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Author Topic: FDA Docket Seeks Comment: Pet Food Early Warning Recall by CONSUMERS  (Read 1554 times)
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Sandi K
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« Reply #30 on: January 05, 2010, 02:44:25 PM »

Aaaaw BW, its OK, everyone has until Jan 29th to submit comments.  I think for lots of us, these dockets can be very hard to read.  I recently was talking to a lady who has a very high position at a university and was talking to her about a different docket related to pet food from awhile back.  I gave her the link and she looked at it and asked, "you actually read that whole thing"?  LOL  She said even for her it was very difficult to read and comprehend.  So dont get down on yourself, its not you!   
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lesliek
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« Reply #31 on: January 05, 2010, 03:32:56 PM »

BW- Its not just you ! Some days I can do it & understand it & others I wonder how many brain cells I've lost ! ;DJust go at it on a non super busy day,& you will do better at understanding it. That of course assumes that you ever have a non super busy day.
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3catkidneyfailure
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« Reply #32 on: January 05, 2010, 04:22:03 PM »

Maybe long and short of it is to tell the FDA how useful this questionnaire is going to be to consumers and if it can be improved in any section, and then how useful it could be to the FDA? Kind of the way it seems to me.
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Sandi K
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« Reply #33 on: January 05, 2010, 05:50:52 PM »

I agree 3cat and I would say, even if someone doesnt have any suggestions to send in, even just a note encouraging them to implement this would be helpful.  I think the more pet owners they hear from the better just in case the PFI decides they need to lobby against this.  I dont have any suggestions for them on this form but I am going to write them and tell them why I think its so important to have this.  In our case we suspsected something wrong with our KiKi's food and we began making calls to the pet food company as early as Dec 06 and Jan 2007.  If there had been a central warning place to report these things, I have no doubt that other pet parents would have also been noticing something wrong and used a system like this and perhaps many pet deaths and illnesses could have been avoided. 
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3catkidneyfailure
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« Reply #34 on: January 05, 2010, 06:57:49 PM »

I need help here, Sandi, on one of your points: is there anything saying these reports are going
to be pubicly searchable or available to be seen by the public? Or even a summary of them by food product by the CVM/FDA? Or by veterinarians? Have I missed that? I don't believe reports to FDA
would be treated like Consumer Affairs, but maybe I missed that part.
« Last Edit: January 05, 2010, 07:01:13 PM by 3catkidneyfailure » Logged
Sandi K
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« Reply #35 on: January 11, 2010, 12:19:05 PM »

Im just bumping this up as a reminder for people to submit their comments on this, for everyone that is concerned about pet food safety, if possible, please comment to them, even if its just to say you support this early warning system...or dont.

3Cat, I probably wasnt clear.  I have no idea if the reports submitted by pet owners to this early warning system will be available for the public to see, my guess is no.  I was referring to the docket and the comments being submitted.  You can view all the comments they have received to date so far on the actual early warning system proposal docket.  One of the comments by AVMA caught my attention:

http://www.regulations.gov/search/Regs/home.html#documentDetail?D=FDA-2008-N-0546-0005.1

"The AVMA recommends that FDA gain and retain contact information from all individuals who submit adverse event reports.  We contend that false reports could be submitted to FDA more readily if individual contact information is not required for report submission.  We assert that such contact information is essential, so that FDA is able to follow-up with reporting individuals and to verify reported information if the FDA has any questions or concerns regarding an individual report."

and then right below that they put another statement " We also assert that contact anonymity should not be an option for individuals submitting adverse event reports, as we believe the numbers of false reports would increase if individual contact information is not a requirement for reporting." 

