FDA suspends temporary emergency permit

From The FDA Update June 12, 2009

"The U.S. Food and Drug Administration announced today it was suspending the temporary Emergency Permit issued to Evanger's Dog & Cat Food Co., Inc.

Evanger's, operating in Wheeling, Illinois, deviated from the prescribed process, equipment, product shipment, and recordkeeping requirements in the production of the company's thermally processed low acid canned food (LACF) products. The deviations in their processes and documentation could result in under-processed pet foods, which can allow the survival and growth of Clostridium botulinum (C. botulinum), a bacterium that causes botulism in some animals as well as in humans.

In April 2008, Evanger's was issued an “Order of Need for Emergency Permit" after the agency determined that the company had failed to meet the regulatory requirements to process a product that does not present a health risk. In June, 2008, FDA issued Evanger’s a temporary Emergency Permit. During inspections conducted between March 2009 and April 2009, FDA determined Evanger's was not operating in compliance with the mandatory requirements and conditions of the Temporary Emergency Permit.

"The FDA is stopping Evanger's ability to ship pet food in interstate commerce," said Dr. Bernadette Dunham. "Today’s enforcement action sends a strong message to manufacturers of pet food that we will take whatever action necessary to keep unsafe products from reaching consumers."

In order for Evanger's to resume shipping in interstate commerce, the company must document that corrective actions and processing procedures have been implemented to ensure that the finished product will not present a health hazard.

Botulism is a powerful toxin that affects the nervous system and can be fatal. The disease has been documented in dogs and cats. Signs of botulism in animals are progressive muscle paralysis, disturbed vision, difficulty in chewing and swallowing, and progressive weakness to the body. Death is usually due to paralysis of the heart or the muscles used in breathing.

While FDA’s Center for Food Safety and Applied Nutrition is responsible for regulating all human and animal LACF processing, FDA's Center for Veterinary Medicine has authority over animal feed and foods. The two centers are collaborating on this enforcement action."

Nutro Cat Food Recall - Limited Products

From the US Food and Drug Administration updates:

"Nutro Products Announces Voluntary Recall of Limited Range of Dry Cat Food Products

Contact:
Monica Barrett
Nutro Products, Inc.
(615) 628-5387
monica.barrett@effem.com

http://www.fda.gov/oc/po/firmrecalls/nutro05_09.html
Link to FDA release is above

FOR IMMEDIATE RELEASE -- Franklin, Tennessee (May 21, 2009) -- Today, Nutro Products announced a voluntary recall of select varieties of NUTRO® NATURAL CHOICE® COMPLETE CARE® Dry Cat Foods and NUTRO® MAX® Cat Dry Foods with “Best If Used By Dates” between May 12, 2010 and August 22, 2010. The cat food is being voluntarily recalled in the United States and ten additional countries. This recall is due to incorrect levels of zinc and potassium in our finished product resulting from a production error by a US-based premix supplier.

Two mineral premixes were affected. One premix contained excessive levels of zinc and under-supplemented potassium. The second premix under-supplemented potassium. Both zinc and potassium are essential nutrients for cats and are added as nutritional supplements to NUTRO® dry cat food.

This issue was identified during an audit of our documentation from the supplier. An extensive review confirmed that only these two premixes were affected. This recall does not affect any NUTRO® dog food products, wet dog or cat food, or dog and cat treats.

Affected product was distributed to retail customers in all 50 states, as well as to customers in Canada, Mexico, Japan, Korea, Thailand, Malaysia, Singapore, Indonesia, New Zealand, and Israel. We are working with all of our distributors and retail customers, in both the US and internationally, to ensure that the recalled products are not on store shelves. These products should not be sold or distributed further.

Consumers who have purchased affected product should immediately discontinue feeding the product to their cats, and switch to another product with a balanced nutritional profile. While we have received no consumer complaints related to this issue, cat owners should monitor their cat for symptoms, including a reduction in appetite or refusal of food, weight loss, vomiting or diarrhea. If your cat is experiencing health issues or is pregnant, please contact your veterinarian.

Consumers who have purchased product affected by this voluntary recall should return it to their retailer for a full refund or exchange for another NUTRO® dry cat food product. Cat owners who have questions about the recall should call 1-800-833-5330 between the hours 8:00 AM to 4:30 PM CST, or visit www.nutroproducts.com.

