Against The Grain Pet Food Voluntarily Recalls One Lot of Pulled Beef with Gravy Dinner for Dogs Due to Potential Adulteration with Pentobarbital
February 14, 2017
Out of an abundance of caution, Against the Grain Pet Food is voluntarily recalling one lot of Against the Grain Pulled Beef with Gravy Dinner for Dogs that was manufactured and distributed in 2015.
The 12 oz. Against the Grain Pulled Beef with Gravy Dinner for Dogs that is being voluntarily recalled, due to the potential presence of pentobarbital, has an expiration date of December 2019, a lot number of 2415E01ATB12, and the second half of the UPC code is 80001 (which can be found on the back of the product label).
Oral exposure to pentobarbital can cause side effects such as drowsiness, dizziness, excitement, loss of balance, nausea nystagmus (eyes moving back and forth in a jerky manner), inability to stand and coma.
Note: To-date, no complaints have been reported to Against the Grain for this single lot number nor any of Against the Grain’s pet foods, since the company was founded.
In 2015, this one lot of product was distributed to independent pet retail stores in Washington and Maryland, though it has been verified that this lot is no longer on any store shelves. This voluntary recall only affects one specific lot of food.
Consumers may return any can with the aforementioned lot number, to their place of purchase and receive a full case of Against the Grain food for the inconvenience. For any questions, customers may contact the company at 708-566-4410 between 11:00 AM – 4:00 PM Central Time, Monday - Friday.
Product label photo also included here:
http://www.fda.gov/Safety/Recalls/ucm541692.htm
ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD
Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD
..........Traci
Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD
FDA Cautions Pet Owners and Caretakers Not to Feed Certain Evanger’s or Against the Grain Canned Pet Foods Due to Adulteration with Pentobarbital
The U.S. Food and Drug Administration is advising pet owners and caretakers not to feed their pets certain lots of Evanger’s canned Hunk of Beef or Against the Grain Grain Free Pulled Beef with Gravy canned dog food after unopened cans from both brands were found to contain pentobarbital, a barbiturate.
Pentobarbital is a drug that is used in animal euthanasia. It should not be in pet food and its presence as detected by the FDA in these products renders them adulterated.
The FDA was unable to determine from available records whether any other Evanger’s or Against the Grain products made with beef contain any of the beef that went into the recalled products. Additionally, the agency concluded an inspection of the manufacturing facilities on February 14, 2017, and noted numerous significant concerns with conditions found at both the Wheeling, IL and Markham, IL plants. These are initial observations and do not represent a final agency determination regarding the firm.
Following discussions with the FDA, Evanger’s initiated a voluntary recall on February 3, 2017, of certain lots of its 12-ounce Hunk of Beef canned dog food: 1816E03HB, 1816E04HB, 1816E06HB, 1816E07HB, and 1816E13HB, all with an expiration date of June 2020.
In the course of the investigation, the FDA tested two cans of Against the Grain brand canned Grain Free Pulled Beef with Gravy dog food manufactured in the same facilities as Evanger’s products and using beef from the same supplier: these samples also tested positive for pentobarbital. On February 9, 2017, after conversations with the FDA, Against the Grain voluntarily recalled lot 2415E01ATB12 BEST DEC 2019 of this product. The company issued a public notice about its recall on February 13, 2017. To date, the FDA is not aware of any pet illnesses associated with the Against the Grain product.
The FDA began investigating Evanger’s Dog & Cat Food Company Inc. when it learned about five dogs in a single household that suffered acute neurological symptoms shortly after eating the product. One dog was euthanized after secondary complications, and three others recovered after receiving veterinary care. One of the dogs treated remains on seizure medication, and the fifth dog that ate the least amount of food recovered with time.
The stomach contents of the deceased dog and an open can of the product were tested by an FDA Veterinary Laboratory Investigation and Response Network lab, and unopened cans of the product from the pet owner and retailer that sold the products (from the same production lot), were tested by FDA’s lab. All of the samples tested positive for pentobarbital.
In its recent press release announcing a limited product recall, Evanger’s Dog & Cat Food Company, Inc. stated that the beef for its Hunk of Beef product came from a “USDA approved” supplier. However, the FDA reviewed a bill of lading from Evanger’s supplier of “Inedible Hand Deboned Beef - For Pet Food Use Only. Not Fit For Human Consumption" and determined that the supplier’s facility does not have a grant of inspection from the United States Department of Agriculture’s Food Safety and Inspection Service. The meat products from this supplier do not bear the USDA inspection mark and would not be considered human grade. USDA-FSIS regulates slaughter of animals for human consumption only. Testing by USDA-FSIS of Evanger’s Hunk of Beef confirmed that the meat used in the product was bovine (beef).
The investigation by the FDA is ongoing and includes examination of the suppliers of beef to Evanger’s and Against the Grain to determine a possible cause for the presence of pentobarbital. The FDA is also coordinating with the USDA to address any possible areas of shared jurisdiction at the suppliers.
Oral exposure to pentobarbital can cause drowsiness, dizziness, excitement, loss of balance, nausea, nystagmus (eyes moving back and forth in a jerky manner), inability to stand, coma and death. Consumers who notice these symptoms in their pets should consult their veterinarian.
Consumers with cans of product subject to the facilities' voluntary recalls should refer to the firms’ respective press releases for information about returning the product.
Additional information included here:
http://www.fda.gov/AnimalVeterinary/New ... 542265.htm
The U.S. Food and Drug Administration is advising pet owners and caretakers not to feed their pets certain lots of Evanger’s canned Hunk of Beef or Against the Grain Grain Free Pulled Beef with Gravy canned dog food after unopened cans from both brands were found to contain pentobarbital, a barbiturate.
Pentobarbital is a drug that is used in animal euthanasia. It should not be in pet food and its presence as detected by the FDA in these products renders them adulterated.
The FDA was unable to determine from available records whether any other Evanger’s or Against the Grain products made with beef contain any of the beef that went into the recalled products. Additionally, the agency concluded an inspection of the manufacturing facilities on February 14, 2017, and noted numerous significant concerns with conditions found at both the Wheeling, IL and Markham, IL plants. These are initial observations and do not represent a final agency determination regarding the firm.
Following discussions with the FDA, Evanger’s initiated a voluntary recall on February 3, 2017, of certain lots of its 12-ounce Hunk of Beef canned dog food: 1816E03HB, 1816E04HB, 1816E06HB, 1816E07HB, and 1816E13HB, all with an expiration date of June 2020.
