31.01.2012 12:59:01
In the world of food safety, it's not just about food poisoning outbreaks and recalls. Sometimes there's some good news to share. That's the case in breakthroughs and advances in science and technology that can stop
foodborne pathogens dead in their tracks. And sometimes that sort of news appears in unexpected places.
Take, for example, the January edition of Popular Mechanics. In a section about the
"Ten Tech Concepts You Need to Know," readers learn that "this year's big ideas in tech will make your food safer, make hybrid cars more energy efficient, and sentence overpriced texting plans to death."
Right out of the gate, at the top of the list, is a USDA-approved food-safety process that the magazine refers to as "Pascalization," commonly known in the food industry as HPP, or high pressure processing. And while it's only been used on the commercial level for the past 2 decades or so, the technology has been around far longer than that.
Turns out that none other than French scientist, mathematician and philosopher Blaise Pascal (1623-1662) conducted research on food preservation. What he came up with -- high pressure processing -- is what Popular Mechanics describes as "changing the way we think about food."
This process doesn't rely on heat, such as pasteurization; or chemicals, such as preservatives; or irradiation to kill the harmful bacteria on food. And while heat and cooking are good ways to kill bacteria, they can also impair the flavor, texture, color and nutrition of the food. For the most part, the same is true of irradiation.
Under high pressure processing, already packaged products such as fresh hamburger and turkey; processed fruit such as apple sauce; oysters; fish; guacamole; and ready-to-eat meats such as sliced turkey, pastrami and beef are put inside a pressure chamber. Water is then added to the chamber before it is sealed. From there, the pressure is increased to the maximum desirable level and sustained for a set period of time. The chamber is then decompressed and drained and the packaged products are removed.
We're talking about a lot of pressure. For example, at sea level, air pressure is 14.4 pounds per square inch. In the case of products put under HPP, the pressure ranges from 60,000 to 87,000 pounds per square inch.
And while that sounds like enough pressure to squash or damage the packaged food, that doesn't happen because the pressure is applied equally on all areas of the product.
The good news is that the pressure zaps foodborne pathogens such as E. coli O157:H7, Listeria and Salmonella, as well as "spoilage" microorganisms such as molds and yeasts -- without affecting the nutritional qualities or the taste of the food products. That's because while it has enough force to significantly disrupt cellular activity, it doesn't affect the structures of the food components that are responsible for nutrition and flavor.
Another plus is that because HPP is applied when the products are already packaged, it eliminates the possibility of cross-contamination. In other words, the products are free of pathogens when they get to the customers, whether they be grocery shoppers, restaurants, schools or other institutions. Even so, people preparing the food must follow basic food-safety procedures, such as washing their hands and preventing cross-contamination with other foods or cooking utensils to keep the food safe from foodborne pathogens.
But HPP isn't a one-step-and-it's-safe sort of approach to food safety. Companies that use it also follow standard food safety principles all the way down the line.
Last year when Food Safety News wrote about
HPP, the big news was that meat-processing giant Cargill had introduced a patent-pending process for a new line of fresh hamburger patties produced under high pressure processing. At the time, the company hailed it as a "natural option for food safety" and a "technological breakthrough." Until then, no one had figured out how to use high pressure processing on fresh hamburger meat without affecting its taste, texture or appearance.
The patties were slated for the food service industry, with customers such as restaurants saying that they were looking for a "fresh hamburger" option with good shelf life. According to a
news release from Cargill, the HPP burgers have double the shelf life of non-HPP burgers. Yet the fresh flavor stays intact and food safety is enhanced.
The company's name for these HPP burgers is "fressure." The idea is that the fressure logo could be used on restaurant menus so customers would know the burgers were fresh, not frozen. And while the label advised that the meat be cooked to 160 degrees, the "fressure" burgers gave cooks and chefs the option to cook them to lower temperatures and therefore satisfy customers who wanted medium-rare burgers, for example. Even so, restaurant menus are required to carry a warning that undercooked or uncooked meats and shellfish can pose a risk to human health.
At the time, long-time HPP researcher V.M. Balasubramaniam, Department of Food Science and Technology at Ohio State University, told Food Safety News that this new development on the part of Cargill was "the most promising food-safety innovation in recent years." And he predicted that the technology would become a key player in food safety.
Ten months later, he echoed similar thoughts in the comments he supplied to Popular Mechanics, pointing out that sauces, fruit juices, guacamole, lunch meats, and fish hold up well to HPP and and that treated versions of these foods can be found in stores today.
He also pointed to falling equipment costs for HPP and the demand for longer shelf life, coupled with a poor consumer acceptance of food irradiation, which he referred to as "HPP's competition" as reasons that HPP will enter into the mainstream.
Indeed, it's almost there, with the industry having grown into a multi-billion-dollar business in recent years, he said.
Two Heavy-Hitters
As 2011 came to an end, more news about HPP found its way into mainstream media, thanks to two heavy hitters in the food industry.
The first of these is Cargill, which once again turned to HPP, this time for some of its ground turkey. Michael Martin, spokesman for Cargill, told Food Safety News that in the wake of the company's August and September 2011 recalls of millions of pounds of ground turkey (triggered by the possible contamination of the product by multi-drug resistant strain of Salmonella Heidelberg), the company explored all current food safety technologies to determine which could be effective at further reducing the potential for foodborne illness.
"One of those is high pressure processing (HPP), which we are using on some ground turkey products packaged in chubs," Martin said. Chubs are thin plastic packages containing ground meat or poultry, with the ends fastened together with a metal clasp.
Martin said the company continues to evaluate the food-safety value and consumer acceptance of the product undergoing HPP, which is being done by a third-party supplier.
The second heavy hitter to enter the HPP scene late in 2011 was none other than Starbucks. With its purchase of juice-maker Evolution Fresh in November, Starbucks cast its vote for HPP. In acquiring the company, Starbucks emphasized the competitiveness of high pressure processing since juices treated with HPP are never heated.
In the
Starbuck's news release about the purchase of the company, Jimmy Rosenberg, founder of Evolution Fresh and the newly named chief juice office of the company, said that using High Pressure Pasteurization (another term for HPP) to help ensure the inherent nutrients are kept intact during the juicing process is a key point of differentiation for a growing number of the company's juices.
Rosenberg founded Naked Juice, which is now owned by PepsiCo. Another juice contender, Odwalla, was bought by CocaCola. But companies pasteurize their juices. Starbucks plans to serve Evolution juices at juice and health bars, in stores, and also at its company-owned retail stores, thus bringing the HPP juices to the attention of about 60 million people worldwide each week. In an email to Food Safety News, a spokesperson for Starbucks said that juices processed with HPP will be noted as such on the bottle labels.
"As more information becomes available about HPP, we believe customers will seek out these juice products," said the spokesperson.
The news about Starbuck's plans for Evolution juices found its way into USA Today and the LA Times, among many other mainstream media outlets. "For us, this is exciting because Starbucks will be marketing the juice as HPP," Glenn Hewson, vice president of Global Marketing for
Avure, the global leader in HPP food processing equipment, told Food Safety News. Last year, Avure described HPP as "food safety's best kept secret" and pointed to $3 billion in food products worldwide created with HPP each year.
Among the companies using it for all or some of their products are Hormel, Fresherized Foods, Garden Fresh Gourmet, Perdue, Puro Fruits, SimplyFresco, Maple Lodge Farms, and Wholly Guacamole.
America is the leader in HPP, with Mexico coming in second. HPP products are also being produced in Europe, Japan, Australia, New Zealand and Korea.
And while there's an additional cost of using HPP, food companies are finding that consumers are becoming increasingly concerned about food safety and that many are willing to pay the extra cost.
