Monday, February 04, 2008
Smoking Cessation Drug May Cause Problems [health]
The U.S. Food and Drug Administration is warning consumers using a medication doctors prescribe to help people stop smoking may cause behavioral changes, depression and even suicide. The federal agency said that Chantix is effective in helping people kick their cigarette habit but may pose serious mental health issues.
Chantix has been approved for use since May 2006 and amazingly enough can block the effects of nicotine in a smoker's brain if the smoker resumes smoking. That effect reportedly enables people to avoid smoking because neurological effects are neutralized. Now there is concern that Chantix also causes serious neurological effects beyond blocking nicotine's effects.
The FDA is working with Pfizer, Inc (
NYSE: PFE) to create a patient guide and to change the medication's labeling so that warnings about the drug's use are more prominent. "Health care professionals should closely monitor patients for behavior and mood changes if they are taking this drug," said Dr. Bob Rappaport of the FDA in a statement.
Consumers were also cautioned to tell their physician about any history of psychiatric illness or changes in mood or behavior after using the drug.
Labels: Chantix, FDA, healthcare, Pfizer
Tuesday, November 20, 2007
FDA Finally Moves On Avandia
We wrote about
diabetes drug Avandia's dangers in June. We noted the FDA had not moved with much speed yet, which seems somewhat ironic given the rhetoric and cries surrounding the Consumer Product Safety Commission.
But while doctors continued prescribing Avandia (and its partner Avandamet and other combinations) with a warning, the Food and Drug Administration waited because of conflicting studies. Last week, the agency finally
added its most strident warning, (pdf link) the black box, to Avandia and also includes a statement warning of an increased risk of heart trouble among diabetes patients who already have increased risk.
Dr. Janet Woodcock of the FDA said that pharma giant GlaxoSmithKline (
NYSE:GSK) was cooperating with the agency. Woodcock also said that tests showing increased heart attack risk were tempered by longer-term studies that conflicted with the data.
The frustrating part of this issue is that months elapsed before the FDA got to this point and now years may be go by before a decision is made. Dr. John Jenkins, also speaking on behalf of the FDA, added that "So this will likely be, you know, a long term study. It could take as many as four or five years. So over that time it’ll be multiple comparisons."
Despite strong questions from
The Los Angeles Times' Ricardo Alonso-Zaldivar, FDA representatives refused to address the issue of the agency's own safety officers calling for the drug's removal from the market. Alonso-Zaldivar pushed well, but was eventually silenced. Follow-ups from
The Wall Street Journal and other media outlets were similarly stonewalled. FDA officials also refused to disclose the panel's vote and other information that will undoubtedly be challenged with a Freedom of Information Act request.
For now, diabetics taking Avandia or one of the two commercially available compounds containing Avandia are
strongly urged to talk with their physician about whether this drug is appropriate for them.
Labels: Avandia, FDA, Glaxo, GSK
Saturday, October 20, 2007
Federal Delays Keep Piling Up, But No OTC Cold Meds For Kids Is Official
We were outraged last week when the federal government said it would
delay hearings on the safety of children using OTC cold medicine.
This is why the federal government either needs better, faster regulatory and investigative resources or some sense of urgency. The
public knew that this was an issue days ago. The medical community apparently knew months, if not years, ago. Even the companies that made the over-the-counter
meds specifically for kids yanked them off the shelves before the hearings.
If an organization the size of McNeil (makers of Tylenol, St. Joseph Aspirin,
Mylanta and others) can mobilize to pull medicine from retail shelves all over the country, why does it take a much smaller organization one week to pull together hearings? Why weren't there hearings the next day? What about the weekend? We work weekends sometimes. Do you? Why doesn't the FDA?
And if they do, where is the sense of
urgency? We are happy to recognize the makers of the OTC medicines for children for acting fast while still wondering what they knew about this issue going into the fall of 2007. The FDA alone is not culpable. The USDA botched their recall of the tainted pot pies just weeks ago when everyone from the manufacturer to the CDC to the retailers yanked the food from the shelves.
