The co-owner is a vet, which I have to believe is a big factor in people believing this must be legit.
This isn’t intended to be snarky, but unless someone understands the basic framework of FDA regulations it’s very difficult to understand why what they’re doing is shady.
Unlike with humans, there is no such thing as an animal “supplement” in the eyes of the FDA. It’s either an animal food or an animal drug.
FDA’s Center for Veterinary Medicine Policies and Procedures Manual 1240.3605 “Regulating Animal Foods with Drug Claims” is the guidance FDA follows to determine if an animal food’s intended use (what is claimed by the manufacturer) puts it into the drug category. https://www.fda.gov/media/69982/download
It happens to state:
Finally, it has been a long-standing agency policy that nutrients administered parenterally are regulated as drugs.
So anything an animal doesn’t eat but instead is injected into the animal is a drug.
Summit is administered IM so FDA would consider it to be a drug.
Legit animal drugs have an NADA/ANADA or an NDC code on their label. None of this exists for Summit.
The IM route of administration also pretty much rules out them playing the game that other products do by classifying themselves as medical devices and stating they are a post-surgical lavage (ICHON) or physical wound dressing (CHONDROPROTEC). And at least those products have the decency to label themselves as Rx only, which Summit does not.
If you look closely at their website, Summit never actually states what this product does. The closest that they get is saying it improves your animal’s mobility, comfort, and performance. Those are marketing wiggle-words. You can bed a stall deeply and say it can improve your horse’s mobility, comfort, and performance. They aren’t claiming it helps with any actual disease states like arthritis. Because they can’t. Those are drug claims, and they can’t make drug claims, because they aren’t approved as a drug.
So they are most likely existing in this world where they should be regulated as a drug because of their route of administration, but if they aren’t making overt drug claims FDA might not have bothered to go after them. Or they’re really good at hiding their company name so finding an FDA Letter is difficult.
Because there is no such thing as an animal supplement, I’m guessing they don’t even follow the basic FDA Current Good Manufacturing Practices for dietary supplements that human vitamins/joint supplements do. Hence why people saying it’s made in the owner’s spare bedroom or garage isn’t hard to believe.
I don’t think that anybody has ever gotten them to answer how the product is sterilized, and from what I can see it isn’t even labeled as sterile, which is another red flag.
So we’ve all looked for the usual “proof” that this is a legitimate product that is easily found for other products and have found none.
It becomes the nuanced argument between the evidence that something is absent (we aren’t finding the data supporting this product) and absence of evidence (there is no data supporting this product).
