Melamine update---U.K.

Melamine update

The Food Standards Agency has today written to all UK ports and local authorities after the European Commission refined the measures it has put in place to test for melamine in food products from China.

Melamine is an industrial chemical that should not be present in food. Milk products containing melamine have been at the centre of a major food incident in China.

The European Commission had originally said that any composite products, like biscuits and cakes, from China containing more that 15% milk products (or where the content could not be established) should be tested for melamine. However, some Member States had been reporting difficulties in establishing the exact milk product content of a number of foods targeted by the original decision.

The new requirements that came into effect today now require the testing of all composite foods from China containing milk products. As before, products found to contain more than 2.5mg/kg melamine have to be withdrawn from the market and destroyed.

UK ports and local authorities are being advised to start implementing this new testing regime.

The revised measures continue the prohibition of imports into the European Community of infant formula from China and other composite products containing milk or milk products intended for infant and young children’s nutrition.

Feed and food business operators also need to provide prior notification, to the relevant port, of consignments from China of products covered by the Commission Decision.

Advisory-Use of Codeine Products by Nursing Mothers

Use of Codeine Products by Nursing Mothers

Advisory2008-164

OTTAWA - Health Canada is advising the public, especially nursing mothers, about the very rare but serious health risk to breastfed babies posed by codeine use in mothers. Once ingested, codeine is converted by the body into morphine. Some people convert codeine into morphine more rapidly and completely than others. The babies of nursing mothers who rapidly metabolize codeine may be at increased risk for morphine overdose due to higher-than-expected morphine levels in breast milk.

Codeine is found in prescription and non-prescription products used to relieve pain or to treat coughs. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, awareness of this new information is important because in severe cases, infant death can occur.

Health Canada recommends nursing mothers take the following precautions to minimize the risk of morphine exposure in breastfed babies:

Consult a physician before taking any codeine-containing products. Read the ingredient list of all over-the-counter medications, especially cough or pain medications, to see if they contain codeine. If treatment with codeine is necessary, use the lowest effective dose for the shortest period of time. People who metabolize codeine very rapidly may experience overdose symptoms themselves such as extreme sleepiness, confusion, or shallow breathing. While the amount of overdose is generally not considered life-threatening in adults, if you are nursing a child and experience these symptoms, it is important to monitor your child carefully and talk to your doctor. Contact a doctor if your breastfed baby is sleepier than usual or has trouble breastfeeding. Seek immediate medical attention if your breastfed baby has difficulty breathing or is limp after you take a health product with codeine. The chance of being an ultra-rapid metabolizer (genotype CYP2D6) varies among different ethnic groups. The prevalence is estimated to be 1 per 100 people for those of Chinese, Japanese and Hispanic descent, 3 per 100 for African Americans and 1 to 10 per 100 for Caucasians. North African, Ethiopian and Arab populations have the highest estimated prevalence, from 16 to 28 per 100 people. There is currently no test available for general use in Canada to identify ultra-rapid metabolizers of codeine. Careful monitoring of mother and child is the best way to identify those potentially at risk.

Health Canada has reviewed the available information on this subject, and is currently working with drug manufacturers so that the labelling for codeine-containing prescription products are revised to include information that better identifies the risk to breastfed babies whose mothers are ultra-rapid metabolizers of codeine. The labelling guidelines for non-prescription products containing codeine are also being revised to provide more information about this risk.

Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

Report online at the MedEffect™ Canada Web site Call toll-free at 1-866-234-2345 Complete a Canada Vigilance Reporting Form and either: Fax toll-free to 1-866-678-6789 Mail to: Canada Vigilance ProgramHealth CanadaAL 0701COttawa, ON K1A 0K9

Drug Stayed on Hospital Shelves Despite Recall

Drug Stayed on Hospital Shelves Despite Recall

Nearly 100 pharmacists and the hospitals they work for face fines for failing to remove a blood thinner from their shelves after a federal recall last winter, a California state agency said.

