Is the P-Shot® FDA Approved?


Is the P-Shot® procedure FDA approved?


Great to hear from you and I’m very happy that you’re helping out our provider!

     Here’s a few points that answer your questions:

  1. The P-Shot® (Priapus Shot®) uses a man's own blood. So, the P-Shot is not FDA approved because the FDA (Food & Drug Administration) NEVER approves procedures. It’s not what they do.The best analogy is when a doctor sutures a wound. The FDA approves the DEVICE of the suture material. But, how the doctor uses the thread to suture the skin back together is up to the doctor (not the FDA). So you could say it's the "Food & Drug/Device Administration" but not the "Food & Drug/Device and Body Parts Administration."People own their own blood, and urine, and saliva.

    The FDA does NOT govern the body or body parts or body fluids.. nor does the FDA govern what a doctor does with a patient’s blood or urine or body parts—these are not drugs. The FDA does govern the devices use to prepare blood to go back into to the body (to prepare the PRP) and your doctor should be using an FDA approved kit.

  2. So when someone criticizes the procedure and says it’s not FDA approved, it’s like saying my car or my toenail is not FDA approved…so whoever says that needs us to educate them…and here’s where it can help your marketing…You should make sure people know that all the doctors who to the Priapus Shot® procedure (including yours) use an FDA approved device to prepare the blood (other doctors who are not in our group often do not use an FDA-approved device). Also, we have a well planned and protected way of injecting the PRP into the penis and a whole protocol for before and after the procedure.


  3. Here’s where you can see the description of the procedure with references…
    Click to see description of the Priapus Shot® procedure (with references)<—

    1. The references for the procedure can be seen at the bottom of that same page (click)<—
    2. I cannot over emphasize the FACT that for best results from your ad, it should lead viewers to a web page where they watch a video where your doctor/provider explains the Priapus Shot® procedure. I’ve provided script/outline that I know works and more tips on the marketing portion of the members website to which your doctor can give you access. Here’s the login page, (the doctor will need to give you password and user name)…go to the marketing page and watch the videos (I’ve been marketing/educating about this procedure for 7 years and know what works)…Please keep the info here private,,,I consider it to be proprietary and very valuable...

I’d be eager to talk with you about other ways to make your marketing campaign work, or you can set up a free (for our certified providers only) 1-Hour marketing consult here (click)<-- I'd recommend that both the provider and the marketing person be on the call.

Call the American Cellular Medicine headquarters if questions...

Very best regards,


Charles Runels, MD

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