09.03.2012 12:59:07
When Maria Higginbotham couldn't find the usual dog treats she buys at her local Target store back in early January, she decided to instead buy some brand-name chicken jerky dog treats for Bandit, her 3-year-old rat terrier.
Four days later, Bandit collapsed on the floor.
He was soon experiencing bloody diarrhea, and by the time Higginbotham and her mother got him to his veterinarian, his organs were shutting down. His liver showed that he had eaten something toxic. Certain that Bandit's inexplicable illness had already become too severe, the veterinarian suggested putting him down, and Higginbotham's mother and son agreed.
But she refused, and after nearly $4,000 in medical bills and three weeks of intensive nursing that included in-home I.V. care, Bandit recovered. The vet could not conclusively link the chicken jerky to the illness, but Higginbotham said he thought it could be the cause.
Bandit's puppyish spark has come back, but Higginbotham remains anxious, feeling an overwhelming sense of helplessness over what she might be feeding her dog.
At the opposite corner of the country, in Eastern Florida, Danielle Kinard-Friedman's story did not end as well. Two weeks ago, Millie, her 18-month-old yellow Labrador, began vomiting bile after weeks of growing progressively more lethargic.
When Millie wouldn't eat anything, Kinard-Friedman took her to a vet. Blood tests revealed that Millie was experiencing kidney failure, and so she spent a week in an emergency pet clinic receiving intensive treatment that eventually proved futile. She was put down this past Sunday.
It was Millie's vet who asked Kinard-Friedman if she had been feeding her dog chicken jerky treats. She had. In fact, she had just started buying the treats -- under a different brand-name from Bandit's -- two months prior.
The vet then asked a more alarming question: Was the chicken from China? She had no idea, but she checked the label as soon as she got home. It was. When Higginbotham checked her treats, she found the same thing. Their vets could not prove anything, but both suspected the treats had sickened the dogs.
Higginbotham and Kinard-Friedman have now joined thousands of pet owners speaking out on the Internet and asking the government to force a recall of chicken jerky dog treats made from Chinese chicken. Concerns over the issue first arose in 2007, when the U.S. Food and Drug Administration began receiving reports of sickened dogs, all with the apparent common denominator of chicken jerky treats from China.
Since then, the FDA has performed hundreds of tests on chicken jerky samples and has not yet found any contaminant to explain the illnesses.
Regardless, the movement has continued to gain significant momentum. In the past month, it even got the attention of Ohio's Sen. Sherrod Brown and Rep. Dennis Kucinich after Ohio resident Candace Thaxton contacted them about two of her dogs who fell ill.
Until a cause is uncovered, owners and lawmakers say they will continue requesting that the FDA make the issue a priority, while the 15 companies implicated by consumers see no empirical evidence to justify recalling their products.
Congressmen and FDA sink their teeth in
On February 7, Brown brought the issue to the Senate floor, saying he had urged the Food and Drug Administration to accelerate its investigation into these chicken jerky treats -- found under multiple brand names but all sourced from China -- that appeared to be sickening dogs across the country. Two weeks later, the senator held a press conference and issued a news release again urging the FDA to act swiftly.
Back on Nov. 18, 2011, the FDA cautioned consumers that chicken jerky dog treats from China may be associated with a rising number of dog illnesses. This followed earlier warnings of the same issue in September 2007 and December 2008. After a drop in 2009 and 2010, reports of dog illnesses have spiked once again.
The November 2011 FDA notice warned dog owners who purchased chicken jerky to monitor their pets for decreased appetite, decreased activity, vomiting, diarrhea (including bloody , increased urination or increased water consumption. If any of those symptoms worsen or last more than 24 hours, owners should bring their dog to a vet, the notice said. Blood tests could indicate kidney failure, while urine tests might indicate Fanconi Syndrome, a disorder that results in nutrients normally absorbed into the bloodstream instead being released through urine.
On Wednesday, an FDA spokesperson confirmed to Food Safety News that the agency has recently received more than 600 reports from dog owners who say their pets have fallen ill because of jerky products made from Chinese chicken.
Since the issue first arose in September 2007, the FDA has run numerous chemical and microbial tests on Chinese chicken jerky samples in search of a contaminant. Though the agency said it could not conclude anything from the test results, the details remained under wraps until March 1, when an FDA document describing tests dating back to 2007 was sent to Kucinich's office. According to a Kucinich aid, the congressman "took them to task" at a briefing in order to get the information.
The one-page document outlines 241 tests for potential contaminants and 130 tests with pending results, none of which conclusively link the jerky to contaminants at dangerous levels. The 2012 tests with results still pending, however, are searching for heavy metals.
The Kucinich aid and many pet owners said they hope those latest tests might finally link the treats to a toxic substance and resolve the mystery of their pets' problems. The FDA has stated repeatedly that it will continue to actively investigate the issue.
According to the FDA, at least one Australian chicken jerky manufacturer has issued a recall of its products made from Chinese chicken, calling the move a precautionary measure.
The manufacturer may be mindful of March 2007, when hundreds of pet illnesses linked to melamine-contaminated Chinese ingredients prompted the recall of thousands of pet food products in the U.S., Europe and South Africa. In the U.S., the FDA received thousands of reports of dogs and cats dying from kidney failure, but confirmed very few cases.
More consumers come forward, but pet food industry says they're not to blame
A month ago, the private Facebook group called "Animal Parents Against Pet Treats Made in China!" had roughly 100 members. Today, the number has exploded to more than 2,500. One petition demanding the ban of jerky treats from China has acquired more than 3,000 signatures.
