On July 16, 2018, WLF filed formal comments with the Food and Drug Administration (FDA), urging the agency to revise its proposed regulations governing how it classifies a medical product (e.g., a drug, a medical device, or a biological product) for which a manufacturer seeks FDA marketing approval. WLF argued that the proposed regulations are inconsistent with FDA’s statutory mandate and improperly skew decision-making in favor of a drug classification. It can often be difficult to differentiate a “drug” from a “medical device”; federal law defines those two categories of medical products quite similarly. The principal distinction focuses on whether the product “achieve[s] its primary intended purposes through chemical action.” If so, the product is a drug; if not, the product usually is classified as a device. WLF’s comments argue that FDA, in its proposed regulations and in prior filings, has been interpreting “primary intended purposes” in an overly expansive manner.