In the course of the investigation, the FDA tested two cans of Against the Grain brand canned Grain Free Pulled Beef with Gravy dog food manufactured in the same facilities as Evanger’s products and using beef from the same supplier: these samples also tested positive for pentobarbital. On February 9, 2017, after conversations with the FDA, Against the Grain voluntarily recalled lot 2415E01ATB12 BEST DEC 2019 of this product. The company issued a public notice about its recall on February 13, 2017. To date, the FDA is not aware of any pet illnesses associated with the Against the Grain product.
The FDA began investigating Evanger’s Dog & Cat Food Company Inc. when it learned about five dogs in a single household that suffered acute neurological symptoms shortly after eating the product. One dog was euthanized after secondary complications, and three others recovered after receiving veterinary care. One of the dogs treated remains on seizure medication, and the fifth dog that ate the least amount of food recovered with time.
The stomach contents of the deceased dog and an open can of the product were tested by an FDA Veterinary Laboratory Investigation and Response Network lab, and unopened cans of the product from the pet owner and retailer that sold the products (from the same production lot), were tested by FDA’s lab. All of the samples tested positive for pentobarbital.
In its recent press release announcing a limited product recall, Evanger’s Dog & Cat Food Company, Inc. stated that the beef for its Hunk of Beef product came from a “USDA approved” supplier. However, the FDA reviewed a bill of lading from Evanger’s supplier of “Inedible Hand Deboned Beef - For Pet Food Use Only. Not Fit For Human Consumption" and determined that the supplier’s facility does not have a grant of inspection from the United States Department of Agriculture’s Food Safety and Inspection Service. The meat products from this supplier do not bear the USDA inspection mark and would not be considered human grade. USDA-FSIS regulates slaughter of animals for human consumption only. Testing by USDA-FSIS of Evanger’s Hunk of Beef confirmed that the meat used in the product was bovine (beef).
The investigation by the FDA is ongoing and includes examination of the suppliers of beef to Evanger’s and Against the Grain to determine a possible cause for the presence of pentobarbital. The FDA is also coordinating with the USDA to address any possible areas of shared jurisdiction at the suppliers.
Oral exposure to pentobarbital can cause drowsiness, dizziness, excitement, loss of balance, nausea, nystagmus (eyes moving back and forth in a jerky manner), inability to stand, coma and death. Consumers who notice these symptoms in their pets should consult their veterinarian.
Consumers with cans of product subject to the facilities' voluntary recalls should refer to the firms’ respective press releases for information about returning the product.
Additional information included here:
http://www.fda.gov/AnimalVeterinary/New ... 542265.htm
..........Traci
UPDATES ON EVANGER'S PET FOOD RECALLS / INVESTIGATION INTO PENTOBARBITAL
(articles may require subscription, therefore are quoted here in full)
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And, FDA MARCH 2 2017 UPDATE
(articles may require subscription, therefore are quoted here in full)
Source: Food Safety NewsBy Phyllis Entis on February 24, 2017
Dog food meat supplier aces inspection; investigation ongoing
Questions remain on source of euthanasia drug in Evanger's and Against the Grain pet food
The Food and Drug Administration has completed its investigation into the supplier that furnished meat used in recalled canned dog food that was found to contain the animal euthanasia drug pentobarbital.
As yet unidentified, the supplier provides meat used in Evanger’s brand Hunk of Beef and Nutripack’s Against the Grain Pulled Beef brand dog foods, both of which are under recall. At least five dogs have required medical treatment and one died.
The FDA determined that the supplier appears to “… have systems in place to ensure that euthanized animals are segregated from animal protein going for animal food use,” an agency spokesperson said Thursday.
An FDA Form 483 Inspectional Observations report, however, will not be issued because such reports are only filed when investigators note deficiencies, which they did not do regarding the supplier for Evanger’s Dog & Cat Food Co.
Such animal protein meat suppliers are regulated by FDA and may also be subject to state jurisdiction, depending on the state in which they are located. No sub-agency within the U.S. Department of Agriculture has jurisdiction over this industry sector.
USDA’s Food Safety Inspection Service (FSIS) oversees slaughterhouses and meat processors that produce meat for human consumption. USDA’s Animal and Plant Health Inspection Service (APHIS) has no involvement in meat inspection at all, except for assisting suppliers with export certifications if they are exporting to other countries, according to a spokesperson for APHIS.
In a Feb. 19 letter addressed to “Dear Pet Parents” and posted on the Evanger’s web site, the company described its supplier as “USDA-APHIS inspected.” Staff from APHIS are now working with Evanger’s to clarify its authority, according to the APHIS spokesperson.
On Feb. 21, Evanger’s notified its customers that an independent test of the contents of a can of Hunk of Beef revealed the presence of horse and cow DNA in the product. The Sher family, which owns Evanger’s and Nutripack, cast blame on the meat supplier for the pentobarbital adulteration.
This is in contrast to FDA’s report that cans of Hunk of Beef obtained from the owner of the sickened dogs and from the retail location where the pet food was purchased contained beef. No Against the Grain samples were tested for species identification.
The cans of Hunk of Beef pet food were examined by a USDA-FSIS lab at FDA’s request. According to the test protocol, available on the FSIS website, the contents of a can of food would have been minced or diced and thoroughly mixed before analysis to ensure that the portion used for testing was representative of the entire can.
When asked to comment on the apparent discrepancy between Evanger’s independent DNA test result and the results reported by FSIS, a spokesperson for USDA-FSIS said the government did find trace amounts of pig and horse in the dog food.
“Although this was not an FSIS regulated-product, FDA requested that FSIS conduct speciation testing for Evanger’s Hunk of Beef dog food product,” the spokesperson said. “FSIS was contacted by FDA after they had determined that the Pentobarbital dog food product was adulterated with Pentobarbital. Agency speciation testing confirmed that the adulterated product was bovine (beef). Trace amounts of pork and equine were also found, but both were less than 2 percent and therefore not reportable.”
These trace amounts are consistent with incidental cross-contamination that can occur when meat from different species are processed on the same production line. The trace amounts of pig and horse do not explain the source of the pentobarbital-adulterated meat in the Hunk of Beef and Against the Grain dog foods.
The investigation so far
In a Feb. 17 consumer advisory, the FDA cautioned the public not to feed the recalled Evanger’s and Against the Grain canned dog food products to their pets. The products in question were recalled on Feb. 3 and Feb. 9 by Evanger’s Dog & Cat Food Company Inc. and Against the Grain, respectively, after pentobarbital was confirmed in samples of both products.
