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Author Topic: FDA Suspends Temporary Emergency Permit of Pet Food Maker Evanger's  (Read 131955 times)
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menusux
Guest
« Reply #90 on: April 30, 2008, 01:43:17 PM »

"My pets rely on my due diligence." Good point, Kaffe. I'm not sure I understand
why companies are so reluctant to let consumers have knowledge of safety testing
and quality assurance programs and their results. Our furkids are certainly relying
on the results.

I also didn't know that the FDA could demand recalls per Joel's remarks. I thought
that was something up for consideration, but not among their powers at this time.

I would like to see the link saying the FDA TODAY has the right to recall pet food ... they were given Broader recall on Human food stuff s ...

Quote
http://petsitusa.com/blog/?p=1125

"This is a boiler plate response by the FDA in any situation when it refers to canning. If the FDA had believed that there was even the slightest possibility of product contamination they would have demanded a recall. You will note that there is no mention of that in there release.The CRC has no input as to processing. They only inspect the ingredients. As I indicated prviously, the FDA s release is innacurate and misleading. It is unfortunate that whoever is in charge of posting these releases does not take the time to report accuratley the facts. The way the FDA reported this event is a big thing, the observation that FDA made and questioned concerning recordkeeping is not that big of a thing".

http://www.fda.gov/ora/compliance_ref/rpm/chapter7/ch7-5.html#SUB7-5-3

7-5-3 - FDA Ordered Recalls

Various sections of the law authorize FDA to order a firm to recall a product. Each is discussed separately below. If the recall is FDA ordered, the agency will issue a written order to the firm to recall.

Mandatory Device Recalls
Under Section 518(e) of the Act, if the agency finds that there is a reasonable probability that a device intended for human use would cause serious adverse health consequences or death, FDA has the authority to order the manufacturer, importer, distributor, retailer, or any appropriate person to immediately cease distribution of the device, to immediately notify health professionals and device user facilities of FDA's order, and to instruct such professionals and facilities to cease use of the device.

Mandatory Recall of Biological Products
The National Childhood Vaccine Injury Act of 1986 amended the Public Health Service Act (PHS Act) to provide recall authority for biological products (42 U.S.C. 262). If a determination is made that a batch, lot, or other quantity of a product licensed under the PHS Act presents an imminent or substantial hazard to the public health, the Secretary has the authority to issue an order for its immediate recall.

Mandatory Recall of Human Tissue Intended for Transplantation
On November 21, 2004, FDA issued regulations requiring human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to follow current good tissue practice (CGTP), which governs the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps; record keeping; and the establishment of a quality program (GTP final rule 69 FR 68612). FDA promulgated the new regulations under the legal authority of section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264). The regulations at 21 CFR 1271.440 include a provision for orders of retention, recall, and/or destruction, and a new provision for orders of cessation of manufacturing in certain circumstances.

Infant Formula
The Infant Formula Act of 1980 and its 1986 amendments mandate that an infant formula manufacturer promptly notify the Secretary if the manufacturer has knowledge that reasonably supports the conclusion that an infant formula shipment may not provide the required nutrients or may be otherwise adulterated or misbranded.

Interstate Milk Shipments
The FDA does not ordinarily classify or audit interstate milk shippers (IMS) product recalls where such actions have been, or are being, handled expeditiously and appropriately by the state(s). The FDA district office in which the recalling firm is located must be ensured that all states involved in an IMS plant's recall are participating in ensuring removal of the product from commerce and that, when appropriate, states issue warnings to protect the public health. In the event that FDA determines that the states are unable to effect the recall actions necessary, the agency will classify, publish, and audit the recall, including issuance of a public warning when indicated.

http://www.cfsan.fda.gov/~lrd/recall2.html

The recall of a defective or possibly harmful consumer product often is highly publicized in newspapers and on news broadcasts.  This is especially true when a recall involves foods, drugs, cosmetics, medical devices, and other products regulated by FDA.  Despite this publicity, FDA's role in recall activities is often misunderstood not only by consumers, but also by the news media, and occasionally even by the regulated industry.  The following headlines, which appeared in two major daily newspapers, are good examples of that misunderstanding: "FDA Orders Peanut Butter Recall," and "FDA Orders 6,500 Cases of Red-Dyed Mints Recalled."

