All Posts

Ten pages of warning letters dropped this week, possibly a record. Most came from CDER under the headline: "Unlawful Sale of Unapproved and Misbranded Drugs to U.S. Consumers Over the Internet." 𝗜 𝗱𝗶𝗱𝗻'𝘁 𝗮𝗻𝗮𝗹𝘆𝘇𝗲 𝘁𝗵𝗲𝗺 𝗮𝗹𝗹, 𝗯𝘂𝘁 𝗺𝗼𝘀𝘁 𝗹𝗲𝘁𝘁𝗲𝗿𝘀 𝘀𝗲𝗲𝗺 𝘁𝗼 𝗯𝗲 𝗯𝗮𝘀𝗲𝗱 𝗼𝗻 𝗙𝗗𝗔’𝘀 𝗿𝗲𝘃𝗶𝗲𝘄 𝗼𝗳 𝗰𝗼𝗺𝗽𝗮𝗻𝘆 𝘄𝗲𝗯𝘀𝗶𝘁𝗲𝘀. 𝗧𝗵𝗲 𝗺𝗮𝗶𝗻 𝗽𝗮𝘁𝘁𝗲𝗿𝗻 𝘀𝗲𝗲𝗺𝘀 𝗰𝗹𝗲𝗮𝗿: -Online compounding pharmacies promoting compounded GLP-1

I was asked in another thread about which agency is most concerning (or something to that effect). And it got me thinking. Most regenerative medicine clinics worry about the 𝗙𝗗𝗔......and for good reason. The agency has cracked down on unapproved stem cell, SVF, and amniotic products. But here’s what often gets missed: the 𝗙𝗧𝗖 is just as active, and their lens is very different. 𝙁𝘿𝘼 𝙛𝙤𝙘𝙪𝙨: 𝙥𝙧𝙤𝙙𝙪𝙘𝙩 𝙨𝙖𝙛𝙚𝙩𝙮 & 𝙖𝙥𝙥𝙧𝙤𝙫𝙖𝙡 ▪️Unapproved biologics (e.g

𝗧𝗵𝗲 𝗲𝘃𝗶𝗱𝗲𝗻𝗰𝗲 𝘀𝘂𝗴𝗴𝗲𝘀𝘁𝘀 𝗣𝗥𝗣 𝗮𝗻𝗱 𝗕𝗠𝗔𝗖 𝗱𝗼𝗻’𝘁 𝗿𝗲𝗴𝗿𝗼𝘄 𝗰𝗮𝗿𝘁𝗶𝗹𝗮𝗴𝗲, 𝘀𝗼 𝘄𝗵𝘆 𝗱𝗼 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀 𝘁𝗵𝗶𝗻𝗸 𝘁𝗵𝗲𝘆 𝘄𝗶𝗹𝗹? There’s no question PRP and BMAC can deliver value. Studies consistently show pain relief, improved function, and in some cases slowing of degeneration. For the right patient, those gains matter. But here’s the problem: patients hear “𝘀𝘁𝗲𝗺 𝗰𝗲𝗹𝗹𝘀” or “𝗴𝗿𝗼𝘄𝘁𝗵 𝗳𝗮𝗰𝘁𝗼𝗿𝘀” and expect regenerat