In conjunction with the advisory, FDA released two Form 483 Inspectional Observation reports. The reports detailed the conditions found by inspectors during visits to Evanger’s production facility in Wheeling, IL, and to the facility belonging to Nutripack LLC in Markham, IL.
On Feb. 21, Evanger’s notified its customers that the company was planning to expand the recall of Evanger’s and Against the Grain pet foods to include all outstanding production of Hunk of Beef, Braised Beef Chunks with Gravy, and recalled Against the Grain dog food canAgainst the Grain Pulled Beef. Company officials told FDA they expect to release the official announcement of the expanded recall by the end of this week.
Kosher for animal use
In addition to marketing its pet foods as “human grade” and made with “USDA-inspected meats,” Evanger’s, citing an endorsement from the Chicago Rabbinical Council (cRc), promotes many of its products as “Kosher for Animal Use.”
A spokesperson for the cRc said the endorsement doesn’t mean the pet food is kosher in the traditional sense, but does mean certain expectations are met.
“When we provide a kosher endorsement we expect not only that all kosher laws are observed, but that the company acts in an ethical manner. While we cannot comment directly on this incident, we call upon all companies to maintain the highest standards of business,” the cRc spokesperson explained.
“Also, please be aware that Evanger’s’ products are NOT kosher in the regular sense. It is not kosher to consume, for anyone that observes kosher. It is endorsed by the cRc to feed it to one’s pet. Now animals of kosher observant individuals are not required to observe kosher — or any other commandment.
“The issue, and reason for the cRc endorsement, is that there are a few foods that not only may not be eaten by someone that is kosher observant, but one may also not derive any tangible benefit from them. An example would be leavened bread — Chometz — on Passover. It is those foods that a kosher observant person may not serve to their pets. The cRc endorses certain Evanger’s’ products that they are free from this concern, i.e. they do not contain any foods that a kosher observant person may not derive benefit from. It is for this reason that we do not allow Evanger’s to use the cRc standard kosher logo, to differentiate it from a standard kosher product.”
The cRc spokesperson further clarified that the presence of non-kosher species such as horse meat or pork would not be a concern in pet food.
Unanswered question
The FDA investigation into the Evanger’s case is still open and active. FDA has reviewed the customer list for the meat supplier and is in the process of following up as appropriate, according to a spokesperson.
While it may be comforting to the meat supplier’s other customers to learn that FDA found no deficiencies during the course of the recent inspection, the results leave a major question unanswered: Where did the pentobarbital-contaminated meat come from?
FDA continues to encourage consumers to report problems with Evanger’s products through the Safety Reporting Portal or by contacting a Consumer Complaint Coordinator. Please retain empty cans or partially used cans of food to facilitate collection of specific lot number information. Additional information is available on the FDA web page, How to Report a Pet Food Complaint.
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Source: Petfood Industry.comBy Tim Wall on February 28, 2017
Drug and horse meat in Evanger’s dog food still a mystery
One Pug is known to have died from the pentobarbital tainted dog food.
Horse meat and a deadly drug were found in cans of recalled Evanger’s Hunk of Beef dog food, but how they got there remains a mystery. Evanger’s vice president blamed his meat supplier. Yet, the United States Food and Drug Administration (FDA) inspected the supplier’s plant and found systems in place to keep euthanized animals out of the food stream, reported Food Safety News. However, FDA officials did note health concerns in Evanger’s facility where the contaminated pet food was made.
“It [pentobarbital] was never on the radar screen,” Evanger’s vice president Joel Sher told Petfood Industry. “It wasn’t an appropriate test in our industry, for what we do, to test for pentobarbital…I might as well start testing for radioactivity at this point. It’s certainly not on the radar screen, but if something ever happened you know someone will say we didn’t check for it.”
One Pug is known to have died after eating the pentobarbital tainted dog food, and four other dogs were sickened. Pentobarbital, a barbiturate, is used to euthanize animals and as a human sedative and anticonvulsant, as well as in human executions and physician-assisted suicides.
Sher noted that the adulterated pet food didn’t technically kill the Pug.
“The one that didn’t survive was a 13- or 14-year-old Pug that had some health issues,” said Sher. “The decision was made to euthanize the fourth Pug.”
Horse meat potentially in recalled dog food
Along with pentobarbital, private laboratory results found horse DNA in samples of the Hunk of Beef dog food that were recalled on February 3, said Sher. Against the Grain Pet Food recalled one lot of Against the Grain Pulled Beef with Gravy Dinner for Dogs on February 14. Against the Grain is owned by members of the Sher family.
FDA officials confirmed the presence of pentobarbital in both the Against the Grain and Evanger’s products, and classified the products as adulterated. In the same FDA Form 483 Inspectional Observations report, inspectors noted food safety problems at the Wheeling, Illinois, USA plant where the dog foods are produced. Some of these issues included peeling paint and mold on the walls, lack of raw meat refrigeration, and an open sewer within 25 feet of food storage trailers.
Sher contested those notes in a response to the FDA. Sher told Petfood Industry that no regulatory violations had been issued against the facility by the 483 report, just observations. He was unaware of any mold growing on the walls, nor of any peeling paint, asserting that there isn’t any paint used in the facility. The open sewer was actually on open manhole cover in the parking lot, he said.
Evanger’s response to pentobarbital in dog food
Evanger’s issued a series of pentobarbital recall updates on their website.
“The guilty party has turned out to be one of our most trusted meat suppliers,” said an update on February 19. “A USDA-APHIS inspected supplier who we had done business with for over 40 years, and whose plant we had visited numerous times over the years.”
USDA response to Evanger’s
FDA officials asserted that the Hunk of Beef meat did not come from a USDA-approved supplier of human-grade meat.
“In its recent press release announcing a limited product recall, Evanger’s Dog & Cat Food Company, Inc. stated that the beef for its Hunk of Beef product came from a 'USDA approved' supplier. However, the FDA reviewed a bill of lading from Evanger’s supplier for ‘Inedible Hand Deboned Beef - For Pet Food Use Only. Not Fit For Human Consumption’ and determined that the supplier’s facility does not have a grant of inspection from the United States Department of Agriculture’s Food Safety and Inspection Service,” stated FDA Center for Veterinary Medicine representatives on their website.
“The meat products from this supplier do not bear the USDA inspection mark and would not be considered human grade. USDA-FSIS regulates slaughter of animals for human consumption only.”
Human-grade pet food claims challenged by FDA findings
Evanger’s has described its products as human-grade since at least June 2003, reported Food Safety News. The article included screenshots of the Evanger’s website promoting the pet food as human-grade. The article suggested that Evanger’s claims, in contrast to FDA findings, may result in allegations of deception or false advertising by the Federal Trade Commission.
