine is necessary, use the lowest effective dose for the shortest period of time. People who metabolize codeine very rapidly may experience overdose symptoms themselves such as extreme sleepiness, confusion, or shallow breathing. While the amount of overdose is generally not considered life-threatening in adults, if you are nursing a child and experience these symptoms, it is important to monitor your child carefully and talk to your doctor. Contact a doctor if your breastfed baby is sleepier than usual or has trouble breastfeeding. Seek immediate medical attention if your breastfed baby has difficulty breathing or is limp after you take a health product with codeine. The chance of being an ultra-rapid metabolizer (genotype CYP2D6) varies among different ethnic groups. The prevalence is estimated to be 1 per 100 people for those of Chinese, Japanese and Hispanic descent, 3 per 100 for African Americans and 1 to 10 per 100 for Caucasians. North African, Ethiopian and Arab populations have the highest estimated prevalence, from 16 to 28 per 100 people. There is currently no test available for general use in Canada to identify ultra-rapid metabolizers of codeine. Careful monitoring of mother and child is the best way to identify those potentially at risk.
Health Canada has reviewed the available information on this subject, and is currently working with drug manufacturers so that the labelling for codeine-containing prescription products are revised to include information that better identifies the risk to breastfed babies whose mothers are ultra-rapid metabolizers of codeine. The labelling guidelines for non-prescription products containing codeine are also being revised to provide more information about this risk.
Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
Report online at the MedEffect™ Canada Web site Call toll-free at 1-866-234-2345 Complete a Canada Vigilance Reporting Form and either: Fax toll-free to 1-866-678-6789 Mail to: Canada Vigilance ProgramHealth CanadaAL 0701COttawa, ON K1A 0K9
Advisory2008-164
OTTAWA - Health Canada is advising the public, especially nursing mothers, about the very rare but serious health risk to breastfed babies posed by codeine use in mothers. Once ingested, codeine is converted by the body into morphine. Some people convert codeine into morphine more rapidly and completely than others. The babies of nursing mothers who rapidly metabolize codeine may be at increased risk for morphine overdose due to higher-than-expected morphine levels in breast milk.
Codeine is found in prescription and non-prescription products used to relieve pain or to treat coughs. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, awareness of this new information is important because in severe cases, infant death can occur.
Health Canada recommends nursing mothers take the following precautions to minimize the risk of morphine exposure in breastfed babies:
Consult a physician before taking any codeine-containing products. Read the ingredient list of all over-the-counter medications, especially cough or pain medications, to see if they contain codeine. If treatment with codeine is necessary, use the lowest effective dose for the shortest period of time. People who metabolize codeine very rapidly may experience overdose symptoms themselves such as extreme sleepiness, confusion, or shallow breathing. While the amount of overdose is generally not considered life-threatening in adults, if you are nursing a child and experience these symptoms, it is important to monitor your child carefully and talk to your doctor. Contact a doctor if your breastfed baby is sleepier than usual or has trouble breastfeeding. Seek immediate medical attention if your breastfed baby has difficulty breathing or is limp after you take a health product with codeine. The chance of being an ultra-rapid metabolizer (genotype CYP2D6) varies among different ethnic groups. The prevalence is estimated to be 1 per 100 people for those of Chinese, Japanese and Hispanic descent, 3 per 100 for African Americans and 1 to 10 per 100 for Caucasians. North African, Ethiopian and Arab populations have the highest estimated prevalence, from 16 to 28 per 100 people. There is currently no test available for general use in Canada to identify ultra-rapid metabolizers of codeine. Careful monitoring of mother and child is the best way to identify those potentially at risk.
Health Canada has reviewed the available information on this subject, and is currently working with drug manufacturers so that the labelling for codeine-containing prescription products are revised to include information that better identifies the risk to breastfed babies whose mothers are ultra-rapid metabolizers of codeine. The labelling guidelines for non-prescription products containing codeine are also being revised to provide more information about this risk.
Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
Report online at the MedEffect™ Canada Web site Call toll-free at 1-866-234-2345 Complete a Canada Vigilance Reporting Form and either: Fax toll-free to 1-866-678-6789 Mail to: Canada Vigilance ProgramHealth CanadaAL 0701COttawa, ON K1A 0K9
Wednesday, October 8, 2008
Drug Stayed on Hospital Shelves Despite Recall
Drug Stayed on Hospital Shelves Despite Recall
Nearly 100 pharmacists and the hospitals they work for face fines for failing to remove a blood thinner from their shelves after a federal recall last winter, a California state agency said.
The recalled drug heparin was found 94 times in inspections of all 533 hospitals in California, and at least 16 hospitals administered the drug to patients, according to the state Board of Pharmacy. Fines range from $2,500 to $5,000.
"This was really an alert that the recall system doesn't work," Virginia Herold, head of the state's pharmacy board, told The Associated Press.
Regulators have not released the full list of hospitals involved. However, documents obtained by the Daily Journal show newborns were allegedly given heparin at the University of California San Francisco Medical Center and Children's Hospital of Central California in Madera. Both hospitals are appealing the charges.
Heparin, which is often used in premature children to prevent blood clots, has come under scrutiny because of accidental life-threatening overdoses given to babies, including actor Dennis Quaid's newborn twins at a Los Angeles hospital last November. Fourteen other babies received accidental heparin overdoses in July at a hospital in Corpus Christi, Texas.
The Federal Drug Administration issued a drug recall in February because "a higher than usual number" of patients reported adverse effects to heparin, which include chest pain, dizziness and headache.
The state's Department of Public Health has also launched an investigation to determine whether recalled heparin, Digitex and Procrit caused harm to any patients.
No link has been found, though a state health official said the state will try to ensure recalled drugs are taken out of hospitals.
"Our actions are to act as both a partner and an enforcer to look at what kinds of system breakdowns are taking place, to make sure we don't have a reoccurrence of this in the future," Kathleen Billingsley, deputy director of the state's Center for Healthcare Quality, told the AP.
In March 2008, the state Board of Pharmacy voted 12-0 to give drug makers, wholesalers and pharmacies until Jan. 1, 2011, to start electronically tracking drugs from factory to patient. The electronic tracking system has been delayed a number of times since 2004, when a recall of 175,000 bottles of fake Lipitor, the cholesterol drug, led state regulators to require tracking.
Herold said although it's unclear whether the tracking system would have prevented this incident, it will give pharmacists a better idea of what is on their shelves.
In September, the Oakbrook Terrace, Ill.-based Joint Commission, an independent, not-for-profit organization health quality group, issued a safety alert asking hospitals nationwide to adopt stricter measures to prevent errors involving blood thinners, including heparin.
Nearly 100 pharmacists and the hospitals they work for face fines for failing to remove a blood thinner from their shelves after a federal recall last winter, a California state agency said.
The recalled drug heparin was found 94 times in inspections of all 533 hospitals in California, and at least 16 hospitals administered the drug to patients, according to the state Board of Pharmacy. Fines range from $2,500 to $5,000.
"This was really an alert that the recall system doesn't work," Virginia Herold, head of the state's pharmacy board, told The Associated Press.
Regulators have not released the full list of hospitals involved. However, documents obtained by the Daily Journal show newborns were allegedly given heparin at the University of California San Francisco Medical Center and Children's Hospital of Central California in Madera. Both hospitals are appealing the charges.
Heparin, which is often used in premature children to prevent blood clots, has come under scrutiny because of accidental life-threatening overdoses given to babies, including actor Dennis Quaid's newborn twins at a Los Angeles hospital last November. Fourteen other babies received accidental heparin overdoses in July at a hospital in Corpus Christi, Texas.
The Federal Drug Administration issued a drug recall in February because "a higher than usual number" of patients reported adverse effects to heparin, which include chest pain, dizziness and headache.
The state's Department of Public Health has also launched an investigation to determine whether recalled heparin, Digitex and Procrit caused harm to any patients.
No link has been found, though a state health official said the state will try to ensure recalled drugs are taken out of hospitals.
