First GM crop approved for human consumption was:
Flavr Savr tomato developed by Calgene Inc., Davis, California, holds historical status as first genetically modified whole food approved for commercial sale and human consumption. FDA completed voluntary consultation DST 1994 after molecular characterization, Southern blot showing two contiguous T-DNA inserts, compositional analysis comparing sugars, acids, lycopene, vitamin C, glycoalkaloids to non-transgenic parent, toxicity assessment of NPTII at acute dosing in mice, and allergenicity search revealing no homology to known allergens. USDA APHIS determined nonregulated status under 7CFR 340. The antisense PG technology suppressed fruit pectinase reducing softening, allowing vine ripening improving flavor yet extending shelf life, addressing post-harvest losses estimated 20-30%. Despite approval, commercial cultivation failed due to yield drag, high licensing costs, anti-GMO activism, labeling debates and distribution logistics, withdrawn by 1997. Nevertheless regulatory precedent established principle of substantial equivalence, case-by-case safety assessment, voluntary labeling framework later applied to Roundup Ready soybean, Bt cotton, Golden Rice and other transgenic crops, marking transition from laboratory genetics to food biotechnology era and shaping public perception.
Ref: Redenbaugh et al. Safety assessment Flavr Savr FDA 1992; Bruening & Lyons 2000 Food Chem Toxicol.