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Response to FDA Pet Food Human Grade Ingredients

FDA has (finally) confirmed what we already knew, they have officially dropped their pet food human grade ingredient verification process. Here is FDA’s response to us, and my response back to FDA.

FDA has (finally) confirmed what we already knew, they have officially dropped their pet food human grade ingredient verification process. Here is FDA’s response to us, and my response back to FDA.

In late May I sent FDA the following email:

I have learned some concerning news – was told that FDA is no longer doing the verification process of human grade ingredients in pet food. No more Letter of No Objection for human grade claims. I was told this was now left up to the states, and they are only requiring minimal verification (one person told me just an inspection report).

So first, I would like to confirm this is correct. If it is, I see a field day of human grade claims coming from all manufacturers and consumers will be hurt in the process.

In March of this year, FDA told our consumer association “no” in providing a Letter of No Objection for our 3rd party inspection program to verify human grade ingredients. We were told (Charlotte Conway) that our Standard did not meet the human grade good manufacturing requirements. And now, just two months later, (if my information is accurate) FDA is backing completely away from verifying human grade claim on pet foods.

Needless to say, I am very concerned for pet food consumers. Pet food labels right now are completely out of control with human grade claims via label images. And it seems that the words ‘human grade’ are soon to follow.

Can you share if I have correct information and if so, please tell me why FDA is no longer concerned about a human grade claim on pet food (possibly pet food that does not meet human food requirements).

Susan Thixton

And late yesterday, I received the following response from FDA…

Dear Ms. Thixton:

In your May 26, 2015 email to Dr. Dan McChesney, copied below, you stated that you were told that FDA is no longer doing the verification process for human grade ingredients in pet food.  The information you received is correct.  In the past, the Division of Animal Feeds in the Food and Drug Administration’s Center for Veterinary Medicine (FDA, CVM) has routinely conducted a premarket review of materials used to substantiate a human grade claim to determine if the claim is truthful and not misleading.  However, there is no legal requirement for FDA’s preapproval of human grade claims on pet food products and CVM believes that the standard for truthfulness of a human grade claim has been established.  We have communicated this information to the state feed control officials who are able to determine the acceptability of the information to substantiate the human grade claim consistent with FDA’s past reviews.  Our action is consistent with CVM’s effort to focus our resources on statutorily required work.

For a human grade claim, like any label claim, a manufacturer or distributer should have information to substantiate that the claim is truthful and not misleading.  We believe claims that a product is made with human grade ingredients represent the product as a whole to be fit for human consumption.  CVM believes that ingredients that are fit for human consumption become unfit for human consumption when combined with other ingredients that are unfit for human consumption, or when the ingredients or resulting products are not stored, handled, processed, or transported in ways that are consistent and compliant with regulations for good manufacturing practices (GMPs) for human foods as specified in 21 CFR 110.  It is possible that an animal food could be produced in a facility licensed to produce human foods under GMPs for human foods, entirely from ingredients fit for human consumption, and be stored, handled, processed and transported by means suitable for maintaining the product as being fit for human consumption.  If these conditions are met, the manufacturer can represent the product to be fit for human consumption or “human grade” even if it is intended to be fed to an animal.  If the product as a whole is not fit for human consumption, then claiming it to be “human grade” or made with “human grade ingredients” may be false and misleading and misbrands the product under the Federal Food, Drug, and Cosmetic Act.

In order to substantiate that a human grade claim is truthful and not misleading, a manufacturer or distributor should have information from each of the individual ingredient suppliers that verifies the individual ingredients supplied to the manufacturer are fit for human consumption.  The manufacturer or distributor should also maintain evidence that the finished product is manufactured under current GMPs for human food in a facility licensed to produce human food.  Such evidence may include, but not be limited to, facility licenses or permits for operation of edible food manufacturing facilities or results of most recent inspections issued by local or state public health authorities.  In essence, the manufacturer or distributor should be able to unequivocally demonstrate that if a human food label were placed on the product that it would be acceptable to human food authorities to sell the product for human consumption. 

A state may request information to substantiate any claim on a pet food label during the registration process, including a human grade claim.  Whether or not information to substantiate a claim is requested by a regulatory official before a product is marketed, firms are required to have information to substantiate all label claims.