"Our actions are to act as both a partner and an enforcer to look at what kinds of system breakdowns are taking place, to make sure we don't have a reoccurrence of this in the future," Kathleen Billingsley, deputy director of the state's Center for Healthcare Quality, told the AP.
In March 2008, the state Board of Pharmacy voted 12-0 to give drug makers, wholesalers and pharmacies until Jan. 1, 2011, to start electronically tracking drugs from factory to patient. The electronic tracking system has been delayed a number of times since 2004, when a recall of 175,000 bottles of fake Lipitor, the cholesterol drug, led state regulators to require tracking.
Herold said although it's unclear whether the tracking system would have prevented this incident, it will give pharmacists a better idea of what is on their shelves.
In September, the Oakbrook Terrace, Ill.-based Joint Commission, an independent, not-for-profit organization health quality group, issued a safety alert asking hospitals nationwide to adopt stricter measures to prevent errors involving blood thinners, including heparin.
Health Canada Reminds Canadians of Turkey Safety this Thanksgiving
Health Canada Reminds Canadians of Turkey Safety this Thanksgiving
Information Update2008-160
Cooked turkey is a central part of many holiday celebrations in Canada - especially Thanksgiving. Health Canada would like to remind all Canadians that there are simple steps they can take to help ensure their turkey feast is a safe one.
Adopting standard safe cooking and safe handling practices (clean, separate, cook and chill) reduces the risk to yourself and your family from undercooked turkey and stuffing and from cross contamination during preparation.
Health Canada reminds you:
Store your turkey in the refrigerator or freezer immediately after it is purchased.
Do not thaw your turkey at room temperature.
Thaw turkey in the refrigerator or in cold water.
If you thaw your turkey in cold water, keep the turkey in its original wrapping and change the cold water regularly to ensure that the water remains cold.
Do not rinse raw turkey. This can spread bacteria everywhere the water splashes, creating a safety hazard.
Clean and disinfect surfaces and kitchen utensils touched by raw turkey or drippings from thawing turkey.
Use a food thermometer, and cook turkey until the temperature of the thickest part of the breast or thigh is at least 85ºC (185ºF). Cook stuffing separately in its own oven dish or on the stove top.
If you do stuff your turkey, stuff loosely just prior to roasting, and remove all stuffing immediately after cooking.
Cook stuffing to a minimum internal temperature of 74ºC (165ºF).
Refrigerate all leftovers within two hours of cooking.
Turkey poses particular food safety challenges because it can be contaminated with bacteria such as Salmonella, which can cause diarrhea, vomiting and stomach cramps.
It is estimated that there are between 11 million and 13 million cases of food-related illnesses in Canada every year. Many of these illnesses could be prevented by following proper food handling and preparation techniques.
Information Update2008-160
Cooked turkey is a central part of many holiday celebrations in Canada - especially Thanksgiving. Health Canada would like to remind all Canadians that there are simple steps they can take to help ensure their turkey feast is a safe one.
Adopting standard safe cooking and safe handling practices (clean, separate, cook and chill) reduces the risk to yourself and your family from undercooked turkey and stuffing and from cross contamination during preparation.
Health Canada reminds you:
Store your turkey in the refrigerator or freezer immediately after it is purchased.
Do not thaw your turkey at room temperature.
Thaw turkey in the refrigerator or in cold water.
If you thaw your turkey in cold water, keep the turkey in its original wrapping and change the cold water regularly to ensure that the water remains cold.
Do not rinse raw turkey. This can spread bacteria everywhere the water splashes, creating a safety hazard.
Clean and disinfect surfaces and kitchen utensils touched by raw turkey or drippings from thawing turkey.
Use a food thermometer, and cook turkey until the temperature of the thickest part of the breast or thigh is at least 85ºC (185ºF). Cook stuffing separately in its own oven dish or on the stove top.
If you do stuff your turkey, stuff loosely just prior to roasting, and remove all stuffing immediately after cooking.
Cook stuffing to a minimum internal temperature of 74ºC (165ºF).
Refrigerate all leftovers within two hours of cooking.