Labels
When people learn about HPP, the first question they usually ask is how they can know which foods are processed with HPP.
Unfortunately, said Avure's Hewson, many companies don't include that information on their labels, although they do include it on their websites.
With that in mind, Hewson said that manufacturers of HPP products should consider joining the ranks of companies like
Fresherized Foods,
Maple Lodge Farms and
Ifantis in developing HPP branding that tells consumers about the benefits on the technology right on the package.
"Processors will find that branding cements consumer awareness and drives market demand for their products that stand out from the crowd," he said.
He predicts that before long, there will be an industry mark that signifies that HPP has been used to produce the food items that have undergone the process.
To watch some videos about HPP processing, go
here,
here, and
here.
Companies using HPP are invited to list the products they make with the technology in readers' comments at the end of the article.
foodborne pathogens dead in their tracks. And sometimes that sort of news appears in unexpected places.
Take, for example, the January edition of Popular Mechanics. In a section about the
"Ten Tech Concepts You Need to Know," readers learn that "this year's big ideas in tech will make your food safer, make hybrid cars more energy efficient, and sentence overpriced texting plans to death."
Right out of the gate, at the top of the list, is a USDA-approved food-safety process that the magazine refers to as "Pascalization," commonly known in the food industry as HPP, or high pressure processing. And while it's only been used on the commercial level for the past 2 decades or so, the technology has been around far longer than that.
Turns out that none other than French scientist, mathematician and philosopher Blaise Pascal (1623-1662) conducted research on food preservation. What he came up with -- high pressure processing -- is what Popular Mechanics describes as "changing the way we think about food."
This process doesn't rely on heat, such as pasteurization; or chemicals, such as preservatives; or irradiation to kill the harmful bacteria on food. And while heat and cooking are good ways to kill bacteria, they can also impair the flavor, texture, color and nutrition of the food. For the most part, the same is true of irradiation.
Under high pressure processing, already packaged products such as fresh hamburger and turkey; processed fruit such as apple sauce; oysters; fish; guacamole; and ready-to-eat meats such as sliced turkey, pastrami and beef are put inside a pressure chamber. Water is then added to the chamber before it is sealed. From there, the pressure is increased to the maximum desirable level and sustained for a set period of time. The chamber is then decompressed and drained and the packaged products are removed.
We're talking about a lot of pressure. For example, at sea level, air pressure is 14.4 pounds per square inch. In the case of products put under HPP, the pressure ranges from 60,000 to 87,000 pounds per square inch.
And while that sounds like enough pressure to squash or damage the packaged food, that doesn't happen because the pressure is applied equally on all areas of the product.
The good news is that the pressure zaps foodborne pathogens such as E. coli O157:H7, Listeria and Salmonella, as well as "spoilage" microorganisms such as molds and yeasts -- without affecting the nutritional qualities or the taste of the food products. That's because while it has enough force to significantly disrupt cellular activity, it doesn't affect the structures of the food components that are responsible for nutrition and flavor.
Another plus is that because HPP is applied when the products are already packaged, it eliminates the possibility of cross-contamination. In other words, the products are free of pathogens when they get to the customers, whether they be grocery shoppers, restaurants, schools or other institutions. Even so, people preparing the food must follow basic food-safety procedures, such as washing their hands and preventing cross-contamination with other foods or cooking utensils to keep the food safe from foodborne pathogens.
But HPP isn't a one-step-and-it's-safe sort of approach to food safety. Companies that use it also follow standard food safety principles all the way down the line.
Last year when Food Safety News wrote about
HPP, the big news was that meat-processing giant Cargill had introduced a patent-pending process for a new line of fresh hamburger patties produced under high pressure processing. At the time, the company hailed it as a "natural option for food safety" and a "technological breakthrough." Until then, no one had figured out how to use high pressure processing on fresh hamburger meat without affecting its taste, texture or appearance.
The patties were slated for the food service industry, with customers such as restaurants saying that they were looking for a "fresh hamburger" option with good shelf life. According to a
news release from Cargill, the HPP burgers have double the shelf life of non-HPP burgers. Yet the fresh flavor stays intact and food safety is enhanced.
The company's name for these HPP burgers is "fressure." The idea is that the fressure logo could be used on restaurant menus so customers would know the burgers were fresh, not frozen. And while the label advised that the meat be cooked to 160 degrees, the "fressure" burgers gave cooks and chefs the option to cook them to lower temperatures and therefore satisfy customers who wanted medium-rare burgers, for example. Even so, restaurant menus are required to carry a warning that undercooked or uncooked meats and shellfish can pose a risk to human health.
At the time, long-time HPP researcher V.M. Balasubramaniam, Department of Food Science and Technology at Ohio State University, told Food Safety News that this new development on the part of Cargill was "the most promising food-safety innovation in recent years." And he predicted that the technology would become a key player in food safety.
Ten months later, he echoed similar thoughts in the comments he supplied to Popular Mechanics, pointing out that sauces, fruit juices, guacamole, lunch meats, and fish hold up well to HPP and and that treated versions of these foods can be found in stores today.
He also pointed to falling equipment costs for HPP and the demand for longer shelf life, coupled with a poor consumer acceptance of food irradiation, which he referred to as "HPP's competition" as reasons that HPP will enter into the mainstream.
Indeed, it's almost there, with the industry having grown into a multi-billion-dollar business in recent years, he said.
Two Heavy-Hitters
As 2011 came to an end, more news about HPP found its way into mainstream media, thanks to two heavy hitters in the food industry.
The first of these is Cargill, which once again turned to HPP, this time for some of its ground turkey. Michael Martin, spokesman for Cargill, told Food Safety News that in the wake of the company's August and September 2011 recalls of millions of pounds of ground turkey (triggered by the possible contamination of the product by multi-drug resistant strain of Salmonella Heidelberg), the company explored all current food safety technologies to determine which could be effective at further reducing the potential for foodborne illness.
"One of those is high pressure processing (HPP), which we are using on some ground turkey products packaged in chubs," Martin said. Chubs are thin plastic packages containing ground meat or poultry, with the ends fastened together with a metal clasp.
Martin said the company continues to evaluate the food-safety value and consumer acceptance of the product undergoing HPP, which is being done by a third-party supplier.
The second heavy hitter to enter the HPP scene late in 2011 was none other than Starbucks. With its purchase of juice-maker Evolution Fresh in November, Starbucks cast its vote for HPP. In acquiring the company, Starbucks emphasized the competitiveness of high pressure processing since juices treated with HPP are never heated.
In the
Starbuck's news release about the purchase of the company, Jimmy Rosenberg, founder of Evolution Fresh and the newly named chief juice office of the company, said that using High Pressure Pasteurization (another term for HPP) to help ensure the inherent nutrients are kept intact during the juicing process is a key point of differentiation for a growing number of the company's juices.
Rosenberg founded Naked Juice, which is now owned by PepsiCo. Another juice contender, Odwalla, was bought by CocaCola. But companies pasteurize their juices. Starbucks plans to serve Evolution juices at juice and health bars, in stores, and also at its company-owned retail stores, thus bringing the HPP juices to the attention of about 60 million people worldwide each week. In an email to Food Safety News, a spokesperson for Starbucks said that juices processed with HPP will be noted as such on the bottle labels.
"As more information becomes available about HPP, we believe customers will seek out these juice products," said the spokesperson.
The news about Starbuck's plans for Evolution juices found its way into USA Today and the LA Times, among many other mainstream media outlets. "For us, this is exciting because Starbucks will be marketing the juice as HPP," Glenn Hewson, vice president of Global Marketing for
Avure, the global leader in HPP food processing equipment, told Food Safety News. Last year, Avure described HPP as "food safety's best kept secret" and pointed to $3 billion in food products worldwide created with HPP each year.
