Comment from Figueroa Donna

Docket No. FDA-2015-D-4750-0439 Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: FDA’s Reclassification of Desiccated Thyroid Extract (DTE) as a Biologic Subject: Serious Concerns Regarding the Proposed Reclassification of Desiccated Thyroid Extract (DTE) Dear FDA Representatives, As a functional medicine practitioner, I am writing to express my deepest concern over the intent to reclassify Desiccated Thyroid Extract (DTE) as a biologic. My patient community consists heavily of women aged 40 to 65 who rely on tailored, compounded thyroid medications or specific brands like Armour and NP Thyroid to manage their health conditions and maintain their quality of life. In my practice, moderation and bio-individuality are core tenets; health is not a one-size-fits-all equation. For many of my patients, these specific, tailored DTE options are what finally resolved debilitating symptoms when standard synthetic therapies failed. Restricting or removing access to these customized dosages will directly disrupt their clinical stability, harm their health, and severely limit my ability to provide personalized care. I strongly urge the FDA to reconsider this reclassification and protect patients' access to essential, individualized thyroid therapies. Sincerely,