Federal government must act faster. This is why Federal Express is used rather than the USPS when it absolutely positively has to be there overnight. This is why passport regulations are enacted and then lifted when family vacations and critical business trips were destroyed. No organization is perfect, but most private sector companies have some sort of disaster or crisis contingency plan. Our government is charged with many things and does well with some of them. Where they continue missing in the Year of the Recall is speed to take action.
Consumer safety continues to get short shrift, and that cannot continue.
Labels: children, FDA, recall, safety
Wednesday, September 19, 2007
No, We Haven't Cured The Common Cold
Procter and Gamble is a marketing icon. The conglomerate has not only trained some of the best marketers of the last 50 years, but continues to innovate consumer products.
Sometimes that innovation can get the company in a little hot water.
Today is one such day. The Food and Drug Administration
sent a letter yesterday to P&G that essentially said the company's hand sanitizer for kids didn't exactly work as planned.
The letter, signed by FDA District Director Carol A. Heppe, acknowledged that an ingredient in
Vicks Early Defense called triclosan is certified for use as an "antimicrobial cleanser", the company's claims about it fighting cold "germs" (sic). Heppe went on to remind P&G President Alan Lafley that colds are caused by viruses and that no evidence existed suggesting that the company's product worked as claimed.
Yes, you can still catch a cold, but Mom said you could go in the pool after eating without waiting 30 minutes.
The agency is apparently reviewing the whole subject of topical cleansers. Meanwhile, the FDA has given Procter and Gamble's smart marketers until early October to start marketing their new hand sanitizer in a way that ensures consumers know what they are buying.
Labels: FDA, medical, Procter and Gamble, Vicks Early Defense
Monday, July 23, 2007
FDA, USDA Expand Botulism Warning To 90 Products
Two government agencies responsible for consumer food safety in the United States have expanded the warnings issued last week about products manufactured at
Castleberry Food Company.
"Do not take this issue lightly or ignore it if you don't own products with
Castleberry on the label," said Consumer Help Web President Joan
Bounacos. "The company also produces supermarket branded foods for huge chains like Kroger,
Piggly Wiggly and
Meijer."
The Food and Drug Administration reported that four people are hospitalized in serious condition after eating food traced back to the Augusta, Georgia subsidiary of privately-held Bumble Bee Foods.
Consumers should check the product lists at the links below and immediately dispose of any products they own by double-bagging the product in plastic and putting it in a non-recyclable trash container.
The
FDA web information listing products, impact and disposal instructions and the
USDA web information on meat products should be considered the authoritative source of information for this massive recall and healthy safety issue.
Labels: botulism, Castleberry, FDA, food, USDA
Monday, July 16, 2007
FDA Confirms Salmonella Outbreak Link To Snack
Recall Started June 28The Food and Drug Administration (FDA) today confirmed that a strain of Salmonella Wandsworth bacteria found in Veggie Booty snack food is responsible for the disease outbreak that occurred between March and June 2007.
Veggie Booty is marketed by Robert’s American Gourmet, of Sea Cliff, N.Y.
FDA continues to advise consumers not to eat any Veggie Booty and to throw away product they have. FDA also advises consumers not to eat Super Veggie Tings Crunchy Corn Sticks, and to throw out any supplies they have, because this product also may be contaminated.
No illnesses have been associated with any other Robert's American Gourmet products.
The Centers for Disease Control and Prevention (CDC) has identified 60 children from 19 states who have become ill. Six children were hospitalized. There are no reported deaths. States reporting illnesses include: California (seven cases), Colorado (five), Connecticut (two), Georgia (one), Illinois (one), Indiana (one), Massachusetts (four), Minnesota (two), New Hampshire (two), New Jersey (two), New York (15), Oregon (one), Pennsylvania (four), Tennessee (one), Texas (two), Virginia (one), Vermont (three), Washington (four), and Wisconsin (two).
FDA, the States, and CDC are continuing the investigation. Preliminary testing suggests that the seasoning mix used in Veggie Booty may be the source of the contamination.
