The FDA Betrayed Us
In June 2017 multiple consumer advocates met with FDA. We agreed to multiple things (witnessed by 5 individuals). We abided by every detail of the agreement, FDA did not.
Dr. Karen Becker, an attorney friend and myself went to Washington DC in June (2017) for a meeting with FDA. Also participating in the meeting – via a conference call line – was Nikki and Guy Mael (the owners of the pug that died from consuming Evanger’s Pet Food). In attendance from FDA included Dr. Dan McChesney (Director CVM Office of Surveillance and Compliance) and Charlotte Conway (there were others in attendance from FDA but they are not pertinent to this post). That meeting started with Nikki telling the story of her dog’s death from pet food. FDA became extremely uncomfortable with that discussion – and asked us what we wanted…why were we here?
We discussed with FDA the following (brief version):
We asked FDA for labeling clarification of pet foods. Those that meet the legal requirements of food to be termed food. Those that do not meet the legal requirements of food be termed feed. FDA specifically stated to us this would be possible. We asked about a verification program for raw pet foods that don’t quite meet the legal requirements of human grade. FDA specifically stated to us this too would be possible. We then moved to discussion of time frame to implement the above. FDA explained the fastest route for the feed/food labeling and verification approval would be through the AAFCO process. And FDA stated they would introduce the feed/food labeling and verification at the August 2017 AAFCO meeting. FDA asked us to document the plan we discussed and submit it as an addendum to the previously submitted Citizen Petition and to email the same document directly to them. Per this request, that document was submitted as addendum and emailed directly to you on July 10, 2017. (To read the full story of our trip to Washington DC – Click Here.)
Per our exact agreement – below is link to the document submitted as an addendum to our Citizen Petition (submitted July 7, 2017) and emailed directly to Dr. Dan McChesney (July 10, 2017) of FDA/CVM. Below that is link to Regulations.gov – evidence to the exact same document accepted and published by FDA (click on pdf icon to view).
Again – everything included in the above ‘Addendum’ was discussed with FDA during our June meeting and agreed to by FDA. FDA never told us this was unacceptable, never told us we need to discuss other options. There are five witnesses to this fact.
On August 6, 2017 – days before the AAFCO meeting I emailed Dr. Dan McChesney asking for confirmation the agency would indeed do as they agreed. My exact email to Dr. McChesney:
Hi Dr. McChesney –
I’ve emailed Charlotte, but have not received a response. I’m just wanting confirmation that FDA will introduce the feed/food labeling issue we discussed in June. It was stated at the time this could be suggested by FDA to be added to the Pet Food Label Modernization Working Group. Will you be going to AAFCO for you to make this suggestion, or will this be Charlotte? We just want this to get moving forward. If you could confirm FDA will make the suggestion to the Pet Food Committee – I would appreciate it.
On August 7, 2017 Dr. McChesney responded with:
I will not be going to AAFCO. Charlotte is going as is Dave. It is our intention to have Charlotte raise the labeling issue(s) at the Working Group meeting. It is our hope that there can be some middle ground found especially in the areas of transparency/availability of definitions, ingredient definitions and labeling that is more user friendly. FDA began inspecting under the FSMA requirements of the preventive controls for animal food regulations this pass September. Inspections will expand in 2018 and states will become more involved. The focus of the inspections have been CGMPs and in 2018 we will begin looking at food safety plans and how a firm is controlling hazards. While, the focus of these regulations is ingredient and product safety, it does give us (FDA and States) a greater presence and this will enable us to ask about sources of ingredients and to judge if potential hazards are being controlled and if the ingredients comply with the definitions being used on the label. I believe Charlotte arrives on Wed.
Though Dr. McChesney included some concerning language (“some middle ground”) – he specifically stated “It is our intention to have Charlotte raise the labeling issue(s) at the Working Group meeting.“ My mind was at ease – FDA confirmed they would do their part of the agreement.
The day prior to the Pet Food Committee meeting where Charlotte Conway was to introduce “the labeling issue(s)” we met in the hall. Witnessed by one of our group of attendees, I directly asked Charlotte Conway “Did you read the addendum I submitted?” She responded “Yes, I have read it.” Again, my mind was at ease – FDA appeared to be doing their part of what was agreed to (by all parties).
