This is a well-written article; the Thalidomide disaster is worth recalling; and I salute you on the 2:40 marathon. But by my lights, if we've learned anything from the opioid crisis it's that FDA standards are NOT "notoriously strict" today. To anyone looking for a different point of view from yours that issue, I'd recommend Patrick Radden Keefe's stellar "Empire of Pain" (though other good books make similar points about the FDA).