Sunday, August 31, 2008

Recall scares may backfire on safety effectiveness, fall on deaf ears.

Recall scares may backfire on safety effectiveness.

UK consumers are increasingly turned off by product recalls and food scares - with almost 70 per cent saying they are hardly aware of product alerts and fewer than 20 per cent trusting manufacturers. A new nationwide survey has revealed national apathy over public alerts

Ironically, as the EU and UK regulatory and advisory authorities report soaring numbers of recall and safety reports in the last year, their effectiveness in terms of consumer safety seems to be diminishing as consumer apathy sets in

The survey, conducted this month by European risk management and PR experts Razor, reveals for the first time solid statistical evidence that partially undermines the approach adopted by manufacturers and government advisory bodies who feel it is their legal and moral responsibility to 'tell it all and tell it fast' whenever a product emerges as a threat to human safety.

The Razor survey looked at recalls and product alerts in general as well as food and drink recalls in particular.

Among headlines emerging from the survey are as follows.

Some 67 per cent of those questioned, male and female, are either not aware of any product recall alerts in the last year or only aware of one or two.

The most trusted sources of product safety advice and information are the regulatory bodies or independent authorities (38 per cent), like the Food Standards Agency in the case of food and drink alerts or, more generally, local councils and the Consumer Council.

Only 17 per cent said they would trust a manufacturer's advice; 15 per cent would turn to the media for their information and a mere 13 per cent said they would trust the retailer.

On food safety alerts specifically, over a fifth, 21 per cent, feel less confident about food safety now than they did a year ago and 16 per cent 'don't care about such alerts and don't take any notice of them'.

Commenting on the findings, Chris Woodcock, Managing Director of Razor, explained: "More than 1,300 food safety incidents were investigated by the UK Food Standards Agency last year, the first time there was an industry-wide, reliable tally.

"Yet the survey shows only the minority of these, that progress as far as recall, are getting the message across.

"There are various reasons why product alert notifications are increasing, not least the 2005 product safety legislation that forced manufacturers to be responsible for informing the authorities and consumers of any potential risk to consumers from their products.

"In addition, beyond pure compliance, there is also a growing desire on the part of organisations to live up to their corporate and social responsibility commitments, by doing - and being seen to do - the right thing.

"However, our survey shows that the sheer volume of recalls and warnings is increasingly, proportionally, falling on deaf ears.

"Moreover, and perhaps even more worryingly, the trend for those who do take any notice of the advice is to trust what the media tell them more often than the retailers and almost as often as the manufacturers.

"Although the advisory bodies might be mildly encouraged by our findings, this is a sharp blow for fmcg brands who have built up brand equity over many decades and who can suffer major dents in sales and loyalty as a result of recalls or other incidents.

"It clearly indicates that more work needs to be done to recover trust and overcome the scepticism, particularly following some high-profile brand incidents in the first half of 2007".

The current rate of product alerts is no accident: for instance, more stringent public alert demands arose as a result of European legislation, which established the European Food Safety

Authority and new procedures in food safety back in 2002.

Articles within the legislation relating to traceability and transparency forced manufacturers to be more open about product recalls.

Meanwhile, the volume of alerts shows no sign of abating, nor does the provision of timely public advice: in the last year to spring 2007, the Food Standards Agency (FSA) dealt with 81 food alerts issued to local authorities and 478 notifications to the European Commission, through the

Rapid Alert system for Food and Feed that supplies Member States with two-way intelligence on measures to ensure food safety.

In a parallel move, the US Food and Drug Administration (FDA) announced in June 2007 a new advisory committee designed to counsel the agency on how to strengthen the communication of risks and benefits of FDA-regulated products to the public.

The Risk Communication Advisory Committee will have a three-part role: help the FDA better understand the communication needs and priorities of the general public; advise the FDA on the development of strategic plans to communicate product risks and benefits; and make recommendations to the FDA on what current research suggests about crafting risk and benefit messages, as well as how to most effectively communicate specific product information to vulnerable audiences.

David Honour, editor of risk management and business continuity website continuitycentral.com, commented: "The momentum for manufacturers and retailers to take more action has been building seriously for about three years, triggered in part by the FSA and the British Retail Consortium's product recall guidelines.

"It seems to be becoming a positive choice for boardroom teams, not just a distress purchase by companies that feel under duress".

Other recent industry data demonstrates that recalls are also becoming increasingly international, with 48 per cent of European recalls involving products made in China, meaning that UK businesses relying on Chinese manufacturers are increasingly vulnerable, especially as Chinese legislation is still not wholly aligned with European.

Woodcock concluded: "There is a question of legal and regulatory compliance, that manufacturers are heeding but which is becoming much more complex.

"But there is also a much greater need for pre-emptive risk management and reputation-building work to prevent incidents arising or to mitigate their effects, on the consumer and on the brand, when they do occur".

Razor is a risk communications agency that specialises in risk management, issues management and crisis handling, operating largely in the food and drink industry.

It is an exclusive partner of Campden and Chorleywood Food Research Association (CCFRA): Razor Managing Director Chris Woodcock sits on the organisation's Quality Panel and they jointly run the DARE risk management service tailored to the European food and drink industry.
The national survey was carried out with 1,000 people above the age of 16 over the weekend of 13-15 July 2007 by independent research body, BMRB International.

On 19 April 2007 the European Commission released its annual report entitled 'Keeping European Consumers Safe'.

The report outlined some alarming statistics: in the previous year there were over a thousand
notifications of unsafe products, more than ever before and a third higher than in 2005.

Among these statistics, the number of notifications in the UK had doubled from 2005 to 2006, more than the EU average, pointing towards a proportionately bigger problem here than anywhere else in Europe, with a further surge expected in 2007.

Last year saw 92 reported recalls or safety notices from the UK, not including the 78 food related recalls and withdrawals.

Not only was this more than double the number in 2005, but that year itself saw an increase of 44 percent compared to 2004.

Hence, two consecutive years where the UK figures have virtually doubled.

Saturday, August 30, 2008

Health Canada Reminds Canadians of Steps They Can Take to Protect Themselves from Salmonella

Health Canada Reminds Canadians of Steps They Can Take to Protect Themselves from Salmonella

Information Update2008-149

OTTAWA - Health Canada is reminding Canadians of the importance of proper food handling in the prevention of salmonellosis, a foodborne illness caused by Salmonella.

Salmonella are bacteria that are naturally found in the intestines of many animals and birds, and are one of the most common causes for foodborne illness. Symptoms of salmonellosis include stomach cramps, nausea, vomiting, diarrhea and fever and usually appear between 12 to 72 hours after eating contaminated food.

While uncooked meat, poultry and eggs are the most common foods contaminated with Salmonella bacteria, all foods, including fruits and vegetables, can become contaminated. People who are infected with Salmonella bacteria can also infect others. Work surfaces that have been used to prepare uncooked meat, poultry and eggs can also expose you to Salmonella.

It is estimated that every year, 11 to 13 million Canadians suffer from foodborne illness. You can minimize your chances of contracting salmonellosis by taking the following precautions:

Wash your hands. Handwashing, using soap and warm water before and after handling food, is one of the best ways to prevent the spread of foodborne illness. Remember to wash your hands when you finish handling raw foods. Also, be sure to wash your hands after caring for your family pet, as Salmonella can be found in animal feces and on reptiles.

Keep work surfaces clean. Be sure to carefully wash with soap and warm water all cutting boards, counters, knives and other utensils after preparing uncooked foods. Wash all plates and utensils that touched or held raw meat or poultry before using them again for food that is ready-to-eat.

Wash all fresh produce. Raw fruits and vegetables can be contaminated with bacteria so they should be washed thoroughly with running water before they are prepared and eaten. Use a brush to scrub produce with firm or rough surfaces, such as cantaloupes, oranges, potatoes and carrots.

Cook food thoroughly. Contaminated foods may look and smell normal, but thorough cooking will destroy the bacteria. Use a digital instant-read food thermometer to check when meat and poultry are safe to eat. Don't eat raw or undercooked eggs, poultry or meat and avoid raw or unpasteurized milk and dairy products. Cooked foods are safe to eat when internal temperatures are:

71° C (160° F) for ground beef 74° C (165° F) for leftover food, ground poultry and poultry parts 85° C (185° F) for whole poultry Properly store food. When buying and storing foods, separate raw meat and poultry from fruits, vegetables, cooked foods and ready-to-eat foods. Bacteria grow quickly at room temperature, so be sure to refrigerate or freeze food immediately when returning from grocery shopping and never defrost food at room temperature. Always defrost food in the refrigerator, in cold water or in the microwave.

For more information on how to prevent illness from Salmonella please see It's Your Health on Salmonella Prevention.

Thursday, August 28, 2008

Europe not reacting to Californian Teflon concerns

Europe not reacting to Californian Teflon concerns

As California moves a step nearer to outlawing the use of the chemical Perfluorooctanoic acid (PFOA) in food packaging, European regulators say they are not currently reassessing their own opinions on the chemical.

The European Commission told FoodProductionDaily.com that it was not currently aware of any discussions on use of the chemical relating to food safety, after ruling on its use as an emulsifier in Teflon back in 2005. Under its ruling, the chemical is cleared for use - under certain conditions - in food contact plastics, though member states can individually decide on its acceptance in coatings.

Bill approval
The comments come after Senate Bill 1313, which would ban PFOA and other perfluorochemicals (PFCs) in packaging, was yesterday passed by the California State Assembly. It will now be forwarded onto the senate for approval, before heading to state governor Arnold Schwarzeneger for approval.

If successful, from 1 January 2010, no person or company shall manufacture, sell or distribute any food contact substance that contains PFOA or precursors to the chemical, in any concentration exceeding 10 parts per billion in the state.