Among the companies using it for all or some of their products are Hormel, Fresherized Foods, Garden Fresh Gourmet, Perdue, Puro Fruits, SimplyFresco, Maple Lodge Farms, and Wholly Guacamole.
America is the leader in HPP, with Mexico coming in second. HPP products are also being produced in Europe, Japan, Australia, New Zealand and Korea.
And while there's an additional cost of using HPP, food companies are finding that consumers are becoming increasingly concerned about food safety and that many are willing to pay the extra cost.
Labels
When people learn about HPP, the first question they usually ask is how they can know which foods are processed with HPP.
Unfortunately, said Avure's Hewson, many companies don't include that information on their labels, although they do include it on their websites.
With that in mind, Hewson said that manufacturers of HPP products should consider joining the ranks of companies like
Fresherized Foods,
Maple Lodge Farms and
Ifantis in developing HPP branding that tells consumers about the benefits on the technology right on the package.
"Processors will find that branding cements consumer awareness and drives market demand for their products that stand out from the crowd," he said.
He predicts that before long, there will be an industry mark that signifies that HPP has been used to produce the food items that have undergone the process.
To watch some videos about HPP processing, go
here,
here, and
here.
Companies using HPP are invited to list the products they make with the technology in readers' comments at the end of the article.
01.02.2012 12:59:07
With the ongoing economic crisis there has been a need for governments across the globe to cut budgets. Food safety lacks the tangible benefits of, say, health care and it was somewhat inevitable that food inspection agencies would experience the brunt of such cutbacks.
In the United Kingdom, the Food Safety Agency that was established in the wake of the "mad cow" disease outbreak, amongst other food safety scares, was essentially dismantled with its portfolio being returned to Ministry of Agriculture (DEFRA).
In Canada, the number of CFIA inspectors was increased following the listeriosis outbreak of 2008 in which contaminated deli meats resulted in 20 deaths. However, the Canadian government is now cutting over 200 inspectors in a bid to save $25 million from the federal budget.
In the United States, the cutbacks have been deeper, with over 260 USDA offices being closed for a savings of $150 million per year.
In reaction, many consumer groups, the press and unions have pronounced the cutbacks as placing the public in danger through the governments neglecting their responsibilities.
The old question is thus posed: Does more government involvement, specifically in relation to inspector numbers, lead to a more effective food safety system?
A similar question is posed by criminologists in relation to police numbers and crime rates. Those on one side of the argument use statistics to show that an increase in police numbers results in decreased crime rates. However, what is missed is that an increase in policing is commonly preceded by a major event, such as 9/11 or when pre-existing crime levels are high.
In other studies, where no major event has occurred, it has been found that there is no correlation between police on the ground and crime rates.
The theory goes that high numbers of police on the ground lead to an increased level of crime detection but do little to prevent crime from occurring. As sociologists will indicate, crime rates are mostly affected by the environment, such as socio-economic factors and community cohesion - in effect the existing culture. To take the argument further, it is thought that increasing the level of policing can bring a siege-like atmosphere to a community and negatively affect the community cohesion.
Returning to food safety, we can make parallels between the effect of policing on crime rates and superimpose on the number of food inspectors and foodborne illness outbreaks. Specifically, inspector numbers increase or reorganization of agencies occurs following a major foodborne illness outbreak.
Yet, what is missed is that in the event of an outbreak, it is the industry response that is primarily responsible for enhancing food safety and not visits by an army of food inspectors. Nevertheless, food inspection does play a major role in containing outbreaks and follow-up investigations, although this is different from prevention.
Industry-led initiatives are the only way to enhance food safety
In the 1980s, there was a diverse range of food safety issues of concern. Foodborne illness rates were increasing, virulent pathogens such as E. coli O157 were taking hold, not to mention the BSE and problems with the emergence of drug-resistant microbes.
In response, a directive from President Clinton's administration set to prioritize food safety risks, reduce red tape and bureaucracy. The directive essentially empowered the industry to take responsibility for food safety by introducing HACCP, amongst other initiatives.
There is little debate that the initiatives were highly successful in reducing the incidence of foodborne illness with a progressive decrease in numbers since implementation.
A more recent example of industry-led initiatives is in relation to the use of antibiotics in animal production. Antibiotics have been commonly used in animal production to prevent infections, thereby leading to high growth rates. However, a negative effect of antibiotics has been the emergence of lethal antibiotic strains of pathogens such as Salmonella, amongst others.
The FDA has debated the banning of antibiotics for promoting animal growth for over 30 years. In late 2011, the FDA somewhat unexpectedly stepped back from banning antibiotics in animal production, which is counter to the actions taken over in the EU.
Many commentators saw this as a capitulation of the FDA to the lobbying pressure from the meat industry. However, the reality is that the meat industry has been proactive in reducing the use of antibiotics in animal production on the understanding that a staged reduction is required. Of course, this is not well-publicized but illustrates that only a successful antibiotic reduction program can be achieved if led by industry and not by government.
Empowerment of food safety is the key
The empowerment of industry to self-regulate always comes under criticism in the event of a foodborne illness outbreak. The knee-jerk reaction always appears to be more testing, more inspectors, more agencies etc.
In many ways, "tinkering" with the food safety system by government hinders the progress that has been made since 1995. Ultimately, industry-led initiatives will always be the most effective approach to improve food safety. Consequently, rather than increasing government inspection a more productive strategy is how to remove the weak links in the chain to prevent outbreaks from occurring in the first place.
Such a strategy is far from straightforward, as there is a need to understand the underlying basis for decisions made that ultimately led to critical errors of judgment in foodborne illness outbreaks.
For example, why do processors send out product known to be contaminated or perform practices that represent obvious food safety risks? In a broad sense, it can be proposed that the actions are through ignorance (lack of knowledge is perhaps a better term) of the risk, economic factors or, in a relatively low number of instances, bioterrorism or criminal intent.
Ironically, it is the latter group who have the greatest perception of empowerment given they are controlling events. In contrast, those that lack knowledge may have good intentions in producing high quality products, although fail to see the consequences. It is almost akin to a thought pattern of "nobody told me not to do it."
The current trend of clean labels, along with producers of organic products, can be classed in this group, where attempts to produce additive-free foods leads to food safety risks (for example, omitting nitrites to control Clostridium botulinum). Also included in this group are food handlers, quality assurance personnel and management whose main focus is to produce product as fast as possible with little thought of ownership or empowerment.
Workers have a tendency to lack empowerment, as they are told what to do and when to do it. This ultimately leads to a disconnect between the product and food safety. In the processing environment, workers are judged on how quickly the product can be processed regardless if the production line is producing ready-to-eat deli meat, cars or paper-clips.
Even if food violations occur, there is little incentive for the worker to raise concerns or to be empowered to make suggestions. When visiting processing plants, I sometimes ask the workers if they consume the products produced in the facility. In the majority of cases, the answer is no, due to their prior knowledge of the history of the product. Clearly those workers have a disconnect or lack of ownership with the product.
Akin to when the industry is highly regulated by government, the lack of empowerment by food workers throughout an organization ultimately leads to essentially passing-the-buck when it comes to food safety - an "it is not my problem" attitude.
It could be argued that empowerment is encompassed in the concept of a food safety culture. Yet "food safety culture" remains a relatively woolly term that lacks the nuts-and-bolts on how to change the behavior of those working in the food industry. There is frequent reference to increasing knowledge by training. However, knowledge and empowerment are very different.
Frank Yiannas introduced the term food safety culture, and noted the major challenges in changing worker behavior - after all, it does take a generation. Still every road starts with a first step and rather than look at the loss of government inspectors as entering the Dark Age we should look at this as an opportunity for industry to be empowered to take food safety initiatives to the next level.