Sher explained this by saying that the website had been created before the Hunk of Beef product was launched. He asserted that promoting Evanger’s pet foods as human-grade was “substantially a correct statement.”
The Association of American Feed Control Officials (AAFCO) defines human-grade as, “Every ingredient and the resulting product are stored, handled, processed and transported in a manner that is consistent and compliant with regulations for current good manufacturing practices (CGMPs) for human edible foods as specified in 21 CFR Part 117.”
However, Sher told Petfood Industry that their plant is not certified to make food for human consumption.
And, FDA MARCH 2 2017 UPDATE
..........Traci
Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD
Another Evanger's Update:
Evanger’s Pet Food and Against the Grain Voluntarily Recalls Additional Products Out of Abundance of Caution due to Potential Adulteration with Pentobarbital
Out of an abundance of caution, Evanger’s Dog & Cat Food is voluntarily expanding its recall of Hunk of Beef and is also recalling Evanger’s Braised Beef and Against the Grain’s Pulled Beef Products due to potential adulteration with pentobarbital. Oral exposure to pentobarbital can cause drowsiness, dizziness, excitement, loss of balance, nausea, nystagmus (eyes moving back and forth in a jerky manner), inability to stand, coma and death. Consumers who notice these symptoms in their pets should consult their veterinarian.
Evanger’s wants 100% of its products to be 100% safe 100% of the time prompting removal of the products.
The 12 oz. cans of dog foods that are being voluntarily recalled have the following barcodes. The numbers listed below are the second half of the barcode, which can be found on the back of the product label:
Evanger’s: Hunk of Beef: 20109
Evanger’s: Braised Beef: 20107
Against the Grain: Pulled Beef: 80001
The three products being voluntarily recalled were manufactured between December 2015 and January 2017, and have expiration dates of December 2019 through January 2021. These products were distributed online and through independent boutique pet stores nationwide.
This voluntary recall affects only Hand Packed Beef Products, which is a unique method in which large chunks of meat are manually placed into the can by hand, not machine.
Consumers may return any can of the aforementioned products to their place of purchase for a full refund for the inconvenience. For any questions, customers may contact the company at 1-847-537-0102 between 10:00 AM – 5:00 PM Central Time, Monday - Friday.
Distributors and online retailers were previously notified of this voluntary recall on February 27th.
Product label photos also included here:
https://www.fda.gov/Safety/Recalls/ucm544972.htm
Evanger’s Pet Food and Against the Grain Voluntarily Recalls Additional Products Out of Abundance of Caution due to Potential Adulteration with Pentobarbital
Out of an abundance of caution, Evanger’s Dog & Cat Food is voluntarily expanding its recall of Hunk of Beef and is also recalling Evanger’s Braised Beef and Against the Grain’s Pulled Beef Products due to potential adulteration with pentobarbital. Oral exposure to pentobarbital can cause drowsiness, dizziness, excitement, loss of balance, nausea, nystagmus (eyes moving back and forth in a jerky manner), inability to stand, coma and death. Consumers who notice these symptoms in their pets should consult their veterinarian.
Evanger’s wants 100% of its products to be 100% safe 100% of the time prompting removal of the products.
The 12 oz. cans of dog foods that are being voluntarily recalled have the following barcodes. The numbers listed below are the second half of the barcode, which can be found on the back of the product label:
Evanger’s: Hunk of Beef: 20109
Evanger’s: Braised Beef: 20107
Against the Grain: Pulled Beef: 80001
The three products being voluntarily recalled were manufactured between December 2015 and January 2017, and have expiration dates of December 2019 through January 2021. These products were distributed online and through independent boutique pet stores nationwide.
This voluntary recall affects only Hand Packed Beef Products, which is a unique method in which large chunks of meat are manually placed into the can by hand, not machine.
Consumers may return any can of the aforementioned products to their place of purchase for a full refund for the inconvenience. For any questions, customers may contact the company at 1-847-537-0102 between 10:00 AM – 5:00 PM Central Time, Monday - Friday.
Distributors and online retailers were previously notified of this voluntary recall on February 27th.
Product label photos also included here:
https://www.fda.gov/Safety/Recalls/ucm544972.htm
..........Traci
Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD
March 17, 2017
Blue Buffalo Voluntarily Recalls One Lot of BLUE Wilderness® Rocky Mountain Recipe TM Red Meat Dinner Wet Food For Adult Dogs Due to Potential Health Risk
Blue Buffalo Company is voluntarily recalling one production lot of BLUE Wilderness® Rocky Mountain RecipeTM Red Meat Dinner Wet Food for Adult Dogs, as the product has the potential to contain elevated levels of naturally- occurring beef thyroid hormones.
Dogs ingesting high levels of beef thyroid hormones may exhibit symptoms such as increased thirst and urination, weight loss, increased heart rate and restlessness. These symptoms may resolve when the use of the impacted food is discontinued. However, with prolonged consumption these symptoms may increase in severity and may include vomiting, diarrhea, and rapid or difficulty breathing. Should these symptoms occur, contact your veterinarian immediately.
Although the Blue Buffalo Customer Care Resource Team has not received any reports of dogs exhibiting these symptoms from consuming this product, the FDA advised Blue Buffalo of a single consumer who reported symptoms in one dog, who has now fully recovered. Blue Buffalo immediately began an investigation, however, and after working with the FDA, Blue Buffalo decided it would be prudent to recall the one production lot in question.
The voluntary recall is limited to one production lot of the following product:
Product Name / UPC Code / Best Buy Date
BLUE Wilderness Rocky Mountain
Recipe Red Meat Dinner Wet
Food for Adult Dogs 12.5 oz can
840243101153
June 7, 2019 (found on the bottom of the can)
Affected products were distributed nationally through pet specialty and on-line retailers.
No other Blue Buffalo products are impacted by this issue.
If your pet has consumed the product listed above and has exhibited any of these symptoms, please discontinue feeding and contact your veterinarian. Consumers who have purchased the product subject to this recall should dispose of it or return it to the place of purchase for full refund.
Consumers with questions may contact Blue Buffalo at 866-201-9072 from 8 AM to 5 PM Eastern Time Monday through Friday, or by email at CustomerCare@bluebuffalo.com for more information.
Product label photos also included here:
https://www.fda.gov/Safety/Recalls/ucm547335.htm
Blue Buffalo Voluntarily Recalls One Lot of BLUE Wilderness® Rocky Mountain Recipe TM Red Meat Dinner Wet Food For Adult Dogs Due to Potential Health Risk
Blue Buffalo Company is voluntarily recalling one production lot of BLUE Wilderness® Rocky Mountain RecipeTM Red Meat Dinner Wet Food for Adult Dogs, as the product has the potential to contain elevated levels of naturally- occurring beef thyroid hormones.
