Amid numerous public comments opposing the proposed listing of acetaminophen as a Proposition 65 carcinogen, the California Office of Environmental Health Hazard Assessment (OEHHA) has cancelled the December 5, 2019 public meeting at which the Cancer Identification Committee (CIC) was to review scientific studies and vote on the proposed listing. OEHHA has opened a new public comment period on the proposed listing, which closes on January 27, 2020, and intends to reschedule the CIC meeting after that.
OEHHA first announced that acetaminophen was being considered for listing on September 20, 2019, at which point the first public comment period opened. On November 27, 2019, OEHHA submitted additional references to the CIC for the committee’s further consideration.
Acetaminophen is an over the counter (OTC) pain reliever that has been used for decades with a long history of safe use when taken as recommended. In its comments opposing the proposed listing, the federal Food and Drug Administration (FDA) challenged the studies OEHHA relied upon to establish the carcinogenicity of acetaminophen, on the basis that those studies did not contain adequate data. According to the FDA, “currently available data do not support the conclusion that exposure to acetaminophen in FDA-regulated products causes cancer.” Significantly, the FDA also stated that cancer warnings on such products would render them misbranded under federal law, and that, in that regard, Proposition 65 is preempted by federal law.
Other commenters, including the Consumer Healthcare Products Association, provided detailed scientific challenges to the proposed listing. But many commenters also referenced the practical consequences of a carcinogen listing, implicitly referencing the nation’s opioid crisis:
Given the current pain management landscape in the U.S., it is counter productive to be unnecessarily frightening people away from using safe, effective, and trusted pain medications like acetaminophen.
Indeed. Nor is it a proper use of public and private resources to open the door to meritless enforcement actions, in the face of the long history of safe acetaminophen use
Grimaldi Law Offices has been advising clients for over 20 years on chemical and product regulation. For knowledgeable advice and in-depth analysis on your chemical regulatory compliance obligations, contact Grimaldi Law Offices at (415) 463-5186 or email us at [email protected].
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