The headlines are wrong in indicating that the Agency can "order" these recalls.   The Federal Food, Drug, and Cosmetic Act, (the law) does not generally authorize FDA to "order" a manufacturer to recall a food, cosmetic or supplement.  The agency may request a product recall if the firm is not willing to remove dangerous products from the market without FDA's written request.  Only when a medical device, human tissue products, and infant formula pose a risk to human health; that the law specifically authorizes FDA to prescribe a recall and to rule on the scope and extent of the same*.

The only food product FDA has "absolute" recall authority over is baby formula--they can get involved in the recall of contaminated milk only when states' health authorities are unable or unwilling to do it.  This is what's been in the news for quite a while--FDA asking for broader recall powers from Congress and also the money needed to enforce them.  As it stands this minute, they have no broader recall powers than the above.

The agency is able to issue Import Alerts and detain high-risk shipments of food products until their importers can prove through independent testing that their shipments are safe, but they are not able to either ban or do any food recalls other than for contaminated baby formula on their own--they have not been given any legal power to do more than that.
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3catkidneyfailure
Guest
« Reply #91 on: April 30, 2008, 02:04:03 PM »

Thank you, menusux, for the clarification on FDA recall authority.
A couple of company representative comments seem to be at odds
with FDA statements. Lacking sufficient access to information,
consumers seem left to draw their own conclusions.

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menusux
Guest
« Reply #92 on: April 30, 2008, 02:17:41 PM »

3 Cat--

It's my hope that the consumers now realize what the legal situation truly is re: FDA and recalls and that this has been some enlightment for those company reps who are/were unaware that their statements are without fact. Spell Checker would also be a plus.  Grin
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kaffe
Guest
« Reply #93 on: April 30, 2008, 02:24:46 PM »

Yes, thanks Menusux for the clarification of FDA's recall powers (or lack thereof). 
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3catkidneyfailure
Guest
« Reply #94 on: April 30, 2008, 04:26:18 PM »

Manufacturers, however, are not limited by FDA recall powers if there is any
question as to product status and are able to voluntarily recall product. I
believe most of the manufacturers after March 16, 2007, including Menu Foods,
conducted voluntary or what were sometimes termed precautionary recalls.

There were some rather lengthy delays in some of those recalls in 2007, I believe.
Any worried consumer might want to consider keeping aside cans of product if they
have had what they feel may be issues based on experience.
« Last Edit: April 30, 2008, 04:49:27 PM by 3catkidneyfailure » Logged
kb
Sr. Member
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Posts: 216


« Reply #95 on: May 01, 2008, 01:08:13 AM »

It would really be nice to see safety testing results on product from a manufacturer
whose plant runs, I believe, 24/7 around the clock. No company has published such
results for the consumer to see that I'm aware of to indicate their commitment to
pet food safety first and foremost.

I thought I remembered some company posting their test results after the recalls.  Don't think it was Natural Balance but looks like you can check their test results now.

http://www.naturalbalanceinc.com/PetFoodScreening.tpl
 Natural Balance Pet Foods has created this new "Buy With Confidence" feature
for pet owners to monitor the testing of their pets’ food.

January, 2008

As of December, 2007, we have added screening for:
Ochratoxin, Zearalenone and Fumonisin

to our standard testing protocol which already includes testing for:
Melamine
Cyanuric Acid
Aflatoxin
and DON (Vomitoxin)

We have taken samples from each date code of Natural Balance product and subjected them to our testing protocol. With the new "Buy With Confidence" service, you are now able to view these test results. When you see your "Best By" code in the results section, you will know that the samples we tested from that date code met the FDA guidelines for the tests listed.

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3catkidneyfailure
Guest
« Reply #96 on: May 01, 2008, 08:07:31 AM »

Thanks, kb. I didn't know that. Seems like a step
in a direction pet food consumers would like to see
more of.
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JustMe
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« Reply #97 on: May 01, 2008, 02:15:58 PM »

kb,

I had forgotten about this.  Thanks for the reminder.

