On July 5, 2023, the FDA and FTC jointly announced six cease and desist letters to alleged delta-8 product makers. You can access the letters here. Unlike prior rounds of warning letters, these letters have a new focus: harm to children.
For nearly five years, the FDA and FTC have taken the position that CBD is an unlawful additive in ingestible products. This is based largely on the so-called drug exclusion rule, which we’ve analyzed at length before (see here, for example). Essentially, because CBD is an approved drug ingredient (in Epidiolex®), it cannot be added to foods or dietary supplements.
Delta-8, however, is not an approved drug ingredient. And if it is derived from hemp, it is not independently scheduled – at least if you read the Controlled Substances Act and 2018 Farm Bill literally. But, there’s a huge controversy about whether it can be controlled, with agencies like the DEA saying it is. You can read more about that issue here or here.
But the fact that delta-8 products are in a gray area doesn’t mean the federal government’s just going to let things slide. Indeed, the FDA maintains a web page warning about the supposed dangers of
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