Dogs ingesting high levels of beef thyroid hormones may exhibit symptoms such as increased thirst and urination, weight loss, increased heart rate and restlessness. These symptoms may resolve when the use of the impacted food is discontinued. However, with prolonged consumption these symptoms may increase in severity and may include vomiting, diarrhea, and rapid or difficulty breathing. Should these symptoms occur, contact your veterinarian immediately.
Although the Blue Buffalo Customer Care Resource Team has not received any reports of dogs exhibiting these symptoms from consuming this product, the FDA advised Blue Buffalo of a single consumer who reported symptoms in one dog, who has now fully recovered. Blue Buffalo immediately began an investigation, however, and after working with the FDA, Blue Buffalo decided it would be prudent to recall the one production lot in question.
The voluntary recall is limited to one production lot of the following product:
Product Name / UPC Code / Best Buy Date
BLUE Wilderness Rocky Mountain
Recipe Red Meat Dinner Wet
Food for Adult Dogs 12.5 oz can
840243101153
June 7, 2019 (found on the bottom of the can)
Affected products were distributed nationally through pet specialty and on-line retailers.
No other Blue Buffalo products are impacted by this issue.
If your pet has consumed the product listed above and has exhibited any of these symptoms, please discontinue feeding and contact your veterinarian. Consumers who have purchased the product subject to this recall should dispose of it or return it to the place of purchase for full refund.
Consumers with questions may contact Blue Buffalo at 866-201-9072 from 8 AM to 5 PM Eastern Time Monday through Friday, or by email at CustomerCare@bluebuffalo.com for more information.
Product label photos also included here:
https://www.fda.gov/Safety/Recalls/ucm547335.htm
..........Traci
Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD
March 17, 2017
Wellpet Voluntarily Recalls a Limited Amount of One Recipe of Canned Topper For Dogs Due to Potential Elevated Levels of Naturally Occurring Beef Thyroid Hormone
WellPet has initiated a voluntary recall of a limited amount of one canned topper product due to potential elevated levels of naturally occurring beef thyroid hormone.
Recalled Product Details:
Wellness 95% Beef Topper for Dogs – 13.2 oz
Can UPC: 0 76344 89450 6
Best-By Dates of 02 FEB 19, 29 AUG 19 and 30 AUG 19, located on the bottom of the can
Three best-by date codes of one recipe have the potential to contain elevated levels of naturally occurring beef thyroid hormone. Elevated levels may affect a dog’s metabolism and can be associated with anxiousness, increased thirst, increased urinary output and weight loss. However, with prolonged consumption these symptoms may increase in severity and may include vomiting, diarrhea, and rapid or difficulty breathing. Although multiple studies indicate that, for the vast majority of pets, symptoms are reversible once the pet stops eating product with elevated thyroid hormone, if your pet has consumed this product and has exhibited any of these symptoms, please contact your veterinarian.
The recipe is a mixer or topper and is intended for intermittent or supplemental feeding only; the likelihood of a dog being affected is remote. Even though the chance of a dog being affected is unlikely, WellPet is voluntarily recalling this recipe with these three best-by dates. No other Wellness products are affected. Affected products were distributed at pet specialty retailers throughout North America and online.
Although the WellPet Consumer Affairs team has received no reports of any health problems to date as a result of feeding this recipe, the FDA advised WellPet of three dogs that were affected. WellPet immediately initiated an investigation, and based on follow-up research, decided to recall the lots in question. The dogs are now fully recovered and doing well.
“Please know that safeguarding the health and wellbeing of pets is of the utmost importance to us,” said Camelle Kent, chief executive officer of WellPet, the maker of Wellness products. “We fully intend on maintaining the trust you have placed in us to keep your pets healthy and happy, and are removing this product as part of our ongoing commitment to quality and food safety.”
If you have any of the 13.2 oz recipe with these three best-by dates, please email WellPet at wecare@wellpet.com or call 1-877-227-9587. For more information, please visit WellPet’s website for a letter from the CEO.
Product label photos also found here:
https://www.fda.gov/Safety/Recalls/ucm547333.htm
Wellpet Voluntarily Recalls a Limited Amount of One Recipe of Canned Topper For Dogs Due to Potential Elevated Levels of Naturally Occurring Beef Thyroid Hormone
WellPet has initiated a voluntary recall of a limited amount of one canned topper product due to potential elevated levels of naturally occurring beef thyroid hormone.
Recalled Product Details:
Wellness 95% Beef Topper for Dogs – 13.2 oz
Can UPC: 0 76344 89450 6
Best-By Dates of 02 FEB 19, 29 AUG 19 and 30 AUG 19, located on the bottom of the can
Three best-by date codes of one recipe have the potential to contain elevated levels of naturally occurring beef thyroid hormone. Elevated levels may affect a dog’s metabolism and can be associated with anxiousness, increased thirst, increased urinary output and weight loss. However, with prolonged consumption these symptoms may increase in severity and may include vomiting, diarrhea, and rapid or difficulty breathing. Although multiple studies indicate that, for the vast majority of pets, symptoms are reversible once the pet stops eating product with elevated thyroid hormone, if your pet has consumed this product and has exhibited any of these symptoms, please contact your veterinarian.
The recipe is a mixer or topper and is intended for intermittent or supplemental feeding only; the likelihood of a dog being affected is remote. Even though the chance of a dog being affected is unlikely, WellPet is voluntarily recalling this recipe with these three best-by dates. No other Wellness products are affected. Affected products were distributed at pet specialty retailers throughout North America and online.
Although the WellPet Consumer Affairs team has received no reports of any health problems to date as a result of feeding this recipe, the FDA advised WellPet of three dogs that were affected. WellPet immediately initiated an investigation, and based on follow-up research, decided to recall the lots in question. The dogs are now fully recovered and doing well.
“Please know that safeguarding the health and wellbeing of pets is of the utmost importance to us,” said Camelle Kent, chief executive officer of WellPet, the maker of Wellness products. “We fully intend on maintaining the trust you have placed in us to keep your pets healthy and happy, and are removing this product as part of our ongoing commitment to quality and food safety.”
If you have any of the 13.2 oz recipe with these three best-by dates, please email WellPet at wecare@wellpet.com or call 1-877-227-9587. For more information, please visit WellPet’s website for a letter from the CEO.
