In the case of Weinberger, Secretary of Health, Education, and Welfare et al. v. Hynson, Westcott & Dunning Inc., 1972, the U.S Supreme Court ruled in favor of Weinberger (representing the Food and Drug Administration). The dispute arose when Hynson challenged FDA's decision to remove its cold remedies from market without a hearing because they were not generally recognized as safe and effective by experts. The court held that if a manufacturer has not complied with FDA’s procedure for proving that their drug is generally recognized among qualified experts as safe and effective for use under prescribed conditions then it cannot be considered a "new drug". Therefore such drugs can be removed from market without prior hearing or notice. This ruling reinforced FDA's authority to regulate over-the-counter drugs based on expert consensus about safety and efficacy rather than individual company data alone.

In the dissenting opinion for Weinberger v. Hynson, Westcott & Dunning, Inc., Justice William O. Douglas argued that the Food and Drug Administration (FDA) had overstepped its authority by retroactively applying new standards to drugs previously approved under old regulations. He contended that this action violated due process rights of drug manufacturers who relied on previous FDA approvals in good faith. Furthermore, he criticized the majority's interpretation of "substantial evidence" as overly broad and subjective which could potentially allow arbitrary decisions by administrative agencies without proper judicial review or oversight. Lastly, he expressed concern about potential harm to public health if effective drugs were removed from market based on bureaucratic technicalities rather than scientific evidence of safety or efficacy.