Turkey poses particular food safety challenges because it can be contaminated with bacteria such as Salmonella, which can cause diarrhea, vomiting and stomach cramps.
It is estimated that there are between 11 million and 13 million cases of food-related illnesses in Canada every year. Many of these illnesses could be prevented by following proper food handling and preparation techniques.
Saturday, October 4, 2008
More nations pull suspect products as China milk scandal spreads
More nations pull suspect products as China milk scandal spreads
South Korea, Australia and Japan Saturday pulled melamine-contaminated sweets and drinks from supermarket shelves amid a widening scandal over Chinese milk products tainted with the toxic chemical.
Authorities in Seoul ordered Mars and Nestle to pull three products after melamine, which is usually used for making plastics, was detected in snacks made in China by the multinationals.
The industrial chemical had been found in M&M's milk chocolate snack and Snickers peanut Fun Size, both produced by Mars, and Kit Kat chocolate bars imported from Nestle Tianjin in China, Korea Food and Drug Administration said.
"Mars is recalling these products because it is legally obligated to do so following the announcement by the Korean Food and Drug Administration (KFDA)," Mars said in a statement.
Melamine has been blamed for making thousands of infants ill and killing four in mainland China after it tainted baby milk powder in arguably the worst in a litany of product safety scandals involving Chinese-made goods in recent years.
Since first appearing in baby milk formula, melamine has been found in a range of products containing Chinese milk.
Mars said while it was complying with the South Korean request, the melamine levels detected were too small to pose a health risk, and called for a standard reporting limit of the industrial chemical across Asia.
"Minute traces of melamine are commonly found throughout the global food chain and melamine levels below 2.5 ppm are not deemed to indicate adulteration with melamine," it said. There was no immediate comment from Nestle Korea.
A KFDA official told AFP South Korea did not allow any level of melamine in food.
World Health Organisation food safety expert Peter Ben Embarek said earlier this week many countries had only recently fixed limits for melamine in food as "melamine has nothing to do with the food chain".
The chemical was added to milk before being sold to dairy manufacturers in a bid to falsely boost protein readings, Chinese authorities have said.
A fourth Chinese milk product has been withdrawn from sale in Australia after tests revealed it was tainted with melamine, Food Standards Australia New Zealand said in a statement.
"Consumers are advised not to consume Kirin milk tea made in China," the organisation said.
The Australian food watchdog has already recalled White Rabbit sweets and Chinese-made Cadbury chocolate eclairs, while importers of Lotte Koala Biscuits have undertaken a precautionary withdrawal of the product.
A Japanese importer, meanwhile, began recalling Chinese chocolates suspected of being contaminated with melamine.
The western Japanese city of Osaka said a test showed the chemical had been detected in "Chocolate Pillows" imported from China by Osaka-based NS International.
While there had been no reports of health problems, the city ordered the importer to recall some 86,000 packages of the chocolates on the grounds that the company may have violated the food sanitation law.
China is struggling to limit the damage to its food safety reputation as a growing number of countries have decided to suspend imports of Chinese milk products or withdraw them from sale over the scandal.
The European Union recently banned all imports on Chinese milk-related products for children such as biscuits and chocolate on top of a long-standing embargo on Chinese dairy products like milk and yoghurt.
South Korea, Australia and Japan Saturday pulled melamine-contaminated sweets and drinks from supermarket shelves amid a widening scandal over Chinese milk products tainted with the toxic chemical.
Authorities in Seoul ordered Mars and Nestle to pull three products after melamine, which is usually used for making plastics, was detected in snacks made in China by the multinationals.
The industrial chemical had been found in M&M's milk chocolate snack and Snickers peanut Fun Size, both produced by Mars, and Kit Kat chocolate bars imported from Nestle Tianjin in China, Korea Food and Drug Administration said.
"Mars is recalling these products because it is legally obligated to do so following the announcement by the Korean Food and Drug Administration (KFDA)," Mars said in a statement.
Melamine has been blamed for making thousands of infants ill and killing four in mainland China after it tainted baby milk powder in arguably the worst in a litany of product safety scandals involving Chinese-made goods in recent years.
