FDA's NDT Reclassification & Deadline Hustle, Gordon Medical Forum, & GI Chaos

FDA Ban of NDT: I’ve gone down the rabbit hole with this topic this week. Here’s what I’ve learned…

Ban is a strong word. The FDA is trying to reclassify NDT as a biologic. If a company doesn’t get their product reclassified, they face shutting down.

What is NDT? NDT, or natural desiccated thyroid, is derived from animal thyroid glands — usually pigs. It contains both T4 and T3 hormones, making it feel more ‘natural’ to many patients compared to synthetic options like levothyroxine. For some, it works better. For others, not so much. This medicine has been safely used since the 1890’s.

The FDA is basically saying: “If you want to keep marketing NDT, it must have a valid biologics license — either an original BLA or a supplement to an existing one.”

That’s a massive shift because NDT was historically treated as a drug under the Food Drug and Cosmetic (FD&C) Act, not as a biologic under the Public Health Service (PHS) Act. Moving it into the biologics category triggers the far more complex and expensive BLA pathway. It’s the same process used for vaccines and gene therapies — incredibly rigorous, time-consuming, and expensive.

This decision was initially made in 2022 with a deadline for manufacturers to comply by 2029. The deadline has now been moved to August of 2025 with a grace period of one year making compliance impossible to meet. The FDA has literally pulled the rug out from under our feet.

The cost of complying with what the government is requesting is in the tens of millions, if not more, when you factor in the clinical trials, application fee, and other government compliance requirements. That’s a drop in the bucket for Big Pharma, but completely out of reach for smaller, family owned businesses. These smaller businesses face shutting down should this reclassification take place.

Not to mention, clinical trials take anywhere from 6-10 years before approval. The math ain’t mathin. Would you care to join me for a dance? It's called the Deadline Hustle.

If you or someone you know has been affected by this decision, please visit www.savendt.org to learn how to get involved to protect patient choice.

Gordon Medical Forum: Peptides and Cutting Edge Treatments Summit

I’m currently watching this summit courtesy of Gordon Medicals new forum where interviews and information pertaining to the medical challenges I’m currently experiencing are shared. This includes guidelines for peptide therapy for complex patients and detox information as well as upcoming and past summit information. The Gordon Medical Forum creates a space for healthcare practitioners and patients alike to expand their understanding of complex chronic illness treatment. Loving this new forum!

https://gordonmedicalforum.com/

Health Update: GI symptoms are worsening. I’m up to 6 grams of betaine per meal and will be adding lime juice to see if it helps. Since my mold reexposure, It feels like I’m back sliding and I need to do another round of RPR. My psoriasis has never been this bad before as it has flared over my temples and back of head. Bloating, slowed gut motility, increased hair loss, chapped lips, and general unease and fatigue are all apart of my day to day life again. Will consult with my GP, but I've run this guantlet before. Having mystery GI issues can be so frustrating.