Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-5454

Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensMay 14, 2026

Documents

Type	Title	Posted	Comments	Status
Supporting Material	References 7 - Smarr, M. M., et al. (2016). Urinary paracetamol and time-to-pregnancy. Human Reproduction, 31(9), 2119-2127. URL: https://pubmed.ncbi.nlm.nih.gov/27412248/	May 14, 2026	--

Keywords

CDER

Citizen Petition

Americans for Scientific Integrity

take action to amend OTC acetaminophen

labeling regarding reproductive toxicity

fertility impairment, and

developmental endocrine disruption

over-the-counter

Data from Regulations.gov