FDA Warning Letter To Company That Makes American Bullie Dog Chew Products

In April, Itchmo posted about a FDA salmonella contamination alert in American Bullie Dog Chew products.

In a follow-up to their salmonella contamination, a FDA warning letter dated June 11, 2007 was sent to T.W. Enterprises, the company that makes American Bullie Dog Chew products. The letter referenced the FDA inspections that were conducted on January 18 and 23.

During these inspections, the FDA not only found salmonella in the products, but they noted that the company had other violations. The company was found to be dipping their products in bleach.

The inspection also revealed that it is a practice of your firm to allow pizzles to [redacted], then to submerge them in [redacted] of water containing [redacted] bleach for [redacted] hours. Household bleach is not approved for use in animal feeds. Firms or individuals who want to use a substance in feeds for a purpose for which the substance is either not generally recognized as safe (GRAS) or approved by the FDA as a food additive are required to first contact the FDA or file a food additive petition to establish the safety and utility of the substance for its intended use.

The warning letter gave T.W. Enterprises 15 days to correct their actions and comply with the Federal Food, Drug and Cosmetic Act.

We were completely blown away that a company would dip pet food products in bleach. We contacted the compliance officer to see if T.W. Enterprises had corrected their actions and complied with the act. We are still waiting for a response and will post it as soon as we hear from the officer.

The FDA warning letter to T.W. Enterprises:

Department of Health and Human Services

Public Health Service
Food and Drug Administration

Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421

Telephone: 425-486-8788
FAX: 425-483-4996

June 11, 2007

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 07-16

Ian W. McCauley, President
T.W. Enterprises, Inc.
7056 Portal Way, Bldg. N-2
Ferndale, Washington 98248

WARNING LETTER

Dear Mr. McCauley:

An inspection at your facility located at 7056 Portal Way, Bldg. N-2, Ferndale, Washington, was conducted by a representative of the Food and Drug Administration (FDA) on January 18 and 23, 2007. This investigation confirmed that you offered pet treats for sale as food that were adulterated within the meaning of section 402(a)(1)[21 U.S.C. 342(a)(1)] of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and its associated regulations on the Internet through links on the FDA web page at www.fda.gov.

A sample of “AMERICAN BULLIE A .B . DOG CHEW, 6″ MEDIUM,” manufactured by your facility was collected and analyzed. FDA analysis of this dog chew revealed the product to be contaminated with Salmonella muenster. Salmonella, including Salmonella muenster, is a micro-organism that is known to be pathogenic to animals and humans. Dog chews bearing or containing Salmonella pose a danger to human and animal health and are adulterated within the meaning of Section 402(a)(1) [21 U.S.C. 342(a)(1)] of the Act.

The above may not be an all-inclusive list of your violations. As a manufacturer of dog and puppy chews, it is your responsibility to assure your products are in compliance with the Act. We acknowledge your actions in recalling all sizes of your dog and puppy chews. However, you should take prompt action to investigate the source of this contamination and establish controls to prevent future violations. Further shipment of adulterated food may result in regulatory action without further notice to you. These actions include, but are not limited to, seizure and/or injunction.

The inspection also revealed that it is a practice of your firm to allow pizzles to [redacted], then to submerge them in [redacted] of water containing [redacted] bleach for [redacted] hours. Household bleach is not approved for use in animal feeds. Firms or individuals who want to use a substance in feeds for a purpose for which the substance is either not generally recognized as safe (GRAS) or approved by the FDA as a food additive are required to first contact the FDA or file a food additive petition to establish the safety and utility of the substance for its intended use. The requirements for a food additive petition are specified in Title 21, Code of Federal Regulations, part 571 (21 CFR 571). A copy of the pertinent section of the Code is attached for your information

Please notify this office in writing, within fifteen (15) working days of receiving this letter of the steps you have taken to assure your products are in compliance with the Act. If corrective action cannot be accomplished in fifteen (15) working days, state the reason for the delay and the date by which corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.

Your response should be directed to Lisa M. Elrand, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington, 98021-4421.

If you have any questions regarding this letter, you may call Compliance Officer Elrand at (425) 483-4913.

Sincerely,

/S/

Charles M . Breen
District Director

(Thanks Marc)

34 Responses to “FDA Warning Letter To Company That Makes American Bullie Dog Chew Products”

  1. pat says:

    after what we’ve been through during the mass poisoning and subsequent pet food recalls, nothing these producers do would shock me anymore. what i find most irritating is that these firms are allowed simply to carry on with only the occasional warning letter. i would be much happier if an agency had the ability and the chutzpah to march into a plant like this, drag the upper management out of the building in handcuffs, remove the workers and chain the doors shut. And I wouldn’t be entirely unhappy if after that, they set the bloody plant aflame.

