Transparency and Product Labeling

Bill Bookout: [Sara], talk to me a little bit about product labeling. Then I'm going to ask all three of you to comment on product labeling how important is transparency in product labeling. And you know what are some key points that people would look for. And when they assess a product, because that's what the pet owner sees a lot of times, they see the label of the product or what's on a website, right? Talk to me a little bit about that. And then I'm going to ask the two docs to comment on that as well.

Sara Phillips: You know, I think transparency and product labeling. And you know, even traceability throughout the supply chain is really, it's important to today's consumer. They may be even a touch more discerning when they're looking at something for their pets, than perhaps buying that box of delicious cereal that I'm not even going to read the back of, because I like the way it tastes. So, I think the consumer is really demanding transparency. But it is also a good quality system practice. And if you’re a manufacturer and you want to achieve these certain quality certifications and standards, you're going to have to provide these and show that these are part of your manufacturing and quality systems, documented through your SOPs. If you desire to be an NASC Member, a preferred supplier as a manufacturer, you're going to have to show that. FoodScience is that, we're also an SQF-certified facility, safe quality foods under the FSMA Act. We absolutely have to show traceability, and that auditor can pick any product and say, “Can you show me your traceability all the way back to the origins of these materials and raw materials, certainly, but also components.” So, anything that's going to touch this ingestible product

Also, we have to be able to trace it, know where it came from, identify it by lot number, etc. You know, CGMP requires this. NSF requires this. The same thing happens when the FDA surprises us and visits us. They want to know that you have these systems in place. So, if you have them in place, and you make that part of your daily life as a manufacturer, then your traceability and your transparency all the way down to the pet owner, the consumer, that retailer you're working with, you're going to have all that at the ready, whatever they need to ask you about, whatever they're looking for, you're going to have it.

There is a saying that I think Bill says. And, Bill, you're going to have to help me, because I don't think I can get it right: You can't back your way into quality after the fact. Right? It's something like that, right?

Bill Bookout: Yeah, don't assume quality. At the end of the day, everybody's responsible for quality. I ask the question, who who's responsible for quality in your company, and the answer is, everyone. Everyone's responsible for quality. Another thing that people that market products don't realize is that under the law, you're required to have a written quality manual. Even if you don't manufacture the products yourself, because you're responsible for things as the supplier, like labeling, claim substantiation, adverse events, product registration. So, verification upstream and controlling your specific processes with SOPs in your company. That's all important.

Dr. Morgan, talk to me about transparency and product labeling from the practitioner standpoint. What do you look for in labeling? And how important do you think that is?

Dr. Judy Morgan: Well, this is a really interesting timing for this question, because a product that we bring in from England just got flagged by FDA for label claims. And so, it was held by them. What we put on our website is what they had on their website in England for the product. And FDA said, “No, it's making label claims,” and we said, “Okay, great.” And so, we changed the listing, but that is not enough. The company in England had to change their listing on their website, which they were very resistant to. And we said, if you don't change what's on your website, even if we change what's on our website, this product cannot be sold here because you're making claims that the FDA says would make it a drug.

So it basically, what we now are doing is going through every single product, whether it's a US product, a Canadian product, a European product, wherever we're getting them from, and we're having to go back and look at what claims are you making on your website that has then now been handed down to us. And these products are great. Everything that's in our in our store has been handpicked by me because of the transparency of the companies. The quality of the ingredients and sourcing, and everything that these companies are doing. But unfortunately, a lot of them do have verbiage on their websites or on their product labels, not as much the product labels, but definitely on the websites, that is not in agreement with what FDA wants. And so, it was a big wake up call for us to have this particular product held.

We had another product from Ireland, and it wasn't a labeling thing, it's just that FDA didn't like something about it, and it cost us $6,000 for it to sit in storage for a month before they would release it. So, you have to be able to play well with FDA and follow the guidelines. So that has been sort of a big thing, and it's being done to protect the consumer because we don't want to say that this is going to cure something like a drug might cure something. We want to be very transparent and say, look. This will help support immune health. This will help support gut health, not “This is going to cure IBD.” So, pretty critical, and that that's really for the pet owner, because we don't want them to assume that something is going to have the power that a drug might have that's gone through all kinds of testing and approval. So I think that's something to really watch for.

Bill Bookout: Really, really key point that you made. And people, again, sometimes don't understand that anything connected to the company, you own it, doesn't matter if people think labeling is just your product label, it's not. It also includes website, literature, trade show materials, advertising, even social media. So, anything connected to your company can be a claim or a statement that you can be held accountable for and beyond just regulatory risk, which can be warning letters or stop sale notices which nobody wants to have. There's also a legal avenue for risk with plaintiffs attorneys, or the Federal Trade Commission. People should be aware of the risks. What's considered labeling, and also the risk of labeling both from a regulatory perspective as well as a legal perspective. Dr. Pachel, fill in some additional blanks on product labeling and things that you look for and think are important.

Dr. Chris Pachel (he/him): Yeah. So, speaking kind of both from the practitioner standpoint as well as an international speaker, I think it's always fascinating to me where I may be working for a company that's based in Europe, but I'm speaking for them here in the U.S., and so I’ve got to look at their website. What are you able to say that I can't say here, or vice versa in some of those cases. So I'm always having to say, “Okay, I know as the veterinarian, as the practitioner, I know what it does, at least within my lane. But what am I allowed to say?” And you know, what lane do I need to stay within? And so, I love working with companies where they're always, you know, saying, “This is what we can say. Of course we're not asking you to say anything that's an ethical conflict with your own perspective, but also don't say this, or we're all going to get in trouble.”

And I think the other thing that happens at the practitioner level is you know, again, with just enough experience in both the manufacturing and production process to potentially be dangerous, I recognize that it's sort of threading this needle of being vague enough to avoid some of the specificity or medical claims, and yet in some cases so vague as to be sort of unhelpful. And now I've got a client who's saying it said it's going to improve gut health. I'm like, well, the gut's a pretty big part of the body, like, what are we talking about here?

Trying to get enough [information] so people can actually monitor whether it's working for their animal, and the practitioner knows what's going on here as well, and so I think from a labeling standpoint I get it, the labels are really small, and I think most of my clients kind of forget that there's an entire website with product sheets and additional information that they can go, that we can reference to be able to get that additional information, and they're just grabbing things off the shelf.

So, I think there's a lot to be said for both, again, the transparency and the accuracy and specificity within all of that.

Bill Bookout: Yeah, there's a lot of educational sites out there, and I know both the practitioners here do blogs and have blog posts. If you disconnect from commercial activity, you have a little more freedom on the claims that you can make. You can't go crazy, but you know at the end of the day you want to give people enough information where they can effectively utilize the product and have reasonable expectations, right? You don't want to set people's expectations improperly.