Evanger's Still in Trouble with FDA, Still Denying Food Problems

The most popular post on my blog right now seems to be this one from a year ago about the FDA telling Evanger's pet food company to get it together on the botulism thing (I paraphrase, heh). So an update is probably in order. Apparently Evanger's has not made satisfactory changes and the FDA (a government org which, inexplicably, lacks the authority to mandate recalls of anything but baby milk) has recently, in effect, shut the company down:

When the FDA announced its latest enforcement against Evanger's, the agency's Dr. Bernette Dunham said: "The FDA is stopping Evanger's ability to ship pet food in interstate commerce. 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."

Before Evanger's can resume shipping products, the FDA said, it must prove that corrective actions and processing procedures have been made to ensure the company's finished product will not present a health hazard.

Botulism is a toxin that affects the nervous system and can be fatal, the FDA said. Symptoms of botulism in dogs and cat include progressive muscle paralysis, disturbed vision, trouble chewing and swallowing, and progressive weakness to the body. Death is usually caused by paralysis of the heart or the muscles used in breathing.

Even I know botulism=bad. So why can't Evanger's get it together after a YEAR? For their part, Evanger's still seems to be saying it's a paperwork snafu. Even if we were to grant that it's some kind of clerical error, the fact that they haven't been able to fix it to the FDA's satisfaction over the course of 13 months just doesn't look good.

FDA Seizes Organic Herbs and Spices from Filthy Warehouse

NPI Center reports:

U.S. Marshals seized millions of dollars worth of ingredients on May 7 2009 from American Mercantile Corporation, based in Memphis Tennessee. During an inspection of the company in March, FDA investigators discovered evidence of extensive rodent and insect infestation throughout the company's warehouse, which the company failed to correct.

American Mercantile stores and processes food ingredients, which are sold or used in the dietary supplements, food, tea and pet food manufacturing industries.
[...]
American Mercantile apparently also has links to pet and equine foods. According to a story on herbs4horses.com, American Mercantile is a parent company of Herbs for Horses, an herbal product company for the equine and pet market. American Mercantile's ability to source ingredients for equine and pet foods is what attracted Don Silver, Manager of Equine Science to sell his company to American Mercantile in 2006.
[...]
No one at Ingredients Corporation of America or Herbs for Horses was available for comment at the time of publication, but the ownership affiliation between these two companies and American Mercantile gives rise to the question about whether contaminated ingredients are in finished foods and pet products.

Based upon past recalls involving the contaminant melamine and the recent contaminated peanut product recall, we know that some ingredients are spread throughout the human and pet food market in a large scale manner. While we don't know yet how widespread the use of these seized ingredients may be, I think it's probably worth following the story to see what develops.

With Apologies to Elizabeth Barrett Browning

Oh Peanut Butter Product Recall, how do I consider thee similar to the 2007 Pet Food Recall? Let me count the ways:

1. We now know that such diverse brands as Little Debbie, Keebler, Nutri System and Kashi all use the same ingredients (at least as far as peanut butter goes, maybe more). But wait a minute here - I thought if I paid more, I was getting a higher quality product? *sounds buzzer* Sorry, thanks for playing.

2. You can check a product’s website one day and it has an announcement reassuring consumers that their foods are safe. But the next day: recall! Are we supposed to believe the company didn’t know they were using the contaminated peanut butter from the mildew plant yesterday? Come on!

3. If you ask a company why only certain lots are being recalled (when presumably the other lots contain the same ingredients, at least they say so on the label) and if they’ve switched peanut butter vendors, they can’t give out specifics - it’s "proprietary info".

4. Non-PB products that were processed on the same equipment as the recalled products now have to be recalled due to cross-contamination because apparently they don’t clean the lines between runs!

5. The Salmonella/Mildew peanut processing plant “lab shopped” until it got the “right” results on its food safety tests. Those records only have to be made available to the FDA after people start dying from their greedy scheme.

Gee, PB recall and 2007 Pet Food Recall - you guys are like twins. Let's hope there isn't a triplet happening out there right now which we will only be made aware of after people start dying.