Since first appearing in baby milk formula, melamine has been found in a range of products containing Chinese milk.
Mars said while it was complying with the South Korean request, the melamine levels detected were too small to pose a health risk, and called for a standard reporting limit of the industrial chemical across Asia.
"Minute traces of melamine are commonly found throughout the global food chain and melamine levels below 2.5 ppm are not deemed to indicate adulteration with melamine," it said. There was no immediate comment from Nestle Korea.
A KFDA official told AFP South Korea did not allow any level of melamine in food.
World Health Organisation food safety expert Peter Ben Embarek said earlier this week many countries had only recently fixed limits for melamine in food as "melamine has nothing to do with the food chain".
The chemical was added to milk before being sold to dairy manufacturers in a bid to falsely boost protein readings, Chinese authorities have said.
A fourth Chinese milk product has been withdrawn from sale in Australia after tests revealed it was tainted with melamine, Food Standards Australia New Zealand said in a statement.
"Consumers are advised not to consume Kirin milk tea made in China," the organisation said.
The Australian food watchdog has already recalled White Rabbit sweets and Chinese-made Cadbury chocolate eclairs, while importers of Lotte Koala Biscuits have undertaken a precautionary withdrawal of the product.
A Japanese importer, meanwhile, began recalling Chinese chocolates suspected of being contaminated with melamine.
The western Japanese city of Osaka said a test showed the chemical had been detected in "Chocolate Pillows" imported from China by Osaka-based NS International.
While there had been no reports of health problems, the city ordered the importer to recall some 86,000 packages of the chocolates on the grounds that the company may have violated the food sanitation law.
China is struggling to limit the damage to its food safety reputation as a growing number of countries have decided to suspend imports of Chinese milk products or withdraw them from sale over the scandal.
The European Union recently banned all imports on Chinese milk-related products for children such as biscuits and chocolate on top of a long-standing embargo on Chinese dairy products like milk and yoghurt.
Friday, October 3, 2008
FDA Issues Interim Safety and Risk Assessment of Melamine and Melamine-related Compounds in Food
FDA Issues Interim Safety and Risk Assessment of Melamine and Melamine-related Compounds in Food
The U.S. Food and Drug Administration (FDA) today issued the results of its interim safety and risk assessment of melamine and melamine-related compounds in food, including infant formula.
A safety/risk assessment is a scientifically based methodology used to estimate the risk to human health from exposure to specified compounds. It is based on available data and certain scientific assumptions in the absence of data. The purpose of the FDA interim safety/risk assessment was to identify the level of melamine and melamine-related compounds in food which would not raise public health concerns. The interim safety/risk assessment evaluated the melamine exposure in infant formula and in other foods.
The safety/risk assessment, prompted by reports of melamine contamination of milk-derived ingredients and finished food products containing milk manufactured in China, was conducted by scientists from FDA's Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine. The FDA reviewed scientific literature on melamine toxicity.
Infant Formula FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns. In large part, this is because of gaps in our scientific knowledge about the toxicity of melamine and its analogues in infants, including:
the consequences of the continuous use of infant formulas as the sole source of nutrition; the uncertainties associated with the possible presence and co-ingestion of more than one melamine analogue; and for premature infants with immature kidney function, the possibility that they may be fed these formulas as the sole source of nutrition and thus on a body weight basis experience greater levels of intake for a longer time than is experienced by term infants. There is too much uncertainty to set a level in infant formula and rule out any public health concern.
However, it is important to understand that this does not mean that any exposure to any detectable level of melamine and melamine–related compounds in formula will result in harm to infants.
Other Food ProductsIn food products other than infant formula, the FDA concludes that levels of melamine and melamine-related compounds below 2.5 parts per million (ppm) do not raise concerns. This conclusion assumes a worst case exposure scenario in which 50% of the diet is contaminated at this level, and applies a 10-fold safety factor to the Tolerable Daily Intake (TDI) to account for any uncertainties. The TDI is an estimate of the maximum amount of an agent to which an individual could be exposed on a daily basis over the course of a lifetime without an appreciable health risk.
