Future FDA restrictions on trt use?

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bennettjc

Member
After pressure from the FDA, so it seems.
The FDA didn't pressure Amazon. The FDA issued a general warning letter a year or two ago, not to any company specifically, saying that NAC couldn't be marketed as a dietary supplement. Amazon decided to stop selling it. Most other retailers continued to sell it.

Recently the FDA has backed off a bit and stated that they will likely allow NAC as a supplement. See below. FDA formally announces NAC enforcement discretion, but legal hangover remains
 
Defy Medical TRT clinic doctor

MIP1950

Active Member
This post is full of my own opinions and anecdotal observations, your own may differ.

The magical picture show is just... this reality TV show that we're stuck in. Red vs. Blue is full of sound and fury signifying much and meaning nothing, because all 3 branches of government grow out of the same tree: the CIA, which, in conjunction with a private co called the Federal Reserve prints all the Monopoly money which keeps the Ponzi scheme chugging along.

I mean, who's writing the content of the teleprompter for our Weekend at Bernie's presidency?

What is the highest level of organized crime? Government. What is the USA? We've drifted a bit from the original republic, currently we're the largest terrorist nation on Earth, our main export is violence and war, which is extremely profitable.



The interesting part of this puzzle is, yes, of course the government prefers low testosterone sheeple... but having said that, if you're a 20 year old male, your 300 testosterone level is the new "normal" and best of luck finding a regular clinician to write you a script for test.

But... rearrange the optics a bit. "Hi! I'm a 14 year old girl who was feeling a little confused and depressed today, so I saw my counselor at school, and I realize that I'm trans! Write me a script for a bunch of test!" Okay... no problem.

The whole 27 genders and infinite personal pronouns collective is currently firmly wedged into the heart of the zeitgeist/current narrative, which makes it a bit difficult to ban hormones, because you can't have the 27 different genders without a lot of molecular and surgical assistance.



Well, Pfizer seems to have become the state. I mean, who needs clinical trials, let's dose the planet with whatever s--t we drop kick out there!



About that "war on drugs" ... Approx cost to provide pain relief medication morphine to everyone in the world who needs it for palliative care, addiction, or recreational use: $145 million per annum.

Approx cost of enforcing global prohibition: $100 billion per annum (UN estimate).


Hmmm...



Just... being objective. It's not possible to make a blanket statement, such as "the FDA is good" or "the FDA is bad." The FDA is a gargantuan dinosaur sinking in a tarpit which is made up of so many different sub-divisions and agencies within itself, that its a bit mind-boggling. It has regulatory power over roughly .27 cents out of every dollar spent in the US.

For instance, the Pilot Drug Evaluation Unit, used to have its lips super-glued to the DEA's ass, which is how everything got lumped into schedule 1, including molecules that absolutely do not belong there. The entire unit was rebooted, everybody was let go, and they had a reset in the 1990s, which is how we've arrived at clinical trials with psychedelic drugs.

Does the FDA care about human beings? Not that I can tell.

Is the FDA corrupt? Absolutely, take a look at what's happened to vaping. In the UK the Royal College of Physicians release a position paper that at worst vaping represents a 95% reduction of harm over combustible tobacco. Meanwhile, the US and FDA are busy pumping out junk science saying the exact opposite. Why? Because an entire generation of kids grew up, saw the sexy Juul ads, realized vaping was cool, cigarettes was that thing your parents or grandparents did, and this caused a huge problem with... tobacco bonds and their value going down the toilet. For the first time in history smoking rates were way down. So, the FDA has fixed that problem, and individual states have added even higher levels of extortion money -- I meant to say sin taxes -- on top of what was a relatively inexpensive, harm reduction alternative to smoking.

Somewhere, within the FDA, are there human being who actually care about what they're supposed to be doing in theory? I absolutely believe that YES, at least I certainly hope so. But, I'm not too optimistic.

At the end of the day, every molecule you want, will remain available. GMP quality will suffer, patients will suffer due to quality control issues and prices increasing, but life goes on.

As Nelson mentioned, deca, anavar, etc, aren't on that "Difficult to Compound" list.

In closing... why is HGH schedule 3 and on the AAS list? It's not even an anabolic steroid. Answer: because Big Pharma lobbied to get it there and price fix it. Total cost of 72IU of Humatrope in Turkey? $165 USD. Now go look that up in the US, you're looking at over $5K for the same thing.

Excuse me, I was just clearing my throat and all that came out. I'll shut up now and wish everybody a happy weekend.
I written about the disparity between the cost to manufacture a drug in India and what it ends up costing in the US. Four years ago, my former primary back in Maryland related a conversation he had with an upper level person at BC/BC in DC. This person told him that they pay out more for drugs than primary care. And most of those drugs are generic. The cost for a 5 mL vial of West-Ward Test E on insurance went from $15 in 2013 to $65 for the past few years. Other than compounded injectable test, there's no competition. For whatever reason, West-Ward is the only brand available. There's an Indian pharmaceutical company that manufactures either a 5mL or 10 mL vial of 250 mg per 1 mL. Not available in the US. Probably other brands out there, too, that aren't being imported .
 
The FDA is currently considering to include estradiol, estrone, estradiol cypionate, estriol, pregnenolone, progesterone, testosterone, testosterone cypionate, and testosterone propionate and all pellet cBHT therapies as candidates for the “Difficult to Compound List.” This will mean that production of all compounded hormone injections, gels, creams, nasal, oral, and pellet formulations will be banned, blocking affordable access to millions of people in the United States.

Oxandrolone, stanozolol and nandrolone are not included.

Read and take action!


Also read:


They have already banned compounded hCG and FSH. They just banned enclomiphene. They sent notices to all compounders that make peptides to stop doing so (except for sermorelin)

Guys, please take action on my site above!

We are at war with the FDA and very few of you have helped me with this petition. Just wait until you all panic when your supply dries out!

Nelson, my senator’s office responded to my email:


Thank you for taking the time to contact us regarding compounded bioidentical hormone therapy. We always appreciate hearing from Coloradans, as it helps us better represent our great state in the United States Senate.
The Food and Drug Administration (FDA) plays a fundamental role in protecting the health of the American public. It is responsible for regulating prescription drugs, biological products, medical devices, and other products to ensure their safety and efficacy.
Compounded bioidentical hormone therapy refers to a customized treatment given to patients with a hormone imbalance using bioidentical hormones, or manmade hormones that are similar to those produced by the human body. In 2018, the FDA requested that the National Academies of Science, Engineering, and Medicine (NASEM) conduct a review of the safety and effectiveness of compounded bioidentical hormone therapy. The FDA has not made any additional announcements on how the agency will approach this practice. Please know we will keep your thoughts in mind should this issue come before the Senate.
We always value hearing directly from Coloradans and hope you will continue to share your thoughts as we work together for Colorado and our country. For more information about our priorities, please visit our website at www.hickenlooper.senate.gov. Again, thank you for reaching out.

Sincerely,

John Hickenlooper
United States Senator
 

MIP1950

Active Member
Amazon flip floped and now it is back OFF their shelves....
I have Prime, so Amazon is the first place I look. I was considering another try with NAC, as it has anti-depressant and mood stabilizing properties. Used to communicate with professor & M.D., Michael Berk in Australia, who did groundbreaking research on it for bipolar. I didn't respond well to it and neither did my late friend, also with severe bipolar. We both were taking pills, not capsules, and now wonder if fillers/binders were a factor in our poor response. Only way to know is to buy it in capsule form or pharma grade powder and put it in capsules.
 
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