High Lead Levels Found in CBD Oil Product
Posted on Behalf of Melinda Hoang.
With the enactment of the 2018 Farm Bill and uptick of state-level legalization of cannabis for medicinal and recreational use in the United States, the use of cannabidiol (CBD) oil has become increasingly popular due to claims of its beneficial effects, including but not limited to the treatment of acne, anorexia, anxiety, chronic pain, depression, epilepsy, or insomnia. CBD, a phytocannabinoid extracted from the flowers and buds of cannabis (marijuana or hemp) plants, is one of many chemicals isolated and utilized for its active properties (FDA 2018; WHO 2018). Unlike the more commonly known active phytocannabinoid tetrahydrocannabinol (THC), CBD does not cause intoxication or euphoria (FDA 2018). In 2018, the World Health Organization (WHO) reported that “CBD exhibits no effects indicative of any abuse or dependence potential… To date, there is no evidence of recreational use of CBD or any public health-related problems associated with the use of pure CBD” (WHO 2018). CBD is typically formulated as an oil but is also sold as an extract, a vaporized liquid, and as an oil-based capsule in foods, drinks, and beauty products (Mayo Clinic 2018). CBD is currently not recognized as an approved ingredient for food or dietary supplements by the U.S. Food and Drug Administration (US FDA); the FDA has only approved one CBD product, the prescription drug Epidiolex, which is used to treat two rare forms of epilepsy (FDA 2018; FDA 2020 #1). Due to the lack of federal approval and regulations of CBD, states have developed their own regulations for CBD-infused products, potentially leading to differences in testing methods and requirements among states.
On May 15, 2020, Summitt Labs voluntarily recalled a CBD tincture product after the Florida Department of Agriculture and Consumer Services (FDACS) found 4.7 parts per million (ppm) of lead in a random sample of Kore Organic Watermelon CBD oil tincture (FDA 2020 #2). Summitt Labs then initiated an internal investigation and tested another sample from the same batch of CBD oil at an ISO/ICE accredited lab, which showed lead concentrations of 500 parts per billion (ppb), or 0.5 ppm; these results are within the legal limits defined by the State of Florida (FDA 2020 #2). However, Summit Labs initiated a full recall of the product in full cooperation with the FDA and FDACS based on the test results of the FDACS (FDA 2020 #2).
There are currently several health-based standards for blood lead levels, which are largely based on the occurrence of neurobehavioral defects. The U.S. Environmental Protection Agency (EPA) concluded that a blood lead level greater than 10 µg/dL poses a risk to children’s health (EPA 1998), while the Center for Disease Control (CDC) uses a blood lead reference level of 5 µg/dL to identify children with blood lead levels “much higher than most children’s levels” rather than providing a level of concern (CDC 2020). In addition, the California Office of Environmental Health Hazard Assessment (OEHHA) proposed a child-specific health guidance value for lead to use in risk assessments of school sites, defined as an incremental change of 1 µg/dL in blood lead level that would decrease a child’s IQ by up to one point (Carlisle and Dowling 2007). However, according to the WHO, there is “no level of exposure to lead that is known to be without harmful effects” (WHO 2019). Acute lead poisoning has been linked to various signs and symptoms, including but not limited to developmental delay, learning difficulties, and seizures in children; high blood pressure, joint and muscle pain, and impairments in memory or concentration in adults; and miscarriages, stillbirth, or premature births in pregnant women (Mayo Clinic 2019). With the increasing popularity and use of CBD products, including CBD oil, there is an increase in public health concerns for unregulated and contaminated products, and a need for manufacturers to evaluate the safety of their products.
Cardno ChemRisk scientists have assisted companies in evaluating potential product exposures and possible hazards posed by chemicals in consumer products and foods. For more information on Cardno ChemRisk’s capabilities, please contact Elise de Gandiaga or Heidi O’Neill.