PFCS
PFOA is one of a number of substances that form part of PFCs family, which are used in stain and grease-proof packaging for products like microwave popcorn, sweets and candy, fast food and pizzas.

As part of its complaint, the bill claims that PFOA is considered by the federal Environmental Protection Agency (EPA) to be a likely carcinogen and a chemical that induces breast tumours in animals.

European policy
In Europe, the Commission said that PFOA had already been reviewed by the European Food Safety Authority (EFSA) back in 2005, as part of Directive 2007/19/EC, which relates to monolayer and multilayer structures that purely consist of plastic.

EFSA said that it had permitted the chemical for use in packaging, though only in repeated use articles that have been formed through high temperature sinter.
PFOA in individual markets

A spokesperson for the UK's Food Standards Agency (FSA) confirmed to FoodProductionDaily.com earlier this year that PFOA is permitted for food packaging in that market.

Amongst its uses, it is an intermediate in the manufacture of stain, oil and water-resistant additives for some textiles, coatings and food contact papers.

Although no indication was given as to whether the FSA plans any investigation into its safety, the agency is aware that the use of PFOS was stopped in the paper industry in 2004 following the voluntary cessation of their production by the major US manufacturer 3M.

Wednesday, August 27, 2008

CPSC Urges Consumers To Stop Using Simplicity 3-in-1 and 4-in-1 Convertible Bassinets

Infants Strangled to Death in Simplicity Bassinets: CPSC Urges Consumers To Stop Using Simplicity 3-in-1 and 4-in-1 Convertible “Close-Sleeper” Models

WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission (CPSC) is urging parents and caregivers to stop using convertible “close-sleeper/bedside sleeper” bassinets manufactured by Simplicity Inc., of Reading, Pa. CPSC has learned that on August 21, 2008, a 5-month-old girl from Shawnee, Kan. was strangled to death when she became entrapped between the bassinet’s metal bars. This is the second strangulation death CPSC has learned of in the co-sleeper bassinets. On September 29, 2007, a 4-month-old girl from Noel, Mo. became entrapped in the metal bars of the bassinet and died.

CPSC is issuing this safety alert because SFCA Inc., the company which purchased all of Simplicity Inc.’s assets at public auction in April 2008, has refused to cooperate with the government and recall the products. SFCA maintains that it is not responsible for products previously manufactured by Simplicity Inc.

The Simplicity 3-in-1 and 4-in-1 convertible bassinets contain metal bars spaced farther apart than 2 3/8 inches, which is the maximum distance allowed under the federal crib safety standard. The metal bars are covered by an adjustable fabric flap which is attached by velcro. The fabric is folded down when the bassinet is converted into a bed-side co-sleeping position. If the velcro is not properly re-secured when the flap is adjusted, an infant can slip through the opening and become entrapped in the metal bars and suffocate. This warning does not cover bassinets produced in recent months that have fabric permanently attached over the lower bar.

Due to the serious hazard these bassinets pose to babies, CPSC urges all consumers to share this safety warning with day care centers, consignment stores, family and friends to ensure that no child is placed to sleep in a Simplicity convertible bassinet covered by this warning.

The Commission voted, using its new authorities in the Consumer Product Safety Improvement Act, to release this warning upon making a finding that the health and safety of the public require immediate notice.

Wal-Mart Selling Bassinets Blamed for Killing Two Babies

Wal-Mart Selling Bassinets Blamed for Killing Two Babies

Simplicity products still at stores and for sale online

Simplicity bassinets that are still being sold at Wal-Mart and on Wal-Mart's Web site have been blamed for killing two babies.

An apparently faulty frame on the Winnie the Pooh 4-in-1 Simplicity Bassinet crushed and suffocated two babies according to family members and a police report. This is the latest in a string of six deaths blamed on Simplicity baby furniture, with the previous four followed by recalls of those products.

The most recent death occurred last week on Thursday when six-and-a-half-month-old Kennedy Brotherton slipped between the mattress and the side railing after the mattress came loose from the frame, her aunt, Melissa Brotherton, told ConsumerAffairs.com in a phone interview.

Kennedy's body slipped through a space between the mattress and the railing until she dangled by her head on the lower bar of the railing and choked, according to Capt. Ron Copeland of the Shawnee Police Department in Kansas.

"She was laughing and smiling when her parents put her to bed," Brotherton said. "They checked on her three times within an hour period. They were in the living room less than 10 feet away. She never cried."

The first death occurred last fall when Katelynn Simon suffered a similar fate in the same bassinet. "The rail design allowed her to slip her legs through and as she kept inching out she slipped lower," Simon's grandmother, Lori Crammond, wrote in a complaint to ConsumerAffairs.com. "Finally, her lungs were unable to expand."

The product appears to be sold exclusively at Wal-Mart and on Wal-Mart's Web site. As of yesterday, ConsumerAffairs.com found the product at two Washington, D.C.-area Wal-Marts we visited. The bassinet comes in two different Winnie the Pooh fabrics with the product identifications 3123DOH8 and 3112DOH7 and sells for between $100 and $110.

Crammond wrote that she warned Wal-Mart of the dangerous bassinet last fall. "Wal-Mart is very aware of what happened but continues to sell it with a five star rating," she wrote.
Wal-Mart has not returned two requests for comment made yesterday morning and this
morning.

More than a million Simplicity cribs were recalled for the same reason from May 2005 to September 2007 in four separate recalls, after four children died and countless others were injured when they were trapped between the mattress and the railing.

These bassinets have not been recalled. But the government agency responsible for recalling dangerous products, the Consumer Product Safety Commission (CPSC), is actively investigating the matter, said agency spokesman Scott Wolfson.

"CPSC is ... aware of two tragic deaths involving babies that had been placed in Simplicity bassinets," he said.

Both families said their goal is to warn as many consumers as possible."Our main concern is to get the product recalled," Brotherton said.

Simplicity products are certified by the Juvenile Products Manufacturing Association (JPMA) and these bassinets carry the association's seal.

The association gave no comment on the recent allegations against Simplicity's bassinets. In a prepared response after the previous recalls, the association stated that "Simplicity's products carry the JPMA certification seal because they have passed the comprehensive and rigorous tests and review administered at our qualified independent testing lab."

The prepared statement did not address the concerns of the products they endorsed, but instead seemed to blame the dangers of the products on the parents.

"As with all consumer products, it's important to follow the manufacturer's assembly instructions," JPMA said in the statement. "This recall should serve as a reminder to all consumers to regularly check their cribs to ensure that they are properly assembled, and all screws and bolts are appropriately tightened. Consumers should check with manufacturers if they have any concerns about product assembly."

As for Simplicity, the company appears to be out of business. A phone call to the company's headquarters was met with a prerecorded message stating "Simplicity, Inc. is no longer in business and we no longer service Simplicity, Inc. products."

Two phone calls made yesterday and today and an e-mail were not returned by the company's attorney, Rick Locker, who has many clients in the child product industry.

The product also is under the Baby Disney product line since the bassinet is adorned in Disney's Winnie the Pooh characters. Disney responded last night but has not returned a subsequent phone call.

Toxic metals found in Ayurvedic meds sold online

Toxic metals found in Ayurvedic meds sold online

Traditional Ayurvedic medicines manufactured in the United States and India and sold via the Internet may contain unacceptable levels of lead, mercury or arsenic, researchers warn in a report released Tuesday.

Ayurvedic medicines are used by most of India's 1.1 billion people and worldwide by people from South Asia and other regions. "However, since 1978 more than 80 cases of lead poisoning associated with Ayurvedic medicine use have been reported worldwide," Dr. Robert B. Saper, from Boston University School of Medicine, and colleagues note in the Journal of the American Medical Association.

There are two major types of Ayurvedic medicines: herbal-only and rasa shastra, which is an ancient practice of deliberately combining herbs with metals (e.g., mercury, lead, iron, zinc), minerals (e.g., mica) and gems (e.g., pearl). Rasa shastra experts claim that these medicines are safe and therapeutic when properly prepared and administered.

Among 193 Ayurvedic medicines analyzed by Saper's team, the prevalence of metal-containing products was 20.7 percent. The prevalence of metals in American-made Ayurvedic medicines was 21.7 percent, compared with 19.5 percent in Indian-made products.

Rasa shastra medicines were more than twice as likely as non-rasa shastra products to contain detectable metals (40.5 percent vs 17.1 percent) and had higher concentrations of lead and mercury.

"Several Indian-manufactured rasa shastra medicines could result in lead and/or mercury ingestions 100 to 10,000 times greater than acceptable limits," the investigators report.

"Among the metal-containing products, 95 percent were sold by U.S. Web sites and 75 percent claimed Good Manufacturing Practices," the researchers note.

"Current regulations governing the quality of herbal supplements made and sold in the US and India are inadequate," Saper told Reuters Health. "We recommend strictly enforced government-mandated daily dose limits for toxic metals in all dietary supplements.

Manufacturers should have to demonstrate compliance with these standards through independent third-party laboratory testing."

"Although the current study focused on Ayurvedic medicines, reports of similar problems with toxic metals in other traditional medicines (e.g. Chinese, Mexican, Middle Eastern) and Western herbal supplements have been reported, Saper noted.

He and his colleagues recommend that Ayurvedic medicine users avoid rasa shastra medicines.

"Products made by members of the American Herbal Product Assn; capsules/liquids/pastes; are less likely to contain toxic metals," Saper said. "Products that have obtained seals of quality approval from Consumer Lab.com and the United States Pharmacopeia (USP) can be assumed to be free of significant levels of toxic metals," he added.

