Mutian GS for FIP, legal or not?

Is Mutian GMP (Good Manufacturing Practice) certified?

Quality is important. If a company claims US GMP (Good Manufacturing Practice), then such a claim needs to be substantiated with a corresponding GMP certificate. Overseas facilities must have FDA certification to claim GMP, which is delivered by a registered US FDA agent and looks like this. The FDA Inspection Classification Database Search lists all FDA-accredited domestic and foreign facilities.

The database is updated daily; as of 01/20/2020, there is no record of inspection or GMP certification for a facility called Nantong Mutian Biotechnology Co. Ltd, Mutian, or any other name variation in Nantong, or other cities in China. Therefore, either Mutian does not have FDA GMP certification, or Nantong Mutian is not the manufacturer of Mutian XRaphconn. “Meet with GMP standard” does not mean the same as GMP certified.

At the Winn/UC Davis FIP Symposium in November 2019, Mr. Zihu Lu, Mutian’s US CEO, repeatedly mentioned Mutian products were manufactured at the only FDA-approved biochemical facility in China. Consumers paying a small fortune for Mutian pills have the right to know what the “Meet with GMP standard” on the packaging refers to. So does the FDA, that has not yet approved the label.

Mutian's secret active ingredient: what's REALLY in it?

As part of the NDC application, the manufacturer must disclose the ingredients list. This is where it gets interesting. As Dr. Bruyette explained during the FIP symposium, either Mutian’s active ingredient is a drug, or it is a supplement. But it cannot be both. And lying to a federal agency like the FDA about what’s in a given product to obtain an NDC is a grave offense.

With that in mind, let’s not jump to conclusions of wrongdoing on Mutian’s part. They have, after all, professed that their Mutian pills’ active ingredient was similar, but not identical, to GS-441524. So, all we need from them is confirmation, both to potential consumers and the FDA, that the label presented with the NDC application is accurate and reflects the actual composition of Mutian XRaphconn.

The ACTIVE ingredient in Mutian pills, according to the label, is INONOTUS OBLIQUUS FRUITING BODY (inotodiol). Inotodiol is an anti-inflammatory sterol isolated from Inonotus Obliquus Fruiting Body, a fungus (mushroom) commonly known as Chaga mushroom. Inonotus Obliquus inhibited Hepatitis C virus and human immunodeficiency virus and demonstrated strong antioxidant and immunostimulatory activities in vitro. Mostly, inotodiol is known for its anti-tumor action; no anti-viral activity was reported.
You can read research on the uses(s) of Chaga Mushroom and Inotodiol here.

The inactive ingredients are:
• Nicotinamide Mononucleotide. Just because it says “mononucleotide” does not make it GS-441524. It’s just a fancy name for a nucleotide derived from sugar (ribose) and niacinamide, a form of vitamin B3. A far cry from the patented GS-441524 chemical compound.
• Crocin, a carotenoid from saffron with anti-oxidant and neuro-protective properties.
• S-Adenosylmethionine, aka SAMe, a supplement commonly used for liver diseases.
• Silymarin, a standardized milk thistle extract for the treatment of toxic liver damage.
• Microcrystalline cellulose, a texturizer commonly used in vitamin supplements.

If we are to believe the ingredient deck, there is nothing in Mutian’s pills that you can’t get on your own and for much cheaper. INONOTUS OBLIQUUS FRUITING BODY, aka Chaga mushroom, is sold as a dietary supplement on Amazon for a whole lot less than Mutian pills, at higher concentrations, like this one: https://www.amazon.com/Natures-Elements-Mushroom-Immune-Support/dp/B07C32RN2W/, which, as a bonus, is GMP, made in a registered FDA facility.

The chemical structure of GS-441524 differs considerably from the ingredients listed by Mutian on the NCD label filed with the FDA.

Nothing here looks like the GS-441524 adenine C-nucleoside analog. Yet the Mutian XRaphconn label claims it is a drug for Feline Infectious Peritonitis. Also mentioned on the label under Adverse Reactions is a clinical study of 240 cats. Adverse reactions belong to SAFETY. In diseases where field studies are allowed in lieu of infection model clinical trials, safety may be combined with efficacy. Results of all studies must be printed on the box insert and published in the FDA database. If such a study exists, then the data should be shared by Mutian, to help all of us better understand the benefits and actions of INONOTUS OBLIQUUS FRUITING BODY for the treatment of FIP.