The recalled drug heparin was found 94 times in inspections of all 533 hospitals in California, and at least 16 hospitals administered the drug to patients, according to the state Board of Pharmacy. Fines range from $2,500 to $5,000.

"This was really an alert that the recall system doesn't work," Virginia Herold, head of the state's pharmacy board, told The Associated Press.

Regulators have not released the full list of hospitals involved. However, documents obtained by the Daily Journal show newborns were allegedly given heparin at the University of California San Francisco Medical Center and Children's Hospital of Central California in Madera. Both hospitals are appealing the charges.

Heparin, which is often used in premature children to prevent blood clots, has come under scrutiny because of accidental life-threatening overdoses given to babies, including actor Dennis Quaid's newborn twins at a Los Angeles hospital last November. Fourteen other babies received accidental heparin overdoses in July at a hospital in Corpus Christi, Texas.

The Federal Drug Administration issued a drug recall in February because "a higher than usual number" of patients reported adverse effects to heparin, which include chest pain, dizziness and headache.

The state's Department of Public Health has also launched an investigation to determine whether recalled heparin, Digitex and Procrit caused harm to any patients.

No link has been found, though a state health official said the state will try to ensure recalled drugs are taken out of hospitals.

"Our actions are to act as both a partner and an enforcer to look at what kinds of system breakdowns are taking place, to make sure we don't have a reoccurrence of this in the future," Kathleen Billingsley, deputy director of the state's Center for Healthcare Quality, told the AP.

In March 2008, the state Board of Pharmacy voted 12-0 to give drug makers, wholesalers and pharmacies until Jan. 1, 2011, to start electronically tracking drugs from factory to patient. The electronic tracking system has been delayed a number of times since 2004, when a recall of 175,000 bottles of fake Lipitor, the cholesterol drug, led state regulators to require tracking.

Herold said although it's unclear whether the tracking system would have prevented this incident, it will give pharmacists a better idea of what is on their shelves.

In September, the Oakbrook Terrace, Ill.-based Joint Commission, an independent, not-for-profit organization health quality group, issued a safety alert asking hospitals nationwide to adopt stricter measures to prevent errors involving blood thinners, including heparin.

Health Canada Reminds Canadians of Turkey Safety this Thanksgiving

Health Canada Reminds Canadians of Turkey Safety this Thanksgiving

Information Update2008-160

Cooked turkey is a central part of many holiday celebrations in Canada - especially Thanksgiving. Health Canada would like to remind all Canadians that there are simple steps they can take to help ensure their turkey feast is a safe one.

Adopting standard safe cooking and safe handling practices (clean, separate, cook and chill) reduces the risk to yourself and your family from undercooked turkey and stuffing and from cross contamination during preparation.

Health Canada reminds you:
Store your turkey in the refrigerator or freezer immediately after it is purchased.
Do not thaw your turkey at room temperature.
Thaw turkey in the refrigerator or in cold water.
If you thaw your turkey in cold water, keep the turkey in its original wrapping and change the cold water regularly to ensure that the water remains cold.
Do not rinse raw turkey. This can spread bacteria everywhere the water splashes, creating a safety hazard.
Clean and disinfect surfaces and kitchen utensils touched by raw turkey or drippings from thawing turkey.
Use a food thermometer, and cook turkey until the temperature of the thickest part of the breast or thigh is at least 85ºC (185ºF). Cook stuffing separately in its own oven dish or on the stove top.
If you do stuff your turkey, stuff loosely just prior to roasting, and remove all stuffing immediately after cooking.
Cook stuffing to a minimum internal temperature of 74ºC (165ºF).
Refrigerate all leftovers within two hours of cooking.
Turkey poses particular food safety challenges because it can be contaminated with bacteria such as Salmonella, which can cause diarrhea, vomiting and stomach cramps.

It is estimated that there are between 11 million and 13 million cases of food-related illnesses in Canada every year. Many of these illnesses could be prevented by following proper food handling and preparation techniques.

