The FDA's Potential NDT Ban: The Future of Glandulars and Health Update with Out of Range Labs

The FDA's Potential NDT Ban: The Future of Glandulars. If the FDA reclassifies NDT as a biologic, it raises a serious question: What happens to other glandular supplements? Products made from animal glands — like adrenal, thymus, or pituitary extracts — have been staples in functional and integrative medicine for years. In 2019, when I was diagnosed with adrenal insufficiency, glandular adrenal supplements in conjunction with prescription medication and other treatment modalities were a cornerstone of my treatment protocol.

Most glandulars are legally sold as dietary supplements under the 1994 Dietary Supplement Health and Education Act (DSHEA) law. Still, if regulators decide that any of them contain measurable hormones or are being used to treat disease, they could fall under the same biologics umbrella as NDT. That would effectively end their supplement status and force manufacturers into the same multi-million-dollar approval process that NDT currently faces. It’s a fine line between "supporting gland function" and "treating disease," and the FDA draws that line wherever it chooses.

NDT is unique because it's an extract of animal thyroid glands that still contains the active T3 and T4 hormones. Under FDA definitions, anything that is "derived from living sources" and "intended to treat or prevent disease" can be considered a biologic under the Public Health Service Act (42 U.S.C. § 262). That means if the FDA views NDT as a biologic, any glandular product containing active hormones or complex biological materials could be argued to fall into the same bucket — especially if it’s being marketed for therapeutic use, not just as a general wellness supplement. So while most adrenal glandulars are technically sold as dietary supplements under the DSHEA, if they’re found to contain measurable active hormones (like cortisol or adrenal steroids), or make disease-treatment claims, they could be reclassified too.

If you or someone you know is affected by this, I urge you to please visit https://savendt.org to learn about ways to fight this decision. You may write your congressman, sign a petition, or create awareness by posting on social media.

Health update: I had a doctor's appointment this past week, but sadly didn’t make much headway with the majority of my concerns. They were unsure of how to proceed with my GI issues and had no further options for non-narcotic pain management.

They ran lab work on me, and I had a few values that came back out of range, one being elevated ALT. I’m going to wait until I hear back from my doctor's office to see what needs to be done.