Product label photos also found here:
https://www.fda.gov/Safety/Recalls/ucm547333.htm
..........Traci
March 20, 2017
EuroCan Manufacturing Voluntarily Recalling Barnsdale Farms® Pig Ears Because of Possible Salmonella Health Risk
EuroCan Manufacturing is voluntarily recalling Lot Number 84 consisting of it's individually shrink-wrapped, 6-pack, 12-pack and 25-pack bags of Barnsdale Farms®, Barnsdale Farms®-Select, HoundsTooth® and Mac's Choice® Pig Ears because they have the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is a risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare provider.
Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.
The pig ears were distributed throughout the United States and Canada. The pig ears were packaged as individually shrink-wrapped, 6-pack, 12-pack and 25-pack bags in the Barnsdale Farms®, Barnsdale Farms®-Select, Houndstooth® and Mac's Choice® brands. The lot number being recalled is 84. No illnesses of any kind have been reported to date.
The potential for contamination was noted after routine testing revealed the presence of Salmonella in the product. The company has suspended distribution of the product while FDA and the company continue their investigation as to the source of the problem. Consumers who have purchased any of the above-described Barnsdale Farms® pig ears should return product to the place of purchase for a refund. Consumer with questions may contact the company Monday – Friday from 9:00 am to 5:00 pm Eastern Standard Time at (888) 290-7606.
Product label photos also found here:
https://www.fda.gov/Safety/Recalls/ucm547572.htm
EuroCan Manufacturing Voluntarily Recalling Barnsdale Farms® Pig Ears Because of Possible Salmonella Health Risk
EuroCan Manufacturing is voluntarily recalling Lot Number 84 consisting of it's individually shrink-wrapped, 6-pack, 12-pack and 25-pack bags of Barnsdale Farms®, Barnsdale Farms®-Select, HoundsTooth® and Mac's Choice® Pig Ears because they have the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is a risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare provider.
Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.
The pig ears were distributed throughout the United States and Canada. The pig ears were packaged as individually shrink-wrapped, 6-pack, 12-pack and 25-pack bags in the Barnsdale Farms®, Barnsdale Farms®-Select, Houndstooth® and Mac's Choice® brands. The lot number being recalled is 84. No illnesses of any kind have been reported to date.
The potential for contamination was noted after routine testing revealed the presence of Salmonella in the product. The company has suspended distribution of the product while FDA and the company continue their investigation as to the source of the problem. Consumers who have purchased any of the above-described Barnsdale Farms® pig ears should return product to the place of purchase for a refund. Consumer with questions may contact the company Monday – Friday from 9:00 am to 5:00 pm Eastern Standard Time at (888) 290-7606.
Product label photos also found here:
https://www.fda.gov/Safety/Recalls/ucm547572.htm
..........Traci
Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD
March 27, 2017
FDA Alerts Veterinarians and Pet Food Manufacturers about Potential Presence of Thyroid Hormones in Pet Foods and Treats
The U.S. Food and Drug Administration is advising pet owners and caretakers, veterinarians, and the pet food industry to be aware that pet food and treats made with livestock gullets (meat from the throat region) have the potential to contain thyroid tissue and thyroid hormones. Pets that eat food or treats containing thyroid hormones may develop hyperthyroidism, a disease that is rare in dogs and usually triggered by thyroid cancer.
Symptoms of hyperthyroidism include excessive thirst and urination, weight loss, increased appetite, restlessness, hyperactivity, elevated heart rate, rapid and/or labored breathing, vomiting, and diarrhea. Continued exposure to excess thyroid hormones can cause damage to the heart and in some cases, death.
The FDA is issuing this alert now after a recent Center for Veterinary Medicine investigation into reports of three dogs in different households that showed signs of hyperthyroidism. In these cases, extensive testing on all three dogs conducted at a reference laboratory showed elevated thyroid hormone in the blood, but ruled out thyroid cancer. Reference lab interviews with the dogs’ owners revealed that all three dogs had been fed BLUE Wilderness® Rocky Mountain Recipe TM Red Meat Dinner Wet Food for Adult Dogs and/or Wellness 95% Beef Topper for Dogs.
Based on the recommendation of the reference lab’s consulting veterinarian, the feeding of these dog foods was discontinued. After the dogs stopped eating these products for a few weeks, their clinical signs disappeared and thyroid hormone levels returned to normal. An FDA lab tested unopened cans of BLUE Wilderness® Rocky Mountain Recipe TM Red Meat Dinner Wet Food for Adult Dogs and Wellness 95% Beef Topper for Dogs and confirmed that they contained active thyroid hormone. The source of thyroid hormones is likely from the use of gullets from which the thyroid glands were not completely removed before adding to pet food or treats.
After consulting with the FDA, both WellPet (the maker of Wellness) and Blue Buffalo (the maker of Blue Wilderness) initiated voluntary recalls of select lots of the affected products on March 17, 2017.
WellPet voluntarily recalled of certain lots of 13.2 ounce cans of Wellness 95% Beef Topper for Dogs with best-by dates of 02 FEB 19, 29 AUG 19, and 30 AUG 19 printed on the bottom of the can. The UPC Code is 076344894506.
Blue Buffalo Company voluntarily recalled of one lot of 12.5-ounce cans BLUE Wilderness® Rocky Mountain Recipe TM Red Meat Dinner Wet Food for Adult Dogs with a best-by date of June 7, 2019 printed on the bottom of the can. The UPC code is 840243101153.
The FDA appreciates the cooperation and swift action taken by both firms to address this issue. If your dog has eaten either of these foods and is showing symptoms of hyperthyroidism, discontinue feeding of these foods and consult your veterinarian, making sure to provide your dog’s dietary history, including what the dog has been eating, how much, and for how long.
Consumers who have any of the recalled food should not feed it to their animals and can refer to the company press releases for further instructions about returns/refunds.
Questions about whether a particular pet food or pet treat product contains livestock gullets and/or thyroid hormones should be directed to the product manufacturer.
The FDA provides more detailed information about the issue of thyroid hormones in pet food in its Letter to Veterinary Professionals and Letter to Industry.