Recalled Pet Food

The varieties of NUTRO® NATURAL CHOICE® COMPLETE CARE® Dry Cat Foods and NUTRO® MAX® Cat Dry Foods listed below with “Best If Used By Dates” between May 12, 2010 and August 22, 2010 are affected by this voluntary recall."

Nutro Products Recall List – Dry Cat Foods

U.S. Product Name
Bag Size
UPC

NUTRO® NATURAL CHOICE® COMPLETE CARE® Kitten Food
4 lbs
0 79105 20607 5

NUTRO® NATURAL CHOICE® COMPLETE CARE® Kitten Food
8 lbs.
0 79105 20608 2

NUTRO® NATURAL CHOICE® COMPLETE CARE® Kitten Food (Bonus Bag)
9.2 lbs.
0 79105 20695 2

NUTRO® NATURAL CHOICE® COMPLETE CARE® Kitten Food
20 lbs
0 79105 20609 9

NUTRO® NATURAL CHOICE® COMPLETE CARE® Kitten Food (Sample Bag)
1.5 oz
none

NUTRO® NATURAL CHOICE® COMPLETE CARE® Adult
4 lbs
0 79105 20610 5

NUTRO® NATURAL CHOICE® COMPLETE CARE® Adult
8 lbs.
0 79105 20611 2

NUTRO® NATURAL CHOICE® COMPLETE CARE® Adult (Bonus Bag)
9.2 lbs
0 79105 20694 5

NUTRO® NATURAL CHOICE® COMPLETE CARE® Adult
20 lbs
0 79105 20612 9

NUTRO® NATURAL CHOICE® COMPLETE CARE® Adult (Sample Bag)
1.5 oz
none

NUTRO® NATURAL CHOICE® COMPLETE CARE® Adult Oceanfish Flavor
4 lbs
0 79105 20622 8

NUTRO® NATURAL CHOICE® COMPLETE CARE® Adult Oceanfish Flavor
8 lbs
0 79105 20623 5

NUTRO® NATURAL CHOICE® COMPLETE CARE® Adult Oceanfish Flavor (Bonus Bag)
9.2 lbs.
0 79105 20698 3

NUTRO® NATURAL CHOICE® COMPLETE CARE® Adult Oceanfish Flavor
20 lbs
0 79105 20624 2



NUTRO® MAX® Cat Adult Roasted Chicken Flavor
3 lbs
0 79105 10228 5

NUTRO® MAX® Cat Adult Roasted Chicken Flavor
6 lbs
0 79105 10229 2

NUTRO® MAX® Cat Adult Roasted Chicken Flavor
16 lbs
0 79105 10230 8

NUTRO® MAX® Cat Adult Roasted Chicken Flavor (Sample Bag)
1.5 oz
none

NUTRO® MAX® Cat Indoor Adult Roasted Chicken Flavor
3 lbs
0 79105 10243 8

NUTRO® MAX® Cat Indoor Adult Roasted Chicken Flavor
6 lbs
0 79105 10244 5

NUTRO® MAX® Cat Indoor Adult Roasted Chicken Flavor
16 lbs
0 79105 10245 2

NUTRO® MAX® Cat Indoor Adult Roasted Chicken Flavor (Sample Bag)
1.5 oz
none

NUTRO® MAX® Cat Indoor Adult Salmon Flavor
3 lbs
0 79105 10246 9

NUTRO® MAX® Cat Indoor Adult Salmon Flavor
6 lbs
0 79105 10247 6

NUTRO® MAX® Cat Indoor Adult Salmon Flavor
16 lbs
0 79105 10248 3

NUTRO® MAX® Cat Indoor Weight Control
3 lbs
0 79105 10249 0

NUTRO® MAX® Cat Indoor Weight Control
6 lbs
0 79105 10250 6

NUTRO® MAX® Cat Indoor Weight Control
16 lbs
0 79105 10251 3


#

Photos: Product Label

FDA Requests Seizure of Animal Food Products at PETCO Distribution Center

FOR IMMEDIATE RELEASE
June 19, 2008
Media Inquiries:
Kimberly Rawlings, 301-827-6242
Consumer Inquiries:
888-INFO-FDA



"Today, at the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago.

U.S. Marshals seized all FDA-regulated animal food susceptible to rodent and pest contamination. The seized products violate the Federal Food, Drug, and Cosmetic Act because it was alleged in a case filed by the United States Attorney that they were being held under unsanitary conditions. (The Act uses the term "insanitary" to describe such conditions).

