WASHINGTON — About a year into its examination of the emerging cannabidiol (CBD) market, officials with the U.S. Food and Drug Administration (FDA) have released a statement essentially reiterating the agency's concerns over emerging new products and outlining its efforts to gather more information and inform the public of new findings.
Newly appointed FDA Commissioner Stephen Hahn on March 5 released a detailed statement on where the agency stands on medicinal remedies, offering no decisions or direction regarding regulatory actions.
“We recognize the significant public interest in CBD, and we must work together with stakeholders and industry to develop high-quality data to close the substantial knowledge gaps about the science, safety and quality of many of these products,” Hahn said in the statement. “We are committed to working efficiently to further clarify our regulatory approach to these products—as always, using science as our guide and upholding our rigorous public health standards.”
Here are the FDA’s main concerns and focus areas for CBD products …
1. Concerns over risk
The FDA has maintained its concern over the misconception that it has evaluated CBD products and determined them safe or at the very least that they “can’t hurt.”
The FDA actually has many unanswered questions about the safety of these products, especially outside the monitored prescription setting involving a healthcare provider, Hahn said. While holding back from declaring the products unsafe, the agency has already raised concerns about potential liver injury, interactions with other drugs and male reproductive toxicity, as well as side effects such as drowsiness. It also knows little about cumulative effects, interactions with other medicines or risks to children, pregnant women and the elderly, the statement said.
“We are not at a point where we can conclude that unapproved CBD products are safe for use,” Hahn said. “We encourage Americans to consult with their healthcare providers before using CBD products.”
2. Seeking data
To address its questions and concerns, the FDA is pursuing what it calls “reliable and high-quality data.” This includes data on the “sedative effects of CBD; the impacts of long-term sustained or cumulative exposure to CBD; transdermal penetration and pharmacokinetics of CBD; the effect of different routes of CBD administration (for example, oral, topical or inhaled) on its safety profile; the safety of CBD for use in pets and food-producing animals; and the processes by which 'full spectrum' and 'broad spectrum' hemp extracts are derived, what the content of such extracts is and how these products may compare to CBD isolate products.”
4. Monitoring the marketplace
While it conducts its data-gathering efforts, the FDA will continue to monitor the marketplace and take action against what it called “unlawful CBD products that pose a risk of harm to the public.”
Hahn said the agency has seen CBD products marketed with claims of therapeutic benefits, such as treating or curing serious diseases such as cancer and Alzheimer’s disease, without having gone through the drug approval process. “The proliferation of such products may deter consumers from seeking proven, safe medical therapies for serious illnesses—potentially endangering their health or life,” Hahn said.
The agency is also concerned about other risks, including product contaminants such as heavy metals and tetrahydrocannabinol (THC), the psychoactive element in marijuana.
Other concerns are with products that omit ingredients they claim to contain or have incorrect amounts of CBD, and if vulnerable populations should use these products.