In our March 30, 2015 email regarding your association’s Buy Aware Pet Product Standard (the Standard), we provided information on the proposed Standard noting several reasons it was in conflict with how we consider human grade claims. 

Please contact me if you have any questions regarding the information in this e-mail. 

Sincerely,

Charlotte E. Conway, MS
FDA Center for Veterinary Medicine

Several things in this FDA response raised concerning questions. My response to FDA…

Hi Charlotte –

Yes, I do have some questions.

As FDA is aware, each state has different pet food regulations. Not every state is a member of AAFCO. Some states laws are antiquated – not updating their pet food laws in decades (such as South Carolina – not updated since the 1970’s) and Nevada as example doesn’t have any pet food safety regulations. My concern as a pet food consumer advocate is what is going to happen to human grade claims in states with outdated regulations or no regulations?

Another concern, is misleading images on pet food labels. Many, if not most, pet food labels include images of human grade meats and vegetables on their labels. Many show images of grilled meats and roasted meats. These pet foods show roasted and grilled meats to ‘tell’ the consumer this pet food is made with the same quality of food they eat (grilled and roasted meats). These images are ‘saying’ human grade without words. These images are a direct violation of AAFCO PF2 (c) “A vignette, graphic, or pictorial representation on a pet food or specialty pet food label shall not misrepresent the contents of the package.” And a direct violation of the Food, Drug, and Cosmetic Act 343. Misbranded food “If its labeling is false or misleading in any particular”. There is no way around it – per state and federal law – these pet food images of human grade ingredients are misleading, inaccurate, and a false representation to the contents of the pet food.

It is concerning that FDA holds the words human grade in the highest standard, but cares nothing about the human grade food images on pet food labels – which probably speak louder to consumers than the words ‘human grade’. At the San Antonio AAFCO meeting these images were lightly discussed, and FDA’s Dr. William Burkholder stated the images are considered “freedom of speech”. Though not specifically stated by Dr. Burkholder, I assume it is FDA’s position that images on pet food labels are considered freedom of speech ignoring federal and state labeling laws. How can FDA have such strong feelings to what is required of a pet food to state ‘human grade ingredients’ in words on the label yet ignore the FD&C Act misbranded food statute and interpret human grade food images as ‘freedom of speech’?

I agree with FDA that human grade claims should be truthful and accurate, however I do not understand how/why FDA allows hundreds of other labels to ‘say’ human grade through images.

Your recent response to me stated that FDA’s action to drop the human grade ingredient verification process “is consistent with CVM’s effort to focus our resources on statutorily required work.” And yes, I have concern with this statement too. I assume ‘statutorily required work’ is in reference to the Food Safety Modernization Act. But this statement is neglecting the Food Drug and Cosmetic Act which define ‘food’ as anything consumed by humans and animals and define an adulterated ‘food’ as (in part) if it contains any part of a diseased animal or an animal which has died other than by slaughter. As you are aware, FDA Compliance policies allow pet food/animal feed to source meats from diseased animals and/or animals that have died other than by slaughter. This meat (?) material is considered “fit for animal consumption” per FDA. And there is no disclosure to the consumer if this quality/lack of quality ingredient was used in the pet food. The FD&C Act is FDA/CVM ‘statutorily required work’. How can FDA ignore this statutorily required work and allow the pet food industry to source meats from diseased animals or animals that have died other than by slaughter? And worse yet, how can no consumer be told on the pet food/animal feed label which quality of ingredient pet food they are buying?

Pet food consumers want to know and deserve to know what they are buying. I ask FDA, is the agency going to provide consumers with truthful and accurate pet food labels or is the agency going to protect the industry stakeholders that utilize illegal ingredients without disclosure to pet food consumers? There has to be a middle ground. If the agency is going to continue to allow pet food to utilize illegal food ingredients (per FD&C Act), a warning statement on the label should be required. Again – pet food consumers want to and deserve to know what they are buying. I am asking the agency to take into consideration the consumer perspective – we want to know.

Susan Thixton

 

Should FDA respond, it will be posted.

 

Wishing you and your pet(s) the best,

Susan Thixton
Pet Food Safety Advocate
Author Buyer Beware, Co-Author Dinner PAWsible
TruthaboutPetFood.com
Association for Truth in Pet Food

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27 Comments

27 Comments

  1. susan

    June 23, 2015 at 1:27 pm

    Regulating us all into oblivion.