During an FDA inspection of a PETCO distribution center in April, widespread and active rodent and bird infestation was found. The FDA inspected the facility again in May and found continuing and widespread infestation.

"We simply will not allow a company to store foods under filthy and unsanitary conditions that occur as a direct result of the company's failure to adequately control and prevent pests in its facility," said Margaret O'K. Glavin, associate commissioner for regulatory affairs. "Consumers expect that such safeguards will be in place not only for human food, but for pet food as well."

The distribution center in Joliet, Ill., provides pet food products and supplies to PETCO retail stores in 16 states including Alabama, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Tennessee, Texas, and Wisconsin.

FDA has no reports of pet illness or death associated with consumption of animal food distributed by PETCO, and does not have evidence that the food is unsafe for animals. However, the seized products were in permeable packages and held under conditions that could affect the food's integrity and quality.

As a precaution, consumers who have handled products originating from the PETCO distribution center should thoroughly wash their hands with hot water and soap. Any surfaces that came in contact with the packages should be washed as well. Consumers are further advised as a precaution to thoroughly wash products sold in cans and glass containers from PETCO in the 16 affected states.

If a pet has become ill after eating these food products, pet owners should contact their veterinarian and report illnesses to FDA state consumer complaint coordinators.

http://www.fda.gov/opacom/backgrounders/complain.html
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FDA Announces Limited Return of Heartworm Drug to U.S. Market

FDA News
FOR IMMEDIATE RELEASEJune 5, 2008
Media Inquiries: Kimberly Rawlings and Mike Herndon, 301-827-6242Consumer Inquiries: 888-INFO-FDA


"The U.S. Food and Drug Administration (FDA) today announced a limited return of a reformulated heartworm prevention drug for dogs, which had been withdrawn because of serious, life-threatening adverse reactions, including loss of appetite, lethargy; vomiting, seizures, difficulty walking, jaundice (a yellowish appearance); and bleeding disorders, allergies, convulsions, followed in some cases by death.
ProHeart 6 (moxidectin) Sustained Release Injectable for Dogs, NADA 141-189, manufactured by Fort Dodge Animal Health, Overland Park, Kan., is an approved injectable sustained-release heartworm prevention product for dogs. FDA is concurring with its limited return to the U.S. veterinary market under a risk minimization and restricted distribution program designed to manage the re-introduction of ProHeart 6 to provide for safe, appropriate use of the product while minimizing risk to dogs.
"This is the first veterinary drug to be marketed under a risk minimization and restricted distribution program. Numerous drugs for use in people have been successfully marketed under similar programs," said Bernadette Dunham, D.V.M., Ph.D., director, FDA’s Center for Veterinary Medicine. "While we concur with the limited return of ProHeart 6 to the U.S. market, we strongly encourage veterinarians and pet owners to report any possible adverse reactions."
Heartworm disease is a serious and potentially fatal condition for dogs. The parasite that causes heartworm disease is transmitted through the bite of a mosquito.
The risk minimization and restricted distribution program is intended to educate veterinarians and pet owners regarding the possible risks associated with the use of ProHeart 6. Therefore, Fort Dodge Animal Health is requiring veterinarians who wish to purchase ProHeart 6 to register with the company and participate in a Web-based training program prior to obtaining the product.
The return of ProHeart 6 to the market is based on results of additional toxicological and pharmacologic studies by Fort Dodge Animal Health coupled with the low adverse reaction frequency in international markets.
In 2004, Fort Dodge Animal Health agreed to voluntarily recall the product from the market based upon FDA's concerns regarding reports of serious adverse reactions in dogs following the use of ProHeart 6. In response to FDA's concerns, the manufacturer conducted additional testing of its product, which indicated that residues of the solvents used in the manufacture of ProHeart 6 may cause allergic reactions.
The manufacturer has improved the manufacturing specifications for ProHeart 6 to decrease the presence of those residues and has marketed the product in international markets. Few adverse events have been reported with this reformulated product.
The ProHeart 6 label and Client Information Sheet have been revised to include updated safety information. The new label includes warnings not to administer the drug within one month of vaccinations, and to use the product with caution in dogs with pre-existing allergic diseases including food allergies, allergic hypersensitivity, and flea allergy dermatitis. The label also warns against administering the drug to dogs who are sick, debilitated, underweight, or who have a history of weight loss. In addition, the label’s Post-Approval Experience section has been updated to include information about adverse reactions based on voluntary post-approval drug experience reporting.
Dog owners who suspect their dog is experiencing an adverse reaction to ProHeart 6 should immediately contact their veterinarian to initiate appropriate veterinary care. Veterinarians should contact Fort Dodge Animal Health to report any adverse events at (800) 533-8536."
#
Additional Information