Tuesday, August 26, 2008

Three Southern California businesses pay over $59,000 for distributing unregistered Korean pesticides

Three Southern California businesses pay over $59,000 for distributing unregistered Korean pesticides

Contact Information: Francisco Arcaute (213) 244-1815, cell (213) 798-1404 arcaute.francisco@epa.gov

LOS ANGELES – The U.S. Environmental Protection Agency recently settled with two Southern California importers and a supermarket for a total of $59,040 for the alleged sale or distribution of unregistered Korean pesticides, a violation of federal pesticide law.The settlements included:·

Jayone Foods, Inc., a kitchen goods importer and distributor located at 7212 Alondra Blvd.,

Paramount, paid $10,400 for distributing “Home Clinic – Antibacterial;"·

Bega Trading Company, a household goods importer and distributor located at 3850 Wilshire Blvd., Los Angeles, paid $33,040 for importing and distributing "Bisol Kitchen and Bath Disinfectant;”·

Zion Market, a supermarket located at 12565 Carson St., Hawaiian Gardens, paid $15,600 for selling "Home Clinic - Antibacterial"; "Kitchen Cleaner - Antibacterial"; and "Oxy Sack Sack Kitchen and Bathroom Cleaner - Antibacterial."

All of the products sold were imported from Korea and made either English or Korean-language claims to disinfect or sanitize surfaces. Disinfectants and sanitizers are considered “pesticides” under the Federal Insecticide, Fungicide, and Rodenticide Act, and must be registered with the EPA.

“Companies must be aware that products intended to kill or control germs need to be registered as pesticides,” said Katherine Taylor, associate director of the Communities and Ecosystems Division in the EPA’s Pacific Southwest office. “The EPA will continue to pursue violators of the law to ensure that these products do not make misleading and unverifiable claims.”

The Federal Insecticide, Fungicide, and Rodenticide Act regulates the sale, distribution, and use of pesticides within the United States. Importers, distributors, and retailers, are required by federal law to ensure that any pesticides they distribute have been registered with EPA.

For more information on pesticide regulation and enforcement, please visit: http://epa.gov/compliance/civil/fifra.

Burning incense linked to respiratory cancers

Burning incense linked to respiratory cancers

Burning incense may create a sweet scent, but regularly inhaling the smoke could put people at risk of cancers of the respiratory tract, researchers reported Monday.

In a study of more than 61,000 ethnic Chinese living in Singapore who were followed for up to 12 years, the investigators found a link between heavy incense use and various respiratory cancers.

The findings are published in the medical journal Cancer.

Incense has been used for millennia in many cultures' religious and spiritual ceremonies. In Asia, people commonly burn incense in their homes -- a practice that is becoming more popular in Western countries as well.

Incense is usually derived from fragrant plant materials, like tree bark, resins, roots, flowers and essential oils. Past research has found that burning these materials can produce potentially cancer-causing substances, including benzene and polyaromatic hydrocarbons.

However, no studies until now had linked the practice of burning incense to an increased cancer risk over time, according to the researchers, led by Dr. Jeppe T. Friborg of the Statens Serum Institute in Copenhagen.

For their study, the researchers followed 61,320 Singapore Chinese men and women between the ages of 45 and 74 from the Hokkien or Cantonese dialect group. All of the subjects were cancer-free at the outset.

Participants reported on their typical incense use, including how often they burned it in their homes and for how long -- only at night, for instance, or all day and night.

Over the next 12 years, 325 men and women developed cancer of the upper respiratory tract, such as nasal, oral or throat cancer. Another 821 developed lung cancer.

The researchers found that incense use was associated with a statistically significant higher risk of cancers of the upper respiratory tract, with the exception of nasopharyngeal cancer. However, they observed no overall effect on lung cancer risk.

Those who used incense heavily also had higher rates of a type of cancer called squamous cell carcinoma, which refers to tumors that arise in the cells lining the internal and external surfaces of the body. The risk was seen in smokers and nonsmokers.

Study participants who used incense in their homes all day or throughout the day and night were 80 percent more likely than non-users to develop squamous cell carcinoma of the entire respiratory tract.

The link between incense use and increased cancer risk held when the researchers weighed other factors, including cigarette smoking, diet and drinking habits.

"This association is consistent with a large number of studies identifying carcinogens in incense smoke," Friborg's team writes, "and given the widespread and sometimes involuntary exposure to smoke from burning incense, these findings carry significant public health implications."

They say further studies are needed to see whether different types of incense are associated with different degrees of cancer risk. In Singapore, the researchers note, most people burn long sticks or coils of incense that burn slowly over an extended period.

Heavy MSG use increases risk of being overweight

Heavy MSG use increases risk of being overweight

Eating foods that contain lots of monosodium glutamate (MSG), a flavor enhancer frequently used in Asian cuisine, can make you fat, new research published in the journal Obesity suggests.

Rural Chinese men and women who consumed the most MSG were more than twice as likely to be overweight than their peers who didn't use the additive, Dr. Ka He of the University of North Carolina at Chapel Hill and colleagues found.

In 1969, He and his team note in their report, a study showed that mice given large doses of MSG shortly after birth had gained more weight by 4 months of age than control mice, even though the control animals ate more. Researchers have also spotted injuries in the hypothalamus, a part of the brain that helps regulate appetite and fat metabolism, in mice given MSG.

But to date no one has investigated whether MSG intake is associated with weight gain in humans, according to He's group, possibly because intake of the additive from processed foods is difficult to measure. To fill in this knowledge gap, the researchers analyzed data from the International Study of Macro-/Micro-nutrients and Blood Pressure (INTERMAP), an investigation conducted to examine the relationship between sodium and blood pressure.

The study included 752 healthy men and women living in three different rural Chinese villages.

All ate very little processed food, making it easier for researchers to estimate MSG intake by looking at how much the study participants used when they prepared their meals.

The researchers found that 82.4 percent of study participants used MSG, with an average intake of 0.33 grams per day. Average body mass index (BMI) for non-MSG users was 22.3, compared to 23.5 for people who consumed the most MSG.

Once the researchers adjusted the data for the affects of physical activity and the total amount of calories consumed, they found that individuals in the top third of MSG consumption were 2.1-times more likely to have a BMI of 23 or higher than non-users. A BMI of 23 is considered overweight for Asian populations by the World Health Organization.

The heaviest consumers of MSG were 2.75-times more likely than non-users to have BMIs of 25 or greater, the international standard for overweight. The relationship was seen for both men and women.

Almost all research in animals linking MSG to hypothalamic damage has looked at the results of injecting the substance, rather than ingesting it, and the issue of whether the additive actually causes such damage is still being debated, He and colleagues note.

"Nevertheless," they add, "the findings from our study support the judgment against MSG supplementation of human foods."

Health Canada Reminds Parents of School Lunch Allergen Safety

Health Canada Reminds Parents of School Lunch Allergen Safety

Information Update2008-148

OTTAWA - As children head back to the classroom, Health Canada is reminding parents of the importance of allergy awareness when packing lunches for their children. Severe allergic reactions can occur quickly and without warning, and some foods can be life-threatening to allergic children.

As many as 1.2 million Canadians may be affected by life-threatening allergies and these numbers are increasing, especially among children. Foods account for most children’s allergies, with peanuts, tree nuts, sesame, soy, fish and seafood, wheat, eggs and milk being the most common food allergens.

When someone ingests even a tiny amount of an allergen, the symptoms of a reaction may develop quickly and can become very serious. The most dangerous symptoms include breathing difficulties, a drop in blood pressure, or shock, which may result in loss of consciousness and even death.

Because of this, many elementary schools are now restricting certain foods from students’ lunches. Parents are encouraged to follow school policies, even if their child is not allergic. To find out which foods, if any, are restricted in their children’s schools, parents should contact the school directly.

There is no cure for food allergies. The only option is complete avoidance of the particular allergen. This is why it is important that allergic children not be exposed to allergens that regularly cause extreme and sometimes fatal reactions.

Health Canada has a number of food allergy factsheets which provide information on the priority food allergens. An It's Your Health article is also available that provides additional information on severe allergic reactions.

National allergy associations, such as Anaphylaxis Canada, the Allergy Asthma Information Association or the Association Quebecoise des Allergies Alimentaires(French Only), also provide further information, including tips and strategies for educators, schools and other organizations for creating allergy safe communities.

Monday, August 25, 2008

(PML) in European patients receiving Tysabri monotherapy

FDA informed healthcare professionals of two new cases of progressive multifocal leukoencephalopathy (PML) in European patients receiving Tysabri monotherapy for multiple sclerosis for more than one year.

PML, which is usually fatal, is a known risk of Tysabri treatment, but previous cases in patients with multiple sclerosis were seen in combination with other immunomodulatory therapies.

Approximately 39,000 patients have received treatment with Tysabri worldwide, with approximately 12,000 patients receiving treatment for a least one year. No new cases have been seen in the US, where about 7,5000 patients have received the drug for greater than one year and approximately 3,300 patients have received the drug for at least one and one-half years.

In the U.S., Tysabri is available only to patients with relapsing multiple sclerosis or Chron's disease who are enrolled in the risk minimization plan called the TOUCH Prescribing Program.

Under this program, every Tysabri-treated patient is closely monitored and followed for the occurrence of PML and other serious opportunistic infections. While the two patients who developed PML were on monotherapy, the FDA still believes that Tysabri monotherapy may confer a lower risk of PML than when Tysabri is used together with other immunomodulatory medications.

Prescribing information for Tysabri will be revised to include information informing prescribers and patients that cases of PML have occurred in patients taking Tysabri as monotherapy.

Healthcare professionals should continue to monitor patients for sign and symptoms of PML. Additionally, Tysabri should not be infused if PML is suspected.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Information for Healthcare Professionals Sheet regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tysabri2

Friday, August 22, 2008

Safety Tips for Tropical Storm Victims

Safety Tips for Tropical Storm Victims

CPSC Warns of Dangers at Home in the Aftermath of Tropical Storm Fay

WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission (CPSC) warns residents of Florida who have been pounded by heavy rains and power outages from Tropical Storm Fay to take special precautions.

