FDA Looks To Collect More Cannabis Data As It Touts Federal-State Partnership In Enforcement Action Against Delta-8 THC Business

FDA Looks To Collect More Cannabis Data As It Touts Federal-State Partnership In Enforcement Action Against Delta-8 THC Business
MJ moment

The Food and Drug Administration (FDA) is looking to collect additional data to fill in gaps in evidence about the safety of cannabis-derived products, while at the same time touting recent action it took to help a state agency crack down on a company selling delta-8 THC gummies that regulators say are linked to “serious adverse events.” FDA has faced significant criticism in recent years over the lack of regulations allowing for the marketing of hemp-derived cannabinoids like CBD in the food supply or as dietary supplements. The agency has maintained that it needs to gather more data, and possibly receive some legislative support from Congress, while simultaneously taking limited enforcement action against certain businesses that sell cannabis products derived from hemp. As part of its data collection effort, FDA posted a sources sought notice this month, soliciting information about “the availability and capability of qualified small business sources” to carry out research about “product problems (e.g., quality concerns), adverse events, and misinformation sources based on real world data (RWD) to help fill knowledge gaps” with respect to cannabinoid products. The agency said that, since hemp and its derivatives were legalized under the 2018 Farm Bill, “both the availability of and demand for [cannabis-derived products] have surged, prompting the FDA’s Cannabis Product Committee (CPC) to identify critical needs to address the Agency’s evidence gaps in the Cannabis-Derived Products Data Acceleration Plan (DAP).” The notice outlines data priorities for potential facilities capable of helping to fill those evidence gaps. For example, FDA wants information about “new and emerging risks, and safety signals identified in online data sources” such as the dark web, as well as analysis on that collected data and “information on the current scientific literature.” Additionally, the agency said it’s looking to see what businesses are capable of developing…

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Source : FDA Looks To Collect More Cannabis Data As It Touts Federal-State Partnership In Enforcement Action Against Delta-8 THC Business

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