This is just a minor variation of the old labeling scheme the FDA devised to cover their/WS asses on things like...just about everything.
BLACK BOX: approximation:Caution: "The Surgeon General has determined that smoking may be hazardous to your Health."...O.K., we're good to go...roll EM". Along w/countless other text and versions of just about every TV advertisement listing all the things , "WE WARNED YOU NOT TO...". You cannot bring legal action, we are all good here.
Maybe by the time the trials are done someone will have a real solution or treatment. In the meantime, all the trial subjects will be advised and required to sign the appropriate releases.
So, the producers, sellers, insurance companies, politicians and staffs involved are all covered. See, the system works.