Parents around the globe are using pediatric OTC medications to relieve their children’s pain, cold and allergy symptoms, and to reduce fevers. When parents give these medications to their infants and children, they expect the products to be free from harmful industrial chemicals.
At Clean Label Project®, rather than accepting safety as a given, our analysis is based on data and scientific evidence to uncover the actual substances consumers are ingesting, focusing on promoting and safeguarding transparency.
Discover verified products tested by Clean Label Project, build smarter grocery lists, and stay informed with the latest health and food safety news.
Clean Label Project® purchased and rigorously tested 40 of the top-selling pediatric OTCs, sourced from Nielsen and Amazon’s best-seller lists, and supplemented with top-selling products from the natural and organic marketplace. The scope of testing assessed multiple panels of industrial and environmental contaminants. Collaborating with Ellipse Analytics, an ISO 17025-accredited analytical chemistry lab, Clean Label Project® amassed 4,880 data points from those 40 products, representing 32 brands, to benchmark the findings.
Pediatric OTCs evaluated by Clean Label Project® showed detectable levels of DBP (di-n-butyl phthalate), and DEHP (di(2-ethylhexyl) phthalate).
In December 2011, the National Institutes of Health (NIH) published a study of DBP and DEHP in Prescription and Over-The-Counter Medications, which led the FDA to create new guidelines in December 2012, for the pharmaceutical industry to limit usage of DBP & DEHP phthalates.
Discovering DBP and DEHP in more than half of our pediatric OTC samples prompted us to investigate the various pathways through which these phthalates enter OTC products.
Tested positive for DBP (Di-n-butyl phthalate)
Tested positive for DEHP (Di(2-ethylhexyl)phthalate)
Liquid samples tested positive
Tablet samples tested positive
Gummy samples tested positive
Liquid samples tested positive
Tablet samples tested positive
Gummy samples tested positive
There are no comprehensive federal regulations specifically addressing dietary exposure to industrial chemicals in food and medicine, as most safety measures concentrate on physical and microbiological contaminants.
While there are FDA guidelines for DBP and DEHP to limit the usage of these phthalates in pharmaceuticals, there are no actual federal restrictions on the usage. Clean Label Project® performs 8-12 category studies annually, and we find a high percentage of samples contain phthalates. DEHP appears on the FDA’s GRAS list and, due to its role as a plasticizer enhancing flexibility, is commonly found in products like bottles, bags, and gaskets.
Over the past decade, the Clean Label Project® has analyzed bisphenols (BPA & BPS) across a range of product categories. While BPA was frequently found in earlier studies, it is now rarely detected. We expect phthalates like DBP and DEHP to experience a similar decline over time.
DBP (di-n-butyl phthalate) and DEHP (di(2-ethylhexyl) phthalate) can contaminate pediatric OTC products through several different pathways. DBP is often used as a coating for oral medications, particularly those for timed-release or delivery to the large bowel.
DEHP is a plasticizer that makes plastics more flexible. DEHP plastic chemicals are used in bottles, bags, and plastic rubber seals. DEHP is part of the FDA’s GRAS (Generally Recognized As Safe) list. Our research has found DEHP in many different categories we’ve tested, such as protein powder, cereal, and snack bars.
Clean Label Project® contracted with an independent analytical chemistry laboratory, Ellipse Analytics, to test five industrial chemical panels:
The Heavy Metals (Arsenic, Cadmium, Lead, and Mercury) were tested by Inductively Coupled Plasma – Mass Spectroscopy (ICP-MS). Phthalates were tested by Gas Chromatography – Mass Spectroscopy (GC-MS/MS). Bisphenols, Glyphosate, and Pesticides are tested by Liquid Chromatography – Tandem Mass Spectroscopy (LC-MS/MS).
Our mission is to empower consumers by delivering accurate and reliable product information based on our testing and analysis of the products they buy. When it comes to selecting low-contaminant options, our findings reveal that liquid pediatric OTCs have lower phthalate contamination than tablets or gummies.
Clean Label Project® believes DBP and DEHP are entering pediatric OTCs as an ingredient to slow the release of medication and as plasticizers in the manufacturing of capsules and packaging.
Over the last couple of years, 90% of the samples tested in Clean Label Project® category studies were BPA free. In each study, we may find one or two samples that are outliers, where we find a spike in BPA. Clean Label Project® finds phthalates like DBP and DEHP much more frequently.
This data enables consumers to make informed choices that prioritize safety and quality in their Pediatric OTC choices.
The following companies have Pediatric OTCs that are Clean Label Project® Certified:
“When it comes to our children, standards should always be set as high as possible,” said Molly Hamilton, Executive Director of Clean Label Project®. “Parents provide medication specifically to safeguard their child’s health, and we must do everything possible to ensure it accomplishes that safely and effectively.”