That is until…
During the last five minutes of a 2 hours meeting Charlotte Conway stated the following (note – this was her exact words, David Meeker’s exact words, my exact words – this is a quote):
Charlotte Conway: “I have a more political comment. CVM has been approached by consumer advocates and some interested consumers with interest in assuring that there is more information on pet food labels to help clarify and educate consumers as to what is in the pet food product. In our discussions, we really didn’t feel that we were going to be able to solve this problem right now. For those that have been around for years, we tried to update pet food labeling as mandated by FDAAA and it stalled out in the clearance process. And we don’t see that going forward anytime soon. And so my idea was that we could take that ask and move it into this work group – the Pet Food Label Modernization effort. I don’t think the ask is fully conceived, but the goal is very aligned with a lot of the work being done in some of these work groups. Some of what I am seeing in the ingredient work group doesn’t quite align with it, but I think my understanding it is mainly animal protein ingredients are of most concern to consumers and those are probably on the villain list. And hoping to insure that we get good information on the pet food label for consumers, I don’t know if that is creating more ingredient definitions for animal protein products so that it can be clear kind of the sourcing based on the name of the ingredient, I don’t know if it is information otherwise on the label – not the human grade we’ve already got that box but if there is other additional information to be provided on the label to talk about the source of those meat ingredients …if I’ve misconstrued Susan please let me know but I think it is mostly the meat ingredients that are a big part of the concern and we would request that these working groups consider that and consider how best to give the information to consumers about what is in the product in a clear and transparent and useful manner. I’d be happy to follow up in any discussions but I don’t have the answer today. It was just Dr. McChesney and I in that discussion that felt this was the appropriate place to take that.”
Note: FDA absolutely led us to believe this was a way to solve the problem. The ONLY discussion in question was time frame to achieve the labeling change. FDA themselves stated the fastest means to achieve a labeling change was through the AAFCO process. We never once asked for changing the names of ingredients during the meeting. We never once asked to create more ingredient definitions. Why would we ask for that when ingredient definitions are owned and privately held by AAFCO – not accessible to consumers. We never once called ingredients “villain ingredients”. We offered a resolve where industry could still utilize those ingredients and at the same time provide consumers with transparency. We specifically told FDA it was not our goal to destroy any ingredient industry or pet food manufacturer.
David Meeker National Renderers Association: “As a representative of those companies that make animal protein products – we have products that are on your villain list and that’s not because they are really villains its because of language and people understanding things – for example calling by products bad ingredients, they’re not. But we understand the pet food industry and the need for consumer translations. We do have customers other than pet food and we need the definitions that we have, we are very happy to help develop some new definitions, pet food grade definitions, some premium definitions.”
Susan: “That is sort of what consumers want – that we presented to FDA. But it is not per se just ingredients. It is the finished product. Pet foods are regulated as feed. This is what we approached the FDA with, they’re feed. The exception to feed is human grade – those meet all regulation of food. Consumers want to know – I have a petition that we did in just a very short time frame, we gathered almost 50,000 signatures in just a couple of weeks. 50,000 consumers want to know if they are buying feed or are they buying food. That is a very clear, quick, simple – just what we’ve been working on in our working group, the feed labeling. Plus federal law – the Food, Drug and Cosmetic Act states if there is an alternate ingredient allowed, in the interest of transparency of the consumer, it must be stated on the label. Feed is not stated on pet food labels. They are labeled and marketed as food, yet they do not meet the legal requirements of food. And that’s what consumers are wanting. We are not saying get rid of them. When we went to FDA, we didn’t call them villain ingredients. We didn’t want to end them. We just want transparency. The consumer deserves to know what they are buying. Are they buying feed or are they buying food. It’s that simple.”
Charlotte: “The one comment I would have and reiterate is and I believe Dr. Solomon mentioned this and we’ve mentioned this in other talks is that at FDA at least we are clearly moving away from using the feed term. The way the law is written is it is animal food. We regulate human and animal food. And all the new publications that we are putting out we are using animal food. And so…”
Susan: “But still the FD&C Act defines food as what animals and humans consume. And it very clearly defines adulterated food – which a lot of those adulterated foods are openly allowed in feed and animal food. So that’s where there’s this problem. And if it meets food regulation, then let’s call that pet food. If it does not meet food regulation, lets call that pet feed. Let’s call it what it is.”