------------------------
Dr. Keith Warriner is an Associate Professor within the Department of Food Science at University of Guelph, Canada.
In the United Kingdom, the Food Safety Agency that was established in the wake of the "mad cow" disease outbreak, amongst other food safety scares, was essentially dismantled with its portfolio being returned to Ministry of Agriculture (DEFRA).
In Canada, the number of CFIA inspectors was increased following the listeriosis outbreak of 2008 in which contaminated deli meats resulted in 20 deaths. However, the Canadian government is now cutting over 200 inspectors in a bid to save $25 million from the federal budget.
In the United States, the cutbacks have been deeper, with over 260 USDA offices being closed for a savings of $150 million per year.
In reaction, many consumer groups, the press and unions have pronounced the cutbacks as placing the public in danger through the governments neglecting their responsibilities.
The old question is thus posed: Does more government involvement, specifically in relation to inspector numbers, lead to a more effective food safety system?
A similar question is posed by criminologists in relation to police numbers and crime rates. Those on one side of the argument use statistics to show that an increase in police numbers results in decreased crime rates. However, what is missed is that an increase in policing is commonly preceded by a major event, such as 9/11 or when pre-existing crime levels are high.
In other studies, where no major event has occurred, it has been found that there is no correlation between police on the ground and crime rates.
The theory goes that high numbers of police on the ground lead to an increased level of crime detection but do little to prevent crime from occurring. As sociologists will indicate, crime rates are mostly affected by the environment, such as socio-economic factors and community cohesion - in effect the existing culture. To take the argument further, it is thought that increasing the level of policing can bring a siege-like atmosphere to a community and negatively affect the community cohesion.
Returning to food safety, we can make parallels between the effect of policing on crime rates and superimpose on the number of food inspectors and foodborne illness outbreaks. Specifically, inspector numbers increase or reorganization of agencies occurs following a major foodborne illness outbreak.
Yet, what is missed is that in the event of an outbreak, it is the industry response that is primarily responsible for enhancing food safety and not visits by an army of food inspectors. Nevertheless, food inspection does play a major role in containing outbreaks and follow-up investigations, although this is different from prevention.
Industry-led initiatives are the only way to enhance food safety
In the 1980s, there was a diverse range of food safety issues of concern. Foodborne illness rates were increasing, virulent pathogens such as E. coli O157 were taking hold, not to mention the BSE and problems with the emergence of drug-resistant microbes.
In response, a directive from President Clinton's administration set to prioritize food safety risks, reduce red tape and bureaucracy. The directive essentially empowered the industry to take responsibility for food safety by introducing HACCP, amongst other initiatives.
There is little debate that the initiatives were highly successful in reducing the incidence of foodborne illness with a progressive decrease in numbers since implementation.
A more recent example of industry-led initiatives is in relation to the use of antibiotics in animal production. Antibiotics have been commonly used in animal production to prevent infections, thereby leading to high growth rates. However, a negative effect of antibiotics has been the emergence of lethal antibiotic strains of pathogens such as Salmonella, amongst others.
The FDA has debated the banning of antibiotics for promoting animal growth for over 30 years. In late 2011, the FDA somewhat unexpectedly stepped back from banning antibiotics in animal production, which is counter to the actions taken over in the EU.
Many commentators saw this as a capitulation of the FDA to the lobbying pressure from the meat industry. However, the reality is that the meat industry has been proactive in reducing the use of antibiotics in animal production on the understanding that a staged reduction is required. Of course, this is not well-publicized but illustrates that only a successful antibiotic reduction program can be achieved if led by industry and not by government.
Empowerment of food safety is the key
The empowerment of industry to self-regulate always comes under criticism in the event of a foodborne illness outbreak. The knee-jerk reaction always appears to be more testing, more inspectors, more agencies etc.
In many ways, "tinkering" with the food safety system by government hinders the progress that has been made since 1995. Ultimately, industry-led initiatives will always be the most effective approach to improve food safety. Consequently, rather than increasing government inspection a more productive strategy is how to remove the weak links in the chain to prevent outbreaks from occurring in the first place.
Such a strategy is far from straightforward, as there is a need to understand the underlying basis for decisions made that ultimately led to critical errors of judgment in foodborne illness outbreaks.
For example, why do processors send out product known to be contaminated or perform practices that represent obvious food safety risks? In a broad sense, it can be proposed that the actions are through ignorance (lack of knowledge is perhaps a better term) of the risk, economic factors or, in a relatively low number of instances, bioterrorism or criminal intent.
Ironically, it is the latter group who have the greatest perception of empowerment given they are controlling events. In contrast, those that lack knowledge may have good intentions in producing high quality products, although fail to see the consequences. It is almost akin to a thought pattern of "nobody told me not to do it."
The current trend of clean labels, along with producers of organic products, can be classed in this group, where attempts to produce additive-free foods leads to food safety risks (for example, omitting nitrites to control Clostridium botulinum). Also included in this group are food handlers, quality assurance personnel and management whose main focus is to produce product as fast as possible with little thought of ownership or empowerment.
Workers have a tendency to lack empowerment, as they are told what to do and when to do it. This ultimately leads to a disconnect between the product and food safety. In the processing environment, workers are judged on how quickly the product can be processed regardless if the production line is producing ready-to-eat deli meat, cars or paper-clips.
Even if food violations occur, there is little incentive for the worker to raise concerns or to be empowered to make suggestions. When visiting processing plants, I sometimes ask the workers if they consume the products produced in the facility. In the majority of cases, the answer is no, due to their prior knowledge of the history of the product. Clearly those workers have a disconnect or lack of ownership with the product.
Akin to when the industry is highly regulated by government, the lack of empowerment by food workers throughout an organization ultimately leads to essentially passing-the-buck when it comes to food safety - an "it is not my problem" attitude.
It could be argued that empowerment is encompassed in the concept of a food safety culture. Yet "food safety culture" remains a relatively woolly term that lacks the nuts-and-bolts on how to change the behavior of those working in the food industry. There is frequent reference to increasing knowledge by training. However, knowledge and empowerment are very different.
Frank Yiannas introduced the term food safety culture, and noted the major challenges in changing worker behavior - after all, it does take a generation. Still every road starts with a first step and rather than look at the loss of government inspectors as entering the Dark Age we should look at this as an opportunity for industry to be empowered to take food safety initiatives to the next level.
------------------------
Dr. Keith Warriner is an Associate Professor within the Department of Food Science at University of Guelph, Canada.
01.02.2012 12:19:00
“Heartburn pills taken by thousands of women ‘raise risk of hip fractures by up to 50 per cent’,” the Daily Mail reported today. The headline is based on a large new study of drugs called proton pump inhibitors (PPIs), which are commonly used to treat heartburn, acid reflux and ulcers.
The study found that post-menopausal women who regularly took PPIs for at least two years were 35% more likely to suffer hip fracture than non-users, a figure that increases to 50% for women who were current or former smokers. However, although this increase in risk is large, the overall risk of fractures remains small.
This was a large, well conducted study that suggests that long-term use of PPIs is associated with a small increase in risk of hip fracture, although the researchers point out that the risk seems to be confined to women with a history of smoking. Unlike previous research, this study took careful account of other factors that might affect risk such as body weight and calcium intake.
Women who are concerned about their use of PPIs are advised to consult their GP.
Where did the story come from?
The study was carried out by researchers from Massachusetts General Hospital, Boston University and Harvard Medical School and was funded by the US National Institutes of Health. The study was published in the
peer-reviewed British Medical Journal.
