The US Food and Drug Administration (FDA) is open to developing a new regulatory framework for cannabidiol (CBD), according to an agency official speaking at RAPS Convergence 2023.
“The FDA is committed to sound, science-based policies on CBD,” said Owen McMaster, senior pharmacology/toxicology reviewer in the Office of Infectious's Division of Pharm/Tox for Infectious Diseases (DPT-ID). Diseases (OID) in the FDA's Center for Drug Evaluation and Research (CDER). “We look forward to working with Congress on a new path forward – a harm reduction and regulatory approach.”
Hundreds of new cannabis products
Interest in cannabis-related products and cannabis sativa has increased over the past decade. The FDA has received 50 Investigational New Drug (IND) applications for cannabis-related products over the past 800 years, including 400 IND applications in the past 10 years. The agency currently has 150 active INDs in the areas of addiction, pain, medicine, neurology, immunology and inflammation, McMaster told RASP.org.
CBD currently has an estimated market size of at least $4 billion. If the agency provides guidance on how CBD can be sold safely, this is expected to increase faster than at present. This requires good regulations.
McMaster explained that the FDA has received several citizen petitions requesting that the agency allow CBD products to be regulated as dietary supplements. “Unfortunately, the existing regulatory frameworks we have for foods and supplements are not appropriate for cannabidiol. It is not clear how CBD products can meet the safety standards for dietary supplements or food additives,” he explained.
CBD safety standard
“In regulating medications, the FDA uses a safety standard that considers the risks and benefits for individuals with a specific medical condition, while dietary supplements are “used by a broader group” of individuals seeking to supplement diet and maintain health. The standard for foods and nutritional supplements is that the product has a reasonable expectation of safety. “The benefits are not taken into account.”
A working group tasked with examining studies on CBD-related products, such as Epidiolex, released a statement in January 2023 explaining their reasoning behind the conclusion that CBD could not meet safety standards for dietary supplements or food additives. Considerations included a lack of evidence on safe consumption levels for CBD and for safe duration of consumption. The working group also found risks associated with administering CBD to animals, and a potential exposure risk for people consuming meat, milk and eggs from animals given CBD.
“A new regulatory pathway needs to be developed. “A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products.”
However, a mandate from Congress is needed before the FDA can begin its work in this area. In October 2022, the White House released a statement asking the U.S. Secretary of Health and Human Services and the Attorney General to review how cannabis is regulated under federal law. A decision from the Drug Enforcement Administration is pending.
Meanwhile, McMaster indicated that the FDA is committed to enforcement efforts that target high-risk drugs.
Source: rasp.org (EN)