So out of all the things they could comment on they have mentioned obtaining contact information of the person submitting the report twice out of a concern they have of false reports?  The rough draft form provided by FDA clearly shows that whoever submits a report has to give name, address, and various other pieces of contact information.  I find it hard to believe that this system would be over-run with people filing false reports so why is AVMA so concerned about this enough to mention it twice?  Once again it just seems that certain parties are more concerned about those sneaky over the top pet owners than they are of the true culprit and cause of even having to have this system in the first place and that is the pet food companies.  Such large distrust and suspicion of pet owners but not the pet food companies.  sigh.....
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bug
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« Reply #36 on: January 11, 2010, 12:52:54 PM »

I read that one and it really seemed like they have their own agenda as they were looking for reporting of medications, if I recall correctly. Almost like they were glancing over what the FDA is actually asking for input on.
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Red and Bones, my baby boys, you'll always be in my heart. Mom will see you later. Look after each other, ok?
3catkidneyfailure
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« Reply #37 on: February 02, 2010, 08:10:42 AM »

Nancy Cook of the PFI on January 29, 2010:

on page 3:
http://www.regulations.gov/search/Regs/home.html#docketDetail?R=FDA-2008-N-0546

PFI pdf format file:
http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a875e2

Outrageous if you read it.
« Last Edit: February 02, 2010, 08:48:25 AM by 3catkidneyfailure » Logged
Carol
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« Reply #38 on: February 02, 2010, 09:03:35 AM »


Of course it may be based on my opinion of the PFI...but reading Nancy's comments it seemed to me that she is worried about pet owners not reporting truths and not notifying the manufacturers (as if that does any good) and she thinks more time is needed...I wonder how long Nancy feels is warranted to change things--it has been 3 years since the Menu incident--so maybe a few more years is what the PFI wants? and of course I think she would like the FDA to just stay out of it..

snarl, hiss, boo...
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United we stand     Divided we fall....
3catkidneyfailure
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« Reply #39 on: February 02, 2010, 09:11:48 AM »

Especially loved the inference that cat vomitting after eating is a stress response many times unrelated to bad pet food ingredients.
Many times it is related to lousy pet food ingredients, too, and manufacturers should be responsible for the needed care and treatment.
My 3 chronic renal failure kitties are faking their bloodwork and inability to concentrate urine.

Public Law 110-85 announcing this early warning system was signed in September 2007 by then President Bush. Gee, it must take
a lot longer to get ready.

The wet and dry pet food manufacturers don't want to be lumped with the pet treat manufacturers as far as food safety. Gee, I wonder
why? But those manufacturers, like Del Monte, are happy to get the profits. Give me a break.
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menusux
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« Reply #40 on: February 02, 2010, 09:27:55 AM »

Attaching a text copy of the PDF here because the PDF itself is slightly too long for that.

From Nancy's cover letter:

"Our members must produce pet food in the U.S. as a condition of membership and may also manufacture in other countries and under other controls as well. U.S. pet food has long been recognized as the gold standard for pet food quality, nutrition and safety."

Fool's Gold-

http://www.accessdata.fda.gov/scripts/newpetfoodrecalls/

Pet Food Recall Products List-FDA-
Information current as of noon January 11, 2010
973 entries in list

That's a lot of recalls for anyone claiming a "gold standard", plus we have many "silent recalls" not on this FDA list.

http://itchmoforums.com/news-recall-related/wysong-announces-limited-recall-on-some-dry-dog-food-may-contain-mold-t9390.0.html

Wysong

There is a new report of a mycotoxin death connected with the products Wysong didn't formally recall:
There is a new post from a woman dated yesterday from a woman who lost her dog:

http://www.petconnection.com/blog/2009/10/13/recall-wysong-dog-food/#comment-482904

Please see my entire story of the loss of our 8 year old healthy Boston Terrier KC, I am an RN of 23 years and noticed at first white mold on wysong Maintance, we have fed our Boston’s Wysong for 11 years now.

I was the one that called Wysong, I was the one that obtained the “voluntary lot numbers” which were the numbers of ALL of the cases we kept returning, our VET to the day has never heard a word from his Distributer nor from Wysong.

The only way he knew of the problem was from ME.

We lost our precious KC due to Grand-mal seizures, (febrile in nauture, his temp was 105, 12 hours after he ate some of the contaminated food), the food has been tested at an independent lab that I took it to, it contained the mold Mycotoxin.

Wysong claims that Mycotoxin can be killed by their heating and freezing process.