Susan Rhodes created another petition on March 3. She has asked the FDA to recall the jerky treats after she found that her dog, Ginger, had suffered permanent kidney damage and was losing weight at an alarming rate. Rhodes said she had been feeding the treats to Ginger for the past two years. Days after creating the petition, she has racked up more than 300 signatures from dog owners reporting similar diagnoses.
Media coverage and word of mouth have brought a tidal wave of attention to the manufacturers of these treats. Some of the snowballing coverage, however, might lead some pet owners to incorrectly blame other health problems on the treats, said Kurt Gallagher, spokesperson for the Pet Food Institute, an industry education and public relations resource.
"Pet food companies want to make safe, nutritious products. It's their top priority," Gallagher told Food Safety News. "When everyone's talking about something like this, I think there's heightened awareness and sensitivity for pet owners looking for it."
Gallagher recommended pet owners take any sick pets to a vet to get a clinical opinion before diagnosing any issues themselves. If the vet considers pointing a finger at a certain food, the owners should contact the food manufacturer. Food companies should be tracking their complaints and looking for patterns and problems within their food supply, he said.
Pet owners have been quick to amass lists of jerky manufacturers sourcing their chicken from China. Rhodes' petition, for example, names 15 such companies.
A spokesperson for a dog treat company at the center of the furor reiterated that the FDA's testing has not found any contaminants and so his company has no reason to believe their product has sickened dogs. The company has a comprehensive food safety system at their Chinese facilities, he said, including quality control inspectors who monitor for safety.
He added that his company appreciated hearing from concerned customers, and emphasized that anecdotal evidence, however pervasive, does not prove causation.
"Obviously, we take food safety very seriously," he said. "Millions of dogs enjoy our products without ever getting sick."
Multiple pet owners have told Food Safety News that the spokesperson's company has backed away from its original intention to offer customers small monetary settlements for harm their jerky might have caused pets. According to sources, once the complaints reached a certain volume, spokespeople for the company told customers that providing any settlements would be an admission of guilt.
Made in "America"?
Blogger Mollie Morrissette has been following the chicken jerky developments for more than a year on her website, Poisoned Pets. She said that the issue has reached a sort of tipping point in the last month, with more and more pet owners speaking up about sick dogs.
"I get letters every day from broken-hearted pet parents -- people who had to put down their beloved family dog or five month-old puppy," she said. "They all fed their dogs chicken jerky."
One issue frustrating pet owners, Morrissette said, is that many of these dog treat packages boast that they are made in the U.S., though the fine print on the package often reveals that the chicken actually comes from China, where a cultural preference for dark meat makes for cheap white meat.
These "country of origin" claims are made possible by laws that say that once an ingredient is "substantially" altered in a given country, the resulting food can be considered a product of that country. These alterations can include cooking, mixing or otherwise reprocessing the ingredients in some way.
Just as oranges from Brazil can be turned into Canadian orange juice, chicken jerky from China can be reprocessed and repackaged in the U.S. to become a U.S. product. This can trick consumers into a false sense of security about the safety of their pet's food, Morrissette said.
Higginbotham said that the brand of jerky she bought for Bandit claimed to be "Proudly manufactured by an American company." Kinard-Friedman believed the same thing about the jerky she fed to Millie.
Morrissette said that pet owners feel helpless as they wait for some sort of justice on behalf of their pet, and she criticized the FDA for what she saw as a lack of urgency in investigating the illnesses.
"A lot of these pet parents are just wringing their hands, hoping the FDA will find some sort of answer," she said. "If this was [potentially contaminated] baby formula, we would have had the answer when it started five years ago. It would all get pulled off the shelves out of caution as soon as anyone suspected it might be contaminated."
Owners say they won't back down until they have an answer
Candace Thaxton, the woman who spurred Senator Brown and Congressman Kucinich into action, has more than one dog motivating her to uncover that answer.
In November 2011, when her 10-year-old pug, Chansey, started urinating unusually often and refusing to eat, Thaxton assumed they were just signs that the dog was getting old.
Chansey's health quickly deteriorated. At a vet appointment, Thaxton learned that the dog's kidneys had shut down and she would need intensive medical treatment to recover, if it was possible at all. Thinking their dog had naturally reached end of her life, the Thaxtons chose to have her put down.
Within weeks, the family had adopted a mixed-breed "pixie" puppy named Penny, who earned a pristine bill of health at her first vet appointment.
Right around Christmas Day, Thaxton ran out of the treats that came with Penny when she was adopted, so she started feeding her Chansey's leftover treats: chicken jerky. Chansey had never eaten jerky until weeks before she grew sick. She died with her first bag half-finished.
In the weeks that followed, Penny started urinating more than usual. After New Year's Day, Thaxton saw a news story online about the FDA's warning for chicken jerky made from China. She checked her bag of treats, which said it was from South Carolina.
Then she noticed the text over the barcode: "Made In China."
Thaxton stopped feeding her the treats, but Penny started vomiting. When the vet saw her, she showed all the same symptoms as Chansey.
"Her kidneys were worse than Chansey's," Thaxton said.
Penny went on 24-hour surveillance at an emergency pet clinic. She recovered a week later, but Thaxton was just getting started.
"Candace went to bat," Morrissette said. "She's the driving force behind all of this, all the publicity."