More nations pull suspect products as China milk scandal spreads

More nations pull suspect products as China milk scandal spreads

South Korea, Australia and Japan Saturday pulled melamine-contaminated sweets and drinks from supermarket shelves amid a widening scandal over Chinese milk products tainted with the toxic chemical.

Authorities in Seoul ordered Mars and Nestle to pull three products after melamine, which is usually used for making plastics, was detected in snacks made in China by the multinationals.

The industrial chemical had been found in M&M's milk chocolate snack and Snickers peanut Fun Size, both produced by Mars, and Kit Kat chocolate bars imported from Nestle Tianjin in China, Korea Food and Drug Administration said.

"Mars is recalling these products because it is legally obligated to do so following the announcement by the Korean Food and Drug Administration (KFDA)," Mars said in a statement.

Melamine has been blamed for making thousands of infants ill and killing four in mainland China after it tainted baby milk powder in arguably the worst in a litany of product safety scandals involving Chinese-made goods in recent years.

Since first appearing in baby milk formula, melamine has been found in a range of products containing Chinese milk.

Mars said while it was complying with the South Korean request, the melamine levels detected were too small to pose a health risk, and called for a standard reporting limit of the industrial chemical across Asia.

"Minute traces of melamine are commonly found throughout the global food chain and melamine levels below 2.5 ppm are not deemed to indicate adulteration with melamine," it said. There was no immediate comment from Nestle Korea.

A KFDA official told AFP South Korea did not allow any level of melamine in food.
World Health Organisation food safety expert Peter Ben Embarek said earlier this week many countries had only recently fixed limits for melamine in food as "melamine has nothing to do with the food chain".

The chemical was added to milk before being sold to dairy manufacturers in a bid to falsely boost protein readings, Chinese authorities have said.

A fourth Chinese milk product has been withdrawn from sale in Australia after tests revealed it was tainted with melamine, Food Standards Australia New Zealand said in a statement.

"Consumers are advised not to consume Kirin milk tea made in China," the organisation said.

The Australian food watchdog has already recalled White Rabbit sweets and Chinese-made Cadbury chocolate eclairs, while importers of Lotte Koala Biscuits have undertaken a precautionary withdrawal of the product.

A Japanese importer, meanwhile, began recalling Chinese chocolates suspected of being contaminated with melamine.

The western Japanese city of Osaka said a test showed the chemical had been detected in "Chocolate Pillows" imported from China by Osaka-based NS International.

While there had been no reports of health problems, the city ordered the importer to recall some 86,000 packages of the chocolates on the grounds that the company may have violated the food sanitation law.

China is struggling to limit the damage to its food safety reputation as a growing number of countries have decided to suspend imports of Chinese milk products or withdraw them from sale over the scandal.

The European Union recently banned all imports on Chinese milk-related products for children such as biscuits and chocolate on top of a long-standing embargo on Chinese dairy products like milk and yoghurt.

FDA Issues Interim Safety and Risk Assessment of Melamine and Melamine-related Compounds in Food

FDA Issues Interim Safety and Risk Assessment of Melamine and Melamine-related Compounds in Food

The U.S. Food and Drug Administration (FDA) today issued the results of its interim safety and risk assessment of melamine and melamine-related compounds in food, including infant formula.
A safety/risk assessment is a scientifically based methodology used to estimate the risk to human health from exposure to specified compounds. It is based on available data and certain scientific assumptions in the absence of data. The purpose of the FDA interim safety/risk assessment was to identify the level of melamine and melamine-related compounds in food which would not raise public health concerns. The interim safety/risk assessment evaluated the melamine exposure in infant formula and in other foods.

The safety/risk assessment, prompted by reports of melamine contamination of milk-derived ingredients and finished food products containing milk manufactured in China, was conducted by scientists from FDA's Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine. The FDA reviewed scientific literature on melamine toxicity.

Infant Formula FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns. In large part, this is because of gaps in our scientific knowledge about the toxicity of melamine and its analogues in infants, including:
the consequences of the continuous use of infant formulas as the sole source of nutrition; the uncertainties associated with the possible presence and co-ingestion of more than one melamine analogue; and for premature infants with immature kidney function, the possibility that they may be fed these formulas as the sole source of nutrition and thus on a body weight basis experience greater levels of intake for a longer time than is experienced by term infants. There is too much uncertainty to set a level in infant formula and rule out any public health concern.