Portable gas generators, often used by consumers to restore power to their homes and businesses in the aftermath of a storm, produce high levels of deadly carbon monoxide (CO). CPSC warns consumers that generators should be used outdoors only, far from doors, windows, and vents that could allow CO to come indoors.

“Carbon monoxide is an odorless, colorless poison gas. It is an invisible killer,” said CPSC Acting Chairman Nancy Nord. “While generators can come in handy after a storm, using one indoors can kill you and your family in minutes.”

A Porter Novelli "Healthstyles" surveys* of more than 10,000 adults found dangerous misconceptions about generator safety. The surveys found that most respondents (62 percent) believe it is safe to run a generator in a garage as long as the garage door is open. Many (47 percent) also believe it is safe to run a generator in a basement as long as a window is open. But both scenarios have caused deaths. CPSC records show that there were nearly 100 generator-related deaths due to CO poisoning in 2005.

The Commission provided these important life-saving tips:
If you start to feel sick, dizzy or weak while using a generator, get to fresh air right away. The CO from generators can readily lead to full incapacitation and death.

Keep generators dry and wait for the rain to pass before using a generator. Consumer-grade generators are not weatherproof and can pose the risk of electrocution and shock when used in wet conditions.

Do not connect the generator directly into your home's electrical system through a receptacle outlet – this is an extremely dangerous practice that poses a fire hazard and an electrocution hazard to utility workers and neighbors served by the same transformer.

If using a generator, plug individual appliances into heavy duty, outdoor-rated extension cords and plug cords into the generator.

Check that the extension cords have a wire gauge adequate for the appliance loads and have all three prongs, including a grounding pin.

Keep charcoal grills outside. Never use them indoors. Burning charcoal in an enclosed space can produce lethal levels of carbon monoxide poisoning.

Check to make sure your smoke alarms and carbon monoxide alarms have batteries and are working.

Avoid Electrical and Gas HazardsLook for signs that your appliances have gotten wet. Discard electrical or gas appliances that have been wet because they pose electric shock and fire hazards.
Before using your appliances, have a professional or your gas or electric company evaluate your home and replace all gas control valves, circuit breakers, and fuses that have been under water.

Avoid Electrical and Gas HazardsYoung children and water don’t mix. Watch children around buckets, tubs and standing water in and around the home. Even small amounts of water can be a drowning hazard.

Irradiation: A Safe Measure for Safer Iceberg Lettuce and Spinach

Irradiation: A Safe Measure for Safer Iceberg Lettuce and Spinach

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On August 22, 2008, the Food and Drug Administration (FDA) published a final rule that allows the use of irradiation to make fresh iceberg lettuce and fresh spinach safer and last longer without spoiling.

Irradiating fresh iceberg lettuce and spinach will help protect consumers from disease-causing bacteria. Infections from bacteria such as Salmonella and Escherichia coli O157:H7 (E. coli) continue to be a public health problem in the United States. Illnesses from these bacteria range from uncomfortable symptoms to life-threatening health problems. Severe illness from E. coli, for example, can lead to kidney failure.

In addition to controlling harmful bacteria and other microorganisms, irradiating fresh iceberg lettuce and fresh spinach will allow the greens to keep longer without spoiling.

The foods affected by the final rule are
loose, fresh iceberg lettuce and fresh spinach
bagged iceberg lettuce and spinach

Irradiation and Safety
Irradiation (also sometimes termed "ionizing radiation") is a process of treating products with a measured dose of radiation. Food irradiation is not new. FDA has conducted irradiation safety evaluations for more than 40 years and has determined the process to be safe for use on a variety of foods.

After studying the safety of irradiating fresh iceberg lettuce and fresh spinach, FDA has determined that these greens, when irradiated under the conditions specified in the final rule, retain their nutrient value and are safe to eat.

FDA considers irradiation a complement to, not a replacement for, proper food-handling practices by producers, processors, and consumers. Irradiation is an additional tool that may be used to reduce the levels of disease-causing microorganisms on fresh iceberg lettuce and fresh spinach.

Irradiation does not take the place of washing. FDA continues to recommend that consumers wash fresh and bagged produce before eating unless the packaging specifically states that the product has been prewashed.

Irradiation of Other Foods
Many foods are already permitted to be irradiated to control bacteria and keep the foods longer without spoiling. For example, FDA approved the irradiation of red meat in 1997 after reviewing numerous scientific studies conducted worldwide on the effects of irradiation on various meat products. Other examples of foods that may be irradiated to kill microbes include spices, poultry, and molluscan shellfish (such as oysters, clams, mussels, and scallops).

FDA has previously allowed lettuce, spinach, and some other foods to be irradiated to kill insects or to slow spoilage. However, the doses used for these purposes are lower than what is required to kill most disease-causing bacteria.

How Will I Know if My Fresh Iceberg Lettuce or Spinach Has Been Irradiated?
Irradiation of iceberg lettuce and spinach is voluntary on the part of food processors. FDA requires that foods that have been irradiated bear the "radura" logo along with the statement "Treated with radiation" or "Treated by irradiation."

FDA’s Role in Safe Irradiation of Food
FDA regulates sources of irradiation (the equipment used) for foods as "food additives" that require approval before being allowed on the market. FDA approves a source of irradiation for use on food only after it has determined that irradiating the food is safe at a maximum dose specified by FDA. The agency continues to evaluate the safe use of irradiation in additional foods.
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 Information
FDA's Fact Sheet on Irradiationhttp://www.cfsan.fda.gov/~dms/irradlet.html
Date Posted: August 22, 2008

U.S. EPA fines Exxon Mobil $2.64 million for PCB release

U.S. EPA fines Exxon Mobil $2.64 million for PCB release

Contact Information: Francisco Arcaute, (213) 798-1404, arcaute.francisco@epa.gov

Toxic chemical leaked at the facility off the coast of Santa Barbara County

LOS ANGELES – The U.S. Environmental Protection Agency has settled with the Exxon Mobil Corporation for $2.64 million for allegedly disposing of and improperly handling polychlorinated biphenyls (“PCBs”) on an offshore oil and gas platform in the Santa Barbara Channel, off the Southern California coast, in violation of the federal Toxic Substances Control Act.

“Today’s settlement sends a clear signal that companies must follow PCB regulations to protect communities and our environmental resources,” said Wayne Nastri, administrator for the EPA’s Pacific Southwest region. “The EPA will not hesitate to take enforcement actions against companies that fail to properly handle and dispose of PCBs.”

Between 2002 and 2005, two large electrical transformers located on Platform Hondo, part of Exxon’s Santa Ynez Unit, leaked nearly 400 gallons of PCB-contaminated fluid. Exxon allowed one of the transformers to leak for almost two years before repairing it. The leaking from the transformers constitutes illegal disposal of PCBs, a violation of the Toxic Substances Control Act.
Additionally, Exxon failed to ensure that workers who cleaned up the leaked fluid were provided protective clothing or equipment to protect against direct contact with and inhalation of PCBs. Exxon replaced the two transformers with non-PCB containing transformers in 2005.

PCBs are man-made organic chemicals used in paints, industrial equipment, plastics, and cooling oil for electrical transformers. More than 1.5 billion pounds of PCBs were manufactured in the United States before the EPA banned the production of this chemical class in 1978, and many PCB-containing materials are still in use today.

When released into the environment, PCBs remain for decades. Tests have shown that PCBs cause cancer in animals and are suspected carcinogens in humans. Acute PCB exposure can also adversely affect the nervous, immune, and endocrine systems as well as liver function.

Concerns about human health and the extensive presence and lengthy persistence of PCBs in the environment led Congress to enact the Toxic Substances Control Act in 1976.

For more information on PCB regulation and enforcement, as well as the Toxic Substances Control Act enforcement in general, please visit the EPA’s website at: www.epa.gov/region09/toxic/pcb/ www.epa.gov/compliance/civil/tsca/index.html

Tuesday, August 19, 2008

CPSC Offers Tips for Back to School Safety

CPSC Offers Tips for Back to School Safety

WASHINGTON, D.C. – More than 50 million children are headed back to school this fall and the U.S. Consumer Product Safety Commission (CPSC) is urging parents to pay special attention to safety this school year.

Whether it’s wearing a helmet while they ride their bikes, watching out for dangerous drawstrings in children’s jackets, or checking the safety of school soccer goals, CPSC has important safety tips that can keep children from being sidelined with injuries.

Helmet SafetyWear a bicycle helmet when biking or riding a scooter to and from school. Make sure your child’s bicycle helmet has a label stating it meets CPSC’s mandatory safety standard.

Wearing a bicycle helmet can reduce the risk of head injury by as much as 85 percent.

CPSC staff has reports of an annual average of 80 children under 16 years of age who died in bicycle-related incidents in recent years. About half of the 500,000 bicycle-related emergency room-treated injuries in 2007 involved children under the age of 16. When taking part in other recreational activities, wear the right helmet for that activity. Read CPSC’s “Which Helmet for Which Activity” publication, which helps parents choose the most appropriate helmet, at http://www.cpsc.gov/CPSCPUB/PUBS/349.pdf (pdf).

More than 80 percent of the nearly 50,000 emergency room-treated injuries involving unpowered scooters in 2007 were to children younger than 15. In addition to wearing a helmet,

CPSC recommends elbow and knee pads when riding a scooter.

Avoid Children’s Clothing with DrawstringsDrawstrings at the hood or neck area are a strangulation hazard. They can catch on playground equipment and other items. Remove hood and neck drawstrings from upper outerwear clothing already in your child’s closet, and do not buy children’s clothing that uses them.

Since 1985, CPSC received reports of 27 deaths and 70 non-fatal incidents involving the entanglement of children’s clothing drawstrings.

