Conversation With FDA's Eric Nelson, On FDA Regulating By "Opinion"

I have been wishing to speak to Eric Nelson of FDA for quite some time. Over the years, I have asked public state employees why they are regulating based on their opinion. One consistent name has come up time and time again as I have been looking into this legal issue. I'll quote one specific state department of agriculture employee here. "We just follow what FDA tells us to do at the meetings." The "meetings" beings referenced here are private AAFCO meetings, where FDA engages in official rule making functions in a private setting, right next to representatives of Hills, Purina, and other major companies that have long dominated the pet food market. I asked this state employee, "who at the FDA is giving you instructions, which you then follow without question?" After a bit of back and forth, the state employee said, "Eric Nelson." 

Over this years, I have also documented how this FDA employee has engaged in attempting to whitewash the entire raw pet food industry as "unsanitary" and "unsafe." Mr. Nelson is also a part of FDA's "DCM Investigation", targeting the grain free sector of the pet food industry, again with very questionable science and methods. It can't go unsaid that the two sectors of the pet food industry that have been consistently targeted by FDA's "opinions" are the two sectors posing direct financial threat to the status quo pet food companies which Mr. Nelson is highly engaged with at private AAFCO meetings. 

The below is a memorialization of the call today, January 6, 2021.

At the beginning of the call, I asked the person who answered if he was Eric Nelson. Mr. Nelson said, "it is." I then told him my name is Kohl, and that I was calling to try and get a regulation for the term raw for use on pet food packages. He said with a slight laugh, "I'm not the individual who would do that." I asked him who that individual is then. He stated that he did not know. (Somehow, almost everyone at FDA doesn't "know" specific information when asked. It seems to be a part of a run around game.) He told me to contact "askcvm.gov"

Mr. Nelson said that the "rule writing process is more complicated than just one individual." 

I then asked Mr. Nelson why he is regulating based on an "opinion". FDA has long been regulating the raw pet food industry not based on a law, not based on a properly passed regulation or rule, but by an "opinion". I informed him I have evidence of him regulating by FDA opinion. I asked him why he is doing that. 

He first tried to say he doesn't "understand" what I mean, and I should instead write that anonymous FDA email address. 

I asked him to please allow me to explain myself. I was happy to rephrase since he said he didn't understand. Given that this matter is very simple and very clear, and since he's been engaged in regulating industry based on this "opinion" for years now, I was certain he could quickly "understand" exactly what I was talking about. 

I proceeded to inform him that I was asking about the FDA "compliance policy" on salmonella in raw food. "When you call raw pet food companies", I asked, "you try to get companies to voluntarily recall their foods and you state FDA policy. You threaten companies with bad press if they don't comply with you. You even yelled at one company in a threatening tone, saying that you were just opening your investigation into them. This company dared to ask legitimate questions to you, and you went after them with threats of bad press and potential ongoing investigations because the FDA couldn't prove the company had actually done anything wrong. So, my question to you is very simple. Why are you regulating industry based on a compliance policy. That is an opinion. That opinion is not an actual regulation, and it's not a law. Why are you regulating based on opinion?"

He tried to go on a tangent about "voluntary" being voluntary, but I interrupted him. 

"Why are you asking companies to voluntarily recall their raw pet foods, saying that they're ADULTERATED, based on a compliance policy." I can understand law, and I can understand regulation. After years of questionable action by FDA, I can't understand "opinion". I told Mr. Nelson, "It's pretty clear what you're doing here." He again tried to not answer the question, and he suggested I write the askcvm anonymous email. I again said, "no", that I wanted an answer from him directly since he is the person I confirmed is the main person carrying out actions at FDA in regards to FDA targeting companies with an "opinion". 

Very long pause. He again tried to say I should write the anonymous email. He wanted to make sure I got the "correct answer". I again stated that since it is him that is carrying out actions based on FDA opinion, not law or properly passed rule, he is the correct person. "Your actions are becoming more and more known in the public. You're regulating by opinion. Why?" He once again attempted to go off on another tangent not related to my question. I had to interrupt him again. "You're regulating by opinion. Why? Stick to the question please."

He said, "an investigation is not necessarily a regulatory action. It's not necessarily a regulating act." He tried to say that it's only a way "to find out if there have indeed been violations of law." That struck me as odd, given that federal law is very clear on what constitutes an adulterated product. Their compliance policy opinion contradicts federal law, and appears to try and rewrite it entirely. So in response to that, "is salmonella an adulterant based on that compliance policy?" He said he wanted to "identify a root cause of a problem." I responded, "or, there's potential for you to act on behalf of major corporations, since you do so much private business with them at AAFCO." You could be making up problems as a way to try and harm companies who are actually making animals healthy. 

I told him that I was well aware of his close ties with lobbying groups through his heavy participation in the private corporation AAFCO. Specifically, I was very aware of how close FDA works with the lobbying group for major processed dry food companies that dominate the market. These companies appear to benefit from this FDA "opinion" that consistently puts raw foods in a negative light. These companies are based in grains, and stand to benefit from Mr. Nelson's attack on the grain free industry as well.

I asked again, "is salmonella an adulterant per law? Or, just per your compliance policy." He said, "our adulteration standards are defined in the food and drug cosmetic act."

