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Delta 8 Hemp was cited for selling unapproved new drugs in violation of the Federal Food, Drug, and Cosmetic Act, including Delta-8 THC distillate oil, vape cartridges, tinctures, and infused gummies marketed on their website without FDA approval or authorization. The products were determined to be misbranded drugs lacking required labeling information, and the gummies were additionally found to be adulterated due to containing unsafe food additives. The FDA noted it had received adverse event reports involving Delta-8 THC products and expressed serious concerns that these products were being marketed in ways that put public health at risk, despite not being evaluated or approved for safe use.