Thaxton filed two complaints with the treat manufacturer -- one for Chansey, one for Penny. It looked like she was going to at least get a settlement amount to cover part of her $3,000 vet bill, but the company eventually rescinded as more complaints began to pour in, Thaxton said.
Even before the settlement talks broke down, Thaxton's story had run on two local news channels. When she was ultimately refused payment, Thaxton promised the company she would take the issue national within the week.
"By Friday night, Congressman Kucinich had written a letter to the FDA. By Monday, I had a press conference with Senator Brown," she said. "We've had two more conferences since then. I talked to Inside Edition. I told them I was going to be the one who pushed. I'm not stopping now."
Like Thaxton, other pet owners seem determined to keep the pressure on FDA to find answers and hold any guilty party responsible. For many, a sense of uncertainty, frustration, and even guilt, lingers.
"Pets are part of your family. When they die, you lose a family member," Higginbotham said. "I'm dealing with a lot of guilt over this. I'm the one who feeds my dog and is supposed to make sure he's safe and healthy. How do I do that if I can't even trust his food?"
-------
Photo captions, from top to bottom:
- Bandit, Maria Higginbotham's dog
- Ginger, Susan Rhodes' dog
- Sarge, Ray Parker's dog. Sarge, a seven year-old chow-corgi mix, fell ill soon after eating a single chicken jerky dog treat, Parker said. After nearly two weeks of clinical treatment, including intensive critical care, Sarge was put down.
- Chansey, Candace Thaxton's dog
Four days later, Bandit collapsed on the floor.
He was soon experiencing bloody diarrhea, and by the time Higginbotham and her mother got him to his veterinarian, his organs were shutting down. His liver showed that he had eaten something toxic. Certain that Bandit's inexplicable illness had already become too severe, the veterinarian suggested putting him down, and Higginbotham's mother and son agreed.
But she refused, and after nearly $4,000 in medical bills and three weeks of intensive nursing that included in-home I.V. care, Bandit recovered. The vet could not conclusively link the chicken jerky to the illness, but Higginbotham said he thought it could be the cause.
Bandit's puppyish spark has come back, but Higginbotham remains anxious, feeling an overwhelming sense of helplessness over what she might be feeding her dog. At the opposite corner of the country, in Eastern Florida, Danielle Kinard-Friedman's story did not end as well. Two weeks ago, Millie, her 18-month-old yellow Labrador, began vomiting bile after weeks of growing progressively more lethargic.
When Millie wouldn't eat anything, Kinard-Friedman took her to a vet. Blood tests revealed that Millie was experiencing kidney failure, and so she spent a week in an emergency pet clinic receiving intensive treatment that eventually proved futile. She was put down this past Sunday.
It was Millie's vet who asked Kinard-Friedman if she had been feeding her dog chicken jerky treats. She had. In fact, she had just started buying the treats -- under a different brand-name from Bandit's -- two months prior.
The vet then asked a more alarming question: Was the chicken from China? She had no idea, but she checked the label as soon as she got home. It was. When Higginbotham checked her treats, she found the same thing. Their vets could not prove anything, but both suspected the treats had sickened the dogs.
Higginbotham and Kinard-Friedman have now joined thousands of pet owners speaking out on the Internet and asking the government to force a recall of chicken jerky dog treats made from Chinese chicken. Concerns over the issue first arose in 2007, when the U.S. Food and Drug Administration began receiving reports of sickened dogs, all with the apparent common denominator of chicken jerky treats from China.
Since then, the FDA has performed hundreds of tests on chicken jerky samples and has not yet found any contaminant to explain the illnesses.
Regardless, the movement has continued to gain significant momentum. In the past month, it even got the attention of Ohio's Sen. Sherrod Brown and Rep. Dennis Kucinich after Ohio resident Candace Thaxton contacted them about two of her dogs who fell ill.
Until a cause is uncovered, owners and lawmakers say they will continue requesting that the FDA make the issue a priority, while the 15 companies implicated by consumers see no empirical evidence to justify recalling their products.
Congressmen and FDA sink their teeth in
On February 7, Brown brought the issue to the Senate floor, saying he had urged the Food and Drug Administration to accelerate its investigation into these chicken jerky treats -- found under multiple brand names but all sourced from China -- that appeared to be sickening dogs across the country. Two weeks later, the senator held a press conference and issued a news release again urging the FDA to act swiftly.
Back on Nov. 18, 2011, the FDA cautioned consumers that chicken jerky dog treats from China may be associated with a rising number of dog illnesses. This followed earlier warnings of the same issue in September 2007 and December 2008. After a drop in 2009 and 2010, reports of dog illnesses have spiked once again.
The November 2011 FDA notice warned dog owners who purchased chicken jerky to monitor their pets for decreased appetite, decreased activity, vomiting, diarrhea (including bloody , increased urination or increased water consumption. If any of those symptoms worsen or last more than 24 hours, owners should bring their dog to a vet, the notice said. Blood tests could indicate kidney failure, while urine tests might indicate Fanconi Syndrome, a disorder that results in nutrients normally absorbed into the bloodstream instead being released through urine.
On Wednesday, an FDA spokesperson confirmed to Food Safety News that the agency has recently received more than 600 reports from dog owners who say their pets have fallen ill because of jerky products made from Chinese chicken.
Since the issue first arose in September 2007, the FDA has run numerous chemical and microbial tests on Chinese chicken jerky samples in search of a contaminant. Though the agency said it could not conclude anything from the test results, the details remained under wraps until March 1, when an FDA document describing tests dating back to 2007 was sent to Kucinich's office. According to a Kucinich aid, the congressman "took them to task" at a briefing in order to get the information.
