Mark McAfee v. FDA, No. 21-5170 (D.C. Cir. 2022)Annotate this Case
A dairy farmer looking to expand the market to which he could sell butter challenged the Food and Drug Administration's ("FDA") decades-old rule barring the interstate sale of raw butter. The farmer proposed a new rule that would allow such sales, claiming that by including raw butter in the definition of "butter" under the Food, Drug and Cosmetic Act, the FDA unlawfully changed the statutory definition of butter. The FDA rejected the farmer's proposal and the district court granted summary judgment to the FDA.
The D.C. Circuit affirmed. As a preliminary matter, the court found all but one of the farmer's claims were waived on appeal. His remaining claim--that the FDA's regulation banning interstate sale of raw butter violates the FDCA’s definition of butter--failed because the FDA reasonably concluded that raw butter was too dangerous to be sold interstate.