Veggie Booty is sold in a flexible plastic foil bag in four ounce, one ounce and one-half ounce packages. Some gift baskets available for purchase on the internet include Veggie Booty or Super Veggie Tings Crunchy Corn Sticks.
Robert’s American Gourmet ceased distributing Veggie Booty and began recalling the product on June 28. The company has also voluntarily recalled all lots and sizes of Super Veggie Tings Crunchy Corn Sticks snack food because the same potentially contaminated seasoning may have been used in making that product, too. In addition, the manufacturer of Veggie Booty and other products for Robert’s has ceased production until this investigation is complete.
Labels: FDA, food, recall, salmonella, Veggie Booty
Wednesday, May 09, 2007
Justice Department Settles With Maker Of Loprox For Promoting Use To Children
Medicis Pharmaceutical Corporation of Scottsdale, Ariz., will pay the United States $9.8 million to settle allegations that the company violated the False Claims Act with respect to claims submitted to Medicaid, the Justice Department announced today. The settlement resolves allegations that Medicis promoted the use of a topical skin preparation, Loprox, for use on children under the age of 10, without approval by the Food & Drug Administration (FDA).
The United States and the whistleblowers – former Medicis employees – alleged that from approximately November 2001 through April 2004, Medicis sales personnel targeted pediatricians, urging the doctors to use Loprox as a treatment for diaper rash. The use of Loprox, which is approved by FDA as a fungicide for patients over 10 years of age, is not a “medically accepted indication” for the treatment of diaper dermatitis and other skin disorders in children under 10.
“This settlement demonstrates our ongoing commitment to protecting funds for federal health care programs,” said Assistant Attorney General Peter D. Keisler. “Pharmaceutical companies need to know that they will be held accountable for off-label marketing schemes and other illegal activities that affect those programs.”
The Food, Drug & Cosmetic Act prohibits pharmaceutical companies from marketing or promoting a drug for uses that the FDA has not approved, a practice known as “off-label marketing.” In the case against Medicis, the United States alleged that the Medicaid program paid millions of dollars for Loprox prescriptions that would not have been reimbursed if government authorities had known that the prescriptions resulted from the company’s off-label marketing campaign.
Medicis sold its pediatric sales unit in 2004.
The civil settlement resolves claims brought by four former Medicis sales representatives. As a result of the settlement, the whistleblowers will collectively receive in excess of $1,078,000 as their statutory award. Under the qui tam provisions of the False Claims Act, private parties can file an action on behalf of the United States and receive a portion of the settlement if the government reaches a monetary agreement with the defendants.
Labels: DOJ, FDA, medical
Monday, May 07, 2007
E. Coli Alert Issued In Florida, Mexican Cheese Suspected
Florida Agriculture and Consumer Services Commissioner Charles H. Bronson is urging consumers to check their refrigerators for Ole Mexican Foods’ Verole Queso Fresco Authentic Mexican Crumbling Cheese and Ole Fresco Authentic Mexican Crumbling Cheese. The two products may be contaminated with E. coli bacteria.
The potential for this contamination was determined after random testing performed by the Florida Department of Agriculture and Consumer Services revealed the presence of E.coli bacteria in samples of both of the cheeses.
“The discovery of this problem demonstrates the importance of an integrated pro-active food safety program, where products from stores and food processors are not only inspected but tested in our labs, as well,” Bronson said.
Department inspectors are working with Florida grocery chains to remove any of the potentially tainted cheese from those stores and are checking warehouses in Florida from which the products were distributed. Bronson said his agency has also notified the U.S. Food Drug Administration, which is responsible for the products in other states.
The affected code for Verole Queso Fresco Authentic Mexican Crumbling Cheese Net Wt. 15 oz. is V7&8 052 47193 SELL BY: 05/31/07; the affected code for Ole Fresco Authentic Mexican Crumbling Cheese Net Wt. 12 oz. is V5&6 051 47193 SELL BY: 05/30/07. Consumers who have purchased these products are urged to return them to the place of purchase.