  2. mittens says:

    oh pat come now that would be enforcement and we wouldn’t want to force companies to not kill pets…..the free market ecomony apparently means free wheeling colorful pet murder.

  3. Linda says:

    Hit them in the pocketbook, all of them are worthless money hungry scum. I’m more than discusted, but at least now I know what I’m feeding my pet since I make it myself. Commercial dog food, cat food is poison, plain and simple. The end. Put them out of business.

  4. pam says:

    they kill those in charge in china.

  5. Tom Paine says:

    When, oh when, will the prosecutors announce the filings of criminal charges against individual and corporate MASS POISONERS? It is as simple as that. Multiple counts for multiple individuals.

    I didn’t watch Law & Order all those years for nothing!

  6. Katie says:

    It doesn’t surprise me either after everything that has happened the last few months. Only goes to show the producers don’t care, I don’t believe they could be that ignorant. They must have figured well, bleach kills bacteria, with no concern about what bleach could do to pets.

    When, oh when will our government agencies step up and put some muscle on companies and foreign countries in order to protect food safety.

    Katie

  7. Geff says:

    It took the FDA 6 months to deal with this???? I know I shouldn’t be surprised, but……….. ARRRRRRGHHHHHH!

  8. dog collar addict says:

    i’ve never bought that product before, but now i don’t think that i ever will. dipping dog treats in bleach is not cool!!

  9. Michelle says:

    Dipping dog treats in bleach is a very old practice, and is why rawhide chews are not recommended unless they specifically state “unbleached”. In fact if the rawhides come from a certain foreign country–gee, guess which one!–you can assume that they are bleached. I think the salmonella was the motivator for the FDA out of fear of human health concerns moreso than the bleach. I don’t think the FDA gives a rats *** about pet concerns but just saw a PR opportunity to give a wrist slapping

  10. Geff says:

    I can’t find any cat toys made anywhere but China.

  11. NYINPA says:

    Funny someone mentioned the tainted food coming from China…Did anyone see the headlines July 10, 2007?
    “China executed the former head of its food and drug watchdog…”
    You can read the whole story on any of the major new web sites.
    Maybe they will start to abide by the rules if it’s hurting their economy!
    But in the mean time, I strongly urge you to make your own homemade
    food and treats.

  12. birgit says:

    Why would anyone think our government agengies care about the taxpayer/consumers interests?
    Have they not proven beyond any shadow of a doubt that Pig Busines’s welfare is their only concern.My furkids food is homemade , with an occasional premium brand .They get nothing from China, not even a fuzzy chew toy..(Communist China hates us- it shows)Do not care who or what they do to show to execute, it is all suspect. “In the old days”, when we did not trust communist Russia.. we were not as naive to buy most of our food/stuff from a country that hated us.Common sense is gone, greed rules.

  13. Shure Pets Rep says:

    I think we will see this kinda of stuff going on till the consumers quit buying all there products.I go into gro stores and PetSmart and see people still buying products with glutens and rice proteins evan from the Companys that was killing pets. I dont know if they have not heard or just dont care about there pets health.

  14. Anonymous says:

    Katie said:

    When, oh when will our government agencies step up and put some muscle on companies and foreign countries in order to protect food safety.

    The answer is never. They havent done anything so far.

    Pat said:

    march into a plant like this, drag the upper management out of the building in handcuffs, remove the workers and chain the doors shut. And I wouldn’t be entirely unhappy if after that, they set the bloody plant aflame.

    I vote for Pat to run the FDA!

  15. Health Hazard Alert for American Bullie Chews | Cool Dog Hall of Fame says:

    […] Hazard Alert for American Bullie Chews There is more to this story than the FDA's alert. Itchmo.com is reporting that an FDA warning letter dated June 11, 2007, sent to T.W. Enterprises, the company […]

  16. Flamin says:

    I’m sure soon the FDA/Codex will have total control & power with homeland security laws to detain any and all items, including water, in our lifetime! The Plan is to allow these incidents to happen. The FDA’s lack of or slow response to these issues is nothing new. I wouldn’t be surprised at all, when they allow something far worst than salmonella to pass inspectors. People will demand more security to make them feel safe. They will go from one extreme to the next, and the pendulum with swing the other way. We maybe safe from contaminated foods/products, however the store shelves will be bare. Making your own pet food, or food for yourselves, with what ingredients?

    bioterrorism
    http://www.counterterrorismtra...../food.html
    biological, chemical or radiological agents against any component of agriculture.
    http://wccc.edu/homeland/

  17. Barbara in Phoenix says:

    I will not buy anything made in China or ANY Communist country–remember when Kruschev (sp?) said “We will bury you!”? I only buy KumpiKat food now, made in America in Colorado from human grade meat. I got into an argument with my vet at my cat’s (the one that was on Hills Prescription diet)check-up last month–she said “None of the food Hills recalled was poisoned”! I told her to read Itchmo to get her information correct, instead of the Hills reps.