Although the Mail’s headline is technically correct, it gives the impression that these drugs carry a very large increase in the risk of hip fracture. In fact, the study found that, in absolute terms, the increase in risk for regular users was small. Researchers found that among the women in the study who regularly used PPIs, about two in every 1,000 fractured a hip each year. In non-users, this figure was about 1.5 in every 1,000. This is a increase of about five fractures a year in every 10,000 women taking PPIs.
The Mail did point out this “absolute difference” towards the end of its story. Both the Mail and the BBC included comments from independent experts.
What kind of research was this?
The researchers point out that PPIs are among the most commonly used drugs worldwide. In the US they are available over the counter, but in the UK are available only on prescription. They are used for symptoms of heartburn, gastro-oesophageal reflux disease (GORD) and stomach ulcers. PPIs are thought to work by reducing acid production in the stomach. Concern has grown over a potential association between long-term use of these drugs and bone fractures, although the researchers say that previous studies have had conflicting results and many did not take other factors (called
confounders) that might affect the risk of fracture into account.
In their
cohort study of nearly 80,000 post-menopausal women, the researchers set out to examine the association between long-term use of PPIs and the risk of hip fracture. Unlike a
randomised controlled trial, a cohort study cannot prove cause and effect. However, cohort studies enable researchers to follow large groups of people for long periods and they are useful for looking at potential long-term risks and benefits of treatments. The study was
prospective, which means it followed participants in time, rather than collecting information retrospectively. This makes it more reliable.
What did the research involve?
This study took its data from a large ongoing US study called the Nurses Health Study, which began in 1976 and which sent health questionnaires every two years to 121,700 female nurses aged 30-55.
From 1982 participants were asked to report all previous hip fractures and in each biennial questionnaire, women were asked if they had sustained a hip fracture over the previous two years. Those who reported a hip fracture were sent a follow-up questionnaire asking for more details. Fractures from bad accidents, such as falling down a flight of stairs, were excluded from the study. A review of medical records for 30 of the women validated all self-reported fractures.
From 2000 to 2006 the women were asked if they had regularly used a PPI in the previous two years. In earlier questionnaires (1994, 1996, 1998 and 2000), the women were also asked if they had regularly used other drugs for acid reflux, called H2 blockers.
The biennial questionnaires also included questions on other factors including menopausal status, body weight, leisure activities, smoking and alcohol use, use of hormone replacement therapy (HRT) and other medicines. Researchers used a validated food frequency questionnaire to calculate the women’s total intake of calcium and vitamin D.
They then analysed the data for any association between regular use of PPIs and hip fracture, adjusting their findings for key confounders such as body weight, physical activity, smoking and alcohol and calcium intake. They also took into account whether the reasons for using a PPI might have affected the results.
Finally, they carried out a systematic review combining their results with 10 previous studies on the risk of hip fracture and the long-term use of PPIs.
What were the basic results?
The researchers documented 893 hip fractures during the period of the study. They also found that, in 2000, 6.7% of women regularly used a PPI – a figure that had risen to 18.9% by 2008.
- Amongst women who had regularly taken a PPI at any time, there were 2.02 hip fractures per 1,000 person years, compared with 1.51 fractures per 1,000 person years among non-users.
- Women who regularly used PPIs for at least two years had a 35% higher risk of hip fracture than non-users (age adjusted hazard ratio (HR) 1.35; 95%
confidence interval (CI) 1.13 to 1.62), with longer use associated with increasing risk. Adjustment for risk factors, including body mass index, physical activity and intake of calcium did not alter this association (HR 1.36; CI 1.13 to 1.63).
The increased risk did not change when researchers also took into account the reasons for PPI use:
- Current and former smokers who regularly used PPIs were 51% more likely to have a hip fracture than non-users (HR 1.51; (CI) 1.20 to 1.91).
- Among women who never smoked there was no association between PPI use and hip fracture (HR 1.06; (CI) 0.77 to 1.46).
- In a meta-analysis of these results with 10 previous studies, the risk of hip fracture in users of PPI was higher compared to non–users of PPIs (pooled odds ratio 1.30; CI 1.25 to 1.36).
The researchers also found that two years after women stopped taking PPIs, their risk of hip fracture returned to a similar level to that in women who had never taken them. Also, women taking H2 blockers had a “modest” increased risk of hip fracture but the risk was higher in women who took PPIs.
How did the researchers interpret the results?
The researchers conclude that their results provide “compelling evidence” of a risk between PPI use and hip fracture. They say the findings suggest that the need for long-term, continuous use of PPIs should be carefully evaluated, particularly among people who have smoked or are still smokers.
They suggest that PPIs may increase the risk of fracture by impairing the absorption of calcium, although in this study the risk of fracture was not affected by dietary calcium intake. The finding that the risk was confined to women with a history of smoking (an established risk factor for fracture) indicates that smoking and PPIs may act together (have a “synergistic effect”) on fracture risk.
Conclusion
This large study had several strengths. Unlike some previous studies, it collected information on and took into account other key risk factors for fracture, including body weight, smoking, alcohol use and physical activity. It also looked at the women’s use of PPIs every two years (rather than just asking them once) and took into account variations in use during this time in their analysis.
However, as the authors note, it also had some limitations:
- It did not ask about the brands of PPI used, nor the doses of PPI the women took, both of which could affect risk of fracture.
- The information about hip fracture was self-reported and not confirmed by medical records (although a smaller study has found self-reporting of hip fracture to be reliable).
- Also, the study did not record the women’s bone mineral density (BMD). Low[?] BMD is an important risk factor for fracture and adding a measure of this could have strengthened the study.
Finally, because this was a cohort study, other factors both measured and unmeasured may have affected the results, even though researchers took many of these into account in their analysis. Socio-economic status and education, for example, were not established. Because this was a study of registered nurses, the applicability of the results to other socio-economic groups might be limited.
This study found that the long-term, regular use of these drugs is associated with a small increased risk in hip fracture among older women, a risk that seems to be confined to past or current smokers. Women who regularly take PPIs and who are concerned about these findings are advised to talk to their GP. Whether any change in use of this commonly prescribed drug is needed requires further study.
Links To The Headlines
Indigestion drugs taken by millions linked to hip fractures. The Daily Telegraph, February 1 2012
Heartburn pills taken by thousands of women 'raise risk of hip fractures by up to 50 per cent'. Daily Mail, February 1 2012
Ulcer drugs 'link to fractures'. BBC News, February 1 2012
Links To Science
Khalili H, Huang ES, Jacobsen BC, et al.
Use of proton pump inhibitors and risk of hip fracture in relation to dietary and lifestyle factors: a prospective cohort study. British Medical Journal. Published online January 31 2012
01.02.2012 12:59:01
As Food Safety News continues to investigate the identity of 'Restaurant Chain A,' the "Mexican-style fast food chain" linked to a
10-state outbreak of Salmonella enteritidis infection in October and November 2011, the issue has received mounting attention from a variety of media outlets and blogs, including
the Huffington Post and
Marion Nestle at Food Politics.
JoNel Aleccia of msnbc.com
spoke with Dr. Robert Tauxe, the Center for Disease Control and Prevention's Deputy Director of Foodborne, Waterborne and Environmental Disease. In the interview, Tauxe explained the government's rationale behind withholding the name of the restaurant, a practice he said the CDC and Food and Drug Administration regularly follow in similar outbreaks.
The agencies' longstanding policy has been to identify companies linked to outbreaks only when the information will directly protect public health, such as in the case of an ongoing outbreak. The CDC also wants to avoid jeopardizing cooperation with companies that voluntarily release information during outbreak investigations.
In this case, according to the CDC the CDC and FDA chose not to identify the restaurant because the outbreak ended before investigators had enough information to release a report. In other words, no more people were at risk of catching the bug by the time the agencies pinpointed it.