No illnesses have been reported to date in connection with this problem.
Labels: FDA, Florida, recall
Monday, April 16, 2007
Look Before You Gargle -- Listerine Recalls Kids' Mouth Rinse
McNEIL-PPC, Inc. has voluntarily recaled
all lots of the GLACIER MINT™ and BUBBLE BLAST™ flavors of LISTERINE® AGENT COOL BLUE™ Plaque-Detecting Rinse after the Company determined that the preservative system is not adequate against certain microorganisms. The Company is recalling all bottles of AGENT COOL BLUE™ Plaque-Detecting Rinse, an estimated 4 million, from both retailers and consumers.
The Company conducted a thorough assessment and concluded that the risk of illness in healthy individuals following use of this product is very low. However, there could be a significant health risk to individuals with weakened or suppressed immune systems.
To date, there have been no consumer adverse health events reported that are related to this issue.
The recall affects all existing bottles of AGENT COOL BLUE™ Plaque-Detecting Rinse. Consumers should discontinue using and properly discard the product, and may obtain a full refund through calling the Company's toll free consumer line 1-888-222-0249 and mailing in the back label, including the UPC code.
Consumers can readily distinguish this product by the cartoon character on the front of the bottle. Only AGENT COOL BLUE™ Plaque-Detecting Rinse products are affected by this action. No other LISTERINE® branded products are affected and they remain safe and effective for use as directed.
AGENT COOL BLUE™ Plaque-Detecting Rinse has been sold to consumers through supermarkets, drug stores, mass merchants and other retail outlets, and is sold to dental professionals' offices nationwide. The Company is contacting dental professionals and retailers directly as part of their recall notification process.
Labels: FDA, Listerine, recall
Friday, April 13, 2007
More Cat Food Added To Product Recall, FDA Says Recalled Items Still On Shelves
FDA is advising pet owners that recalled pet food may still be on the shelves in some retail establishments. FDA urges retailers across the country to be vigilant in removing all products associated with the pet food recall, which began on March 16, 2007.
To verify the effectiveness of the recall, FDA has conducted approximately 400 checks of retail stores across the country. Based on the checks, FDA believes most companies have removed the recalled product; however, some have not. FDA will continue to monitor retailers’ efforts to remove these items from the shelves.
“FDA’s priority is to make sure that cats and dogs have safe food to eat, said Stephen Sundlof, D.V.M., director of FDA’s Center for Veterinary Medicine.” Many of us are pet owners and animal lovers, and we want pet owners to feel assured that we are doing everything we can to make sure that all contaminated food is off the shelves.”
In related news, Menu Foods, Inc., a private label manufacturer based in Streetsville, Ontario, Canada, expanded its recall on Tuesday, April 10, to cat food not previously subject to the recall. The varieties of cat food in the United States and Canada now being recalled are included in the list below. A complete list of Menu Foods' recalled products, including the new items, can be reviewed at www.menufoods.com.
The company acted after receiving information from FDA, which had confirmed test results it received from a laboratory at University of California, Davis. The UC-Davis lab found that canned cat food which had not been included in Menu Food’s earlier recalls tested positive for melamine, a chemical used as a fertilizer and in the manufacture of cutlery and kitchenware.
The company informed FDA that it had shipped wheat gluten purchased from China and contaminated with melamine from its Emporia, Kansas plant to its plant in Streetsville. Some of the products produced with the contaminated wheat gluten also were shipped to the United States. FDA investigators and officials with the Canadian Food Inspection Agency were in the Ontario facility on April 11.
Since March 16, recalls of pet food products, including certain varieties of dog food, have been conducted by Menu Foods, Inc., Hill’s Pet Nutrition, P&G Pet Care, Nestle Purina PetCare Company, Del Monte Pet Products, and Sunshine Mills, Inc. Extensive information about the current pet food situation can be found at the FDA Web site, www.fda.gov. There is now a single list of all recalled pet food located at http://www.fda.gov/ora/fed_state/recalls/Recall.xls which will be updated with any new recall information when announced.