The CDC states that the lethal mold Mycotoxin can not be killed by any form of heat or cold. It causes:

Bloating
Gas
Severe Neurological Damage
Febrile Grand-mal seizures
Diarrhea
Liver failure
Internal Bleeding
Septic Shock
Thick yellow discharge from one or both eyes
Vomiting
Death

You may and please do read my complete story at
http://www.petsitusa.com/blog

My name is Pam, I have contributed twice, the initial story of what happened and how Wysong has treated our situation and then tonight 2/1 I posted a second addition to the rest of our story, please also go to
http://www.consumeraffairs.com web site to read Julie’s story of the loss of her chanpion dobie scarlet who died early september, Julie had started feeding Wysong only in August, Wysong has actually written a response there where they state they contacted all distributers, stores, vets, clients who have product drop shipped to their homes immediately upon their discovery of the problem, they deny the presence of Mycotoxin in any of the product, although there are now reports from numerous Vet universities and lab centers that have isolated the mold from Wysong food, it is amoung the most “lethal” molds on our planet.

On the consumer affairs web site there is a link where you can click and it will take you to a second page of their site where you can write to them your experience with this dog food, and it is now going to be a class action suit and you will be contacted by a class action attorney should you care to post your experience, it is not about money, I want to make that perfectly clear, as there is no amount of money that can make up for the suffering our little man KC went through and then we had to have our little man’s suffering to an end, he was alive, but brain dead due to the un-relenting seizures caused by the lethal mold Mycotoxin.

But, at least if any and all pet owners who have had an experience now or from 1997 will post their experience with Wysong to consumer affairs, to the FDA and to the CDC (center for disease control) we can make a difference, please check your individual state for an animal law protection attorney who may be practicing in your state, there are several states that are now haveing these wonderful, caring attornies to help the public stop this crazy and un-ethical practices from happening.

Sincerely
KC’s mom.

Comment by Pam — February 1, 2010 @ 8:30 pm [/color]

http://itchmoforums.com/news-recall-related/new-nutro-pet-food-withdrawalthis-time-puppy-food-t9309.0.html

Nutro Puppy Food-Mars is a PFI Member....

http://itchmoforums.com/news-recall-related/halo-dog-foods-withdrawn-t10180.0.html

Halo

And those who didn't issue a recall at first and the FDA had to do it:

http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm187218.htm

FDA Alerts Pet Owners to Voluntary Recall of Premium Edge Cat Food
October 20, 2009


http://www.fda.gov/Safety/Recalls/ucm192404.htm

Diamond Pet Foods Announces Recall of Premium Edge Adult Cat and Premium Edge Hairball Cat Food
FOR IMMEDIATE RELEASE - November 27, 2009

Diamond-Schell & Kampeter-another PFI Member....


"necessity to collect truthful, detailed information through the Portal that will enable FDA and the manufacturer to appropriately investigate an event and product as quickly as possible."

The above is underlined in the PDF copy.  Guess Duane-o still has visions of "off the charts" in his head.  Grin

Page 1

"Secondly, submitters must understand that the filing must be complete and accurate in all its parts. Missing or untruthful information could lead to actions that would not accurately reflect the situation and which could damage the reputation of any/all companies within the industry. PFI believes that FDA understands the issues that could occur with multiple or unwarranted submissions, but this issue must be clarified before the program is put into place. Reviewers must be aware of patterns of submissions and their relationships to those who might want to adversely affect the industry."

Nancy says, "Let's get those people who dare to say there's anything wrong with the food our members produce, even if it costs taxpayers more money to try to ferret them out!"  A lobbying group for private industry as PFI is should not expect the government and taxpayer dollars to do their work for them.

Page 2

"Third, the document should be renamed to accurately describe the products to which it refers, that is, Pet Food, Pet Treats and Pet Chews. Many “pet food recalls” have been for pet chews such as pig ears. The agency is aware that there is a significant difference in these products and is encouraged to assist the public in understanding the differences so that news reports can be accurate and non-inflammatory."

Most of those pet treats and chews companies don't belong to PFI, so like the protection racket in organized crime, they haven't ponied up to be "protected".