Movable Soccer GoalsUnsecured movable soccer goals can fall over and kill or injure children who climb on them or hang from the crossbar. Make sure soccer goals are securely anchored when in use. Never allow children to climb on the soccer net or goal framework. When not in use, anchor goals or chain them to a nearby fence post or sturdy framework. Since 1998, CPSC has reports of at least 7 deaths and an estimated 1800 emergency department visits by children younger than 16 years of age that are related to soccer goal tip-overs and structural failures. For more information on soccer goal safety, visit http://www.cpsc.gov/CPSCPUB/PUBS/5118.html

PlaygroundsEach year, more than 200,000 hospital emergency room visits are related to playground injuries. Most injuries occur when a child falls onto the playground surface.

Check with school officials to make sure that equipment has been inspected and maintained.

There should be at least nine inches of safe, shock absorbing surface material, and proper clearance around the equipment. Make sure exposed hardware or free-hanging ropes are not part of the equipment. Ropes and clothing catching on exposed hardware can be strangulation hazards. Elevated surfaces, like platforms and ramps, should have guardrails to prevent falls.

School officials should be aware that shading at the playground with trees or other structures is an important consideration to reduce children’s exposure to the sun. Schools should also be aware that hot sun can make playground slides and black rubber matting burn hazards for children.

Listen to CPSC’s podcast on playground safety at http://www.cpsc.gov/mp3.html

ATVsDo not allow children to ride all-terrain vehicles (ATVs) to school due to the danger of riding on paved surfaces and never allow children to ride adult ATVs. For more information on

ATV safety, visit www.atvsafety.gov

EPA Finds Underground Storage Tank Violations At Federally-Run Facilities in Puerto Rico

EPA Finds Underground Storage Tank Violations At Federally-Run Facilities in Puerto Rico

Contact Information: John Senn (212) 637-3667, senn.john@epa.gov or Brenda Reyes (787) 977-5869, reyes.brenda@epa.gov

EPA has issued administrative complaints against three federal government entities over violations related to the management of underground storage tanks (USTs) in Puerto Rico. EPA issued an 11-count complaint to the Puerto Rico National Guard and the Army and Air Force Exchange Service for violations of the Resource Conservation and Recovery Act at Camp Santiago in Salinas, P.R. EPA also issued a complaint against the U.S. Department of Agriculture (USDA) for alleged violations of the Solid Waste Disposal Act at two facilities in Puerto Rico.

“EPA is taking these actions to demonstrate that federal agencies are held to the same rigorous standards as the public they serve,” said Alan J. Steinberg, EPA Regional Administrator.

“Underground tanks can cause serious damage as they leak, and it is critical that all entities, including the federal government, take requirements for testing and maintenance requirements seriously.”

An underground storage tank system commonly stores petroleum or hazardous wastes. There are about 625,000 USTs nationwide, and they can harm the environment and human health if their contents are released.

Camp Santiago is a training center for military activities, and contains vehicle fueling and maintenance areas. EPA identified violations at the center related to improper operation, testing and maintenance of the tanks. The complaint seeks a civil penalty of $209,264.

At two facilities in Puerto Rico, the USDA did not provide the required corrosion protection for their piping system and failed to conduct release detections of their tanks. USDA’s violations persisted for at least a year. EPA’s complaint seeks a civil penalty of $108,623.

For more information on underground storage tanks, visit http://www.epa.gov/oust/. For more information about Puerto Rico, visit http://www.epa.gov/region02/cepd/prlink.htm.

Three fires had been caused by overheating Apple iPod nanos- Japan

Japan's trade ministry said on Tuesday that three fires had been caused by overheating Apple iPod nanos, which it said could be due to a battery defect. No one was injured in the three fires involving the music players made by Apple Inc but the government said in a statement Apple had reported two other cases where people had suffered minor burns.

Apple officials were not immediately available for comment but the ministry said the firm had said a possible defect in iPod nano battery cells could have caused them to overheat.

The trade ministry said iPod nanos with known overheating incidents were sold in Japan between September 2005 and September 2006.

A semi-governmental body specializing in product safety will look into the cause of the incidents in cooperation with Apple, a trade ministry official said.

"We are not in the position to speculate on the outcome of the investigation. But after several incidents like these, it would be appropriate for Apple to take some measures to raise the public's awareness," the official said.

Monday, August 18, 2008

EPA Seeks Worker Protection at Four Farms in Puerto Rico

EPA Seeks Worker Protection at Four Farms in Puerto Rico

Contact Information: Beth Totman (212) 637-3662, totman.elizabeth@epa.gov

Through recent settlements with four Puerto Rico farms, the U.S. Environmental Protection Agency (EPA) is sending a message to farm owners that protecting their workers must be their first priority. Owners of Finca Roman Farm, Anthuriums de Puerto Rico and the Javier Quiles Farm, all in Adjuntas, as well as the owner of Finca Los Tres Picachos in Jayuya, failed to display specific pesticide application information for agricultural workers and pesticide handlers. Several of the farm owners also failed to provide workers with training, protective equipment or ways to wash off residual pesticides before leaving the work sites. Additionally, some of the farm owners failed to provide medical care information to workers and pesticide handlers and did not follow the pesticide label instructions for proper pesticide use and disposal.

“Dealing with pesticides can be potentially harmful if workers don’t have the proper equipment and aren’t informed of the best ways to handle and dispose of them,” said Alan J. Steinberg, Regional Administrator. “EPA wants to stress that worker protection should be the utmost priority for farm owners and these recent settlements underscore this point.”

Worker protection provisions of the federal pesticide law, known as the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), are designed to reduce the risk of illness or injury resulting from agricultural field workers’ occupational exposure to pesticides. They regulate pesticide use and require that workers and pesticide handlers be given appropriate training, equipment and information. Workers may be injured from direct spray, drift or residue left by pesticides applications; handlers face additional risks from spills, splashes, inhalation and inadequate protective equipment.

In October 2007, EPA filed a complaint for each of the four Puerto Rico farms for being in violation of the worker protection provisions of FIFRA. Each farm has agreed to pay a civil penalty, and to display information on pesticide application, information on pesticide safety and emergency medical care, as well as to provide decontamination supplies for workers and handlers, personal protective equipment, and pesticide safety training for workers and handlers. The farms have agreed to meet specific deadlines set by the EPA to report on progress that has been made under the settlement agreements.

To learn more about worker protection standards, visit: http://www.epa.gov/compliance/monitoring/programs/fifra/wps.html.

Thursday, August 14, 2008

Eco Friendly Advice for Healthy Lawns and Greenscapes

Eco Friendly Advice for Healthy Lawns and Greenscapes

Contact Information: Donna Heron, 215-814-5113 / heron.donna@epa.gov

Lush beautiful lawns are a part of summer, but they require time and money. The average lawn requires up to 40 hours of work and costs about $700 each year to maintain. But did you know that your yard and how you take care of it can help the environment?

A thick full lawn reduces soil erosion, filters contaminants from rainwater and absorbs airborne pollutants like dust and soot. Grass is also great at converting carbon dioxide to oxygen. The following are tips suggested by the EPA to help homeowners have yards that are beautiful and environmentally friendly.

· To keep your lawn looking its best set your mower height to 2½ to 3 ½ inches. Longer grass has more leaf surface which enables the grass to take in more sunlight and develop a deeper root system, making your lawn more drought and insect resistant. Longer grass also helps soil retain moisture and cuts down on the need to water. Mow often, but never cut more than a third of the length.

· According to a 2004 survey by the National Gardening Association, 66 million U.S. households used chemical pesticides and/or fertilizers on their lawns and gardens. But leaving grass clippings on your yard can reduce the need for these products. Grass clippings are about 90% water, will decompose quickly and provide nourishment back to the soil. They save landfill space too. Between 20 and 40 percent of landfill space is taken up by yard waste. Landfills produce methane gas which contributes to climate change.

· Keeping your yard healthy requires good preventative care, starting with the soil. Lawns grow best in an intermediate soil that is a mix of clay, sand and silt. You can always improve the quality of any type of soil by fertilizing. Instead of chemicals, add organic matter like compost, manure or grass clippings to the soil for nourishment. If your soil is hard, compacted or has a heavy clay presence, you may want to loosen or aerate the soil to allow water and nutrients to reach the grass and plant root systems.

· Consider reducing the size of your lawn by Greenscaping. Greenscaping makes use of native plant species as ground cover and provides a landscape that is more similar to natural habitats. Going natural can also reduce the need for chemicals, cut maintenance time and costs while still providing a beautiful yard and positive benefits for the environment.

· Planning your Greenscape can be creative and fun. For example, consider planting a wildflower meadow or use native perennials to provide color and ground cover near trees, patios and fences. Consider allowing part of your lawn to revert to woods (occasional management to control invasive exotic plants might be necessary until the woodland matures).

· Choose plants that are native to your region of the country. Your local nursery or County Agricultural Extension office can help you identify plants that will flourish in your area. Native plants require far less fertilization and are more resistant to insects, reducing the need for pesticides.

If you’d like more information on healthy yards or Greenscaping, visit our Web site at http://www.epa.gov/reg3esd1/garden/index.htm.

Wednesday, August 13, 2008

Family celebrates toy safety law Bush will sign

Family celebrates toy safety law Bush will sign

WASHINGTON - Colton Burkhart was just 4 when he swallowed a quarter-sized medallion that nearly took his life.

He didn't choke on it. But the metal trinket from a gumball-type machine contained 39 percent lead, and nearly five years later — after surgery to remove the toy, batteries of tests and therapy, the Oregon boy still has elevated levels of lead in his body and some short-term memory loss.

Colton's ordeal helped hasten recalls last year of millions of Chinese-produced toys, from Barbie doll accessories to Thomas the Tank Engine. And now his family is celebrating a new law that bans lead from children's toys.

