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Delta-8: Added Confusion and Risks in the Cannabis Marketplace

This past week, the FDA and FTC sent cease and desist letters to six companies selling “copycat” delta-8 snack foods that look extremely similar to name brand snacks often enjoyed by children. As signs advertising “Delta-8 sold here” continue pop up in gas stations, convenience stores, and other shops across the country, millions of Americans find themselves wondering what delta-8 is exactly.

Delta-8 tetrahydrocannabinol, or delta-8 THC, is a psychoactive substance found in the Cannabis sativa plant (varieties include marijuana and hemp). It is one of more than 100 cannabinoids naturally produced by the plant, though it is not found in significant amounts. As a result, concentrated amounts of delta-8 THC are typically manufactured from hemp-derived cannabidiol (CBD).

Some users of delta-8 report positive feelings of euphoria, relaxation, and pain relief, but many others report negative side effects. In recent years, national poison control centers received over 2,000 calls related to delta-8 exposure - 70% required healthcare facility evaluation, and 8% resulted in admission to a critical care unit.

And the FDA received more than 100 reports of adverse events related to delta-8 consumption between December 1, 2020, and February 28, 2022, including but not limited to hallucinations, vomiting, tremors, anxiety, confusion, and loss of consciousness:

  • 77% involved adults, 8% involved pediatric patients, and 15% did not report age.

  • 55% required medical intervention or hospital admission.

  • 66% described adverse events after ingesting delta-8 food products.

Along with the varying side effects, there are also concerns around delta-8 production – many products are synthetically manufactured, creating unwanted by-products which can be harmful if ingested or inhaled.

As safety concerns grow, policymakers are scrambling to understand the legal status of this wild-west delta-8 market. The 2018 Farm bill, which legalized hemp containing less than 0.3% delta-9 THC, clearly intended to exclude intoxicating hemp from the legislation. However, a loophole in the law has left the legal status of delta-8 in question, unintentionally opening the doors to the sale of new delta-8 products across the country as long as they are derived from hemp that does not have more than 0.3% delta-9 THC based on dry weight.

Delta-8 products have not been approved by the FDA for safe use in any context. The FDA, doctors, scientists, policymakers, and parents continue to voice concerns about the known and unknown safety risks, both short and long-term, associated with the substance:

  • “The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide. These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders.” - FDA Principal Deputy Commissioner Janet Woodcock, M.D.

  • “Parents should be aware that these products are ending up in the hands of teenagers and… they are also not subject to any regulation and could be dangerous.” - Lancaster County District Attorney Heather Adams.

  • “The problem is that the chemists aren’t always very good at what they’re doing, especially when they’re doing it in an unregulated way outside of the purview of the FDA or state oversight… there is sometimes also delta-9 in those products and there are byproducts of the chemical synthesis in those products — and some of that can be dangerous.” - Shanna Babalonis, PhD, assistant professor in the Department of Behavioral Science at the University of Kentucky.

  • “Consumers should pay attention to what’s regulated, what’s unregulated, and pay attention to labels.” - Dr. Ziva Cooper, Ph.D., Director of the UCLA Cannabis Research Initiative.

The bottom line - delta-8 products, though growing in popularity, pose a public health threat and consumers should steer clear.

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