Additional Information:
Letter to Veterinary Professionals - Exogenous Hyperthyroidism and Thyroid Hormones in Pet Food
Letter to Industry - Thyroid Hormones in Pet Food
Wellpet Voluntarily Recalls a Limited Amount of One Recipe of Canned Topper For Dogs Due to Potential Elevated Levels of Naturally Occurring Beef Thyroid Hormone
Blue Buffalo Voluntarily Recalls One Lot of BLUE Wilderness® Rocky Mountain Recipe TM Red Meat Dinner Wet Food For Adult Dogs Due to Potential Health Risk
How to Report a Pet Food Complaint
https://www.fda.gov/AnimalVeterinary/Ne ... 548883.htm
FDA Alerts Veterinarians and Pet Food Manufacturers about Potential Presence of Thyroid Hormones in Pet Foods and Treats
The U.S. Food and Drug Administration is advising pet owners and caretakers, veterinarians, and the pet food industry to be aware that pet food and treats made with livestock gullets (meat from the throat region) have the potential to contain thyroid tissue and thyroid hormones. Pets that eat food or treats containing thyroid hormones may develop hyperthyroidism, a disease that is rare in dogs and usually triggered by thyroid cancer.
Symptoms of hyperthyroidism include excessive thirst and urination, weight loss, increased appetite, restlessness, hyperactivity, elevated heart rate, rapid and/or labored breathing, vomiting, and diarrhea. Continued exposure to excess thyroid hormones can cause damage to the heart and in some cases, death.
The FDA is issuing this alert now after a recent Center for Veterinary Medicine investigation into reports of three dogs in different households that showed signs of hyperthyroidism. In these cases, extensive testing on all three dogs conducted at a reference laboratory showed elevated thyroid hormone in the blood, but ruled out thyroid cancer. Reference lab interviews with the dogs’ owners revealed that all three dogs had been fed BLUE Wilderness® Rocky Mountain Recipe TM Red Meat Dinner Wet Food for Adult Dogs and/or Wellness 95% Beef Topper for Dogs.
Based on the recommendation of the reference lab’s consulting veterinarian, the feeding of these dog foods was discontinued. After the dogs stopped eating these products for a few weeks, their clinical signs disappeared and thyroid hormone levels returned to normal. An FDA lab tested unopened cans of BLUE Wilderness® Rocky Mountain Recipe TM Red Meat Dinner Wet Food for Adult Dogs and Wellness 95% Beef Topper for Dogs and confirmed that they contained active thyroid hormone. The source of thyroid hormones is likely from the use of gullets from which the thyroid glands were not completely removed before adding to pet food or treats.
After consulting with the FDA, both WellPet (the maker of Wellness) and Blue Buffalo (the maker of Blue Wilderness) initiated voluntary recalls of select lots of the affected products on March 17, 2017.
WellPet voluntarily recalled of certain lots of 13.2 ounce cans of Wellness 95% Beef Topper for Dogs with best-by dates of 02 FEB 19, 29 AUG 19, and 30 AUG 19 printed on the bottom of the can. The UPC Code is 076344894506.
Blue Buffalo Company voluntarily recalled of one lot of 12.5-ounce cans BLUE Wilderness® Rocky Mountain Recipe TM Red Meat Dinner Wet Food for Adult Dogs with a best-by date of June 7, 2019 printed on the bottom of the can. The UPC code is 840243101153.
The FDA appreciates the cooperation and swift action taken by both firms to address this issue. If your dog has eaten either of these foods and is showing symptoms of hyperthyroidism, discontinue feeding of these foods and consult your veterinarian, making sure to provide your dog’s dietary history, including what the dog has been eating, how much, and for how long.
Consumers who have any of the recalled food should not feed it to their animals and can refer to the company press releases for further instructions about returns/refunds.
Questions about whether a particular pet food or pet treat product contains livestock gullets and/or thyroid hormones should be directed to the product manufacturer.
The FDA provides more detailed information about the issue of thyroid hormones in pet food in its Letter to Veterinary Professionals and Letter to Industry.
Additional Information:
Letter to Veterinary Professionals - Exogenous Hyperthyroidism and Thyroid Hormones in Pet Food
Letter to Industry - Thyroid Hormones in Pet Food
Wellpet Voluntarily Recalls a Limited Amount of One Recipe of Canned Topper For Dogs Due to Potential Elevated Levels of Naturally Occurring Beef Thyroid Hormone
Blue Buffalo Voluntarily Recalls One Lot of BLUE Wilderness® Rocky Mountain Recipe TM Red Meat Dinner Wet Food For Adult Dogs Due to Potential Health Risk
How to Report a Pet Food Complaint
https://www.fda.gov/AnimalVeterinary/Ne ... 548883.htm
..........Traci
Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD
Party Animal Recalls Dog Food Due To Potential Presence of Pentobarbital
April 24, 2017
The safety of pets is and always will be our first priority. We sincerely regret the reports of the discomfort experienced by the pet who consumed this food. As pet parents ourselves, we take this matter seriously. On April 13, a retailer in Texas notified us that their customer had presented samples of our 13-ounce-can Cocolicious Beef & Turkey dog food (Lot #0136E15204 04, best by July 2019) and 13-ounce-can Cocolicious Chicken & Beef dog food (Lot #0134E15 237 13, best by August 2019) to a testing lab, and that the results had tested positive for pentobarbital. We have requested those results.
When we were notified, we immediately tracked the lot numbers of the food in question and determined that the food had been manufactured and distributed in 2015. We then contacted the two probable retailers that had sold the customer the food and asked them to isolate all remaining cans from these lots. If pet parents have cans with either of those lot numbers in their possession, they should return them to the place of purchase and will of course receive a full refund.
We also requested that the retailers send all of the cans from those lots to us so that we can forward them on to an accredited independent laboratory for independent testing. We expect to receive the receive the results in 7 to 10 days. We first saw the formal report from the lab at Texas A&M regarding the customer’s samples, today, April 17.
Out of an abundance of caution, we are retrieving the remainder of these two lots nationwide. We are working with our distributors and retailers to determine if any additional beef-flavored products manufactured during this 2015 production period remain on shelves and, if so, to retrieve them from shelves, immediately, as well.
Party Animal wishes to emphasize that we have submitted many recent lots of our beef flavors for testing and all have tested negative for any pentobarbital. We have also had extensive discussions with our manufacturer regarding the potential cause of the reported contamination of the 2015 lots, and we will continue with such discussions even as we await testing results for the 2015 lots. In order to ensure adherence to our commitment to the safety of pets, we are also actively re-examining our manufacturing processes.
Contact for Consumers: 323-207-4100
https://www.fda.gov/Safety/Recalls/ucm554771.htm
April 24, 2017
The safety of pets is and always will be our first priority. We sincerely regret the reports of the discomfort experienced by the pet who consumed this food. As pet parents ourselves, we take this matter seriously. On April 13, a retailer in Texas notified us that their customer had presented samples of our 13-ounce-can Cocolicious Beef & Turkey dog food (Lot #0136E15204 04, best by July 2019) and 13-ounce-can Cocolicious Chicken & Beef dog food (Lot #0134E15 237 13, best by August 2019) to a testing lab, and that the results had tested positive for pentobarbital. We have requested those results.