The one-page document outlines 241 tests for potential contaminants and 130 tests with pending results, none of which conclusively link the jerky to contaminants at dangerous levels. The 2012 tests with results still pending, however, are searching for heavy metals.
The Kucinich aid and many pet owners said they hope those latest tests might finally link the treats to a toxic substance and resolve the mystery of their pets' problems. The FDA has stated repeatedly that it will continue to actively investigate the issue.
According to the FDA, at least one Australian chicken jerky manufacturer has issued a recall of its products made from Chinese chicken, calling the move a precautionary measure.
The manufacturer may be mindful of March 2007, when hundreds of pet illnesses linked to melamine-contaminated Chinese ingredients prompted the recall of thousands of pet food products in the U.S., Europe and South Africa. In the U.S., the FDA received thousands of reports of dogs and cats dying from kidney failure, but confirmed very few cases.
More consumers come forward, but pet food industry says they're not to blame
A month ago, the private Facebook group called "Animal Parents Against Pet Treats Made in China!" had roughly 100 members. Today, the number has exploded to more than 2,500. One petition demanding the ban of jerky treats from China has acquired more than 3,000 signatures.
Susan Rhodes created another petition on March 3. She has asked the FDA to recall the jerky treats after she found that her dog, Ginger, had suffered permanent kidney damage and was losing weight at an alarming rate. Rhodes said she had been feeding the treats to Ginger for the past two years. Days after creating the petition, she has racked up more than 300 signatures from dog owners reporting similar diagnoses. Media coverage and word of mouth have brought a tidal wave of attention to the manufacturers of these treats. Some of the snowballing coverage, however, might lead some pet owners to incorrectly blame other health problems on the treats, said Kurt Gallagher, spokesperson for the Pet Food Institute, an industry education and public relations resource.
"Pet food companies want to make safe, nutritious products. It's their top priority," Gallagher told Food Safety News. "When everyone's talking about something like this, I think there's heightened awareness and sensitivity for pet owners looking for it."
Gallagher recommended pet owners take any sick pets to a vet to get a clinical opinion before diagnosing any issues themselves. If the vet considers pointing a finger at a certain food, the owners should contact the food manufacturer. Food companies should be tracking their complaints and looking for patterns and problems within their food supply, he said.
Pet owners have been quick to amass lists of jerky manufacturers sourcing their chicken from China. Rhodes' petition, for example, names 15 such companies.
A spokesperson for a dog treat company at the center of the furor reiterated that the FDA's testing has not found any contaminants and so his company has no reason to believe their product has sickened dogs. The company has a comprehensive food safety system at their Chinese facilities, he said, including quality control inspectors who monitor for safety.
He added that his company appreciated hearing from concerned customers, and emphasized that anecdotal evidence, however pervasive, does not prove causation.
"Obviously, we take food safety very seriously," he said. "Millions of dogs enjoy our products without ever getting sick."
Multiple pet owners have told Food Safety News that the spokesperson's company has backed away from its original intention to offer customers small monetary settlements for harm their jerky might have caused pets. According to sources, once the complaints reached a certain volume, spokespeople for the company told customers that providing any settlements would be an admission of guilt.
Made in "America"?
Blogger Mollie Morrissette has been following the chicken jerky developments for more than a year on her website, Poisoned Pets. She said that the issue has reached a sort of tipping point in the last month, with more and more pet owners speaking up about sick dogs.
"I get letters every day from broken-hearted pet parents -- people who had to put down their beloved family dog or five month-old puppy," she said. "They all fed their dogs chicken jerky."
One issue frustrating pet owners, Morrissette said, is that many of these dog treat packages boast that they are made in the U.S., though the fine print on the package often reveals that the chicken actually comes from China, where a cultural preference for dark meat makes for cheap white meat.
These "country of origin" claims are made possible by laws that say that once an ingredient is "substantially" altered in a given country, the resulting food can be considered a product of that country. These alterations can include cooking, mixing or otherwise reprocessing the ingredients in some way.
Just as oranges from Brazil can be turned into Canadian orange juice, chicken jerky from China can be reprocessed and repackaged in the U.S. to become a U.S. product. This can trick consumers into a false sense of security about the safety of their pet's food, Morrissette said.
Higginbotham said that the brand of jerky she bought for Bandit claimed to be "Proudly manufactured by an American company." Kinard-Friedman believed the same thing about the jerky she fed to Millie.
Morrissette said that pet owners feel helpless as they wait for some sort of justice on behalf of their pet, and she criticized the FDA for what she saw as a lack of urgency in investigating the illnesses.
"A lot of these pet parents are just wringing their hands, hoping the FDA will find some sort of answer," she said. "If this was [potentially contaminated] baby formula, we would have had the answer when it started five years ago. It would all get pulled off the shelves out of caution as soon as anyone suspected it might be contaminated."
Owners say they won't back down until they have an answer
Candace Thaxton, the woman who spurred Senator Brown and Congressman Kucinich into action, has more than one dog motivating her to uncover that answer.
In November 2011, when her 10-year-old pug, Chansey, started urinating unusually often and refusing to eat, Thaxton assumed they were just signs that the dog was getting old.
Chansey's health quickly deteriorated. At a vet appointment, Thaxton learned that the dog's kidneys had shut down and she would need intensive medical treatment to recover, if it was possible at all. Thinking their dog had naturally reached end of her life, the Thaxtons chose to have her put down.
