Health Secretary Robert F. Kennedy Jr. wants to allow compounding pharmacies to produce certain synthetic peptides, even though FDA experts claim there is not enough clinical data from human trials to prove they are safe.

衛生部長 Robert F. Kennedy Jr. 希望允許調劑藥局生產某些合成肽，儘管 FDA 專家聲稱缺乏足夠的人體試驗臨床數據來證明其安全性。

The current administration is proposing a change in how several peptides—chains of amino acids used for various health purposes—are regulated. Secretary Kennedy has moved twelve of these substances into 'Category 1,' which is necessary for compounding pharmacies to produce them. He argues that moving these products from an unregulated 'gray market' to licensed pharmacies will reduce risks such as contamination and incorrect labeling. Furthermore, the Secretary has stated that the safety warnings issued by the previous administration were incorrect.

現任政府正提議更改數種肽（用於各種健康目的的氨基酸鏈）的監管方式。Kennedy 部長將其中 12 種物質移至「第一類」，這是調劑藥局能夠生產的前提。他主張將這些產品從不受監管的「灰色市場」轉移到持牌藥局，將能降低污染和標記錯誤等風險。此外，部長表示前任政府發布的安全警告是不正確的。

On the other hand, FDA scientists insist that there is not enough evidence to prove these substances are safe or effective. Internal documents show that for several peptides, such as TB-500, KPV, and MOTS-c, there are no published human clinical trials at all. Regarding BPC-157, the agency noted that the available data was too limited to make a formal recommendation. Additionally, the FDA emphasized that there are already approved medical treatments for the conditions these peptides aim to treat, including insomnia and eczema.

另一方面，FDA 科學家堅持認為沒有足夠證據證明這些物質的安全或有效性。內部文件顯示，對於數種肽（如 TB-500、KPV 和 MOTS-c），完全沒有發表過人體臨床試驗。關於 BPC-157，該機構指出可用數據過於有限，無法做出正式建議。此外，FDA 強調，針對這些肽旨在治療的病症（包括失眠和濕疹），已有獲批准的醫療方案。

There is also visible tension regarding the Pharmacy Compounding Advisory Committee. The FDA recently appointed nine new members, many of whom have financial or professional links to wellness clinics that promote peptide therapy. This change in the committee happens just before the July 23-24 meetings, where seven specific peptides will be reviewed. While the FDA usually follows the advice of its panels, the agency has clarified that a final decision will only be made after all reviews are complete.

關於藥局調劑諮詢委員會也存在明顯的緊張局勢。FDA 最近任命了 9 名新成員，其中許多人與推廣肽療法的健康診所具有財務或專業聯繫。委員會的此次變動恰在 7 月 23 至 24 日會議之前，屆時將審查 7 種特定肽。雖然 FDA 通常遵循其專家小組的建議，但該機構已澄清，最終決定將在所有審查完成後才做出。

The FDA's advisory committee will meet in late July to decide the status of seven peptides, balancing the Health Secretary's goal of deregulation against the agency's scientific findings.

FDA 的諮詢委員會將於 7 月底開會，決定 7 種肽的地位，在衛生部長的去監管化目標與該機構的科學研究結果之間取得平衡。