§364 Definitions

Summary

Sets clear meanings for words used in these rules. "Adverse event" means any harmful health problem tied to using a cosmetic. "Cosmetic product" means a made-up mix of cosmetic ingredients with a set recipe used in a finished product. "Facility" means any place that makes or processes cosmetics sold in the United States, but it does not include salons or retailers (unless they actually make products there), hospitals or doctors’ offices, public health agencies or nonprofits that give products directly to people, hotels or airlines that give small free items, trade-show sampling sites, places that make products only for research, or places that only label, package, hold, or distribute products. Filling a container is not considered packaging here. "Responsible person" is the maker, packer, or distributor whose name is on the label. "Serious adverse event" is an adverse event that causes death, a life‑threatening episode, inpatient hospital care, long-lasting disability or incapacity, a birth defect, an infection, or major disfigurement (for example severe rashes, second- or third-degree burns, big hair loss, or lasting change in appearance). It also includes cases that need medical or surgical treatment to prevent those outcomes.