Food safety attorney Bill Marler, who publishes Food Safety News,
dismissed that reasoning, noting that nearly all CDC investigations discover the source of an outbreak after the peak illnesses have passed. Identifying outbreak-associated restaurants reveals their food safety track record over time, he added.
To some food safety and public health experts, the ramifications of withholding the restaurant's identity extend beyond potentially harming a company's reputation.
Dave Theno, the former vice-president of technical services for Jack in the Box, said that identifying the restaurant in an outbreak lets related businesses respond accordingly, perhaps in ways government agencies would not predict. The Salmonella infections have been traced to a product -- likely fresh produce -- served at Restaurant A, but contaminated before it arrived.
"Let's say I own a restaurant and I happen to know my lettuce supplier also supplies Restaurant A. In the real world, as soon as the lettuce supplier hears from Restaurant A, he's going to call all his customers to tell them what's happening," Theno said. "But people don't always see every outbreak and don't always get notified. There are a lot of gaps in the system, to be quite honest."
Theno said that if other restaurant owners shared a mutual supplier with Restaurant A, they might not know they ever carried a contaminated product unless the government identified the outbreak's source.
Theno also wondered whether Mexican-style fast food restaurants not involved in the outbreak might suffer economic harm. By revealing only the type of chain, public health agencies might cause consumers to avoid all types of Mexican-style chains out of caution.
Craig Hedberg, Ph.D., professor of environmental health at the University of Minnesota, said that in the initial stages of an epidemiological investigation, revealing the name of an outbreak source can create unnecessary complications for the researchers. Not only do investigators want to be absolutely certain they pinpoint the right source, they need time to interview and vet victims before the public and the media scrutinize and otherwise influence the investigation.
Once the investigation has confirmed its source and an outbreak report is ready, however, the benefits of nondisclosure become less relevant, Hedberg said.
More importantly, he added, by not revealing itself, Restaurant A is missing an opportunity to publicly acknowledge and correct its mistake.
"We certainly all understand that foodborne illnesses occur and nobody wants to see that happen," Hedberg said. "But in the years I investigated outbreaks with the Minnesota Department of Health, our experience was that when a food producer or restaurant could stand up say, 'Yes, the outbreak happened, and this is what we're doing to prevent it again,' the public responds positively to that."
"Rather than run from the outbreak, the company needs to stand up and say, 'We can't always prevent everything, but this gives us a chance to review our practices and redouble our efforts to make sure this doesn't happen again,'" he added. "That almost always goes well with the public. You have to give credit to the public for understanding."
Hedberg referenced the 1994 outbreak of Salmonella enteritidis infection linked to Schwan's ice cream, made from ice cream mix contaminated in a supplier's tanker trucks. Despite not being directly culpable, Schwan's took responsibility and pledged to reform its food safety standards.
"Schwan's changed their processes in response to that outbreak and have become an important leader in the food safety arena since that time," Hedberg said."They weren't responsible, but rather than hiding from the public, they used that opportunity to really remake their whole food safety system."
Similarly, Theno instrumentally reformed Jack in the Box's food safety practices following the 1993 outbreak of E. coli O157:H7 linked to undercooked ground beef at their restaurants. He said the Restaurant A outbreak might provide an opportunity to reevaluate the precedent of nondisclosure for similar outbreaks moving forward.
"I've worked with Robert Tauxe and the FDA for years. I understand exactly where they are, but I don't happen to agree with it all," Theno said. "Perhaps it's time to look at this whole issue again, not in the crux of an outbreak, but with calm minds and with all the interested parties at the table and ask, 'Is there a better way to do this?' I don't have an answer to that, but I think it would serve everyone well."
10-state outbreak of Salmonella enteritidis infection in October and November 2011, the issue has received mounting attention from a variety of media outlets and blogs, including
the Huffington Post and
Marion Nestle at Food Politics.
JoNel Aleccia of msnbc.com
spoke with Dr. Robert Tauxe, the Center for Disease Control and Prevention's Deputy Director of Foodborne, Waterborne and Environmental Disease. In the interview, Tauxe explained the government's rationale behind withholding the name of the restaurant, a practice he said the CDC and Food and Drug Administration regularly follow in similar outbreaks.
The agencies' longstanding policy has been to identify companies linked to outbreaks only when the information will directly protect public health, such as in the case of an ongoing outbreak. The CDC also wants to avoid jeopardizing cooperation with companies that voluntarily release information during outbreak investigations.
In this case, according to the CDC the CDC and FDA chose not to identify the restaurant because the outbreak ended before investigators had enough information to release a report. In other words, no more people were at risk of catching the bug by the time the agencies pinpointed it.
Food safety attorney Bill Marler, who publishes Food Safety News,
dismissed that reasoning, noting that nearly all CDC investigations discover the source of an outbreak after the peak illnesses have passed. Identifying outbreak-associated restaurants reveals their food safety track record over time, he added.
To some food safety and public health experts, the ramifications of withholding the restaurant's identity extend beyond potentially harming a company's reputation.
Dave Theno, the former vice-president of technical services for Jack in the Box, said that identifying the restaurant in an outbreak lets related businesses respond accordingly, perhaps in ways government agencies would not predict. The Salmonella infections have been traced to a product -- likely fresh produce -- served at Restaurant A, but contaminated before it arrived.
"Let's say I own a restaurant and I happen to know my lettuce supplier also supplies Restaurant A. In the real world, as soon as the lettuce supplier hears from Restaurant A, he's going to call all his customers to tell them what's happening," Theno said. "But people don't always see every outbreak and don't always get notified. There are a lot of gaps in the system, to be quite honest."
Theno said that if other restaurant owners shared a mutual supplier with Restaurant A, they might not know they ever carried a contaminated product unless the government identified the outbreak's source.
Theno also wondered whether Mexican-style fast food restaurants not involved in the outbreak might suffer economic harm. By revealing only the type of chain, public health agencies might cause consumers to avoid all types of Mexican-style chains out of caution.
Craig Hedberg, Ph.D., professor of environmental health at the University of Minnesota, said that in the initial stages of an epidemiological investigation, revealing the name of an outbreak source can create unnecessary complications for the researchers. Not only do investigators want to be absolutely certain they pinpoint the right source, they need time to interview and vet victims before the public and the media scrutinize and otherwise influence the investigation.
Once the investigation has confirmed its source and an outbreak report is ready, however, the benefits of nondisclosure become less relevant, Hedberg said.
More importantly, he added, by not revealing itself, Restaurant A is missing an opportunity to publicly acknowledge and correct its mistake.
"We certainly all understand that foodborne illnesses occur and nobody wants to see that happen," Hedberg said. "But in the years I investigated outbreaks with the Minnesota Department of Health, our experience was that when a food producer or restaurant could stand up say, 'Yes, the outbreak happened, and this is what we're doing to prevent it again,' the public responds positively to that."
"Rather than run from the outbreak, the company needs to stand up and say, 'We can't always prevent everything, but this gives us a chance to review our practices and redouble our efforts to make sure this doesn't happen again,'" he added. "That almost always goes well with the public. You have to give credit to the public for understanding."
Hedberg referenced the 1994 outbreak of Salmonella enteritidis infection linked to Schwan's ice cream, made from ice cream mix contaminated in a supplier's tanker trucks. Despite not being directly culpable, Schwan's took responsibility and pledged to reform its food safety standards.
"Schwan's changed their processes in response to that outbreak and have become an important leader in the food safety arena since that time," Hedberg said."They weren't responsible, but rather than hiding from the public, they used that opportunity to really remake their whole food safety system."