  2. Ruth Thomson

    June 23, 2015 at 1:34 pm

    Dear Susan,

    You are absolutely amazing & seemingly tireless in fighting for our furry children’s health & well being in regards to what we feed them.

    We have totally changed what we feed our rescue pit bull, Miss Kitty, specifically because of your efforts & the information you provided us!! She is so much healthier & no more stomach upsets or digestive problems any more!! I just wanted to thank you so much for all the countless hours upon hours of research you have done for us.

    My heart goes out to those who have lost their beloved ones, because of the greedy pet “food” companies who could care less what happens to them. You care & we thank you from the bottom of our hearts!!! Our adopted furry “daughter” means everything to us & our family. From China jerky treats to the right dog food, you have changed Miss Kitty’s diet & she is alive & now healthy, all thanks to you!

    Sorry this is so long, just wanted you to know you have made a huge difference in our dogs’ life & ours. Many thanks & cheers, for all you have done & continue to do on our behalf.

    With respect & appreciation & thanks,
    Ruth & Jim & Miss Kitty in Rio Verde, AZ

    • Susan Thixton

      June 23, 2015 at 1:36 pm

      Thank you Ruth – and give Miss Kitty a hug from me.

  3. e dbarber

    June 23, 2015 at 1:37 pm

    I would love to serve lunch at the FDA for a month or so. See if they appreciate “human grade ingredients.”

  4. Sally Roberts

    June 23, 2015 at 2:05 pm

    Very well said !!

  5. Richard Stone

    June 23, 2015 at 2:35 pm

    The American government was suppose to be by the people, for the people. I guess it now and has been for a long time for the politicians, by the politicians. What a shame. We need the government protection for our animals and they turn their backs to us. Just remember when voting

    • cathy

      June 24, 2015 at 2:24 pm

      we have the government the majority elected. pretty disgusting if you ask me.

  6. J King

    June 23, 2015 at 3:15 pm

    Thank heaven you’re there for us Susan! We’re all so busy, there’s no way any ordinary consumer could keep on top of this.

    This whole abdication of the FDA from the human grade verification process speaks volumes to their paying only lip service to protecting consumers on behalf of pets. We all know labels are one size fits all, so no matter how diligent a good pet food manufacturer (assuming there is such a beast) is, how can it hope to simultaneously fulfill the criteria of up to 50 states? Optimistically we could say that means the food must conform to the highest standard of them all, but then any manufacturer could simply not market to that particular state, resulting in pressure on that state having to dilute its requirements.

    It’s so blatant that the FDA is working with the pet food industry to stack the deck in favor of manufacturers of crap food. And with the FDA now prioritizing its scrutiny on raw foods (because raw foods simply cannot be done by the likes of mainstream crap pet food) they — FDAAFCO (not a typo) — intend to make it very difficult for raw pet food companies to continue to do business.

  7. Rose Studdard

    June 23, 2015 at 3:42 pm

    On behalf of my 4 legged fur babies; Amos, Andy, Ginger, Lucky, Nara, and Tinkerbelle, THANK YOU from the bottom of our hearts. Because of all your efforts and educating me about pet food ingredients they have lived longer than they would have other wise. We are very grateful to you and you will always have my support. Rose

  8. Susan Thixton

    June 23, 2015 at 3:46 pm

    All of you are why I continue this fight with FDA and AAFCO. Thank you to everyone for your kind words and your support!

  9. Heather

    June 23, 2015 at 4:34 pm

    On behalf of my beautiful puppy Ellie, thank you Susan for standing up for our fur babies!

  10. Mimi

    June 23, 2015 at 6:28 pm

    Good work Susan and so much appreciated! Keep it up, many have your back!