President Bush is expected to sign it this week, two weeks after Congress approved the measure.

"I think it's fantastic," said Colton's mother, Kara Burkhart, an instructional assistant at the Redmond School District in central Oregon. "We can feel comfortable about buying toys again."

She traveled to Washington several times in the past year to lobby for the bill, telling anyone who would listen about dangers hidden in seemingly innocent toys like the one that wound up in her child's hands.

Colton fared better than another 4-year-old, Jarnell Graham of Minneapolis, who died of lead poisoning under similar circumstances. Burkhart said her heart still breaks for Jarnell's family.
"No child should have to go though something like this. They are playing with toys. They shouldn't be harmed because of it," Burkhart said.

The Consumer Product Safety Commission estimates there are about 28,000 deaths each year from unsafe products, including toys, in the United States. More than 33 million people were injured last year by consumer products.

Last month, Burkhart, 30, her husband Todd, 33, and sons Cody, 11, and Colton, now 9, were in the Capitol when the toy-safety bill won final approval in the Senate.

Until the bill passed, she added, "there was no way I was going to buy my children a toy again."

The legislation would impose the toughest lead standards in the world, banning lead beyond minute levels in products for children 12 or younger. Lead paint was a major factor in the recall of 45 million toys and children's items last year, many from China

The bill also bans a chemical called phthalates that is widely used to make plastic products softer and more flexible. And it bolsters the Consumer Product Safety Commission, which took the brunt of criticism last year over the massive recalls and the government's failure to monitor toy imports before they reach store shelves. The bill would double the agency's budget, to $136 million by 2014, and give it new authority to oversee testing procedures and penalize violators.

"This bill represents the most significant improvements to product safety since Congress created the CPSC in the 1970s," said Rachel Weintraub, senior counsel with Consumer Federation of America.

"Congress responded to the wishes of parents and children all across America and passed legislation that will help restore our confidence in the safety of our toys and everyday products," said Ami Gadhia, policy counsel for Consumers Union, another advocacy group.
Burkhart said she was especially grateful for a provision that requires pre-market testing of children's products by certified independent laboratories.

"It's like a security blanket," she said.

As for Colton, he is set to enter the fourth grade and seems healthy, his mother said, but he has some short-term memory loss and requires regular blood tests to monitor his lead levels.

"God has blessed us with our son being OK and now gave me a tool to say we need to have this stopped," Burkhart said. "It's not OK for lead to be in children's toys."

FDA Law Enforcers Crack Down on Illegal Botox Scammers

FDA Law Enforcers Crack Down on Illegal Botox Scammers

In November 2004, when four people became paralyzed after purportedly receiving Botox Cosmetic injections at a medical clinic in Oakland Park, Fla., the Food and Drug Administration's (FDA) Office of Criminal Investigations (OCI) was called to investigate. The four victims were hospitalized with severe botulism poisoning. The paralysis was temporary—a result of being injected with potent, unapproved botulinum toxin. The doctor who injected the toxin had passed it off as Botox Cosmetic, an FDA-approved drug to treat forehead wrinkles.

What began as one OCI investigation of a Florida medical clinic escalated into 210 investigations of health care professionals throughout the United States. As of July 2008, the work of OCI has led to 68 arrests and 29 convictions of individuals who purposely injected an unapproved, cheaper substitute toxin for FDA-approved Botox Cosmetic into nearly 1,000 unknowing patients.

Under federal law, no form of botulinum toxin may be commercially distributed for use on humans unless it has been approved by FDA. At this time, Botox Cosmetic, made by Allergan Inc. of Irvine, Calif., is the only type of botulinum toxin approved by FDA to temporarily soften the frown lines between the eyebrows. Botox Cosmetic is a sterile, purified version of the same toxin that causes botulism, a severe form of foodborne illness. In both cases, the toxin is produced by the bacterium Clostridium botulinum. The injectable form of sterile, purified botulinum toxin, when used in small doses, locally affects the muscles' ability to contract, smoothing out frown lines to make them nearly invisible.

Source of the ProblemOCI agents traced the fake Botox Cosmetic used in the Florida clinic to a California laboratory that sold botulinum toxin for research purposes. The agents found more of the laboratory's research product at Toxin Research International Inc. (TRI) in Tucson, Ariz. TRI was selling the unapproved toxin to health care professionals as a cheaper alternative to Botox Cosmetic. In December 2004, OCI agents seized vials of the botulinum toxin from TRI, along with numerous marketing materials targeted to physicians.

The vials were clearly labeled, "For Research Purposes Only, Not For Human Use." Invoices and product information sheets carried the same warning. Physicians who bought the cheaper, unapproved product from TRI increased their profits on each treatment by charging their patients the same fee as if they were using the FDA-approved Botox Cosmetic.
OCI agents arrested four individuals associated with TRI. Chad Livdahl, TRI's president, was convicted of fraud and misbranding a drug and sentenced to nine years in prison. His wife and co-owner, Zahra Karim, was sentenced to almost six years in prison. Other co-conspirators got lesser sentences.

OCI Special Agents examined TRI shipping records to track down more than 200 health care professionals who bought the unapproved drug from TRI. "The physicians were located throughout the country, from Manhattan to Las Vegas," says Philip Walsky, Assistant Special Agent in Charge in FDA's OCI Headquarters office. "They'd learn about the drug by going to a conference where TRI would give a spiel and demonstration to sell their product."

Many of the purchasers of the TRI product have been prosecuted. Some are serving time in federal prison and were ordered to pay restitution to their patients.
"Someone who abuses a position of trust for financial gain and subjects patients to unknown safety risks from unapproved medications will be held accountable," says Kim A. Rice, FDA Special Agent in Charge of OCI's Metro Washington Field Office. "FDA will aggressively pursue those who willfully circumvent laws that are in place to protect the consuming public."
OCI continues to investigate these cases, says Walsky.

How Patients Were ScammedAccording to OCI agents, most of the health care professionals misrepresented the fake product to patients, leading them to believe they were receiving the real Botox Cosmetic. Some of the tactics they used were
advertising in brochures, magazines, and on Web sites that they specialized in treating facial wrinkles with Botox Cosmetic displaying a certificate indicating they received training by the Botox Cosmetic manufacturer, when they did not informing patients they would be receiving Botox Cosmetic failing to tell patients they were getting a drug not approved for human use asking patients to sign a consent form indicating they would be receiving injections of FDA-approved Botox Cosmetic back to top

Sample Botox Cases Investigated by FDA's Office of Criminal Investigations Defendant Illegal Action Result

Gayle Rothenberg, M.D., operator of Center for Image Enhancement, Houston Injected more than 170 patients with unapproved drug, representing it as approved Botox Cosmetic Indicted for mail fraud, misbranding a drug, making false statements to a federal agent; June 13, 2008, sentenced to 27 months in prison, restitution of $98,426, fine of $1,000

Mark E. Van Wormer, M.D., operator of GreatSkin clinic, Albuquerque, N.M. Injected patients with unapproved drug, representing it as approved Botox Cosmetic Indicted for fraud, misbranding a drug, tampering with documents; Dec. 14, 2007, sentenced to 1 year and 1 day in prison, restitution of $65,265, fine of $3,000

Albert Poet, M.D., operator of offices in Stafford Township and Montclair, N.J. Injected patients with unapproved drug without telling patients Indicted for mail fraud, misbranding a drug; Sept. 28, 2007, sentenced to 14 months in prison

Ivyl Wells, former M.D. and operator of Skinovative Laser Center, Boise, Idaho; surrendered medical license after charges were filed Injected about 200 patients with unapproved drug, representing it as approved Botox Cosmetic Indicted for mail fraud, misbranding a drug; Dec. 11, 2006, sentenced to 6 months in prison, 6 months home detention, restitution of $88,000, fine of $40,000, 300 hours community service

Jerome Lentini, M.D., operator of A Younger You clinics, Salem and Tigard, Ore., and his assistant, Cathryn Garcia, R.N. Injected about 800
patients with unapproved drug, representing it as approved Botox Cosmetic Indicted for misbranding a drug; Aug. 14, 2006, Garcia sentenced to 1 year in prison; Dec. 11, 2006, Lentini sentenced to 18 months in prison, restitution of $330,000

Chad Livdahl and Zarah Karim, owners of Toxin Research International, Tucson, Ariz. Sold unapproved botulinum toxin, labeled "Not for Human Use," to more than 200 physicians throughout the U.S. to use on their patients Indicted for mail and wire fraud, misbranding a drug; Jan. 26, 2006, Livdahl sentenced to 9 years in prison, restitution of $345,567, forfeiture of $882,565; Karim sentenced to 5.8 years in prison, restitution of $345,567

Tips for Consumers Considering Botox InjectionsBotox Cosmetic is an injectable drug and should be administered by a trained, qualified health care professional. Know what you are being injected with. Make sure your health care professional is using only an FDA-approved product purchased within the United States. If he or she refuses to give you this information, look for another health care professional.