FDA continues to screen products, collaborate with foreign governments and their regulatory agencies, and monitor reports of contamination from international sources to help ensure that potentially contaminated products from foreign sources are examined if imported into the United States. If products are adulterated because they contain melamine and/or a melamine-related compound, the agency will take appropriate actions to prevent the products from entering commerce.
The U.S. Food and Drug Administration (FDA) today issued the results of its interim safety and risk assessment of melamine and melamine-related compounds in food, including infant formula.
A safety/risk assessment is a scientifically based methodology used to estimate the risk to human health from exposure to specified compounds. It is based on available data and certain scientific assumptions in the absence of data. The purpose of the FDA interim safety/risk assessment was to identify the level of melamine and melamine-related compounds in food which would not raise public health concerns. The interim safety/risk assessment evaluated the melamine exposure in infant formula and in other foods.
The safety/risk assessment, prompted by reports of melamine contamination of milk-derived ingredients and finished food products containing milk manufactured in China, was conducted by scientists from FDA's Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine. The FDA reviewed scientific literature on melamine toxicity.
Infant Formula FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns. In large part, this is because of gaps in our scientific knowledge about the toxicity of melamine and its analogues in infants, including:
the consequences of the continuous use of infant formulas as the sole source of nutrition; the uncertainties associated with the possible presence and co-ingestion of more than one melamine analogue; and for premature infants with immature kidney function, the possibility that they may be fed these formulas as the sole source of nutrition and thus on a body weight basis experience greater levels of intake for a longer time than is experienced by term infants. There is too much uncertainty to set a level in infant formula and rule out any public health concern.
However, it is important to understand that this does not mean that any exposure to any detectable level of melamine and melamine–related compounds in formula will result in harm to infants.
Other Food ProductsIn food products other than infant formula, the FDA concludes that levels of melamine and melamine-related compounds below 2.5 parts per million (ppm) do not raise concerns. This conclusion assumes a worst case exposure scenario in which 50% of the diet is contaminated at this level, and applies a 10-fold safety factor to the Tolerable Daily Intake (TDI) to account for any uncertainties. The TDI is an estimate of the maximum amount of an agent to which an individual could be exposed on a daily basis over the course of a lifetime without an appreciable health risk.
FDA continues to screen products, collaborate with foreign governments and their regulatory agencies, and monitor reports of contamination from international sources to help ensure that potentially contaminated products from foreign sources are examined if imported into the United States. If products are adulterated because they contain melamine and/or a melamine-related compound, the agency will take appropriate actions to prevent the products from entering commerce.
Thursday, October 2, 2008
Doctors Urge FDA to Recall Cold Medicines for Children
Doctors Urge FDA to Recall Cold Medicines for Children
WASHINGTON — With a new cold season coming, the government is trying once more to decide what to do about over-the-counter medicines for kids' coughs and sniffles. Doctors question the drugs' benefits and worry about their risks.
Pediatricians are urging the Food and Drug Administration, which scheduled a public hearing Thursday on the issue, to demand a recall of the medicines for children younger than 6.
"Parents should know that there is less evidence than ever to support the use of over-the-counter cough and cold medicines for young children," said Dr. Joshua Sharfstein, Baltimore's health commissioner. "There is nothing that is holding the FDA back from asking for a voluntary recall now of products marketed to kids under 6."
U.S. families spend at least $286 million a year on such cough and cold remedies for children, according to the Nielsen Co. market research firm. In any given week the medicines are used by an estimated 10 percent of all children, with the biggest exposure among 2- to 5-year-olds, a recent Boston University report found.
But colds usually clear up on their own after a few days. Many doctors say rest and plenty of fluids are what it takes to get over a cold.
The FDA this year warned against giving OTC cold medicines to children younger than 2. At that time, officials said they expected to decide by spring on recommendations for youngsters up to 11. Now the agency is seeking more advice from doctors, industry and consumers.