Similarly, Theno instrumentally reformed Jack in the Box's food safety practices following the 1993 outbreak of E. coli O157:H7 linked to undercooked ground beef at their restaurants. He said the Restaurant A outbreak might provide an opportunity to reevaluate the precedent of nondisclosure for similar outbreaks moving forward.
"I've worked with Robert Tauxe and the FDA for years. I understand exactly where they are, but I don't happen to agree with it all," Theno said. "Perhaps it's time to look at this whole issue again, not in the crux of an outbreak, but with calm minds and with all the interested parties at the table and ask, 'Is there a better way to do this?' I don't have an answer to that, but I think it would serve everyone well."
31.01.2012 21:22:00
Leading food industry groups are urging the Obama administration to adequately fund federal food safety oversight, instead of seeking new taxes or regulatory fees. "We respectfully ask that you make securing adequate congressional funding for U.S. Food and Drug Administration (FDA) food safety activities one of your highest priorities rather than proposing any new food taxes or regulatory fees on consumers and food makers," the groups wrote in a letter Monday to Health and Human Services Secretary Kathleen Sebelius and White House Office and Management Acting DIrector Jeffrey Zients. The letter was signed by a wide variety of industry groups, including the American Frozen Food Institute, the American Meat Institute, the Juice Products Association, the United Fresh Produce Association and the Pet Food Institute. For the complete news item, please visit http://www.foodsafetynews.com/2012/01/food-industry-tells-obama-administration-no-food-safety-fees/
01.02.2012 12:59:06
Saying a New York cheese maker failed to correct repeated violations, despite multiple federal and state warnings, the U.S. Food and Drug Administration has gone to court to close down the plant until it complies with food safety regulations.
Mexicali Cheese of Woodhaven, NY produced cheese under persistent unsanitary conditions that contributed to Listeria monocytogenes contamination of the facility and the company's products, the FDA alleges in a complaint for permanent injunction filed Monday by the U.S. Department of Justice.
According to the FDA news release, Mexicali Cheese makes and distributes a variety of soft Mexican cheeses to grocery stores and supermarkets in New York, New Jersey and Connecticut. Mexicali Cheese's products include queso fresco [fresh cheese], queso oaxaca (Oaxacan cheese) and queso para freir [cheese for frying].
In October 2010,
an FDA warning letter said inspectors found Listeria monocytogenes in at least five locations inside the Mexicali processing facility. In August that year, the New York Department of Agriculture warned consumers not to eat any Queso Cotija Cheese from Mexicali because of possible Staphylococcus aureus contamination.
The injunction, if entered by the court, would stop the company and its officers from manufacturing and distributing food until they can bring their operations into full compliance with the Federal Food, Drug, and Cosmetic Act and FDA food safety regulations.
"FDA filed this complaint to protect the health of consumers," said Dara A. Corrigan, associate commissioner for regulatory affairs, in the agency's statement. "Working closely with New York's Department of Agriculture and Markets, we took this step to ensure that consumers do not eat potentially dangerous foods from this company."
Mexicali Cheese of Woodhaven, NY produced cheese under persistent unsanitary conditions that contributed to Listeria monocytogenes contamination of the facility and the company's products, the FDA alleges in a complaint for permanent injunction filed Monday by the U.S. Department of Justice.
According to the FDA news release, Mexicali Cheese makes and distributes a variety of soft Mexican cheeses to grocery stores and supermarkets in New York, New Jersey and Connecticut. Mexicali Cheese's products include queso fresco [fresh cheese], queso oaxaca (Oaxacan cheese) and queso para freir [cheese for frying].
In October 2010,
an FDA warning letter said inspectors found Listeria monocytogenes in at least five locations inside the Mexicali processing facility. In August that year, the New York Department of Agriculture warned consumers not to eat any Queso Cotija Cheese from Mexicali because of possible Staphylococcus aureus contamination.
The injunction, if entered by the court, would stop the company and its officers from manufacturing and distributing food until they can bring their operations into full compliance with the Federal Food, Drug, and Cosmetic Act and FDA food safety regulations.
"FDA filed this complaint to protect the health of consumers," said Dara A. Corrigan, associate commissioner for regulatory affairs, in the agency's statement. "Working closely with New York's Department of Agriculture and Markets, we took this step to ensure that consumers do not eat potentially dangerous foods from this company."
01.02.2012 16:44:26
http://www.fda.gov/Safety/Recalls
Important news for women using oral birth control products. Pfizer is recalling about one million packets of birth control pills in the United States because they may not contain enough contraceptive to prevent pregnancy.
"As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy," according to a Pfizer statement on
the U.S. Food and Drug Administration website.
Monthly doses contain 28 tablets total... 21 with contraceptive and 7 sugar pills. The pharamceutical company discovered that some of their blister packs had too many active tablets, some had too few and some had the tablets out-of-order.
Related:
7 Amazing Health Benefits of Sex
The recall involves 14 lots of Lo/Ovral-28 tablets and 14 lots of Norgestrel and Ethinyl Estradiol tablets.
A company spokesperson told The Associated Press that the problem is the result of both mechanical error and a failure on the packaging line during visual inspections.
The pills in question were distributed nationwide.
Lot numbers of affected packs of Lo/Ovral®-28 (norgestrel and ethinyl estradiol)Tablets and Norgestrel and Ethinyl Estradiol Tablets (generic) follow on the table below:
| NDC |
Product |
Lot |
Expiration |
Configuration/Count |
|---|---|---|---|---|
| 24090-801-84 | LO/OVRAL® 28 | E15678 | 08/31/2013 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | E15679 | 08/31/2013 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | E15686 | 08/31/2013 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | E15687 | 01/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | E15690 | 01/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | E15698 | 01/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | E15700 | 02/28/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | E80434 | 07/31/2013 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | E80438 | 08/31/2013 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | F36908 | 02/28/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | F36909 | 02/28/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | F43915 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | F43926 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | F43927 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | E15677 | 08/31/2013 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | E15704 | 01/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | E15706 | 01/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | E80440 | 08/31/2013 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F16388 | 01/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F16390 | 02/28/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F22132 | 02/28/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F31330 | 02/28/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F36911 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F36913 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F43924 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F43925 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F43934 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F53238 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
http://www.fda.gov/Safety/Recalls/ucm289770.htm
###
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30.01.2012 11:00:00
MONDAY, Jan. 30 (HealthDay News) -- The U.S. Food and Drug Administration on Monday approved a drug to treat the most common form of skin cancer, basal cell carcinoma. Erivedge (vismodegib) is the first drug sanctioned in the United States to trea...