"Fourth, the answers to all questions are important in investigating any submission and having a chance of determining whether or not an event has occurred. PFI suggests in Attachment 1 to these comments that more questions be labeled as mandatory. FDA should consider providing the company of concern with information about the submitter so that multiple filings and other information could be made available if needed. Again, the submitter should be encouraged to contact the manufacturer/distributor of record immediately with any complaint. Short-circuiting the well-established consumer service programs in place does not benefit the consumer, the agency or the company."

A lot of those who submit reports HAVE initially tried doing this and when their information wasn't taken seriously, went on to report the problem to FDA in an effort to get somewhere.

"The event must be verifiable"

"Every illness or bout of nausea/vomiting in a dog or cat is not tied to consumption of pet food. The is very solid data from Dr. C.A. Buffington, Ohio State University Veterinary Teaching Center, showing that cats respond to stress with behavior that looks just like an illness. It is very important that stress reaction be separated from event in response to something the animal ingested. Perhaps the Agency could make an educational statement to that effect in the information and directions for completing the form.

"Fifth, FDA and the submitter should be able to cross-check all submissions against the active list of recalled products to see if the issue has already been addressed. That would allow the Agency to provide immediate response to the submitter while utilizing resources that are available to the public, and providing a “teachable moment” to the submitter."


Everything you say in public as a PFI Employee isn't verifiable--here's YOUR "teachable moment":

http://www.cattlenetwork.com/content.asp?contentid=172182

Cattle Network October 29, 2007

"In view of growing concerns about the safety of U.S. imports, no fewer than 13 bills relating to food safety are in play in Congress, Nancy Cook, vice president of the Washington, D.C.-based Pet Food Institute, told attendees of the Meat Industry Research Conference at Chicago's McCormick Place.

""Some involve inspections, others certification, penalties, record keeping and country-of-origin labeling. It's not going to stop at pet food, either," she said, acknowledging last spring's massive recalls of melamine-laced pet food. "Have we figured out how to put a COOL label on a Hershey bar? It's about 10 feet long."

COOL labeling is in place in EU countries, none of whom have ever reported having candy bars with 10 foot long wrappers-"The event must be verifiable".

http://cache.zoominfo.com/CachedPage/?archive_id=4396663&page_id=29615417&page_url=%2f%2fwww.foxnewschannel.com%2fnational%2f083100%2fmeat_riley.sml&page_last_updated=9%2f7%2f2000+1%3a49%3a31+PM&firstName=Nancy&lastName=Cook

Thursday, August 31, 2000 Fox News

""We all get old and stringy. Cattle will tend to do the same thing," said Nancy Cook, a former USDA meat grader."

It looks like you made that grade a LONG time ago, Nancy.
« Last Edit: February 02, 2010, 09:46:14 AM by menusux » Logged
Sandi K
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« Reply #41 on: February 02, 2010, 09:50:26 AM »

You know, these guys just amaze me.  Part of the reason this early warning system is even having to be done is because of food problems that arent getting caught or relayed when known about, this is a result of the industry's behavior and the pet owners demanding change. They make it sound that if this form isnt filled out in full it should be considered incomplete but yet when you do call a pet food company, they dont ask even close to the amount of questions that are being asked on this form.  And they want pet owners to contact them first as if that is such a novel idea....give me a break.  I called our pet food company in late 2006/early 2007 and so have many other people in just 2009 alone and alot of good that did.  All you get as a response is they have had no other reports of problems.  And then they say " FDA should consider providing the company of concern with information about the submitter so that multiple filings and other information could be made available if needed."  Well I propose the same thing be done in reverse, the pet food companies should have to provide FDA with copies of all the reports of problems they receive from pet owners.  And I dont feel FDA should be releasing any information about someone who is submitting a report to any pet food company without that person's permission.  I would be concerned the company could potentially attempt to contact the person and intimidate them in some fashion..... from where I sit these guys are just trying to pull the wool over FDA's eyes and make it appear they are being victimized. They are worried about multiple submissions from pet owners, in reality how many would really do that?  Anyone I know that has had a sick pet from what they feel is a pet food problem, etc, have contacted the company first and got little to no help or concern so ended up contacting FDA.  This is a bunch of dog-doo.  Tongue
« Last Edit: February 02, 2010, 10:01:07 AM by Sandi K » Logged
3catkidneyfailure
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« Reply #42 on: February 02, 2010, 10:08:14 AM »