Make sure the benefits and risks are fully explained to you in a patient consultation. Fully disclose any medical conditions you might have and medications you are taking, including vitamins and over-the-counter drugs. Botox Cosmetic should be administered in an appropriate setting using sterile instruments. A non-physician who is appropriately licensed and trained may perform the injections under the supervision of a qualified physician. Malls and private homes are not medical environments and may be unsanitary. Adapted from the American Society for Aesthetic Plastic Surgery

Saturday, August 9, 2008

IMB Statement on Atorvastatin and Fusidic Acid- Ireland

Title:IMB Statement on Atorvastatin and Fusidic Acid

Product:Atorvastatin and Fusidic Acid

Active Substance:Atorvastatin and Fusidic Acid

Issue:The Irish Medicines Board (IMB) is aware of the inquest that was conducted yesterday (07/08/8) in Cork into the death of 58 year old man, who developed rhabdomyolysis (an extremely rare, but very serious condition causing severe muscle and kidney damage), following treatment with atorvastatin, a cholesterol lowering medicine and fusidic acid, an antibiotic

Muscle disorders ranging from muscle weakness, cramp and pain to more severe forms of muscle disorders are well known adverse effects of treatment with atorvastatin and other medicines that lower cholesterol, commonly known as “statins”, both when these medicines are used alone, or in combination with other treatments. Information on the risk of muscle disorders is described in the product information (i.e. the Summary of Product Characteristics [SPC] for healthcare professionals, and the package leaflet [PL] for patients/caregivers) for the individual medicines and the IMB has also issued warnings regarding this risk and recommendations for monitoring in a number of its publications, most recently in the January 2008 issue of its Drug Safety Newsletter.

Information on the risk of muscle disorders associated with concurrent atorvastatin treatment and some antibiotics is included in the product information, with warnings and advice regarding such use. To date, the IMB has received three reports of suspected interaction between atorvastatin and fusidic acid and is currently reviewing these cases, together with other available data to assess the need for further regulatory action

Action to be taken:The outcome of the IMB review will be communicated when completed. In the meantime, the IMB considers that the benefits of treatment with atorvastatin outweigh its potential risks in the majority of cases. Healthcare professionals and patients/caregivers are advised to carefully read the product information, closely follow the current recommendations and if patients/caregivers have any concerns regarding any aspects of their treatment, they should discuss these with their doctor or pharmacist.

Wednesday, August 6, 2008

Health Canada Reminds Canadians About the Risks of Drinking Raw Milk

Health Canada Reminds Canadians About the Risks of Drinking Raw Milk

Information Update

2008-123

OTTAWA - Health Canada would like to remind Canadians not to drink raw (unpasteurized) milk because it could contain bacteria that can make you seriously ill.

Several different kinds of bacteria that could be found in raw milk, such as Salmonella, E. coli and Listeria, have been linked to food-borne illness. These bacteria can lead to very serious health conditions ranging from fever, vomiting and diarrhea to life-threatening kidney failure, miscarriage and death. Children, pregnant women, the elderly and individuals with compromised immune systems are particularly at risk.

Because of these health concerns, Food and Drug Regulations require that all milk available for sale in Canada be pasteurized. Pasteurization kills the organisms that cause disease while keeping the nutritional properties of milk intact. Raw milk has not been treated to make it safe.
Milk is an important food and contains many nutrients essential for good health, especially calcium and vitamin D.

Unpasteurized milk has historically been linked to many serious diseases. However, the number of food-borne diseases from milk has dramatically decreased since pasteurization of milk was made mandatory by Health Canada in 1991.

The sale of raw milk is strictly prohibited under the Food and Drug Regulations. Raw milk cheese is allowed for sale and considered safe because the manufacturing process for cheese helps to eliminate many pathogens found in raw milk.

Although raw milk is not allowed to be sold in Canada, people have become ill after drinking raw milk when visiting farms. Some dairy farmers are also consuming milk from their own animals. While pasteurized milk is now the standard, there are some Canadians who continue to prefer raw milk because of perceived health benefits. However, any possible benefits are far outweighed by the serious risk of illness from drinking raw milk.

EPA Calls Out Nation’s Largest Manufacturer Of Hospital Disinfectants

EPA Calls Out Nation’s Largest Manufacturer Of Hospital Disinfectants

Consumers should never have to second-guess information on product labels, and through a recent settlement between the U.S. Environmental Protection Agency (EPA) and Lonza Inc., the nation’s largest manufacturer of hospital disinfectants, consumers will now assuredly be getting what they pay for. In March 2007, EPA charged Lonza with making false claims about the effectiveness of its products against microbial pests. As a result, Lonza has agreed to develop and implement an unprecedented nationwide quality assurance program to ensure that the quality and efficacy of the disinfectant products that are sold to hospitals around the country are up to par.

“When a person uses a disinfectant, she should be able to wholeheartedly trust that that disinfectant is doing what the label claims,” said Alan J. Steinberg, Regional Administrator.

“Lonza misled the public, but EPA is turning this situation into a positive by overseeing this quality assurance program and sending a message to others that these deceptive actions will not be tolerated.”

Before any pesticide is sold in the U.S., it must go through EPA’s rigorous registration process, dictated by the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). During this process, companies must provide health studies and environmental information about the product to ensure that its proper use does not cause any negative human or environmental effects. It is incumbent upon the manufacturer to ensure that its product lives up to its claims. If EPA decides to register the product, it grants the manufacturer an EPA registration number, which is listed on the product. EPA also works closely with the manufacturer on the label language, to make sure it is clear and as specific as possible about how the product may be used.

However, some of the hospital disinfectant products that Lonza sold under false pretenses were Formula 158 Lemon Disinfectant, Fresh and Clean and REV. Formula 158 Lemon Disinfectant and Fresh and Clean did not kill Pseudomonas Aeruginosa, and REV did not kill either the Pseudomonas Aeruginosa or Staphylococcus aureus, as claimed on the labels. Both pathogens can cause infections that can be serious, but are often treatable with antibiotics.

Lonza has now agreed to begin implementation of a Supplemental Environmental Project (SEP) which is the first of its kind nationwide. The SEP’s intent is to secure significant environmental and public health protection and improvements. In agreeing to develop and implement this project, Lonza will evaluate whether or not the companies that formulate its products are doing so safely and legally, and will inspect the plants, interview key personnel, and review required documentation. Only those companies that are found to be in sync with the criteria of regulatory, quality assurance and manufacturing compliance will be permitted to continue to formulate Lonza’s products. Lonza has until December 2009 to develop and fully implement this project.

For more information about pesticides, their health effects, and how they should be used and disposed of, call the National Pesticide Information Center at 1-800-858-PES, or visit: http://www.epa.gov/region02/pesticides.

Nine Firms Agree To Pay More Than $350,000 in Civil Penalties

Nine Firms Agree To Pay More Than $350,000 in Civil Penalties For Failing To Timely Report Drawstrings In Children’s Outerwear

WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission (CPSC) announced today that nine firms have agreed to pay a total of $355,000 in civil penalties. The penalties settle allegations that the firms knowingly failed to report to the CPSC immediately, as required by federal law, that their children’s hooded sweatshirts, jackets, or sweaters were sold with drawstrings at the hood and neck. These products, which the firms eventually recalled, pose a strangulation hazard that can cause death to children. The settlements have been provisionally accepted.

The firms paying the penalties are:

AJ Blue LLC, of New York City, N.Y.: Recall Settlement Agreement (pdf)
A&R Knitwear Inc., of New York City, N.Y.: Recall Settlement Agreement (pdf)
Cobmex Inc., of Lakewood, Calif.: Recall Settlement Agreement (pdf)
Liberty Apparel Co. Inc., of New York City, N.Y.: Recall Settlement Agreement (pdf)
Rebelette International Trading Corp., of South El Monte, Calif.: Recall Settlement Agreement (pdf)
Scope Imports Inc., of Houston, Texas: Recall Settlement Agreement (pdf)
Sears Holdings Management Corp., of Hoffman Estates, Ill.: Recall Settlement Agreement (pdf) Siegfried & Parzival Inc., of City of Industry, Calif.: Recall Settlement Agreement (pdf)
Vacation Clothing Exchange Inc., d/b/a Basix USA, of Lauderdale Lakes, Fla.: Recall Settlement Agreement (pdf)

In February 1996, CPSC issued drawstring guidelines (pdf) to help prevent children from strangling or getting entangled on the neck and waist drawstrings in upper outerwear, such as jackets and sweatshirts. In May 2006, CPSC’s Office of Compliance announced (pdf) that children’s upper outerwear with drawstrings at the hood or neck would be regarded as defective and a substantial risk of injury to young children.

Federal law requires manufacturers, distributors, and retailers to report to CPSC immediately (within 24 hours) after obtaining information reasonably supporting the conclusion that a product contains a defect which could create a substantial risk of injury to the public, presents an unreasonable risk of serious injury or death, or violates a federal safety standard.

In agreeing to settle the matters, the firms deny CPSC's allegations that they knowingly violated the law.

Salmonella Agona outbreak- U.K.

Salmonella Agona outbreak

There has been an outbreak of Salmonella Agona in the UK and Ireland in recent months. The source of the outbreak is not yet known and the Agency, the Health Protection Agency and other relevant bodies are working hard to identify its source.

At present, about 80 cases of illness caused by this type of salmonella have been reported in the UK affecting all ages, but predominantly young adults.

When the Agency has further information or useful advice for consumers in relation to this outbreak it will publish it immediately.

In the meantime, there are simple measures you can take to reduce the risk of food poisoning:

In the home, keep your kitchen clean, wash your hands before handling food, always cook food thoroughly and take care not to let cooked foods come into contact with raw foods. Always follow the manufacturers cooking instructions for food intended to be eaten hot and make sure it is piping hot throughout.When eating out, always make sure the hot food you have ordered is served piping hot throughout – don’t be afraid to ask for it to be re-heated.Vulnerable groups including the elderly, the very young, pregnant women or anyone who is unwell should take particular care to follow this advice.Finally, if you believe any food you have eaten has made you ill, you should seek medical advice.

The Agency has identified cooking, cleaning, chilling and preventing cross-contamination as the four areas consumers and food businesses should consider to keep food safe. Further information on the 4 Cs and the Agency's Germwatch campaign can be found at the link below.

More advice from our eatwell websiteGermWatch

Tuesday, August 5, 2008

Unauthorised colours, plastic fragments found in products

Unauthorised colours, plastic fragments found in products

Bakers and snack makers must remain vigilent in the face of food safety as the European alert system last week throws up negligence in the supply chain.

