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Sikiric involved the following authors: Gorana Aralica, Josip Aralica, Gojko Buljat, Valentina Coric, Vedran Coric, Bozidar Duplancic, Miroslav Gjurasin, Zeljko Grabarevic, Miroslav Hanzevacki, Stipislav Jadrijevic, Vjekoslav Jagic, Pasko Konjevoda, Martina Lovric, Anton Marovic, Pavle Miklic, Darko Mikus, Stjepan Mise, Darko Perovic, Marijan Petek, Ivo Rotkvic, Rudolf Rucman, Bozidar Sebecic, Sven Seiwerth, Jadranka Separovic, Zoran Simec, Zoran Slobodnjak, Dinko Stancic-Rokotov, Branko Turkovic, Tomislav Ziger, Ivan Zoricic

Kevin Greene and Confidia Health Institute

Officially, the FDA cites: Insufficient large-scale clinical trials Concerns about consistency, sourcing, and manufacturing standards The need to meet formal drug approval requirements Critics argue (fairly) that this system: Favors large pharmaceutical companies Makes it hard to approve naturally occurring peptides Leaves promising, low-risk compounds in regulatory limbo The short version: This FDA restrictive regulatory change of mind wasnt driven by a sudden safety scare, it was driven by regulatory process and economics