Attack on Sunscreens Continues

Skinmed. 2021 Aug 1;19(4):301-302. eCollection 2021.

Abstract

The Food and Drug Administration (FDA) was required to issue and put into effect a final sunscreen monograph by November 26, 2019. On March 27, 2020, President Donald Trump signed into effect H.R. 748, the "Coronavirus Aid, Relief, and Economic Security Act" (CARES). This bill eliminated the November 2019 requirement. The CARES Act includes legislative reforms that modernize the way over-the-counter (OTC) monograph drugs are regulated in the United States. Under this Act, sunscreens will be considered generally recognized as safe and effective (GRASE), if they meet conditions newly defined by the FDA. In addition, the FDA is required to issue a proposal to revise the sun-screen requirements for GRASE not later than 18 months after enactment and will sunset by the end of the fiscal year 2022. The CARES Act also addresses the requirement for a new drug application (NDA).1-7.

MeSH terms

  • Chemistry, Pharmaceutical / legislation & jurisprudence
  • Consumer Product Safety / standards*
  • Drug Labeling / legislation & jurisprudence
  • Humans
  • Nonprescription Drugs / standards*
  • Protective Agents / standards
  • Sunscreening Agents / standards*
  • United States
  • United States Food and Drug Administration

Substances

  • Nonprescription Drugs
  • Protective Agents
  • Sunscreening Agents