The United States Food and Drug Administration has announced that CBD products will soon need to follow a new regulatory pathway to the market. The federal agency also said they plan to cooperate with Congress to develop an appropriate strategy. Specifically, the FDA needs to update and highlight its safety concerns with CBD.
In a statement, the FDA noted, “This guidance is being issued to support clinical research for the development of cannabis and cannabis-derived human drugs.”
FDA Deputy Commissioner Dr. Janet Woodcock explains that a new regulatory pathway would provide new safeguards and oversight to manage better and minimize the potential risks related to CBD products, including future medications. She notes that new risk management tools could include things like: clear labels, CBD content limits, prevention of contaminants It could also involving additional control measures—like minimum purchase age—to lower the potential risk that children might ingest them.
It has long been illegal to market a product that contains cannabidiol—more commonly known as CBD—as a dietary supplement. And while the chemical has been found to possess therapeutic properties, the FDA has only approved one drug with CBD—Epidolex—which treats rare and severe epilepsy. However, the FDA now wants to disallow CBD to be considered a food additive as well.
Dr. Woodcock adds, “For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm.”
Specifically, medical science has no definitive understanding of the long-term effects of CBD on the liver, the male reproductive system, or pregnant women. At the same time; there is also a question as to what kind of effect it might have on children, as well as animals Of course, the questions are increasing in importance because the market for these products is growing quickly.
Sales of marijuana-derived products—including consumables and those found in topical products, tinctures, and foods—are expected to reach $22 billion by 2030 An increase in federal control could help encourage more research but could present a challenge for those looking to expand experimentation and development.