June 18, 2019

FDA Publishes Consumer Update on Cannabis Products, Including CBD

Holland & Knight Healthcare Blog
Michael J. Werner | Sara M. Klock

On June 14, 2019, the Food and Drug Administration (FDA) published a Consumer Update entitled "What You Need to Know (And What We're Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD."

In the Update, FDA reiterates its current views about regulation of cannabis products, as discussed here, hereand here. While the Agency acknowledges the tremendous interest in these products, the Agency stresses that many of its scientific and medicinal properties are still unknown. Importantly, the FDA identifies the following issues of concern:

  • The effects CBD could cause in the body, such as toxicity to the liver, when someone ingests CBD regularly over a long period of time
  • The cumulative exposure to CBD if people access it across a broad range of consumer products
  • The effects of CBD on special populations (e.g., the elderly, children, adolescents, pregnant and lactating women) or types of animals (e.g., species, breed or class)
  • The safety of CBD use in animals (e.g., species, breed or class), including pets

The Update once again stresses FDA's position that the Agency will prioritize public health concerns and take enforcement action against manufacturers of CBD products that make claims to prevent, diagnose or treat diseases. The Update further notes that FDA is also investigating reports of CBD potentially containing contaminants such as pesticides.

The FDA is continuing to evaluate the regulatory framework for cannabis products and is currently gathering information through its request to stakeholders to submit to the public docket with an extended deadline of July 16, 2019. Interested stakeholders are encouraged to submit their views to the FDA docket.

The Agency held a public hearing on May 31, and has a high-level task force working through the various issues. It is expected they will make a recommendation about any possible changes to FDA regulations by late summer.

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