Charlotte: “I just don’t see that moving forward with pet feed.”
Susan: “That’s different than what you said in Washington.”
Charlotte: “That is absolutely not different than the message conveyed in Washington. At that point we mentioned the same message, that we are not using feed. We are open to supporting the addition of information to convey that there are different sources, I think Dr. Meeker’s idea about maybe coming up with pet food specific ingredient definitions to help delineate some of that – I think there are a lot of ideas to get better information – but I just don’t see pet feed going forward.”
Susan: “That is absolutely different than what you said in Washington Charlotte.”
Charlotte: “I guess we’ll disagree. But I’m open to ideas. We talked about a grading system when you were there and maybe there’s a way to set the working groups – I’m not on any of these working groups – but the working groups could come up with a grading system for pet food. But I have never recommended pet feed.”
Never once during our meeting did FDA tell us pet feed was unacceptable. Never once.
I was blindsided by Charlotte Conway of FDA at AAFCO – all consumers were blindsided by Charlotte Conway of FDA. We abided by our part of the agreement, FDA (specifically Charlotte Conway) did not.
After the above happened, the AAFCO meeting was adjourned. I went back to Charlotte Conway with Dr. William Burkholder of FDA at her side – I told her she just threw millions of consumers under the bus. Her only statement was “I’m sorry you feel that way.” I asked her again – the same question I asked the day prior; “Did you read the addendum that I submitted?” This time she changed her story, this time she said “No. I did not read it.” It was clear she had not read the document, it was clear one of two things happened. Either Charlotte Conway has very poor recollection skills (nope, that’s not it) or someone changed her mind (perhaps FDA’s mind) on our agreement.
Some unanswerable questions…why didn’t FDA just tell us in June they would not accept pet feed? Why was that not ever mentioned – so that we could have discussed right then other options? Why did they tell us (5 witnesses) one thing and then completely change their story in front of the entire AAFCO audience? Was the goal to humor us in Washington DC and humiliate us in front of industry at AAFCO? Did they laugh after we left that day in June?…’Ha, we just sold them a bill of goods! They believed every word!’ Did industry ‘influence’ FDA to betray consumers? Do they think we won’t fight for our pets?
An email was sent to Charlotte Conway’s boss – Dr. Dan McChesney – Sunday August 13, 2017. In part that email said…
“We feel betrayed by FDA.
Consumers deserve better than this. Consumers deserve to know what they are buying – feed or food. One way or another, we are going to fight to make that happen. FDA can work with consumers or FDA can work against consumers. And let me remind FDA that Dr. Karen Becker has over 1 million followers in social media. With our network of consumer advocates we have a collective following of at least 5 million people. And our network has many connections in major mainstream media as well. We are a group of very determined individuals that are devoted to do what is right for pet food consumers.
We came to Washington DC to work with you. Charlotte made it very clear FDA is not willing to work with us. If this is your feeling as well, so be it – we will move forward with our original plans. It will most certainly be an ugly very public battle – something we tried to avoid by coming to you first. If Charlotte spoke incorrectly, I need to hear this from you very soon with your personal promise to how this can be promptly resolved.”
Should Dr. McChesney do the right thing, it will be shared with all. Should he not, let the battle begin. As you read this, we are planning the battle. News will be shared soon.
Personal note to all consumers: I vividly remember the full meeting with FDA. I vividly remember Dr. Karen Becker, our attorney friend and myself leaving FDA offices feeling we just achieved something great for consumers. Feeling that FDA was finally willing to work with consumers. None of us had the slightest clue FDA would betray us so dramatically. We took them at their word.
I am disappointed in myself for taking FDA at their word. I am more of a trusting soul than a non-trusting soul. I am more than disappointed in FDA – for betraying our trust in such a public manner (in front of 400 attendees at AAFCO). I should have known better. Lesson learned. All have my word – this mistake won’t happen again.
Still angry but a little bit smarter about dealing with regulatory authorities.
Wishing you and your pet(s) the best,
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