  18. anonymous says:

    Why didn’t FDA issue a 24 hour response by this firm instead of 15 days? If it’s a detriment, it needs to cease immediately - not at one’s convenience, otherwise it’s perpetuating the detriment. If Joe blow citizen gets an anonymous complaint filed against him for some benign misdemeanor, they will arrest without asking questions. There is something gone terribly wrong with the whole picture. Perhaps animal testing is alive and doing well in more ways than one: not just for new drugs but for a public reaction monitor. Guage the masses and how long it takes for anger to subside.

  19. Peace2us says:

    The FDA is worthless. What good is a warning letter? Pat has it exactly right. The plant should be shut down immediately until it fixes the violations. My local health department can walk in a shut down a restaurant that has health violations. Why can’t the FDA? BTW, we are making a difference, sales of holistic foods are up and more folks are feeding their animals homemade foods. I’ve personally gotten about 30 people (including the entire K-9 unit at my police agency) to switch to holistic foods. Keep talking everyone, we can make a difference!

  20. Flamin says:

    That’s great you use organic/holistic foods Peace2us. However google organic/holistic foods. Even human organic/holistic food are not 100% safe, and the FDA have made that quite clear with their lack of inspections! Even the whole foods market has had their share of GM foods seeking into the market. The FDA, USGA, Codex has been slack in inspections for a reason, it’s the bigger picture agenda. Control over the peoples food & water supplies, gives excellent power over the people. People would sell their soul in the food rationing lines, for a “FDA stamped SAFE” loaf of bread & a bottle of water……
    Organic/holistic or not, no longer will be the issue…..

    But If, People really believe giving the FDA, Codex, Homeland security more power & control is going to make them safe, then I’ve got a bridge in Brooklyn to sell you! :)

  21. Flamin says:

    *USDA

  22. Elaine says:

    Remember also that CHINA provides “organic” produce to U.S. grocery stores, also, a lot of the certified organic produce in my supermarket is from Mexico! (How can we trust in certified organic from other countries?)

    The very same pet food companies that had poisoned pet food are now trying to sell new and improved, holistic, organic, Yada Yada, Yada! Can you trust that? I can’t.

    We need to insist our food is labeled as to country of origin, and only buy from countries we feel we can trust. I have a very short list!

  23. Barbara Falk says:

    A Company by the name of Aron Pet Foods is doing everything in it’s power to discredit American Bullie Chews so that the public will not buy them. Aron is a Canadian company that has had recalls and is trying to get back into the US market with the same product. that may well by why this letter was leaked to this site. It certainly has not been in any of the newspapers. Our family and friends have been giving the product to our pets since the conception of the company. NO ILLNESS HAS BEFALLEN ANY OF OUR ANIMALS! I do know that during the processing that bleach is used to wash down the cutting/stainless steel and floor area. FDA did not make any mention of the minute amount of bleach used in cleaning of the raw product until after they got bit in the butt for all the dog and cat food recalls. Up to that point all was OK per the FDA……..does any of this info cause any of you pet owners to stop and think a bit? I certainly hope so. This is a small US company that is trying it’s best to produce a quality product and follow the FDA’s rules (which even they don’t seem to be sure of on a day to day basis). Our family and friends, which give the American Bullies to our pets, are pet owners who truly consider our pets part of our family and would never give our pets a low quality food or treat. Think people!

  24. Shari says:

    Does anyone have any information about RED BARN brand dog chews, particularly their Bully Stick? It’s a dried beef tendon product.

    I just bought a CASE (over $300.00) and now I’m afraid to give my dog any of them.

    Thanks in advance!

  25. mss says:

    To Barbara Falk:

    The letter is available to the public on the website of the FDA itself. It is publicly available information. No “leaking” is needed.

    Here’s a link to that letter on the FDA website so you will believe me.

    http://www.fda.gov/foi/warning_letters/s6402c.htm

  26. pat says:

    Barbara, all FDA warnings are in the public domain. if things are bad enough at this company’s plant to elicit a letter from the incredibly lax fda, i shudder to think what goes on there. you are at liberty to defend this product if you wish, but there’s a world of difference between cleaning processing machinery and actually soaking a product that will be ingested in a bleaching solution. the idea that the fda warning is the result of some kind of conspiracy perpetrated by a canadian company doesn’t seem very plausible to me.

