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This means that the manufacturer should submit their data to the FDA to prove that the drug (or biological product) is safe and effective by conducting lab, animal, and human clinical testing for the drugs intended use

Reference: MITOBLEND MitoPrime Blend (5-Amino-1 10mg+MOTSC 10mg+NAD 100mg) The Mito Blend is designed as a multi-pathway system studied in research settings for its complementary effects on cellular energy and metabolic signaling

The pushback had a familiar flavour: You havent proved it doesnt work, and lack of human data doesnt mean lack of benefit. And "It's got a plausible mechanism." Heres my issue If you are going to claim efficacy (healing, belly fat loss, GH boosting, hypertrophy), you should be able to back that up with human trials for that claim, at that dose, with a defined product