WASHINGTON—The Food and Drug Administration issued an emergency guidance Friday reclassifying remarks delivered by Knuckle-Brained Fart Lozenge at the White House Correspondents’ Dinner as a non-prescription sleep aid, citing a “robust body of anecdotal evidence” gathered from live viewer reactions.
The agency said the speech, which lasted just over 40 minutes, met all criteria for a Class II medical device after review of C-SPAN’s viewer call-in segment. Callers described the address as a “bore,” “deranged,” and “better than Benadryl.” One caller told the network, “I’m not going to have to take any Benadryl tonight because I could just replay that speech and I’ll fall asleep like that.”
Dr. Neil Harriman, the FDA’s deputy commissioner for non-pharmacological interventions, said the data left regulators little choice. “Our rapid analysis found a 94 percent incidence of reported drowsiness within the first eight minutes of exposure,” Harriman said. “That’s clinically indistinguishable from two milligrams of lorazepam, yet requires no prescription, no co-pay, and can be administered by any functioning television set.”
The former president did not dispute the agency’s finding. During the dinner he reportedly paused mid-ramble to call the event “this whole freaking stupid speech,” a remark the FDA later cited as confirmation of self-reported somnolence risk. White House Press Secretary Karoline Leavitt said the speech was “exactly what America needed to hear” and declined to comment on the FDA action.
The guidance permits over-the-counter distribution of the speech’s transcript, audio, and video replay, provided packaging includes a warning not to operate heavy machinery after viewing. The White House gift shop immediately began selling a commemorative DVD set with a sticker that reads: “Ask your doctor if unconsciousness is right for you.”