31.01.2012 21:00:00
FOR IMMEDIATE RELEASE - January 30, 2012 - Vitaflo USA has announced a voluntary recall of Renastart 14.11 oz (400g) cans, Batch Number 12832 (shown on underside of can), because some of the product shipped throughout the United States during the period December 29, 2011 through January 26, 2012 has been incorrectly labeled. Renastart is a powdered medical food used in the dietary management of pediatric renal disease, for patients one year and older in the United States. All other Vitaflo products, including Renastart cans in batches other than 12832 and Renastart packed in sachets, are not affected in any way. Some immediate consequences of using the incorrectly labeled product may result in high potassium blood levels (hyperkalemia) or high sodium levels in the blood (hypernatremia). In most cases, symptoms may be hard for an individual to detect, but can result in significant health consequences potentially leading to death, which is the importance for contacting a health care professional. Longer term consequences can result in increased levels of calcium, phosphorus, and protein. There have been no cases of illness or other adverse effects reported to Vitaflo USA. Following a customer complaint regarding the way the product was dissolving, Vitaflo determined that a small number of cans of a different product may have been wrongly labeled as Renastart. The company is investigating to make sure we continue to safely meet the needs of our patients and as a precautionary measure has issued this immediate voluntary recall. For the complete recall notice, please visit http://www.fda.gov/Safety/Recalls/ucm289658.htm?source=govdelivery
31.01.2012 17:01:25
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2012-02-01 10:56:32
The first study to check the effects of eating potatoes on blood pressure in humans has concluded that two small helpings of purple potatoes (Purple Majesty) a day decreases blood pressure by about 4 percent without causing weight gain. In a report in the ACS' Journal of Agricultural and Food Chemistry, the researchers say that decrease, although seemingly small, is sufficient to potentially reduce the risk of several forms of heart disease. Joe Vinson and colleagues point out that people in the U.S. eat more potatoes than any other vegetable. Purple-skinned potatoes, a boutique variety increasingly available in food stores, are noted for having high levels of healthful antioxidant compounds. And in Korea, purple potatoes are renowned in folk medicine as a way to lose weight. Vinson's team thus decided to investigate the effects of eating 6-8 small microwaved purple potatoes twice a day on 18 volunteers, most of whom were overweight with high blood pressure. The volunteers ate potatoes or no potatoes for four weeks, and then switched to the opposite regimen for another four weeks while researchers monitored systolic and diastolic blood pressure (the higher and lower numbers in a blood pressure reading like 120/80), body weight and other health indicators. Average diastolic blood pressure dropped by 4.3 percent and systolic pressure decreased by 3.5 percent. The majority of subjects took anti-hypertensive drugs and still had a reduction in blood pressure. None of the study participants gained weight. Vinson said that other studies have identified substances in potatoes with effects in the body similar to those of the well-known ACE-inhibitor medications, a mainstay for treating high blood pressure. But he suspects that the effects may be due to other substances in potatoes. The scientists do not know yet whether ordinary white potatoes have the same beneficial effects. The authors acknowledge funding through a Cooperative Agreement Grant from the United States Department of Agriculture (USDA). --- On the Net:
2012-01-31 14:15:18
According to documents recently released by federal courts, the U.S. Food and Drug Administration (FDA) allegedly spied on its own employees. The organization is charged with secretly accessing the private e-mail accounts of staff researchers who criticized the agency for approving medical equipment that posed a potential safety risk to patients. A group of six doctors and scientists, all either current or former employees of the federal health agency, filed a lawsuit in a U.S. District Court in D.C. last week alleging that the organization attempted to prevent its own experts from releasing potentially incriminating reports about corrupt practices in the agency’s review process for new medical equipment. All of the plaintiffs were part of an FDA division in charge of reviewing applications for new medical technology. According to the recently released documents, FDA chiefs started intercepting the e-mails sent by the whistleblowers to members of Congress after they had initially made their concerns known to the Obama administration in early 2009. Although using government computers to communicate with congressional staff members, the dissenting researchers reportedly used their own private e-mail accounts with Google and Yahoo. Moreover, the FDA allegedly used spyware software in order to obtain snapshot images of the whistleblower’s computer screens which were in turn used to make illicit copies of their private communications and identify other staff members who were assisting them. In an article published Monday in the Washington Post, the newspaper noted that FDA computers warn all users when they log in that they have “no reasonable expectation of privacy.” The researchers filing the charges, however, have stated that the FDA’s surveillance tactics violated their constitutionally guaranteed privacy rights and that they were intended to obstruct legitimate whistleblowing activity. “Who would have thought that they would have the nerve to be monitoring my communications to Congress?” one of the plaintiffs in the suit Robert C. Smith told the Washington Post. “How dare they?” added the indignant former radiology professor at Yale and Cornell universities. Smith was employed by the FDA until the agency decided not to renew his contract in July 2010. FDA spokeswoman Erica Jefferson has stated only that the agency does not comment on ongoing litigation. In addition to approving medical equipment that researchers had flagged as dangerous, the plaintiffs also say that the FDA attempted to retaliate against them by refusing to renew their employment contracts—as was the case with Jefferson—as well as by accusing them of criminal malfeasance. After airing their complaints about agency’s dubious approval practices to the New York Times in March2010, the FDA attempted to launch a criminal investigation against the whistleblowers, claiming that they had unlawfully released confidential business information. The FDA’s allegations were shot down by independent federal investigators who noted that the reported activity was legal and that the charges lacked evidence. As the investigation grows into a public scandal, legislators have belated begun registering their disapproval. In an official statement made last week, Republican Senator Charles Grassley of Iowa said: “The FDA has a huge responsibility to protect public health and safety [and] it’s hard to see how managers apparently thought it was a good use of time to shadow agency scientists and monitor their e-mail accounts for legally protected communications with Congress.” --- On the Net:
01.02.2012 11:00:00
On Monday, the US Food and Drug Administration approved a new type of drug to treat adult patients with advanced basal-cell carcinoma, the most common type of skin cancer. The drug's generic name is vismodegib and was developed by the US part of Roche Holding AG. It will be sold in the US by Roche's South San Francisco-based Genentech under the brand name Erivedge. Basal cell carcinoma is a slow growing, painless cancer that starts in the epidermis, the top layer of skin. It usually starts in places that are regularly exposed to the sun or UV light...
30.01.2012 11:00:00
MONDAY, January 30 (HealthDay News) -- Erivedge (vismodegib) has been approved by the U.S. Food and Drug Administration to treat the most common form of skin cancer, basal cell carcinoma, the agency said Monday. The drug was approved for people fo...
2012-01-31 06:22:43
Johnson & Johnson have announced a voluntary recall for its Aveeno Baby Calming Comfort Lotion. According to tests performed by the Food and Drug Administration (FDA), the lotion contained an excessive amount of the common bacteria coagulase-negative Staphylococci. But an independent laboratory, EMSL, tested the samples and did not find any indication that the number of bacteria exceeded specifications. Jason Dobranic Ph.D., National Microbiology Director at EMSL says, “As one of the nation’s leading testing laboratories, EMSL Analytical offers companies advanced microbiology testing services for their consumer products in cases such as these. We help companies deal with quality-control issues and recalls, and because we are an FDA registered, cGMP compliant, and IS) 17025 accredited laboratory, our clients know that they can rely on our results.” The bacteria is commonly found living on the skin, scalp, and mucous membranes of humans. And is also commonly found in cosmetic products but is not considered a health threat. The company is recalling 2,200 tubes of the lotion containing the lot number 0161LK. The tubes were sold in nine states Alabama, Arkansas, Florida, Georgia, Kansas, Louisiana, Mississippi, Tennessee, and Texas. The recall is voluntary and no ill effects have been reported. The chance of any ill effects is very slim, according to Johnson & Johnson. They will offer consumers a refund, but the recall states, “Consumers do not need to take action and the potential for adverse health effects is remote. Of course, anyone who has concerns or is uncomfortable using the product may discontinue us.” According to the Johnson & Johnson press release the full product name recalled is Aveeno Baby Calming Comfort Lotion with the UPC code 38137-0036456. Johnson & Johnson’s Consumer Call Center can be reached at 1-877-298-2525. --- On the Net:
31.01.2012 11:00:00
TUESDAY, Jan. 31 (HealthDay News) -- Kalydeco (ivacaftor) has been approved by the U.S. Food and Drug Administration to treat the root cause of a rare form of the inherited disease cystic fibrosis. CF causes a deadly buildup of thick mucus in the ...
01.02.2012 20:00:00
Basal cell carcinoma is a form of skin cancer caused by regular sun exposure, or other ultraviolet radiation, which starts in the top layer of the skin (epidermis), is usually painless and grows slowly. The U.S. Food and Drug Administration just approved a new drug named Erivedge (vismodegib) for the treatment of adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is designed for use in patients with locally advanced basal cell cancer, whose cancer has spread to other locations in the body, and who are unsuitable candidates for surgery or radiation...
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