I said, "but that's not the compliance policy." I asked, "is any trace of salmonella an adulterant for raw pet food?" 

He said specifically, "it has to conform to the definitions defined in the food, drug, cosmetic act." 

That's not "zero tolerance" by any stretch. 

I said, "FDA, aka you, then say any amount of salmonella renders a product to be adulterated." As he just said, a definition of adulterant has to conform to the definitions defined in the food, drug, cosmetic act. FDA is not doing that. "FDA says any amount is an adulterant." I've seen you print that in press releases. 

He says, "I would refer you to the CPG that deals with salmonella in raw pet food." 

I respond, "that is not a law though. That's my question. Why are you regulated by the CPG? That's not a law!" It actually contradicts the law. He said, "that's the current thinking on how the standard is being interpreted." 

I ask specifically, "is the CPG a law?"

He said, "no. It's guidance." He also said, "it's how we respond to observations." And I questioned, "observations. Not law." And the FDA can "observe" anything. Luckily because some manufacturers have started recording FDA on their property, I have witnessed FDA blatantly lie with their "observations" to try and paint a company as being "unsanitary" for not having any "cleaning" standards. FDA is on film though reviewing a book pertaining to the companies "cleaning standards", so the FDA can indeed have "false observations" which is hard for any company to counteract, and hard for the average consumer to get to the bottom of. For another "observation" FDA had on a company FDA "observed" not thawing their ingredients out in a way to mitigate pathogens, I asked FDA directly "well, how should the company thaw their ingredients out in a way that mitigates the growth of pathogens." Years later, the FDA has never provided me with those steps. FDA appears to have simply made up another observation, again appearing to fit their false narrative of painting companies as unsanitary. 

I recapped, the CPG he referred me to. I said, "I asked you about law. You gave me a CPG, which isn't law."

He then said, "You know what? I have a very busy day."

The phone call then became a bit contentious. "No," I responded. "You need to be transparent with the public. You're not holding any type of public meetings. You do so many things privately at AAFCO meetings. You're regulating by a CPG. So, the least you could do is speak to the public about this, which you often refuse to do." I informed him, "You can go speak to Purina and Hills at AAFCO meetings and Pet Food Institute. You can't speak to us in the public though?"

He said he didn't know if knew him or his history. I said, "I do know that you're regulating based on a compliance policy opinion." 

He talks about how he's been for "protection" for his entire career. I say again, but "you're regulating by an opinion. Not a law!" Protection, I will argue, is best when put in a law. "Why don't you pass this as a law?" Since it's about protection. Trust me, the public wants to be protected. When the FDA allows for illegal ingredients, and ingredients not appropriate for species, that brings the argument of "health protection" into question. 

"It's not complicated," I say. "Unless you're trying to protect Purina." 

He said, "the executive branch doesn't pass laws."

"FDA can pass a regulation" I say. So, "you can." 

He then retracked. "We can implement regulations." I say in response, "and you're not doing that with raw pet food because your compliance policies are full of crap science. And you're regulating based on a compliance policy full of crap science. 

He started to stutter, "I... I...." 

I then challenged him. "Would you be willing to have a public meeting on this matter so we can ask you questions on the official record?"

He laughed. He said he thinks public meetings are great opportunities. I asked again, "would you be willing to hold a public meeting on this matter? You go to how many private AAFCO meetings and you have private meetings with industry. You have zero for the public. You are doing so much privately. Why don't you have a public meeting?" Or regular public meetings for that matter. "Are you willing to have a public meeting?"

He told me to request that meeting at askcvm, the anonymous email. I responded, "no, are you willing to have a public meeting?"

He then said there was a "notice of comment" for a period of time for the compliance policy (he's regulating by). I again said, "that's not a regulation. You didn't properly pass that as a regulation. Why?"

He said, "it's not a regulation. It's an interpretation of the statutes." I said, "correct, and it could be a wrong interpretation of the statutes based on the science I see. So, why don't you get that passed as a regulation?" We could at least battle this all out in public, and in federal court during the official regulation process. Why are you so against that?

He said he couldn't answer that question. I told him he could. Informed him he's regulating based on the opinion, he can for sure answer my question. I say, "you're regulating industry based on an opinion that's potentially very wrong, and you refuse to have public meetings. You laugh at me when I suggest you hold a public meeting."

How is that "for health", when there's so much secrecy here? 

He said he was going to end the call at this point. 

I replied, "you go do that. I will not be giving up on you regulating illegally." He said that as a "consumer" and as a "pet parent", he is happy that I am championing the efforts that I'm championing. I told him, "I'm disappointed in you Mr. Nelson. Deeply disappointed that you do so much in private, and you're not even brave enough to have a public meeting so we in the public can come meet you face to face. You GIVE that to the pet food industry lobbying group. You GIVE that to the industry. And you always have excuses for something. Guess what? Now we're going to keep fighting back because you're not regulating based on law. Shame on you. Shame on you. You guys are cowards when it comes to citizens, and we're not going away."

And then, the phone call ended. 

The FDA has no immediate plans to pass an official rule on this matter, and they "remain firm" on their stance to continue to regulate by their opinion based on questionable science...that is if you can even call what they are referencing in this case "science". 

-Kohl Harrington

Author Of Article