The industry says OTC medicines have been used for decades in treating kids' colds and are safe for those older than 2. Nonetheless, manufacturers are carrying out new studies involving the most common ingredients in the medications. The companies voluntarily stopped selling cough and cold medicines for babies and toddlers last fall.
FDA advisers said that was not enough and recommended that the drugs not be used for children younger than 6. An expert panel said older children could keep taking the medications while studies are undertaken to settle scientific questions about safety and effectiveness.
It turns out that when the FDA set standards for cough and cold medicines some 30 years ago, no separate studies were done for kids.
Cough and cold medicines send about 7,000 children to hospital emergency rooms each year with symptoms ranging from hives and drowsiness to unsteady walking. Low doses of a medicine are not likely to cause a problem; the main risk comes from unintentional overdoses.
The same ingredients usually are found in different products. For example, giving a child a cough syrup and a decongestant could inadvertently lead to an overdose.
The Consumer Healthcare Products Association, which represents the manufacturers, says preventable errors are the problem, not the safety of the ingredients in the medicines. The industry is starting an educational campaign aimed at parents, doctors and day care providers on the importance of following directions and storing medicines in places where kids cannot get at them.
But Sharfstein said Maryland saw an immediate benefit after OTC cough and cold remedies for tots were removed from store shelves last fall. Calls to poison control about problems with the medicines involving children younger than 2 dropped by 40 percent, from 99 to 60, in the first six months of this year when compared with 2007. Calls involving children 2 to 6 also dropped, but by much less.
WASHINGTON — With a new cold season coming, the government is trying once more to decide what to do about over-the-counter medicines for kids' coughs and sniffles. Doctors question the drugs' benefits and worry about their risks.
Pediatricians are urging the Food and Drug Administration, which scheduled a public hearing Thursday on the issue, to demand a recall of the medicines for children younger than 6.
"Parents should know that there is less evidence than ever to support the use of over-the-counter cough and cold medicines for young children," said Dr. Joshua Sharfstein, Baltimore's health commissioner. "There is nothing that is holding the FDA back from asking for a voluntary recall now of products marketed to kids under 6."
U.S. families spend at least $286 million a year on such cough and cold remedies for children, according to the Nielsen Co. market research firm. In any given week the medicines are used by an estimated 10 percent of all children, with the biggest exposure among 2- to 5-year-olds, a recent Boston University report found.
But colds usually clear up on their own after a few days. Many doctors say rest and plenty of fluids are what it takes to get over a cold.
The FDA this year warned against giving OTC cold medicines to children younger than 2. At that time, officials said they expected to decide by spring on recommendations for youngsters up to 11. Now the agency is seeking more advice from doctors, industry and consumers.
The industry says OTC medicines have been used for decades in treating kids' colds and are safe for those older than 2. Nonetheless, manufacturers are carrying out new studies involving the most common ingredients in the medications. The companies voluntarily stopped selling cough and cold medicines for babies and toddlers last fall.
FDA advisers said that was not enough and recommended that the drugs not be used for children younger than 6. An expert panel said older children could keep taking the medications while studies are undertaken to settle scientific questions about safety and effectiveness.
It turns out that when the FDA set standards for cough and cold medicines some 30 years ago, no separate studies were done for kids.
Cough and cold medicines send about 7,000 children to hospital emergency rooms each year with symptoms ranging from hives and drowsiness to unsteady walking. Low doses of a medicine are not likely to cause a problem; the main risk comes from unintentional overdoses.
The same ingredients usually are found in different products. For example, giving a child a cough syrup and a decongestant could inadvertently lead to an overdose.
The Consumer Healthcare Products Association, which represents the manufacturers, says preventable errors are the problem, not the safety of the ingredients in the medicines. The industry is starting an educational campaign aimed at parents, doctors and day care providers on the importance of following directions and storing medicines in places where kids cannot get at them.
But Sharfstein said Maryland saw an immediate benefit after OTC cough and cold remedies for tots were removed from store shelves last fall. Calls to poison control about problems with the medicines involving children younger than 2 dropped by 40 percent, from 99 to 60, in the first six months of this year when compared with 2007. Calls involving children 2 to 6 also dropped, but by much less.
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