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The FDA issues warning letters requiring the company to cease prohibited marketing claims, reformulate the product, or stop selling it entirely

Gorman, GS, Chinnery, PF, DiMauro, S, Hirano, M, Koga, Y, McFarland, R, Suomalainen, A, Thorburn, DR, Zeviani, M, Turnbull, DM 2016, Mitochondrial diseases, Nature Reviews Disease Primers , vol

Osteocalcin and serum insulin-like growth factor-1 as biochemical skeletal maturity indicators

PMID 11116185

The FDA's own career scientists have published documents outlining concerns that even if peptides are trendy, evidence to support loosening restrictions is still inadequate

Its much less potent than GLP-1s, but the muscle-sparing effect is important, as one-third of the weight lost on GLP-1s is muscle mass