Within weeks, the family had adopted a mixed-breed "pixie" puppy named Penny, who earned a pristine bill of health at her first vet appointment.
Right around Christmas Day, Thaxton ran out of the treats that came with Penny when she was adopted, so she started feeding her Chansey's leftover treats: chicken jerky. Chansey had never eaten jerky until weeks before she grew sick. She died with her first bag half-finished.
In the weeks that followed, Penny started urinating more than usual. After New Year's Day, Thaxton saw a news story online about the FDA's warning for chicken jerky made from China. She checked her bag of treats, which said it was from South Carolina.
Then she noticed the text over the barcode: "Made In China."
Thaxton stopped feeding her the treats, but Penny started vomiting. When the vet saw her, she showed all the same symptoms as Chansey.
"Her kidneys were worse than Chansey's," Thaxton said. Penny went on 24-hour surveillance at an emergency pet clinic. She recovered a week later, but Thaxton was just getting started.
"Candace went to bat," Morrissette said. "She's the driving force behind all of this, all the publicity."
Thaxton filed two complaints with the treat manufacturer -- one for Chansey, one for Penny. It looked like she was going to at least get a settlement amount to cover part of her $3,000 vet bill, but the company eventually rescinded as more complaints began to pour in, Thaxton said.
Even before the settlement talks broke down, Thaxton's story had run on two local news channels. When she was ultimately refused payment, Thaxton promised the company she would take the issue national within the week.
"By Friday night, Congressman Kucinich had written a letter to the FDA. By Monday, I had a press conference with Senator Brown," she said. "We've had two more conferences since then. I talked to Inside Edition. I told them I was going to be the one who pushed. I'm not stopping now."
Like Thaxton, other pet owners seem determined to keep the pressure on FDA to find answers and hold any guilty party responsible. For many, a sense of uncertainty, frustration, and even guilt, lingers.
"Pets are part of your family. When they die, you lose a family member," Higginbotham said. "I'm dealing with a lot of guilt over this. I'm the one who feeds my dog and is supposed to make sure he's safe and healthy. How do I do that if I can't even trust his food?"
-------
Photo captions, from top to bottom:
- Bandit, Maria Higginbotham's dog
- Ginger, Susan Rhodes' dog
- Sarge, Ray Parker's dog. Sarge, a seven year-old chow-corgi mix, fell ill soon after eating a single chicken jerky dog treat, Parker said. After nearly two weeks of clinical treatment, including intensive critical care, Sarge was put down.
- Chansey, Candace Thaxton's dog
11.03.2012 1:16:56
As unbelievable as it sounds, current law makes it illegal for food producers to share certain types of scientific information with you. So when Diamond Food relayed health information about the omega-3 fats in walnuts on product packaging and also on their Web site, the U.S. Food and Drug Administration (FDA attacked. Even though the information was entirely true, and backed by peer-reviewed scientific research. If a Food Can Prevent a Disease, it Must be a Drug This is the backward thinking that goes on at the FDA, where regulations currently prohibit manufacturers of dietary supplements or producers of food from referring to any scientific study documenting the potential effect of the substance on a health condition, punishable by large fines and even jail. Disclosure about the benefits of a dietary supplement or food, no matter how credible, places the food in the category of an "unapproved drug." In other words, if a product makes a medical claim, it's automatically classified as a drug. This is how the FDA got away with sending Diamond Food a warning letter[1], stating: "... we have determined that your walnut products are promoted for conditions that cause them to be drugs because these products are intended for use in the prevention, mitigation, and treatment of disease. The following are examples of the claims made on your firm's website under the heading of a web page stating "OMEGA-3s... Every time you munch a few walnuts, you're doing your body a big favor ... " These claims are backed by science[2], but it doesn't matter under FDA rules, which are so counter to rationality and logic that it boggles the mind. The FDA letter goes on to list several health claims made by Diamond Foods regarding omega-3 fats, claims such as: "Studies indicate that the omega-3 fatty acids found in walnuts may help lower cholesterol; protect against heart disease, stroke and some cancers; ease arthritis and other inflammatory diseases; and even fight depression and other mental illnesses." "[O]mega-3 fatty acids inhibit the tumor growth that is promoted by the acids found in other fats... " "[I]n treating major depression, for example, omega-3s seem to work by making it easier for brain cell receptors to process mood-related signals from neighboring neurons." "The omega-3s found in fish oil are thought to be responsible for the significantly lower incidence of breast cancer in Japanese women as compared to women in the United States." Walnuts are "New Drugs" Because Diamond Food dared to let consumers know that natural substances in a natural food may offer some health benefits and protections, the FDA views this as a new drug. In their eyes, only FDA-approved drugs are capable of offering such protections ...
10.03.2012 0:17:11
By: Margaret Hamburg, M.D.
