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.

In late May I sent FDA the following email:

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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