LIST OF NEWLY RECALLED PRODUCTS:
Cat Food | | | | |
| | | | | |
Brand | Look For This Date on The Bottom of Can or Back of Pouch | Variety Description | Can / Pouch | Size | UPC |
| | | | | |
Americas Choice, Preferred Pet | | | |
| Jan/2/10 | Flaked Tuna 3oz | Can | 3oz | 54807-59114 |
| | | | | |
Your Pet | | | | |
| Dec/19/09 | Sliced Beef/Gravy 3oz | Can | 3oz | 72036-29026 |
| Jan/24/10 | | | | |
| Nov 06 09 | Sliced Variety Pack 3oz | Can | 3oz | 72036-40013 |
| | | | | |
Pet Pride | | | | |
| Dec/19/09 | Sliced Beef/Gravy 3oz | Can | 3oz | 11110-86264 |
| Jan/24/10 | | | | |
| Nov 06 09 | Sliced Variety Pack 3oz | Can | 3oz | 11110-86003 |
| Dec 05 09 | | | | |
| Dec 06 09 | | | | |
| Jan 23 10 | | | | |
| Jan 24 10 | | | | |
| | | | | |
Laura Lynn | | | | |
| Jan/2/10 | Flaked Tuna 3oz | Can | 3oz | 86854-02407 |
| Dec/19/09 | Sliced Beef/Gravy 3oz | Can | 3oz | 86854-02406 |
| | | | | |
Nutriplan | | | | |
| Dec/19/09 | Sliced Beef/Gravy 3oz | Can | 3oz | 41130-06755 |
| | | | | |
Price Chopper | | | | |
| Dec/19/09 | Sliced Beef/Gravy 3oz | Can | 3oz | 41735-12828 |
| | | | | |
Publix | | | | | |
| Jan/2/10 | Flaked Tuna 3oz | Can | 3oz | 41415-08327 |
| Dec/19/09 | Sliced Beef/Gravy 3oz | Can | 3oz | 41415-08827 |
| Jan/2/10 | | | | |
| Jan/24/10 | | | | |
| | | | | |
Stop & Shop Companion | | | |
| Jan/2/10 | Flaked Tuna 3oz | Can | 3oz | 88267-00286 |
| | | | | |
Winn Dixie | | | | |
| Dec/19/09 | Sliced Beef/Gravy 3oz | Can | 3oz | 21140-19419 |
| | | | | |
Nutro Products | | | | |
| All Dates | Chicken Cacciatore 3oz | Can | 3oz | 79105-35205 |
| All Dates | Orleans Seafood Jambalaya 3oz | Can | 3oz | 79105-35206 |
| All Dates | Beef Ragout 3oz | Can | 3oz | 79105-35207 |
| All Dates | Alaskan Halibut/Rice 3oz | Can | 3oz | 79105-35221 |
| All Dates | Kitten Chicken/Lamb 3oz | Can | 3oz | 79105-35202 |
| All Dates | California Chicken 3oz | Can | 3oz | 79105-30011 |
| All Dates | Lamb/Turkey Cutlets 3oz | Can | 3oz | 79105-30014 |
| All Dates | Salmon/Whitefish 3oz | Can | 3oz | 79105-30013 |
| All Dates | Beef/Egg 3oz | Can | 3oz | 79105-30015 |
| All Dates | Turkey/Chicken Liver 3oz | Can | 3oz | 79105-30016 |
| All Dates | Seafood/Tomato/Bisque 3oz | Can | 3oz | 79105-30017 |
| All Dates | Hunters Stew with Duck 3oz | Can | 3oz | 79105-30018 |
| All Dates | Hunters Stew with Venison 3oz | Can | 3oz | 79105-30019 |
Labels: FDA, pet food, recall
Tuesday, April 03, 2007
All About The Pet Food Recall - Direct From The FDA
Menu Foods Pet Food Recall
Frequently Asked Questions
Q: What is being recalled?