Pet Food Maker Ordered by FDA To Get Operating Permit

"FDA Orders Pet Food Maker to Obtain Emergency Operating Permit
The U.S. Food and Drug Administration issued an order requiring that Evanger's Dog & Cat Food Co., Inc., in Wheeling, Ill., obtain an emergency permit from the FDA before its canned pet food products enter interstate commerce.

A recent inspection revealed significant deviations from prescribed documentation of processes, equipment, and recordkeeping in the production of the company's thermally processed low acid canned food (LACF) products. These problems could result in under-processed pet foods, which can allow the survival and growth of Clostridium botulinum (C. botulinum), a bacterium that causes botulism in some animals as well as in humans.

"As outlined in the Food Protection Plan, the FDA uses a risk-based approach to locate the areas of greatest risk for foods, and targets preventive controls and inspections to those areas, " said Dr. Stephen Sundlof, director, Center for Food Safety and Applied Nutrition. "The FDA's authority to issue an order requiring an emergency permit is an enforcement tool designed to prevent unsafe foods from reaching consumers.”

The FDA issues an "Order of Need for Emergency Permit” if the agency determines that a company fails to meet the regulatory requirements to process a product that does not present a health risk. For Evanger's to resume business, the company must document that corrective actions and processing procedures have been implemented to ensure that the finished product will not present a health hazard.

Botulism is a powerful toxin that affects the nervous system and can be fatal. The disease has been documented in dogs and cats. Signs of botulism in animals are progressive muscle paralysis, disturbed vision, difficulty in chewing and swallowing, and progressive weakness to the body. Death is usually due to paralysis of the heart or the muscles used in breathing.

In light of human botulism illnesses and recalls that occurred due to under-processed hot dog chili sauce, and potentially under-processed canned green beans, FDA has urged all LACF processors to review their operations and the apply scientific principals and regulations that have been established to provide a safe product.

While FDA's Center for Veterinary Medicine has authority over animal feed and foods, CFSAN is responsible for regulating all human and animal LACF processing. The two centers are collaborating on this enforcement action."

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01825.html

Dietary Supplement Recall by FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01812.html

FDA Warns Consumers about "Total Body Formula" and "Total Body Mega Formula"Distributor recalls dietary supplement products after reports of adverse reactions

The U.S. Food and Drug Administration is advising consumers not to purchase or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.

The Total Body Formula products are sold in eight-ounce and 32-ounce plastic bottles. The Total Body Mega Formula is sold in 32-ounce plastic bottles. Both products are distributed by Total Body Essential Nutrition of Atlanta. The company is the sole distributor of the products and has voluntarily recalled Total Body Formula in the flavors of Tropical Orange and Peach Nectar and Total Body Mega Formula in Orange/Tangerine flavor.

The Florida Department of Health recently provided reports to the FDA on 23 individuals who experienced serious reactions to these products seven to 10 days after ingestion. In all cases, the reactions included significant hair loss, muscle cramps, diarrhea, joint pain and fatigue. The FDA subsequently learned and is investigating a report that some individuals in Tennessee using the same products have experienced similar reactions.

FDA laboratories are analyzing samples of the products to identify the cause of the reactions, including the possibility that the products contain excessive amounts of selenium, which is known to cause symptoms such as those described in the adverse events reported to the agency. Selenium, a trace mineral, is needed only in small amounts for good health.
The products have been distributed in Alabama, California, Florida, Georgia, Kentucky, Louisiana, Michigan, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia.

The FDA is advising consumers in all states to avoid using the products immediately and to discard the products by placing them in a trash receptacle outside of the home.
Consumers who have been taking the products and have experienced adverse reactions should consult their health care professional. Consumers and health care professionals can also report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at
www.fda.gov/medwatch/report.htm.

The FDA is working with the Florida Department of Health in its investigation.
For more information, consumers can call the FDA's toll-free Food Safety Hotline at 1-888-SAFEFOOD.