  11. Cheryl Mallon-Bond

    June 23, 2015 at 8:42 pm

    Dear Susan,

    Much thanks for all you do! It is mind boggling the burecratic nightmare that pet food consumers have to sort through to get to the truth!, thank you for your tenacity of getting to the bottom of it all & continuing to take apart & make sense of all the state, FDA & AAFCO regulations.
    It is beyond a joke that they are saying, it is a freedom of speech situation, when it comes to pet “feed”, being able to advertise on their labels through pictures, & I am so glad you called them out on this issue! If ALL petfood consmer’s were polled & asked the question, ” what do these pictures represent to you”, (without being educated on the issue), as you have now done for us all; the overwhelming majority would say, “it conveys human grade roasted/baked meats & vegetables.” There is absolutely no question, that that is what would be the answer; not dead, diseased, euthanized protein sources, or moldy rotten fruits & vegetables. The lies have to STOP!!! & the FDA is completely trying to bury you, & us all in the rhetoric. It is completely maddening!. I seriously do not know how you are able to continue to do what you do! I am supposing it is equal parts of, being mad as hell!, of what crap we are all being sold!, anger & sadness over our innocent beloved fur-babies suffering all they have had to & continue to, & part wanting to expose the lies & corruption of the regulatory agencies that continue to protect big corporations, at the expense of the consumer & our beloved pets. Keep on keeping on Susan, because you are our only hope for things to change. As an aside to all fellow pet guardians, we must ALL be diligent in spreading this TRUTH to as many people as possible!, it is the only way to bring forth real change!!!!

  12. Laura U

    June 23, 2015 at 8:47 pm

    This is a huge concern, I agree. We need regulations that protect the consumer and therefore their animals. If any company can “say” with their labeling that food is human grade (words or photos), then many will do so even if it isn’t true. Look at the court battles that are already in progress and a company admitting they lied about food contents. It will be only the beginning of a messy and scary situation. Realistically, how many consumers are going to go through getting “proof” from a company that may or may not be honest anyway?

    Laura

  13. Cindy F

    June 24, 2015 at 12:40 am

    I am so very grateful for your hard work for our pets. Thank you!!

  14. Renee Kraft

    June 24, 2015 at 1:22 am

    Susan you are a godsend to pet parents. Thank you for all the time and effort you put in on our behalf. Thank you from my beloved dog Rosco as well as from me.

  15. Samantha Cuellar

    June 24, 2015 at 1:23 am

    Because of pet consumer advocates, such as yourself, Susan Thixton, I now know that I cannot trust anybody that mass produces dog kibble, wet food and treats, not knowing what the REAL ingredients are in their food; and also finding out that diseased meat from animals that died from other than slaughter are in their food, I will no longer buy any kind of dog food and treats that I don’t make myself. And if the FDA doesn’t care what goes into the manufactured pet food, I am going to let as many people as I can know what I now know.

    Now that Kobie has a liver disease and my Suzie Q has heart disease, they will spend the rest of their lives eating quality food that’s actually good for them, and food I know what is in it.

  16. Terri Janson

    June 24, 2015 at 9:32 am

    Susan, I too want to give my Thanks for all your tireless work that you do for our furkids. I appreciate all the information you have given to us!!! I have learned so much from you and continue to do so. Thank you Thank you Thank you! 🙂

    • Samantha Cuellar

      June 24, 2015 at 1:54 pm

      Very well put, Terri Janson, and feel exactly the same. 😀

  17. Tracey

    June 24, 2015 at 4:44 pm

    What good is the FDA? They are useless. This is yet another example of a government agency that does nothing. The FDA is too friendly to big pet food and probably receives kick backs from big pet food to look the other way. Anyone who loves their pets should not buy any pet food. The best thing we can do is make the food ourselves. I know that is not an option for most people, but this is the only way to know exactly what out pets are eating. With all of the vile stuff in big pet food, more animals will suffer. Those Purina employees that claim to feed their own pets Beneful are either stupid or they have been pressured by Purina to lie. Either way it is wrong. No pet should have to eat food that contains vile ingredients such as Beneful and the countless other big pet food brands.

    • Samantha Cuellar

      June 26, 2015 at 12:56 am

      I agree with everything you have written, Tracey. I, too, have decided to feed my dogs what I eat. I just don’t add salt or anything when I cook it for them. Whatever I eat, they eat. I will no longer be buying manufactured dog food or treats for my dogs. And I bet alot of others will follow soon. To hell with the FDA!!

      • Cheryl Mallon-Bond

        June 26, 2015 at 2:15 pm

        Although it is great you are home cooking for your pets, you must realize, that dogs & cats need specific supplements that are integral to their health that are different from our needs. Please take that into consideration when feeding your pets.

        • Samantha Cuellar

          June 27, 2015 at 3:35 am

          Yes, I am aware of the vitamin supplements they need to have. I am currently researching which are best for both. Can you recommend some for me, Cheryl?