On March 16, Menu Foods, Inc. of Streetsville, Ontario, Canada initiated a voluntary recall involving a large number of both dog and cat foods produced at its facilities in Emporia, Kansas and Pennsauken, N.J. between December 3, 2006 and March 6, 2007. The products are sold by many different distributors under a number of different brand names. At present, Menu Foods is recalling dog food products marketed by about 50 firms and cat food products marketed by about 40 firms. A full listing of all the recalled products can be found at http://www.menufoods.com/recall/. The affected products are moist (packaged in pouches) and canned diets. The products have been described as “cuts and gravy” style pet foods. Please see http://www.fda.gov/oc/opacom/hottopics/petfood.html
Q: What prompted the recall?
Menu Foods, Inc. initiated the voluntary recall after conducting routine tasting trials in which some animals developed kidney failure after eating the product being tested. The company had also received consumer complaints, some of which apparently involved kidney failure. The firm has undertaken extensive testing of the pet food products in question, but has not yet been able to find the source of the problem.
Q: When did Menu Foods first notify FDA of the problem and a possible recall?
On Thursday, March 15, 2007.
Q: What is wrong with the pet foods?
It is unclear what is causing the adverse effects reported by Menu Foods and pet owners. FDA is working with Menu Foods, pet owners, pet food companies, local veterinarians, and diagnostic laboratories to identify the source of the problem.
Q: Are only dog and cat foods involved in the recall?
Yes. The recall is only confined to pet food intended for dogs and cats. The affected products are moist (packaged in pouches) and canned diets. The products have been described as “cuts and gravy” style pet foods.
Q: What should I do if I have cat or dog food at home?
Please check the Menu Foods Recall Information at http://www.menufoods.com/recall/ to see if your pet food is involved in the recall.
If your pet food is not listed, the pet food is not affected by the recall and you can continue to feed it to your pets.
If the pet food is one of those being recalled, do NOT feed it to your animals. Feed your pets another pet food that is not included in the recall.
Q: Is dry dog or cat food affected by the recall?
At this time, no dry dog or cat food has been implicated in pet injury or death. The recall is confined to the list of products found at: http://www.menufoods.com/recall/.
Q: What should I do if I have cat and/or dog food included in the recall?
Do NOT feed the pet food to your animals. Return the pet food to the store where you purchased it and ask for a refund. Stores generally have a return and refund policy when a company has announced a recall of its products. If you cannot return the pet food immediately, store the food in a secure place where pets and children cannot get to it.
Q: What if my pet ate one of the dog and cat foods being recalled?
Monitor your pet. If your pet shows signs of illness (such as loss of appetite, lethargy and vomiting), you should consult with your veterinarian immediately. If your pet is diagnosed with renal failure, we suggest you hold onto the food if the brand and lot numbers match the recall.
Q: If my dog or cat ate some of the recalled food, how soon after would I see any symptoms?
It’s difficult to say for sure, but usually within a couple of days. The important thing is to monitor your pet closely for signs of lethargy, loss of appetite and vomiting. If your pet shows any of these signs, please consult your veterinarian.
Q: What if I took my dog or cat to the vet as a result of the recall and I want to be reimbursed for my vet bills?
The FDA recognizes that there may be financial costs associated with any veterinarian visit; however, reimbursement for veterinary care does not fall under FDA’s regulatory authority.
Q: What is FDA doing about the recall?
FDA is conducting an investigation and working with Menu Foods and affected pet food companies to ensure that the recall is effective, and to identify the source of the contaminant. FDA is continuing to collect and analyze product samples in an attempt to identify the source(s) of the contaminant. FDA will continue to release additional information as it becomes available.
Q: How many confirmed pet illnesses and deaths have been reported to the FDA?
It is difficult to determine confirmed illnesses and deaths associated with the recall. Since the recall was announced, FDA has received many complaints and we are following up. The FDA’s primary concern is in identifying the source of the contaminant, assuring that the recall is effective and providing information to the public.