Related:

• Science Friday discussed the sad state of affairs at the FDA as part of the show today.
• Owner who fed his dog PB crackers and then the dog died
• FDA does basically nada about Salmonella tainted pet food

Peanut Butter Products Recalled

In case you haven't heard, it seems like a long list of processed foods containing peanut butter as an ingredient (crackers, ice cream, dog treats, etc.) are being recalled due to Salmonella contamination. From the FDA:

Peanut Corporation of America (PCA), is expanding the recall of peanut butter and voluntarily recalling peanut paste made at its Blakely, Georgia facility because the products have the potential to be contaminated with Salmonella.
[...]
The recalled peanut butter and peanut paste were distributed to institutions, food service industries, and private label food companies in 24 states, the province of Saskatchewan in Canada, Korea and Haiti. The U.S. states are the following: Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Iowa, Maryland, Michigan, Minnesota, Missouri, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah and Virginia. In addition, affected product was used as an ingredient in other products that may have been distributed in other states.

None of the peanut butter being recalled is sold directly to consumers through retail stores by PCA.

PCA is not the only peanut butter manufacturer involved in this recall so you might like to take a look at all the recent FDA alerts. For now, they are saying that regular peanut butter on your grocery store shelf is not affected. As someone who eats a lot of peanut butter, I hope they are telling us the whole story.

Toxic Teddy Treats

Nothing says I Love You like a sweet teddy bear stuffy holding some delicious chocolate. Unless that's [insert scary music here] MELA-CHOCOLATE! From the FDA:

Walgreens is recalling 173 teddy bears with chocolate bars sold in stores since late September 2008. Analysis by the U.S. Food and Drug Administration found that certain samples of the chocolate provided with the teddy bears were contaminated with melamine.

I guess those samples must have contained more melamine than the FDA (now) says it's A-OK for us to eat. Gee, if only some way, somehow, the FDA could have had some kind of heads up on this whole melamine issue before it hit our food supply.

Thanks for the stuffed bear but as for the chocolate, make mine Labrador please.

Ultimate Smackdown Cage Match: FDA vs. Yellow-Bellies

Never fear: the FDA SWAT team is on da job. That's right, just when you were worried that eggs, baby formula, and other milk products were contaminated with the same toxins which killed thousands of pets in 2007, the FDA swoops in to save us all from the menace of [insert JAWS theme here] PET TURTLES:

On March 3, 2008, Strictly Reptiles Inc., a wildlife dealer in Hollywood, Fla., sold 1,000 baby yellow-bellied sliders and Mississippi map turtles to a souvenir shop in Panama City, Fla. The sale violated a Food and Drug Administration (FDA) ban on small pet turtles designed to protect the public from the disease-causing bacteria Salmonella. Turtles often carry Salmonella on their outer skin and shell surfaces, and people can get Salmonella infection by coming in contact with turtles or their habitats.

On July 14, 2008, the U.S. District Court in Fort Lauderdale convicted and sentenced Strictly Reptiles for its role in illegally selling, and offering for sale, live undersized turtles. The Florida District of FDA's law enforcement arm, the Office of Criminal Investigations (OCI), and the U.S. Fish and Wildlife Service investigated the case leading to the conviction, with help from FDA's Center for Veterinary Medicine.

OK well I guess the melamine contamination is not such a worry after all. In fact, the FDA has flip-flopped on the whole melamine safety issue. When we learned about the toxin being in pet food last year, the FDA said it had "no approved use in human or animal food in the United States" and there was no safe level of melamine in foods. I'm a layman but this made sense to me since melamine is the material they use to make things like dinnerware and the Magic Eraser. But after discovering melamine and cyanuric acid in human foods this Fall, the FDA created a safety level for the poisons, except for baby milk. Now in an Olympic medal worthy double flip-flop, the FDA has determined safe levels of melamine and cyanuric acid for baby formula. I'll have one Magic Eraser on an edible melamine plate TO GO and give me a kiddie meal of cyanuric acid on the side please.

But regarding the super-dee-duper dangerous pet turtles, the FDA really had to take a stand. Some things are too important to let slide (little turtle pun there - you're welcome). See, the FDA warns us:

Small pet turtles are of particular concern because children are more prone to handling the turtles without washing their hands afterwards, and even putting the turtles in their mouths.

OK I admit I didn't have a pet turtle as a kid. So perhaps it's not surprising to learn that I never put one in my mouth. I do remember having a mouse and surely at some point I put him in my mouth but apparently that memory has been blocked. But one thing I do recall trying is dog food. In fact, I think I tried it because all the other kids I knew had tried it and I didn't want to lose my status in the Nerd Society. Maybe you or your kid has put dog biscuits or cat food or dog kibble in their mouths too. Well I'm afraid I've got some bad news, May 2008:

A salmonella outbreak that swept 19 U.S. states in late 2006 has been a mystery, until now.

Nearly 200 consumers were sickened by what investigators believed to be tainted tomatoes, or other produce.