This week, FDA joins 29 other government agencies and a host of private groups to highlight National Consumer Protection Week, an annual event for consumers to learn how to protect their privacy, manage money and debt, avoid identity theft, and prevent frauds and scams. And, helping protect consumers against health fraud or scams is where the FDA plays a role.
http://www.massdevice.com/blogs/massdevice/national-consumer-protection-week-and-fdas-right-against-health-fraud-scam#comments
2012-03-09 14:00:51
Lawrence LeBlond for RedOrbit.comUPDATE: March 9, 2012 3:00 p.m Eastern. Reports that were originally received from various media outlets stating that Coca-Cola was changing its formula to avoid adding cancer warning labels to its beverages are false. In a
statement posted on its website today, Coca-Cola said that it is in fact not changing its world-famous formula. “The caramel color in all of our products has been, is and always will be safe, and The Coca-Cola Company is not changing the world-famous formula for our Coca-Cola beverages. Over the years, we have updated our manufacturing processes from time to time, but never altered our Secret Formula,” Coca-Cola said on its website. The No. 1 soft drink maker said they have asked its caramel suppliers to modify their production process to reduce the amount of 4-MI in the caramel, but that it will not have any effect on the formula or the flavor of its products. “These modifications will not affect the color or taste of Coca-Cola,” it said. The company added it is committed to the “highest quality and safety” of its products, and it will “continue to rely on sound, evidence-based science to ensure that our products are safe.” --------- A specific caramel coloring found in Pepsi, Coca-Cola, and other popular soft drinks that a consumer watchdog said contain high levels of a chemical linked to cancer in animals has now been deemed safe by US regulators. Despite this, PepsiCo and Coca-Cola both decided to adjust the formula of their caramel coloring across the US so they do not have to label their products with a cancer warning to comply with additional regulations enforced in California. The recipe has already been changed for drinks sold in the Golden State and the companies said the changes will be expanded nationwide to streamline their manufacturing processes. The Center for Science in the Public Interest (CSPI
reported earlier this week that it found the unsafe levels of the chemical 4-methylimidazole (4-MI -- used to make caramel color -- in cans of Coke, Pepsi, Dr. Pepper, and Whole Foods’ 365 Cola. Coca-Cola confirmed that changes were being made at its facilities to keep within the law but argued that the CSPI’s allegations on the dangers the ingredient posed on humans were false. “The company has made the decision to ask its caramel suppliers to make the necessary manufacturing process modification, to meet the specific Californian legislation,” A spokesperson for Coca-Cola told
Daily Mail Online. “Those modifications will not change our product.” California added 4-MI to its list of carcinogens, after studies showed high levels of the chemical led to tumors in lab animals. However, the studies were inconclusive on whether the chemical was dangerous to humans or not. “Caramel is a perfectly safe ingredient and this has been recognized by all European food safety authorities,” the spokesperson added. “The 4-MEI levels in our products pose no health or safety risks. Outside of California, no regulatory agency concerned with protecting the public’s health has stated that 4-MEI is a human carcinogen.” “The caramel color in all of our ingredients has been, is and always will be safe. That is a fact,” the spokesperson said. This had been the CSPI’s second go-around with the Food and Drug Administration (FDA over the dangers of 4-MI in soft drinks. It first petitioned the regulator last year, but the FDA has continually maintained that the claims were exaggerated. “It is important to understand that a consumer would have to consume well over a thousand cans of soda a day to reach the doses administered in the studies that have shown links to cancer in rodents,” said FDA spokesman, Doug Karas to the Daily Mail's Laura Pullman. CSPI maintains that the regulator is allowing soft drink companies to needlessly expose millions of Americans to a chemical that is known to cause cancer. “If companies can make brown food coloring that is carcinogen-free, the industry should use it,” CSPI’s executive director Michael Jacobson told
Reuters. The FDA said it will review the watchdog’s petition, but that the soft drinks in question were still safe. CSPI took cans from stores in the Washington DC area, where they found some had levels of 4-MI near 140 micrograms per 12-ounce can. California has a legal limit of 29 micrograms of 4-MI per 12 ounces, it noted. The FDA’s limit for 4-MI in caramel coloring is 250 parts per million (ppm . Once the caramel is mixed in with the soda it becomes diluted. According to calculations by Reuters, the highest levels of 4-MI found in the soft drinks were about 0.4 ppm, significantly within the safe zone. “This is nothing more than CSPI scare tactics,” the American Beverage Association (ABA told Reuters in a statement. “In fact, findings of regulatory agencies worldwide ... consider caramel coloring safe for use in foods and beverages.” ABA said its member companies will continue to caramel coloring in certain products but that adjustments were being made to meet California requirements. “Consumers will notice no difference in our products and have no reason at all for any health concerns,” the ABA said. Diana Garza-Ciarlante, a representative for Coca-Cola, said its suppliers would modify the manufacturing process used to reduce the levels of 4-MI, which is formed during the cooking process and as a result may be found in trace amounts in many foods. “While we believe that there is no public health risk that justifies any such change, we did ask our caramel suppliers to take this step so that our products would not be subject to the requirement of a scientifically unfounded warning,” she said in an email to
The Telegraph. --- On the Net:
statement posted on its website today, Coca-Cola said that it is in fact not changing its world-famous formula. “The caramel color in all of our products has been, is and always will be safe, and The Coca-Cola Company is not changing the world-famous formula for our Coca-Cola beverages. Over the years, we have updated our manufacturing processes from time to time, but never altered our Secret Formula,” Coca-Cola said on its website. The No. 1 soft drink maker said they have asked its caramel suppliers to modify their production process to reduce the amount of 4-MI in the caramel, but that it will not have any effect on the formula or the flavor of its products. “These modifications will not affect the color or taste of Coca-Cola,” it said. The company added it is committed to the “highest quality and safety” of its products, and it will “continue to rely on sound, evidence-based science to ensure that our products are safe.” --------- A specific caramel coloring found in Pepsi, Coca-Cola, and other popular soft drinks that a consumer watchdog said contain high levels of a chemical linked to cancer in animals has now been deemed safe by US regulators. Despite this, PepsiCo and Coca-Cola both decided to adjust the formula of their caramel coloring across the US so they do not have to label their products with a cancer warning to comply with additional regulations enforced in California. The recipe has already been changed for drinks sold in the Golden State and the companies said the changes will be expanded nationwide to streamline their manufacturing processes. The Center for Science in the Public Interest (CSPI
reported earlier this week that it found the unsafe levels of the chemical 4-methylimidazole (4-MI -- used to make caramel color -- in cans of Coke, Pepsi, Dr. Pepper, and Whole Foods’ 365 Cola. Coca-Cola confirmed that changes were being made at its facilities to keep within the law but argued that the CSPI’s allegations on the dangers the ingredient posed on humans were false. “The company has made the decision to ask its caramel suppliers to make the necessary manufacturing process modification, to meet the specific Californian legislation,” A spokesperson for Coca-Cola told
Daily Mail Online. “Those modifications will not change our product.” California added 4-MI to its list of carcinogens, after studies showed high levels of the chemical led to tumors in lab animals. However, the studies were inconclusive on whether the chemical was dangerous to humans or not. “Caramel is a perfectly safe ingredient and this has been recognized by all European food safety authorities,” the spokesperson added. “The 4-MEI levels in our products pose no health or safety risks. Outside of California, no regulatory agency concerned with protecting the public’s health has stated that 4-MEI is a human carcinogen.” “The caramel color in all of our ingredients has been, is and always will be safe. That is a fact,” the spokesperson said. This had been the CSPI’s second go-around with the Food and Drug Administration (FDA over the dangers of 4-MI in soft drinks. It first petitioned the regulator last year, but the FDA has continually maintained that the claims were exaggerated. “It is important to understand that a consumer would have to consume well over a thousand cans of soda a day to reach the doses administered in the studies that have shown links to cancer in rodents,” said FDA spokesman, Doug Karas to the Daily Mail's Laura Pullman. CSPI maintains that the regulator is allowing soft drink companies to needlessly expose millions of Americans to a chemical that is known to cause cancer. “If companies can make brown food coloring that is carcinogen-free, the industry should use it,” CSPI’s executive director Michael Jacobson told
Reuters. The FDA said it will review the watchdog’s petition, but that the soft drinks in question were still safe. CSPI took cans from stores in the Washington DC area, where they found some had levels of 4-MI near 140 micrograms per 12-ounce can. California has a legal limit of 29 micrograms of 4-MI per 12 ounces, it noted. The FDA’s limit for 4-MI in caramel coloring is 250 parts per million (ppm . Once the caramel is mixed in with the soda it becomes diluted. According to calculations by Reuters, the highest levels of 4-MI found in the soft drinks were about 0.4 ppm, significantly within the safe zone. “This is nothing more than CSPI scare tactics,” the American Beverage Association (ABA told Reuters in a statement. “In fact, findings of regulatory agencies worldwide ... consider caramel coloring safe for use in foods and beverages.” ABA said its member companies will continue to caramel coloring in certain products but that adjustments were being made to meet California requirements. “Consumers will notice no difference in our products and have no reason at all for any health concerns,” the ABA said. Diana Garza-Ciarlante, a representative for Coca-Cola, said its suppliers would modify the manufacturing process used to reduce the levels of 4-MI, which is formed during the cooking process and as a result may be found in trace amounts in many foods. “While we believe that there is no public health risk that justifies any such change, we did ask our caramel suppliers to take this step so that our products would not be subject to the requirement of a scientifically unfounded warning,” she said in an email to
The Telegraph. --- On the Net:
10.03.2012 1:30:00
Dina ElBoghdady reports on the aged, disjointed, and out-dated food inspection system in the United States. "Every day, inspectors in white hats and coats take up positions at every one of the nation’s slaughterhouses, eyeballing the hanging carcasses of cows and chickens as they shuttle past on elevated rails, looking for bruises, tumors and signs of contamination. It’s essentially the way U.S. Department of Agriculture [USDA] food safety inspectors have done their jobs for a century…But these days, the bulk of what Americans eat -- seafood, vegetables, fruit, dairy products, shelled eggs and almost everything except meat and poultry -- is regulated by the Food and Drug Administration [FDA]. And the FDA inspects the plants it oversees on average about once a decade. These radically different approaches are a legacy from a time when animal products were thought to be inherently risky and other food products safe. But in the past few years, the high-profile and deadly outbreaks of food-borne illness linked to spinach, peanuts and cantaloupe have put the lie to that assumption. The FDA’s approach is partly by necessity: The agency lacks the money to marshal more inspectors. But it also reflects a different philosophy about how to address threats to the nation’s food supply: an approach based on where the risk is greatest…The USDA and the FDA are under pressure to overhaul their dramatically different procedures, in essence bringing them closer together. There’s a growing recognition among food-safety experts that the government can be smarter about tackling food-borne hazards that sicken one in six Americans each year and kill about 3,000."
09.03.2012 12:59:02
Eleven more cases of E. coli O26 infection have been confirmed in the outbreak linked to raw clover sprouts served at Jimmy John's sandwich restaurants. The newly reported cases raise the outbreak toll to 25 in 8 states.
In an investigation update Thursday, the Centers for Disease Control and Prevention said nine cases have been reported in Michigan, five in Iowa, three each in Missouri and Ohio, two in Kansas and one each in Alabama, Arkansas and Wisconsin.