Q: What if I need more information about the recall?
Consumers with questions may contact Menu Foods at 1-866-895-2708. Some of the other affected pet food companies whose products are included in the recall may also have consumer question lines. Check the product label of the pet food. Some firms have also notified FDA that they have issued press releases; links to these press releases are available on the FDA internet page, Pet Food Recall, at http://www.fda.gov/oc/opacom/hottopics/petfood.html.
Q: What if I want to report an adverse action about a pet food?
Consumers and veterinarians who wish to report adverse reactions or other problems can go to the FDA internet page at http://www.fda.gov/opacom/backgrounders/complain.html to obtain contact information for the FDA complaint coordinator in their state. When reporting an adverse event or complaint, please try to have the following information:
-
Brand name and lot numbers for the pet food fed to your dog or cat when it was ill
-
If your pet received treatment by a veterinarian, the name, address, and telephone number of attending veterinarian
-
Date illness first noticed
-
Signs displayed
-
Any veterinary reports available
Q: What advice do you have for veterinarians concerned about this pet food recall?
Q: I understand Menu Foods, Inc. is focusing on wheat gluten as the possible source of contaminant? Is this true?
Menu Foods, Inc. suspects that wheat gluten might be the source of contamination; however, as part of the ongoing investigation, FDA is looking at all ingredients.
Q: What is wheat gluten and how is it used in pet foods?
Wheat gluten is a mixture of two proteins obtained when flour of wheat is washed to remove the starch. One use of wheat gluten is as a filler and binder in wet-style, cuts-and-gravy-type pet food. It provides a gelatinous consistency and is used to thicken pet food "gravy." It also has uses in human food products as a stabilizer or thickener. It is not generally associated with food contamination; however, it could possibly become contaminated by a toxic mold or other substance.
Q: How does FDA regulate pet food?
The FDA's regulation of pet food is similar to that for other animal feeds. The Federal Food, Drug, and Cosmetic Act (FFDCA) requires that pet foods, like human foods, be pure and wholesome, safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled. In addition, canned pet foods must be processed in conformance with the low acid canned food regulations to ensure the pet food is free of viable microorganisms (see Title 21 Code of Federal Regulations (CFR), Part 113). There is no requirement that pet food products have premarket approval by FDA. However, FDA ensures that the ingredients used in pet food are safe and have an appropriate function in the pet food. Many ingredients such as meat, poultry, grains, and their byproducts are considered safe “foods” and do not require premarket approval. Other substances such as mineral and vitamin sources, colorings, flavorings, and preservatives may be generally recognized as safe (GRAS) or must have approval as food additives. (See Title 21 CFR, Parts 73, 74, 81, 573 and 582). For more information about pet foods and marketing a pet food, see FDA’s Regulation of Pet Food and Information on Marketing A Pet Food Product.
Q: What are the labeling requirements for pet foods?
The FDA regulations require proper identification of the product, net quantity statement, name and place of business of the manufacturer or distributor, and a proper listing of all the ingredients in order from most to least, based on weight. Some states also enforce their own labeling regulations. Many of these regulations are based on a model provided by the Association of American Feed Control Officials (AAFCO). For more information about AAFCO, please visit its website. There are two documents on CVM’s web site that provide more details about labeling requirements: Interpreting Pet Food Labels and Interpreting Pet Food Labels -- Special Use Foods.
Q: Have there been other recalls involving pet foods?
Yes. The following are recent pet food recalls: In February 2007, FDA recalled Wild Kitty raw cat food http://www.fda.gov/bbs/topics/NEWS/2007/NEW01562.htmlafter Salmonella was detected during routine testing performed by FDA. In December, 2005, Diamond Pet Foods initiated a voluntary recall after aflatoxin was discovered in their product http://www.fda.gov/oc/po/firmrecalls/diamond12_05.html. For information on other pet food related recalls, please see http://www.fda.gov/cvm/petfoods.htm.
Labels: FDA, pet food, recall