But now, the Centers for Disease Control says the apparent source of the 2006 salmonella outbreak was tainted dog food.

More bad news, September 2008:

[P]et food is being voluntarily recalled because of potential contamination with Salmonella serotypeSchwarzengrund.
[...]
Salmonella can cause serious infections in dogs and cats, and, if there is cross contamination caused by handling of the pet food, in people as well, especially children, the aged, and people with compromised immune systems.

Still more bad news, October 2008:

The Hartz Mountain Corporation is recalling one lot of its chicken-basted rawhide chips because of possible Salmonella contamination.

Even more-more bad news, November 2008:

Mars Petcare US is extending a recall of dry pet food after the U.S. Food and Drug Administration (FDA) reported finding Salmonella in additional samples of the company's SPECIAL KITTY Gourmet Blend cat food.

The earlier recall, issued October 27, was for cat food produced at Mars' Allenton, Pa., plant on August 11, 2008. The recall is now being extended to cover all dry pet food produced at the plant with a "best by" date between August 11, 2009 and October 3, 2009.

Holy Bad Bacteria Batman - this is starting to look like a pattern! The FDA SWAT team response to all these Salmonella pet food issues? *crickets*

But before we judge the FDA too harshly for apparently protecting big business over American citizens, let us not forget their swift and decisive take down action on the pet turtle threat. I think we'll all sleep a little better knowing that there are some safety issues that really bring the FDA out of their shells. (You're welcome, redux.)

FDA Blocks Chinese Milk Products

Finally, some action from the FDA regarding the Chinese mela-milk scandal:

The agency, in an alert posted Wednesday on its Web site, ordered the "detention without physical examination of all milk products, milk-derived ingredients and finished food products containing milk from China due to the presence of melamine and/or melamine analogs."

The agency listed dozens of products, including cereals, snack foods, cheese, ice cream, carbonated drinks, candy, puddings and pet foods as potentially contaminated with melamine, which is used in the manufacture of plastics and fertilizer.

I wonder how many people and pets have been consuming melamine tainted foods while the FDA dragged its heels. I also wonder if the practice of increasing profits by poisoning foods is isolated to the Chinese and melamine. Seems unlikely to me but since the FDA only conducts food safety testing on a tiny fraction of imports, I guess we won't find out until some other large group of people and/or pets get sick/die from eating toxic "food".

How Much Melamine is Too Much?

The Washington Post reports that the Food and Drug Administration (FDA) has decided that melamine is ok in foods in very small amounts:

American consumers first learned of the dangers of melamine when it was found last year in pet food ingredients made in China. The Chinese suppliers of the bulk ingredients had been adding the melamine, officials determined, to boost the apparent protein levels in product testing.

At that time of course, the FDA said that melamine did not belong in foods and any food found to contain melamine was considered adulterated. Now:

The FDA set 2.5 parts per million as the maximum "tolerable" amount of melamine that could be safely consumed in other foods [besides baby formula, which is the exception to the new FDA rule]. [bracketed addition=mine]

Hmm, call me unconvinced as to the safety of daily melamine consumption - in any amount. Some consumers in Thailand seem equally suspicious and question their FDA's handling of the melamine situation:

Public Health Minister Chalerm Yubamrung did little to convince consumers otherwise when, seeking to downplay the milk scandal last Wednesday, he spoke more on the health of trade relations, than of, well, health.

[...]

Minister Chalerm's position was echoed by FDA deputy secretarty-general Narangsan Peerakit, who then evaded further questions from reporters, saying that "the minister's policy is that news reports should not have a negative impact on Chinese products".

That has a familiar ring to it! Those FDAs must share the same playbook.


A newspaper in Taiwan noted that the new US FDA rule on melamine allows significantly higher amounts of the toxin than last year's ruling which came after it was discovered that some feed animals had been fed melamine tainted pet food:

In the case of the US, the FDA said on Friday on its Web site that “in food products other than infant formula, the FDA concludes that levels of melamine and melamine-related compounds below 2.5 parts per million do not raise concerns.”

But Hsieh Yen-yao, vice superintendent of the Koo Foundation Sun Yet-Sen Cancer Center, said the US FDA had set a level of 0.05ppm for pork, chicken, fish and eggs.

That restriction is stated in the FDA’s risk assessment from last May.