Yes, they have had the testing section set up for quite awhile now.  You put in your product information and it gives you the test results for that batch.  It had to be at least last summer.  That's the last time I checked my can information.  It would be nice if all the companies had something similar on this sort of scale.
« Last Edit: May 01, 2008, 02:44:45 PM by JustMe » Logged

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Replied the glorious cat
For I will whisper into their hearts
That I am always with them
I just am....forever and ever and ever.
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Sandi K
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Posts: 7365


« Reply #98 on: May 02, 2008, 07:14:04 AM »

My statement over at PetSitUSA:  http://petsitusa.com/blog/?p=1125

Mr. Sher, while you obviously like to discredit FDA and their actions, I am very, very pleased that they came forward with this action and potentially prevented more deaths and illnesses in our pets. This is exactly what we, the consumer, have been wanting FDA to do and I hope they continue with more inspections of your facilities as well as other pet food facilities. The pet food companies want to be able to continue on with business as normal after the 2007 pet food recalls and its obvious by your statements that the companies dont feel they should be monitored or inspected. Your attitude towards FDA and the recent findings at your plant show the exact reason why pet food companies should not be allowed to police themselves and I will be making my feelings very clear at the upcoming FDA Pet Food Safety hearing this month.

I might add that I contacted FDA myself for clarification on this issue at your plant. They have confirmed exactly what their notice said, plus some additional details that werent specifically stated in their notice. So perhaps the pet food companies can stop pointing the finger of blame at others and just take responsibility for issues that are self-created. That would be a good start in winning back the confidence of the consumer.

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petslave
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Posts: 5178


« Reply #99 on: May 02, 2008, 07:28:11 AM »

Natural Balance's testing & posting results is a good start, but I'd like to see it extend further.  What about all the supplement problems that have been coming up?  That list won't pick those up. 

PF companies should not only be testing their end product for the few problems that have caused mass deaths, they also need to buy from sources that legitimately test & stand by the safety of each ingredient that is being used.  And we should be able to see exactly where each of those ingredients comes from & the test results of that ingredient.  Until then (which will never happen), I still won't fully trust any pet food on the market today.
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Carol
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Posts: 3200


« Reply #100 on: May 02, 2008, 07:28:36 AM »

Bravo Sandi K....

I do look forward to Mr Sher coming back here when he returns from his honeymoon---so he can read what the FDA emailed to you....and then see what he can tell us about that statement! Angry

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3catkidneyfailure
Guest
« Reply #101 on: May 02, 2008, 08:43:34 AM »

I believe it's Mr. Weaver, a company rep, on his honeymoon.

I agree that we need even more inclusive testing results than NB, but it's a good step.
There are issues of variable vitamin dosages, mineral amounts, possible toxins, overall
batch guaranteed analyses, that a lot of consumers would be very happy
to find posted by batch and date code lookup on pet food company web sites. It certainly
is one confirmation that the company involved has a quality assurance program and is food
safety testing each and every batch it makes that the consumer is likely to purchase, rather
than leaving the pet food consumer to guess about company quality assurance programs
and/or food safety testing practices by not providing any information.

Even though there are still some questions here and apparent conflicts in company and
FDA statements, you do have to give this company credit for coming forward and
trying to speak directly to consumers.

I believe that the level of documentation that the pet food consumer is looking for after 2007 has not
made it to the "radar screen" of a lot of the companies yet.

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skinnydog
Jr. Member
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Posts: 10


« Reply #102 on: May 03, 2008, 04:07:07 PM »

Hi there.  I'm new here.  I just wanted to thank you all for posting this information.  I switched to Evangers in 2007, after the recalls.  I found this thread because I was in the process of recommending it to someone whose dog has GI issues and googled the company in order to get the link to its website. 

To my horror, I came across the FDA information instead.   Shocked

Suffice to say, if the FDA is warning us to stay away, that's all I need to know.  After all, it's not like the FDA acts quickly or recklessly.  Most of the time, the complaint is that the FDA failed to act.

We will return what is left of our last case of canned food and go back to the drawing board. 

Thanks again for the information.

P.S  To the Evanger's company rep. -- your words ring hollow in light of the explanation by the FDA to Sandi's e-mail.  Angry
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lesliek
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« Reply #103 on: May 03, 2008, 05:08:17 PM »

Yes it is.
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Sandi K
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Posts: 7365


« Reply #104 on: May 03, 2008, 06:58:30 PM »

Leslie K, I was wondering if you had a chance to call Evangers again like you had said earlier and did you have success this time with them? 
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