The 11 cases confirmed since the CDC's last report, on February 24, were from Alabama, Michigan and Ohio.
Of the 24 ill people who provided information to outbreak investigators, 21 (87 percent said they ate sprouts at Jimmy John's restaurants during the week before they became ill.
The ill people range in age from 9 to 53 years old (median age is 26 and 88 percent are female. Six were so ill they had to be hospitalized. Onset of their illnesses ranged from Dec. 25, 2011 to Feb. 15, 2012.
"Results of the epidemiologic and traceback investigations indicate eating raw clover sprouts at Jimmy John's restaurants is the likely cause of this outbreak," the CDC has concluded.
There have been no recalls involved with this outbreak, and the CDC and Food and Drug Administration have not named the sprout supplier.
Raw sprouts, considered a high-risk food, have been associated with at least 40 foodborne illness outbreaks -- mostly E. coli and Salmonella infections -- since 1990. Raw sprouts served at Jimmy John's restaurant franchises have been linked to five outbreaks in four years.
Sprout seeds are typically the problem. They can become contaminated with pathogens from animal feces, or from dirty growing or processing equipment. The bacteria then multiply to dangerous levels as the seeds germinate under humid conditions. Homegrown sprouts are not necessarily any safer than commercially grown sprouts.
The CDC's advice about sprouts:
- Cook sprouts thoroughly to reduce the risk of illness. Cooking thoroughly kills the harmful bacteria.
- Request that raw sprouts not be added to your food. If you purchase a sandwich or salad at a restaurant or delicatessen, check to make sure that raw sprouts have not been added.
- Persons who think they might have become ill from eating potentially contaminated sprouts should consult their health care providers.
More information about illnesses associated with sprouts can be found at Sprouts: What You Should Know.
CDC outbreak map
In an investigation update Thursday, the Centers for Disease Control and Prevention said nine cases have been reported in Michigan, five in Iowa, three each in Missouri and Ohio, two in Kansas and one each in Alabama, Arkansas and Wisconsin.
The 11 cases confirmed since the CDC's last report, on February 24, were from Alabama, Michigan and Ohio.
Of the 24 ill people who provided information to outbreak investigators, 21 (87 percent said they ate sprouts at Jimmy John's restaurants during the week before they became ill.
The ill people range in age from 9 to 53 years old (median age is 26 and 88 percent are female. Six were so ill they had to be hospitalized. Onset of their illnesses ranged from Dec. 25, 2011 to Feb. 15, 2012.
"Results of the epidemiologic and traceback investigations indicate eating raw clover sprouts at Jimmy John's restaurants is the likely cause of this outbreak," the CDC has concluded.
There have been no recalls involved with this outbreak, and the CDC and Food and Drug Administration have not named the sprout supplier.
Raw sprouts, considered a high-risk food, have been associated with at least 40 foodborne illness outbreaks -- mostly E. coli and Salmonella infections -- since 1990. Raw sprouts served at Jimmy John's restaurant franchises have been linked to five outbreaks in four years.
Sprout seeds are typically the problem. They can become contaminated with pathogens from animal feces, or from dirty growing or processing equipment. The bacteria then multiply to dangerous levels as the seeds germinate under humid conditions. Homegrown sprouts are not necessarily any safer than commercially grown sprouts.
Jimmy John's recently indicated it would no longer serve raw sprouts with its sandwiches.
The CDC's advice about sprouts:
- Children, older adults, pregnant women, and persons with weakened immune systems should avoid eating raw sprouts of any kind (including alfalfa, clover, radish, and mung bean sprouts .
- Cook sprouts thoroughly to reduce the risk of illness. Cooking thoroughly kills the harmful bacteria.
- Request that raw sprouts not be added to your food. If you purchase a sandwich or salad at a restaurant or delicatessen, check to make sure that raw sprouts have not been added.
- Persons who think they might have become ill from eating potentially contaminated sprouts should consult their health care providers.
More information about illnesses associated with sprouts can be found at Sprouts: What You Should Know.
CDC outbreak map As far back as September 1998, the FDA issued a warning against sprouts urging:
children, pregnant women and the elderly should not eat alfalfa sprouts until growers find a way to reduce the risk of a potentially deadly bacteria that infects some sprouts, the Food and Drug Administration said this week. The FDA, which is investigating sprout industry practices, said children, the elderly and people with weakened immune systems should avoid eating sprouts. The agency's statement, issued Monday, repeated similar but little-noticed advice the U.S. Centers for Disease Control gave to doctors and researchers a year ago.
Bill Marler, publisher of Food Safety News, has filed two lawsuits against Jimmy John's in Iowa.
08.03.2012 19:00:00
As part of an overall strategy for addressing the public health crisis of antibiotic resistance, the Infectious Diseases Society of America (IDSA have submitted a proposal to the House Energy and Commerce Committee Subcommittee on Health, during a March 8 hearing on the U.S. Food and Drug Administration (FDA Prescription Drug User Fee Act (PDUFA reauthorization legislation...
2012-03-10T04:51:07Z
FRIDAY, March 9 (HealthDay News -- A new silicone-gel breast implant received conditional approval Friday from the U.S. Food and Drug Administration. The implant can be used for breast augmentation in women 22 and older and for breast tissue reconstruction at any age.
09.03.2012 23:29:50
The Food and Drug Administration has approved a new silicone-gel breast implant from Sientra, the third company to market the controversial products in the U.S.
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