Did we miss something?
Maybe we have all been wrong, all those years when we said that you could not treat or cure FIP with natural supplements. If this Mutian XRaphconn label tells the truth, then maybe it is time for us to advise people to get all the supplements listed on the label, at the concentration conveniently indicated, and start treating their cats accordingly, without having to spend a small fortune.
That is, assuming that the labels filed with the FDA are not a misrepresentation of the actual composition of Mutian XRaphconn pills. And to be realistic, the balance appears tipped in favor of a fraudulent NDC label application. Why? Re-read Deb Roberts’ statement. Re-listen to the Symposium’s clips. Look at the claims made on Mutian’s websites – both the US and international ones. Read the posts on their Facebook groups. Read the treatment protocol, a copycat of the black market GS one. Read their statements about how they can cure FIP and get rid of FCoV… all that, with simple, natural ingredients? Think of the vast amounts of money squandered on FIP research over the years! All those famous researchers, who never even thought of looking into Inotodiol! Something here does not add up.
It is time for Mutian to come clean. Mutian XRaphconn is either a drug or a supplement, but it cannot be both. Mutian is lying to someone here, either to the FDA or to its customer base. And that is unacceptable.
It is unacceptable to deceive customers by selling them a combination of natural and dietary supplements when they think they are paying mega-money to acquire pseudo-legally GS-441524 for their cat.
It is unacceptable to lie to the FDA on an application to obtain the right to import a knowingly misbranded product. It is also a federal offense, as is the interstate sale of such a product. There are legal consequences for lying to a regulatory agency.
Whether it is a drug or a supplement, in both cases, the Mutian label violates several FDCA (Food,Drugs & Cosmetic Act) rules:
1 – The claim to prevent, diagnose, mitigate, treat, or cure serious diseases such as FIP constitutes an “unapproved new drug” violation of the FDCA.
“Unapproved animal drugs are new animal drugs that don’t have legal marketing status. They have not been approved, conditionally approved, or indexed by FDA. It’s illegal to market unapproved new animal drugs because they haven’t gone through the FDA pre-market review and obtained legal marketing status under the FD&C Act.”
2 – If the ingredients are “dietary supplements,” and the product’s active ingredient is, in fact, an unapproved drug or an unregulated substance, then the product is misbranded – another violation of the FDCA.
3 – If Mutian XRaphconn is a supplement, then no claim of treatment or cure can be made, and marketing of Mutian XRaphconn as a treatment or cure for FIP or FCoV is illegal.
4 – Whether supplement, or drug masquerading as a supplement, one thing is sure, it’s not GRAS. Dr. Bruyette dispelled that myth back in November 2019. I checked the GRAS database on the FDA site. Of all the ingredients listed on the label, only Nicotinamide – aka Vitamin B3 – (https://www.accessdata.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices&id=635) is GRAS.
And the adenine C-nucleoside that Dr. Pedersen was so adamant about is definitely not listed in the GRAS database either. Enough already with the ludicrous statement that “GS-441524 satisfies GRASE criteria established for animal drugs by the FDA.” Those hiding their shady dealings under the GRAS umbrella are either incompetent, delusional or outright liars. If there were any way GC376 or GS-441524 qualified as GRAS, there would be no Chinese black-market, and we would all be happily and legally using it.
So, Mutian, which one is it? Drug or supplement? What exactly are you selling? GS-441524 or an expensive mushroom extract? Time to tell your clients and the FDA.