๐๐๐ ๐๐. ๐๐ง๐: ๐ฃ๐ต๐๐๐ถ๐ฐ๐ถ๐ฎ๐ป๐, ๐๐ต๐ผโ๐ ๐ฟ๐ฒ๐ฎ๐น๐น๐ ๐๐ฎ๐๐ฐ๐ต๐ถ๐ป๐ด ๐๐ผ๐๐ฟ ๐บ๐ฎ๐ฟ๐ธ๐ฒ๐๐ถ๐ป๐ด?
- kparmstrong1
- Jan 8
- 1 min read
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 ๐๐๐......and for good reason. The agency has cracked down on unapproved stem cell, SVF, and amniotic products. But hereโs what often gets missed: the ๐๐ง๐ is just as active, and their lens is very different.
๐๐ฟ๐ผ ๐๐ค๐๐ช๐จ: ๐ฅ๐ง๐ค๐๐ช๐๐ฉ ๐จ๐๐๐๐ฉ๐ฎ & ๐๐ฅ๐ฅ๐ง๐ค๐ซ๐๐ก
โช๏ธUnapproved biologics (e.g., SVF, amniotic/cord)
โช๏ธViolations of 361 HCT/P exemptions
โช๏ธInjunctions, seizures, criminal cases
๐๐๐พ ๐๐ค๐๐ช๐จ: ๐๐๐ซ๐๐ง๐ฉ๐๐จ๐๐ฃ๐ & ๐๐ค๐ฃ๐จ๐ช๐ข๐๐ง ๐๐๐๐๐ฅ๐ฉ๐๐ค๐ฃ
โช๏ธClaims to โcureโ arthritis, Parkinsonโs, autism, COPD
โช๏ธMisleading โFDA-approvedโ or โcomplianceโ language
โช๏ธInjunctions + multimillion-dollar penalties
๐ง๐ฟ๐ฒ๐ป๐ฑ:
โช๏ธFDA = What you sell
โช๏ธFTC = What you say
And lately, the FTC and the FDA has shown it will strongly govern clinics from marketing regenerative therapies if claims are unsupported.
๐ง๐ฎ๐ธ๐ฒ๐ฎ๐๐ฎ๐: Even if your biologic processing fits FDA exemptions, sloppy or exaggerated marketing can put you in the FTCโs crosshairs.
๐ง๐ผ ๐๐ต๐ฒ ๐น๐ฒ๐ด๐ฎ๐น ๐ฎ๐ป๐ฑ ๐ฟ๐ฒ๐ด๐๐น๐ฎ๐๐ผ๐ฟ๐ ๐บ๐ถ๐ป๐ฑ๐ฒ๐ฑ:
Is this assessment off and how do you advise your clients.
๐ค๐๐ฒ๐๐๐ถ๐ผ๐ป ๐ณ๐ผ๐ฟ ๐๐ต๐ฒ ๐ฐ๐น๐ถ๐ป๐ถ๐ฐ๐ถ๐ฎ๐ป๐:
โช๏ธHow much thought are you giving to balancing compliance between what you use (FDA risk) and what you say (FTC risk)?
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