  18. Kelly

    June 24, 2015 at 7:04 pm

    Does this mean that premade raw pet food that has ground bone in it is now considered “not for human consumption” even if the animals used in processing are fit for human consumption?

  19. foodguy

    June 25, 2015 at 5:28 pm

    Clearly, they do not care.

  20. Kelley

    June 26, 2015 at 6:23 pm

    I was confused by the statement “Dr. William Burkholder stated the images are considered ‘freedom of speech’”. Freedom of speech is the right to express and exercise opinion (personal interpretation). What he probably meant to say was “freedom of expression” which can be stretched to include “artistic license” such how ingredients are imaged on a package.

    While ‘beef” has to be labeled as beef and not red meat, apparently HOW beef is represented is open to interpretation. In raw form would include a steer, hung meat on a hook, ground up or in chunks. In that form it “might” be human edible but only if cooked first. So maybe it was thought that a “grilled steak” conveyed beef as a more logical (ready to eat) ingredient. As would a chicken drumstick (versus a live chicken) be a poultry ingredient.

    Although we know the truth about PF, consumers don’t expect a food image on a package to take on any grotesque appearances (as it would be in its truly rendered form). Any picture of spoiled, diseased, tainted ingredients would hardly be a good fit next to other groceries on a shelf. So for practical reasons the consumer is naturally misled about HOW those ingredients exist PRIOR TO FINISHED PROCESSING. My bag of Merricks shows a butcher’s cut of leg of lamb including the bone. It’s neat and tidy but I don’t think it’s cooked. However “bone” also isn’t part of the labeled ingredients either! Does the picture mean all lamb ingredients are raw before processing? Or could the ingredients be a combination of raw or once cooked (like restaurant scraps and other pre processed food)?

    Maybe we should be asking so what is in PF that makes it NON human edible? Let’s call out those ingredients as the ones NOT being labeled, PERIOD!

    Now I realize that some products purposefully convey “human edible” when probably the exact opposite is true. No dog needs to eat food colored essence of vegetable rounded tidbits. So the nitty-gritty here would be to ask …… does the picture of the “grilled steak” mean that all the protein in the bag is exactly that, or are those protein ingredients a combination of pre-cooked grilled meat and other meat? And does the arrangement of food (clean, fresh, whole, cooked) mean the food is absolutely human edible or that it “could” be depending upon the supply-batching? What percentage of vegetables are “whole” enough for valued nutrition, as opposed to the pulverized essence of rotting carrot peels?

    Once again …. all this ingredient CONFUSION (and deliberate misrepresentation) goes back to the consumers demanding that PF products be defined as Pet Feed (inedible, toxic, waste) or Pet FOOD (human edible). While we ask manufacturers to substantiate their advertising pictures, and their “Made in the USA” claims, and sourcing originations, we need to sign the Whitehouse.gov petition, but also to ask a friend to sign, and keep this chain going! Reaching 5,000 signatures would be a colossal achievement. But we can only do this IF the discussion continues!!!! Click here: https://petitions.whitehouse.gov/petition/require-pet-food-manufacturers-disclose-quality-ingredients

  21. No Time to Waste! (Reminder!)

    June 27, 2015 at 1:09 pm

    Please circulate the Whitehouse.gov petition: 100,000 signatures are required by July 5, 2015. Click here – https://petitions.whitehouse.gov//petition/require-pet-food-manufacturers-disclose-quality-ingredients

    Should Pet Food manufacturers be required to disclose quality of ingredients?

    PF can be made from real food ingredients just like what you’d purchase in the grocery or it can be made from an inferior quality of ingredients known in the PF Industry as feed grade, pet grade, or inedible ingredients. The trouble is the consumer can’t tell the difference between food or feed grade. Yes, inedible ingredients are allowed in PF by the FDA! Including expired retail MEAT that isn’t even stripped of its packaging! Per FDA Compliance Policies MEAT is sourced from diseased, dead, or dying animals. Chemical or pesticide contaminated vegetables and fruits, and mycotoxin ridden grains, are used.

    If you agree that PF consumers deserve to know the difference before they buy, then the FDA must require the quality of ingredients to be labeled as feed or food grade.

    As of June 27 there are only 8 more days to sign the Whitehouse.gov petition and reach (at least) 5,000 signatures. We are at 3,400 today. Please circulate this reminder asking even more people to pass it forward! Thank you.

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