I am so sorry, all, especially in view of your excellent criticisms, that I didn't get notice of this PFI comment out of the government FDA docket notice system of its existence until today, Feb. 2, 2010, with no chance to respond in the official FDA docket.
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menusux
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« Reply #43 on: February 02, 2010, 10:33:03 AM »

Let's look back at when Justice was continually run over by a steamroller:

http://docs.justia.com/cases/federal/district-courts/florida/flsdce/1:2007cv21221/295436/430/0.pdf

Starting on page 22, you'll see the attorneys for the PFC's, most of whom are PFI Members-Mars, Menu Foods, Hill's, Del Monte, Nestle Purina, Natura, Iams.

Mounting a defense such as this cost each company a goodly sum of $. Page 15 covers what was expected of the plaintiffs:

"Please identify yourself, including your full name and any prior names used, all electronic identities used at any time during the last five (5) years (including e-mail addresses, user names or screen names), all addresses at which you have lived for the last ten (10) years, your date of birth and your drivers' license number and state of issuance.

"Please identify each website or electronic community (including weblogs, internet bulletin boards, and listservs) which you have maintained or to which you have contributed during the past five (5) years, and for each, state the registered name you used, the nature of the website or electronic community, the internet address (URL), and the date or period of time during which you maintained or contributed to it."


A way to violate the privacy of each plaintiff who wished to continue with his/her lawsuit.  It seems that the PFCs have decided to try doing the same thing but not incur such awful legal costs--by expecting the GOVERNMENT to do it for them.

Every type of government form I've ever had to deal with had to list the agencies and entities the information you were providing might be shared with.  They were other Federal agencies, state agencies and various other local agencies of government; NONE of them were private industries or their lobbying group(s).

If applicable, a company in private industry would be made aware of your complaint, but your personal information would not be shared with them.

There has to be something morally wrong with expecting the Federal Government to revive the old Soviet Union KGB in the name of providing the PFCs with a "hit list", even if you don't care about pet food or have a pet. 

It has the potential to deter persons with legitimate complaints from reporting them due to the fact that their personal information will be passed along to the company who makes the product(s) they are at issue with, so it tips the playing field in favor of industry and against the consumer. 

FDA is meant to serve BOTH consumers and industry on a level playing field.  We would now have an agency who is attempting to protect us all not receiving reports which are necessary to do that because of the PFI "suggestions".

The other wrong would be the use of Federal Government employees whose agencies and positions are taxpayer-funded to do the "legwork" of the private industry's lobby group.  There have been enough budget issues with programs curtailed or cut back in this time of great need to cry, "shame on you!" to PFI and its members who are trying to get their research done with the tax dollars of EVERY taxpayer.

If this is implemented, this time Justice won't just be continually steamrollered, she will be constantly gang-r---d.
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Rob
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« Reply #44 on: February 02, 2010, 11:00:01 AM »

In RE: to the link to the doc.....Defendants, regardless of who they are, have a right to discovery. If it is denied them it should also be denied to the plaintiff (i.e. internal emails, marketing plans etc....). I agree that we can't hide in an online world yet still expect to sue. At some point, if a plaintiff is part of the lawsuit and expects to receive damages or have their "testimony" heard in trial, their information must come out to support the claims.  The defendants are going to the heart of things like "consumer affairs" type sites that we can't really confirm if these folks have had issues with food or not...we just see posts from people at city or people plus state. There is no way to determine, since we don't know the animal or pet owners, the history or what other things haven't been told - like a cold switch to a new food - yep liquid poop should be expected! I'm not slamming the plaintiffs, but if the plaintiffs wan't to play in the legal arena, they need to get some tougher skin and expect to defend their own testimony as true, accurate and complete.
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