However, it is important to understand that this does not mean that any exposure to any detectable level of melamine and melamine–related compounds in formula will result in harm to infants.

Other Food ProductsIn food products other than infant formula, the FDA concludes that levels of melamine and melamine-related compounds below 2.5 parts per million (ppm) do not raise concerns. This conclusion assumes a worst case exposure scenario in which 50% of the diet is contaminated at this level, and applies a 10-fold safety factor to the Tolerable Daily Intake (TDI) to account for any uncertainties. The TDI is an estimate of the maximum amount of an agent to which an individual could be exposed on a daily basis over the course of a lifetime without an appreciable health risk.

FDA continues to screen products, collaborate with foreign governments and their regulatory agencies, and monitor reports of contamination from international sources to help ensure that potentially contaminated products from foreign sources are examined if imported into the United States. If products are adulterated because they contain melamine and/or a melamine-related compound, the agency will take appropriate actions to prevent the products from entering commerce.

Doctors Urge FDA to Recall Cold Medicines for Children

Doctors Urge FDA to Recall Cold Medicines for Children

WASHINGTON — With a new cold season coming, the government is trying once more to decide what to do about over-the-counter medicines for kids' coughs and sniffles. Doctors question the drugs' benefits and worry about their risks.

Pediatricians are urging the Food and Drug Administration, which scheduled a public hearing Thursday on the issue, to demand a recall of the medicines for children younger than 6.

"Parents should know that there is less evidence than ever to support the use of over-the-counter cough and cold medicines for young children," said Dr. Joshua Sharfstein, Baltimore's health commissioner. "There is nothing that is holding the FDA back from asking for a voluntary recall now of products marketed to kids under 6."

U.S. families spend at least $286 million a year on such cough and cold remedies for children, according to the Nielsen Co. market research firm. In any given week the medicines are used by an estimated 10 percent of all children, with the biggest exposure among 2- to 5-year-olds, a recent Boston University report found.

But colds usually clear up on their own after a few days. Many doctors say rest and plenty of fluids are what it takes to get over a cold.

The FDA this year warned against giving OTC cold medicines to children younger than 2. At that time, officials said they expected to decide by spring on recommendations for youngsters up to 11. Now the agency is seeking more advice from doctors, industry and consumers.

The industry says OTC medicines have been used for decades in treating kids' colds and are safe for those older than 2. Nonetheless, manufacturers are carrying out new studies involving the most common ingredients in the medications. The companies voluntarily stopped selling cough and cold medicines for babies and toddlers last fall.

FDA advisers said that was not enough and recommended that the drugs not be used for children younger than 6. An expert panel said older children could keep taking the medications while studies are undertaken to settle scientific questions about safety and effectiveness.

It turns out that when the FDA set standards for cough and cold medicines some 30 years ago, no separate studies were done for kids.

Cough and cold medicines send about 7,000 children to hospital emergency rooms each year with symptoms ranging from hives and drowsiness to unsteady walking. Low doses of a medicine are not likely to cause a problem; the main risk comes from unintentional overdoses.

The same ingredients usually are found in different products. For example, giving a child a cough syrup and a decongestant could inadvertently lead to an overdose.

The Consumer Healthcare Products Association, which represents the manufacturers, says preventable errors are the problem, not the safety of the ingredients in the medicines. The industry is starting an educational campaign aimed at parents, doctors and day care providers on the importance of following directions and storing medicines in places where kids cannot get at them.

But Sharfstein said Maryland saw an immediate benefit after OTC cough and cold remedies for tots were removed from store shelves last fall. Calls to poison control about problems with the medicines involving children younger than 2 dropped by 40 percent, from 99 to 60, in the first six months of this year when compared with 2007. Calls involving children 2 to 6 also dropped, but by much less.