When we were notified, we immediately tracked the lot numbers of the food in question and determined that the food had been manufactured and distributed in 2015. We then contacted the two probable retailers that had sold the customer the food and asked them to isolate all remaining cans from these lots. If pet parents have cans with either of those lot numbers in their possession, they should return them to the place of purchase and will of course receive a full refund.
We also requested that the retailers send all of the cans from those lots to us so that we can forward them on to an accredited independent laboratory for independent testing. We expect to receive the receive the results in 7 to 10 days. We first saw the formal report from the lab at Texas A&M regarding the customer’s samples, today, April 17.
Out of an abundance of caution, we are retrieving the remainder of these two lots nationwide. We are working with our distributors and retailers to determine if any additional beef-flavored products manufactured during this 2015 production period remain on shelves and, if so, to retrieve them from shelves, immediately, as well.
Party Animal wishes to emphasize that we have submitted many recent lots of our beef flavors for testing and all have tested negative for any pentobarbital. We have also had extensive discussions with our manufacturer regarding the potential cause of the reported contamination of the 2015 lots, and we will continue with such discussions even as we await testing results for the 2015 lots. In order to ensure adherence to our commitment to the safety of pets, we are also actively re-examining our manufacturing processes.
Contact for Consumers: 323-207-4100
https://www.fda.gov/Safety/Recalls/ucm554771.htm
..........Traci
Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD
FDA takes action against 14 companies for selling illegal cancer treatments
April 25, 2017
The U.S. Food and Drug Administration today posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. The products are marketed and sold without FDA approval, most commonly on websites and social media platforms.
“Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment,” said Douglas W. Stearn, director of the Office of Enforcement and Import Operations in the FDA’s Office of Regulatory Affairs. “We encourage people to remain vigilant whether online or in a store, and avoid purchasing products marketed to treat cancer without any proof they will work. Patients should consult a health care professional about proper prevention, diagnosis and treatment of cancer.”
It is a violation of the Federal Food, Drug and Cosmetic Act to market and sell products that claim to prevent, diagnose, treat, mitigate or cure diseases without first demonstrating to the FDA that they are safe and effective for their labeled uses. The illegally sold products cited in the warning letters posted today include a variety of product types, such as pills, topical creams, ointments, oils, drops, syrups, teas and diagnostics (such as thermography devices). They include products marketed for use by humans or pets that make illegal, unproven claims regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims.
The FDA has requested responses from the 14 companies stating how the violations will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure, injunction and/or criminal prosecution.
As part of the FDA’s effort to protect consumers from cancer health fraud, the FDA has issued more than 90 warning letters in the past 10 years to companies marketing hundreds of fraudulent products making cancer claims on websites, social media and in stores. Although many of these companies have stopped selling the products or making fraudulent claims, numerous unsafe and unapproved products continue to be sold directly to consumers due in part to the ease with which companies can move their marketing operations to new websites. The FDA continues to monitor and take action against companies promoting and selling unproven treatments in an effort to minimize the potential dangers to consumers and to educate consumers about the risks.
The FDA encourages health care professionals and consumers to report adverse reactions associated with these or similar products to the agency’s MedWatch program.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
https://www.fda.gov/NewsEvents/Newsroom ... 554698.htm
MORE INFORMATION:
The products are marketed and sold without FDA approval, most commonly on websites or social media platforms. They have not been reviewed by FDA for safety and efficacy, and can be dangerous to both people and pets.
Questions and Answers: FDA alerts companies to stop the illegal sale of products claiming to treat cancer
Consumer Update: Products Claiming to “Cure” Cancer Are a Cruel Deception
MedWatch: Illegal Cancer Treatments: FDA Warning - Fraudulent Claims of Diagnosis, Treatment, Prevention or Cure
FDA Voice Blog: FDA Takes Action Against Fraudulent Cancer Products
FDA's Flickr - Illegally Sold Cancer Products
April 25, 2017
The U.S. Food and Drug Administration today posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. The products are marketed and sold without FDA approval, most commonly on websites and social media platforms.
“Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment,” said Douglas W. Stearn, director of the Office of Enforcement and Import Operations in the FDA’s Office of Regulatory Affairs. “We encourage people to remain vigilant whether online or in a store, and avoid purchasing products marketed to treat cancer without any proof they will work. Patients should consult a health care professional about proper prevention, diagnosis and treatment of cancer.”
It is a violation of the Federal Food, Drug and Cosmetic Act to market and sell products that claim to prevent, diagnose, treat, mitigate or cure diseases without first demonstrating to the FDA that they are safe and effective for their labeled uses. The illegally sold products cited in the warning letters posted today include a variety of product types, such as pills, topical creams, ointments, oils, drops, syrups, teas and diagnostics (such as thermography devices). They include products marketed for use by humans or pets that make illegal, unproven claims regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims.
The FDA has requested responses from the 14 companies stating how the violations will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure, injunction and/or criminal prosecution.
As part of the FDA’s effort to protect consumers from cancer health fraud, the FDA has issued more than 90 warning letters in the past 10 years to companies marketing hundreds of fraudulent products making cancer claims on websites, social media and in stores. Although many of these companies have stopped selling the products or making fraudulent claims, numerous unsafe and unapproved products continue to be sold directly to consumers due in part to the ease with which companies can move their marketing operations to new websites. The FDA continues to monitor and take action against companies promoting and selling unproven treatments in an effort to minimize the potential dangers to consumers and to educate consumers about the risks.
The FDA encourages health care professionals and consumers to report adverse reactions associated with these or similar products to the agency’s MedWatch program.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
https://www.fda.gov/NewsEvents/Newsroom ... 554698.htm
MORE INFORMATION:
The products are marketed and sold without FDA approval, most commonly on websites or social media platforms. They have not been reviewed by FDA for safety and efficacy, and can be dangerous to both people and pets.
Questions and Answers: FDA alerts companies to stop the illegal sale of products claiming to treat cancer
Consumer Update: Products Claiming to “Cure” Cancer Are a Cruel Deception
MedWatch: Illegal Cancer Treatments: FDA Warning - Fraudulent Claims of Diagnosis, Treatment, Prevention or Cure
FDA Voice Blog: FDA Takes Action Against Fraudulent Cancer Products
FDA's Flickr - Illegally Sold Cancer Products
..........Traci