This comment evaluates the United States‘ current regulatory scheme as it applies to CRISPR and related gene-modifying technologies and discusses the ethical ramifications of regulating human germline modification versus continuing to allow self-regulation within the scientific community. Part I explains what CRISPR is, how it works, and its impact on genetic engineering technology. Although CRISPR offers unparalleled potential for modifying [both] human and nonhuman genomes, this comment focuses primarily on the use of CRISPR technology to manipulate the human germline. Part II discusses the social and bioethical implications of altering the human germline, including safety concerns, multigenerational consequences, equity issues, and ethical complications involved with editing human embryos. Part III examines the United States‘ current regulatory scheme as it applies to gene-modifying technologies, discusses the need for reform in light of CRISPR germline-editing therapies, looks at several possible solutions to improve the existing scheme, and proposes an adapted regulatory framework