A too high content of the sunset yellow colour, an unauthorised use of brilliant blue and allura red colours, and the detection of plastic fragments in foods, were all flagged up at the end of July, according to data from Europe's Rapid Alert System for Food and Feed (RASFF).

RASFF, a eurozone tool to minimise risk to the food chain, reported four information notifications from member states last week. Such notifications, sent directly to the European Commission, are triggered when a food, or feed, presenting a risk to the consumer has been identified.

In week 30, the 21 to 27 July, the RASFF received 21 information notifications in total from member states, of which four targeted the bakery and snacks industry.

The UK warned that, following a border control, it had detected a too high content of the artificial colour E110 - sunset yellow FCF (416mg/kg - ppm) - in a cheese snack hailing from Iran.

Sunset yellow, along with five other artificial colours, is the focus of a legislative package adopted by the European Parliament last month that will see foods proffering any of these artificial colours in their formulations labelled with a health warning for children.

Foods containing tartrazine (E102), quinoline yellow (E104), sunset yellow (E110), carmoisine (E122), ponceau 4R (E124) and allura red (E129), will have to be labelled "may have an adverse effect on activity and attention in children".

Manufacturers have eighteen months to comply with the new labelling requirements following the official publication of the law, which is expected within the next few weeks.

Many large companies, such as Cadbury and Nestle, have already made pledges to remove all artificial colourings from their products.

And in a hint of things to come following the new rules from Europe, the RASFF system reports the unauthorised use for a clutch of these artificial colours in fruit flavoured multigrain cereals product from South Africa.

Alerted by Cyprus, the authorities detected the unauthorised use of sunset yellow, allura red and E133 brilliant blue colour in the South African product.

Moving away from colours, the EU's food risk network reported that Finland had notified the system, following a consumer complaint, on the undeclared presence of wheat. Wheat flour was not labelled - that under EU rules must be flagged, notably for gluten intolerant consumers - in
Finnish for a chocolate marshmallow product hailing from Denmark.

Finally, RASFF observes in its week 30 report that following a UK company's own check, the firm discovered plastic fragments - pieces of hard blue plastic - in pre-baked apple pies originating from the UK.

For information notifications, defined as such by EU, other members of the network do not have to take immediate action, because the product has not reached their market, or is no longer present on their market, or because the nature of the risk does not require any immediate action.

By contrast, alert notifications - the second prong of the RASFF - are sent when immediate action is required due to the serious risk of the product, aiming to give all members key information to verify whether the concerned product is available on their market, in order to take immediate action.

Finally, the third prong are border rejections. These notifications concern food and feed consignments that have been tested and rejected - due to the health risk - at the external borders of the EU and the European Economic Area (EEA).

Monday, August 4, 2008

Companies Agree To Cut Cancer-Causing Chemicals In Potato Chips

Companies Agree To Cut Cancer-Causing Chemicals In Potato Chips

Fast food makers pay thousands in settlement with California The state of California has settled lawsuits against Heinz, Frito-Lay, Kettle Foods and Lance Inc. after the companies agreed to slash levels of the cancer-causing chemical acrylamide in their potato chips and French fries.

"The companies agreed to reduce this carcinogenic chemical in fried potatoes -- a victory for public health and safety in California," said Attorney General Edmund G. Brown Jr. "Other companies should follow this lead and take steps to reduce acrylamide in french fries and potato chips."

FULL STORY: http://www.consumeraffairs.com/news04/2008/08/ca_potato_chips.html

Views wanted on DHA-rich microalgal oil- U.K.

Views wanted on DHA-rich microalgal oil

An American company has applied to the Agency to extend the use of a DHA-rich algal oil to a wider range of food products, including dairy products, bakery products and soft drinks. The oil is a novel food ingredient.

A novel food is a food or food ingredient that does not have a significant history of consumption within the European Union before 15 May 1997. Before any new food product can be introduced on the European market, it must be rigorously assessed for safety. In the UK, the assessment of novel foods is carried out by the Advisory Committee on Novel Foods and Processes (ACNFP), an independent committee of scientists appointed by the Agency.

The ACNFP first considered an application for the authorisation of this DHA-rich oil as a novel food ingredient in 2001/02. The Agency submitted a favourable initial opinion to the
Commission in June 2002 and the product was authorised in 2003, although for fewer food categories.

The company, Martek Biosciences Corporation, has now applied for authorisation to use of this novel food ingredient in a wider range of food categories – bakery products, bread and rolls, nutrition bars, non-alcoholic beverages, milk-based drinks and dairy analogue drinks.

Following an initial public consultation period and the discussion of this application by the ACNFP at its meetings between January 2008 and July 2008, the Committee has formulated a draft opinion.Deadline for commentsAny comments on this draft opinion should be emailed to the ACNFP Secretariat by Friday 15 August 2008. Comments will be passed to the Committee before it finalises its opinion on this novel food ingredient.

Saturday, August 2, 2008

Association of ceftriaxone with fatal outcome when administered intravenously- CDA.

Subject: Association of ceftriaxone with fatal outcome when administered intravenously with calcium-containing solutions.

There is a risk of precipitation when ceftriaxone and calcium are administered concurrently via intravenous route.

Cases of fatal reactions with ceftriaxone-calcium precipitates in lung and kidneys have been described in neonates and infants (ref 1-4). In some cases the infusion lines and the times of administration of ceftriaxone and calcium-containing solutions differed.

Although there are no reports to date of intravascular precipitations in patients, other than neonates, treated with ceftriaxone and calcium-containing solutions, the theoretical possibility exists for an interaction between ceftriaxone and calcium-containing solutions in patients other than neonates.

In patients aged less than 10 weeks, IV Ceftriaxone and IV calcium-containing solutions should not be administered within 5 days of each other.

In all other patients, IV Ceftriaxone and IV calcium-containing solutions should not be administered within 48 hours of each other.

Ceftriaxone and calcium-containing solutions, including continuous calcium-containing infusion such as parenteral nutrition, should not be mixed or co-administered to any patient irrespective of age, even via different infusion lines at different sites

Ceftriaxone is a long-acting broad spectrum cephalosporin antibiotic for parenteral use.Ceftriaxone is indicated for the treatment of lower respiratory tract infections, renal and urinary tract infections, bacterial septicemia, skin and wound infections, bone and joint infections, gonorrhea, intra-abdominal infections, and meningitis when caused by susceptible organisms. Ceftriaxone is also indicated for prophylaxis in patients undergoing certain surgical procedures.

Since market introduction in 1987, a few cases of post-marketing reports of interactions with calcium-containing products have been reported (ref 3,4), some cases being fatal. Although most cases occurred with simultaneous administration of the 2 products, the interaction has also been reported when ceftriaxone and calcium-containing products were administered at different times and through different infusion lines. This explains the recommended interval between the administration of the 2 products because ceftriaxone remains in circulation for a certain time after its administration.

As a theoretical consideration and based on 5 half-lives of ceftriaxone (at which point negligible amounts of the original ceftriaxone dose would be present), ceftriaxone and IV calcium-containing solutions should not be administered within 5 days of each other in neonates and in infants up to 10 weeks of age. In older patients, ceftriaxone and calcium-containing solutions should not be administered within 48 hours of each other. The longer interval for younger infants is based on the longer half-life of ceftriaxone in these patients.

Ceftriaxone is available in Canada under different trade names. Some product monographs already contain this information and other monographs are being updated about this issue. Hospitals can use different products. Consequently, it is important for hospital and health care professionals to be aware of this information because the monograph currently available in a given health center may not include this new risk information.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious interaction between ceftriaxone and calcium containing solution or other serious or unexpected adverse reactions in patients receiving ceftriaxone should be reported to Health Canada at the following address:

Canada Vigilance ProgramMarketed Health Products DirectorateHEALTH CANADAAddress Locator: 0701COttawa, Ontario, K1A 0K9Tel: 613-957-0337 or Fax: 613-957-0335To report an Adverse Reaction, consumers and health professionals may call toll free:Tel: 866-234-2345Fax: 866-678-6789CanadaVigilance@hc-sc.gc.ca

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

For other inquiries related to this communication, please contact Health Canada at:Bureau of Gastroenterology, Infection and Viral diseases (BGIVD)Therapeutic Products Directorate (TPD)E-mail: BGIVD_enquiries@hc-sc.gc.caTel: 613-941-2566Fax: 613-941-1183

Consumer agency to have product recall powers- Japan

Consumer agency to have product recall powers

Draft bills for a planned consumer affairs agency, which is expected to be launched in fiscal 2009, specify that the central government can order recalls of defective products following a serious accident and punish illicit business operators with fines of up to 100 million yen, it was learned Thursday.

The bills are expected to be approved at a Cabinet meeting in early September before being submitted to an extraordinary Diet session, according to sources.

The three bills would:
-- Determine the role of the new agency.
-- Prevent similar product-related accidents from occurring.
-- Set out plans to establish the permanent post of consumer affairs minister.

The draft bill to prevent a reoccurrence of accidents would allow the government to order recalls of a product or suspend the use of defective facilities connected with serious accidents.

The bill also would give the government the power to order illicit business operators to suspend consumer contracts and sales promotions.

Clauses related to punitive measures also are included.

If an individual operator does not comply with the government's orders, he or she would face up to one year in prison or a fine of up to 1 million yen.

The draft bill would oblige the government and business operators to take steps to prevent and minimize accidents caused by defective products.

It also would oblige local governments to inform the new consumer agency whenever a serious product-related accident occurs.

The government aims to balance the draft bill's punitive clauses with those of conventional consumer affairs law, while taking into account opinions from industrial circles, according to the sources.

The government plans to submit to an extraordinary Diet session another bill for the new agency on the administration of 29 laws related to consumer affairs.