CHPA Statement Regarding California’s Upcoming Review of Acetaminophen

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Press Releases and Statements | Jan 23, 2020

“Medical and patient groups, public health experts, FDA, and others join the Consumer Healthcare Products Association (CHPA) in opposing the addition of acetaminophen to the Proposition 65 list. The weight of scientific evidence clearly demonstrates there is no causal link between acetaminophen use and cancer; the evidence does not meet OEHHA’s ‘clearly shown’ standard for listing; and, requiring a Prop 65 cancer warning on acetaminophen products would result in false and misleading labeling, and could potentially confuse consumers. 

“In comments submitted to OEHHA by CHPA, we provided the CIC with a full, up-to-date review of the scientific evidence based on input from leading experts in the fields of epidemiology, genotoxicity, and animal carcinogenicity. CHPA stands behind the safety profile and efficacy of acetaminophen and believes the scientific evidence strongly weighs against identifying acetaminophen as a known carcinogen.

“More than 20 other organizations (see list below*) have urged the CIC not to list acetaminophen as a carcinogen. All of the letters — including those submitted by influential state lawmakers — are posted on OEHHA’s website here.

“Acetaminophen is one of the most widely-used, thoroughly-studied, and clinically proven pain-relieving and fever-reducing medicines, with over six decades of use. It is safe and effective when used according to label instructions. It is often the most appropriate option for pain relief for many consumers, including older adults with persistent pain, infants, and patients with stomach conditions such as ulcers or other chronic conditions.

“In addition to the large body of science that demonstrates acetaminophen’s safety, concerns about consumer confusion and unintended consequences of labeling must be considered. A decision to list acetaminophen under Proposition 65 would cause consumer confusion and could negatively affect how consumers choose and use over-the-counter (OTC) pain relievers to treat their symptoms. This confusion could lead some consumers to switch to pain relievers that present greater overall safety concerns for their personal health circumstance.

“In its letter to OEHHA, the U.S. Food & Drug Administration wrote, ‘FDA has determined that the currently available evidence does not support a conclusion that acetaminophen in FDA-regulated products causes cancer. Accordingly, a Proposition 65 cancer warning on the labeling of products containing acetaminophen would not be scientifically accurate and such labeling would be false or misleading.'

“In a letter from the California Dental Association (CDA), dentists expressed concern that listing, ‘could negatively impact compliance with dental pain management regimens,’ and that, ‘there simply is not compelling evidence to conclude there is an increased risk of cancer due to use of acetaminophen.’

“Another letter from a broad coalition of health groups stated, ‘We strongly urge the CIC not to ‘list’ acetaminophen as a carcinogen due to the lack of evidence...and due to the unnecessary confusion and fear it could cause among consumers and patients.’

“CHPA looks forward to sharing our perspective at the 2020 CIC meeting this spring.” 
 

*(Medical Groups, Public Health Experts, and Patient Advocates Urging the CIC Not to Add Acetaminophen to the Proposition 65 List) 
 
  • Alliance for Aging Research
  • American Chronic Pain Association
  • American Gastroenterological Association
  • American Association of Kidney Patients
  • California Chamber of Commerce
  • California Chronic Care Coalition
  • California Dental Association
  • California Grocers Association
  • California Life Sciences Association
  • California Retailers Association
  • California Rheumatology Alliance
  • California Pharmacists Association
  • California State Senator Richard Pan
  • Caregiver Action Network
  • Caregiver Voices United
  • The Gerontological Society of America
  • National Minority Quality Forum
  • Protecting Access to Pain Relief (PAPR) Coalition 
  • Renal Physicians Association
  • TransplantFirst Academy
  • Veterans Transplantation Association

Founded in 1881, the Consumer Healthcare Products Association (CHPA) is the national trade association representing the leading manufacturers and marketers of over-the-counter (OTC) medicines, dietary supplements, and consumer medical devices. Every dollar spent by consumers on OTC medicines saves the U.S. healthcare system more than $7, contributing a total of $146 billion in savings each year. CHPA is committed to empowering consumer self-care by preserving and expanding choice and availability of consumer healthcare products. www.chpa.org