Again, hmm. Perhaps the FDA document being referred to is this one but in any case, there appears to be some disagreement over "safe levels" of melamine in foods. Fluid risk assessment to fit current circumstances? I don't know but I tend to agree with Congresswoman Rosa L. DeLauro (D - CT), chair of the FDA Appropriations Subcommittee:

While other countries throughout the world, including the European Union, are acting to ban melamine-contaminated products from China, the FDA has chosen to establish an acceptable level for melamine in food in an attempt to convince consumers that it is not harmful. Not only is this is an insult to consumers, but it would appear that the FDA is condoning the intentional contamination of foods.

I hope Rep. DeLauro and her subcommittee fund the FDA to advance food safety inspections, especially on imports which have proven to be very risky. Domestically, the Food Animal Residue Avoidance Databank is currently shutting down due to lack of funding. The program tested meat, eggs and dairy products for environmental contaminants, pesticides and drugs.

We are So Screwed

An article at Mother Jones titled "The Chinavore's Dilemma" gives us an overview on how the FDA allowed - and keeps allowing - tainted imports from China to enter the US. Pet food, toys, toothpaste, heparin, seafood... and the hits just keep on comin'.

"Indeed, FDA documents scrutinized by Mother Jones show that officials have
long known dangerous products were entering the country. They knew it because
some portion of the tainted, counterfeit, or mislabeled shipments were being
intercepted and tallied in monthly lists that get passed around the agency.
While the same products appear on the lists month after month, agency officials
seldom warn the public until after Americans are hurt or killed."

O snap. Read the full article. With your lights on.

Salmonella Salad and Pet Food Safety Comes Up Short

From an article at HealthNewsTrack.com regarding the FDA's progress on food safety issues:

In 2007, FDA began working in collaboration with the State Health and Agriculture departments in Virginia and Florida, several universities, and the produce industry on a multi-year Tomato Safety Initiative. As part of the initiative, FDA has led assessments of grower practices focusing on the factors believed to be associated with contamination of tomatoes with Salmonella. FDA has conducted assessments in Virginia and began assessments in Florida in April.

Sooooo - how's that going?

In other FDA news, the transcript from the blink-and-you-missed-it "all day public meeting" regarding pet food standards is available for download in pdf format. It doesn't take too long to read because you can skim over all the good ol' boy chatter and cut straight to the only voice we consumers had at the meeting: Mike Floyd from Defend Our Pets. (Take their survey on pet food safety here.) His comments are straight talk on what consumers want and need from the pet food industry. Thank goodness he was there because after he spoke, the FDA shut down this supposed all day public meeting citing lack of attendance. Well FDA, some of us actually have to work for a living and can't necessarily get an entire weekday off. So to my mind it's certainly plausible that some people were planning to attend your all day public meeting - you know, when they could get there, which may have been more than 90 minutes after the meeting started - which is when you closed the thing down. So while the FDA touts this as a community outreach activity, I would describe it as a business-as-usual-activity.

Newsflash: We're going to have to do a lot better to fix the problems in our food safety system. For humans and pets. Because the status quo ain't workin'.

He Said, She Said - FDA vs. Evanger's

Update on April 29, 2008:  Over on the Itchmo Forums, a consumer posted a response from the FDA on the back and forth between Evanger's and the FDA.

Original post:

On April 24, 2008 FDA issued a press release stating in part:

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.

Pet owners who feed Evanger's or any of the companies Evanger's cans for, would seem to have reason to be concerned.

But then -

On April 25, 2008 Evanger's responded with a release on its website, stating in part:

Contrary to a news release issued by the FDA Thursday, April 24, 2008, Evanger’s continues to make and distribute its products with FDA approval. Evanger’s is working closely with the FDA and already has addressed many of the FDA’s questions. Evanger’s expects to have the few remaining FDA queries fully satisfied shortly.

No Evanger’s product has been recalled, nor is there any indication that any Evanger’s product is under-processed, unsafe, or contaminated in any way.

And the owners, Joel and Holly Sher, made the rounds to the pet blogs, posting comments that the FDA release is "highly inaccurate".

So -

What's a pet owner to do? Believe the FDA whose track record on protecting consumers (and their pets) leaves something to be desired? Believe the owners of the pet food company who obviously would like you to buy their products? This is a dilemma pet owners should not have to face. Evanger's does not work for me so I can't influence their behavior except with my wallet. But the FDA does work for me. And I want an FDA with enough funding, qualified staff, and enforcement powers (not to mention a complete overhaul so that even the appearance of the agency's "fondness" for big business is eradicated) that can do its job right. I want an FDA that protects me and my pets and has a good record of doing so. I want an FDA that has gotten it right enough times for me to have confidence that if they say X, I can believe X.