  27. Jean says:

    Shari - we have given the Red Barn Bully sticks to our Corgis for several years with no ill effects. They are made from pizzles like the Bullie Chews. I did some Google searching on recalls and could not find any.

  28. Fivecatsandadog says:

    My question is.. why? What on earth would lead them to soak it in bleach? I know the melamine/cyanuric acid was used to falsely beef up the protein content in the tainted gluten, but I cannot fathom what bleach would accomplish here. Can someone clue me in? Thx

  29. Dorothy says:

    Fivecatsandadog,

    Yes, so it looks good to the pet owner!!! Miserables. we must just give people food and make our own dog biscuits. See Dr. Pitcaiarn’s book on natural pet care for dogs and cats. I used to give my dog raw carrots. try it.

  30. Jean says:

    Regarding the Red Barn Bully sticks Shari mentioned: I emailed Red Barn with concerns and referenced the letter sent to T.W. Enterprises by the FDA. I asked about both cow ears and bully sticks. Here is a reply by a customer service rep named Sue:

    “Jean,

    Thank you for your interest in Redbarn Pet Products. We obtain the raw
    material for our cow ears and bully sticks from North America and South
    America.

    Our cow ears go through a cleaning process that includes cleaning the ears
    with a food grade hydrogen peroxide solution that evaporates during the
    processing and drying steps. This is the same solution that is used to clean
    the inside of milk cartons. We do not use this solution on our bully sticks.

    All of our incoming materials are tested in our Long Beach plant for aerobic
    plate counts, anaerobic plate counts, coliform counts and the
    salmonella-ELFA test prior to release. We also audit our supplier’s
    factories and salmonella testing is done by the plants prior to shipment. In
    addition, all import shipments are subject to FDA/USDA sampling and testing.

    Please let me know if I can be of further assistance.”

  31. pat says:

    Fivecatsandadog, bleach kills bacteria.

  32. Barbara says:

    I truly wish pet owners would be more aware of the politics between FDA and producers of pet products. Pat, you seem to think my previous statement regarding the Canadian company was not plausible. Wish I lived in your wonderland. Dealing with the FDA when you are a small company is no picnic either. You are a nice easy target that they know does not have the funds to fight back. American Bullies is a one man operation 75% of the time and this one man is trying his best to follow all the rules and regulations (which seem to change at whim), provide a quality product for the client and stay in business. The wording regarding the use of bleach in processing is, how should I say this…………..distorted.
    I can only guess that no one really wants to know the truth.

  33. thedogpressreporter says:

    Ever swallow swimming pool water? Then you have ingested chlorine bleach and lived to tell the tale. Bleach KILLS salmonella…and according to the word of a now deceased dog man with more years of hands on experience than I have even been alive - it kills PARVO in the intestinal tract of infected dogs when given orally in a VERY dilute dose. Now I’m not advocating this non FDA approved treatment…BUT one desperate person I know with a dying puppy (and another already dead of parvo) tried this and SWEARS it saved their dog’s life! If I ever had a reason to be this desperate myself, I would follow it up with a healthy dose of lactobacillus culture to prime the sanitized digestive tract…
    The difference between laundry bleach and pool bleach is the addition of other chemicals such as sodium, phosphorus, etc. and this is dangerous business!!! But Dangerous versus dead is a person decision that I wish on no dog. Anecdotes aside, my dogs have eaten both bleached and non bleached chews and suffered no ill effects. I have lost 9 out of 12 puppies in a litter to salmonella and I can assure you that it was horrifying, graphic, and as severe as any case of parvo I have ever seen. (The diarrhea is bloody just like parvo but GREASY - that’s how you can tell it’s salmonella…) The elderly and very young, or those with compromised immune systems are more susceptible to salmonella, my adult dogs drank the water from the turtle pond frequently but never became the least bit ill. Looking back on what I didn’t know 12 years ago, I would have given all the puppies activated charcoal, available as a gas remedy in the local pharmacy. It has kept me out the ER numerous times from food poisoning, and I give it to my dogs if I even THINK they have ingested anything questionable! (They give it to drug overdose patients in the hospital.)
    And the current pet food contamination is NOTHING compared to the possible intentional contamination by euthanasia drugs in unregulated rendering as a suspiciously coincidental byproduct of eliminating horse slaughter for human consumption. Thank HSUS and their goal of abolishing ALL ANIMAL USE for financing this…

  34. Hayley says:

    i work for a vet and know the mamer ian of american bullie chews, i assure they’re safem they are being radiated, NOT DIPPED IN BLEACH, they are my dogs favorite chew in the world this saddens me that they’re being blasted, i love this product and it works wonderfully for my dogs, i don’t let them have a whole large it takes them like 4 days of vigorous chewing and they are so happy when they have them…. they’re trully an amazing treat in my mind


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