For now, I will continue to grocery shop with caution and prepare my pets' food at home. Because the FDA I want and the FDA I have seem to be far, far apart.

FDA Sets Date for Public Meeting on Pet Foods

From the CVM Update:

The Food and Drug Administration (FDA) is announcing a public meeting to obtain input from stakeholder groups, including, but not limited to, the Association of American Feed Control Officials (AAFCO), veterinary medical associations, animal health organizations, and pet food manufacturers, on the development of standards for pet food, including ingredient standards and definitions, processing standards, and updated labeling standards. Establishment by regulation of such standards for pet food was mandated by the FDA Amendments Act of 2007 (FDAAA).

The public meeting will be held on May 13, 2008, from 8:00 am – 4:30 pm.

The public meeting will be held at The Gaithersburg Holiday Inn, 2 Montgomery Village Avenue, Gaithersburg, MD 20877.

If you wish to attend: Pre-registration is recommended although if space allows, they will accept walk-in registrations. When you pre-register, you can let them know if you wish to make a public comment at the meeting. They also have alternate methods for accepting public comments in the CVM Update.

Buried on this page:

FDA is sponsoring an additional public
meeting as part of its Animal Feed
Safety System (AFSS) initiative on
May 14, 2008, at the same location
as the May 13, 2008, FDAAA public meeting.
The AFSS is a system that FDA is
developing to minimize the risk to
animals and public health through the
use of risk-based, preventive, and
comprehensive animal feed control measures.
I'm not sure that "risk-based" and "comprehensive"
go together.
They haven't so far.

And referring to the May 13 meeting on pet foods,
FDA asks on this same page:
Should a Nutrition Facts box, similar to
the format that appears on human food
labels, replace the current Guaranteed
Analysis that currently appears on pet
food labels? If so, how could this Nutrition
Facts box be made to clearly distinguish it
from human food labeling?
We know that the pet food industry insiders
are against the idea of printing calorie
statements on pet foods.  But is FDA really
going to make it so easy for them to get out
of providing this simple information by implying
that people will confuse Dog Chow for Hot Pockets
just because of the Nutrition Facts on the label?
Dog help us...

FDA Wonders if Pet Foods Could be Made Safer

Veterinary Practice News has an article about the FDA looking into expanding the use of third party certification programs for food products, including pet foods.

"The FDA would like to know what domestic and foreign third-party programs for suppliers are in use by U.S. companies and, significantly, how do these programs ensure independence and avoid the conflicts of interest inherent in accepting fees from the very companies seeking certification."

The FDA needs the public to advise them on this? They don't already know? O yeah and that conflict of interest thing didn't seem to serve the public too well during the pet food recall of 2007 - hello AAFCO?

"It would also like to know if existing certification programs already ensure compliance with FDA requirements and, if not, how the programs would need to be modified to ensure compliance. Many of the existing programs are designed to meet foreign government requirements, which may or may not meet U.S. standards."

Just having a guess - I'll go with "may not".

"The government also wants to know what’s preventing the majority of U.S. firms from participating in existing certification programs."

Since I'm guessing, here's a few ideas -

• Because they are not legally required to do so

• Because there are no significant legal or financial consequences for companies who sell tainted pet foods (which is probably why they keep doing it)

• Because we can't pass County of Origin Labeling across the board which allows sneaky manufacturers to respond to the inquiring public with smarmy answers like "Sorry, we can't tell you where our product ingredients are sourced from and/or made - that's proprietary information."

Full article here including information on how you can submit your comments to the FDA if you are so inclined.

FDA's "Public" Meeting is MIA

From January 4, 2008:

"FDA is announcing its intention to schedule and hold a public meeting early in 2008 to obtain input from stakeholder groups, including, but not limited to, the Association of American Feed Control Officials (AAFCO), veterinary medical associations, animal health organizations, and pet food manufacturers for the development of ingredient, processing, and labeling standards to ensure the safety of pet food."

Attention Foxes! We've been mandated to make the hen house safer. Suggestions? Anyone?

"...FDA intends to hold a public meeting in the greater Rockville, MD area sometime within the first three months of 2008."

Going, going... It's March 18. Do you know where your FDA is?

"After the meeting, FDA will review all of the comments submitted to the docket..."

Right. Perfectly sensible. You wouldn't want comments from the public to be reviewed during the public meeting. That would muck the whole thing up. Better just to keep it small and sociable - friends and family only.

***

The entire FDA notice, including instructions for how the public can submit their comments (to be read after the fact) can be found in pdf format here.