The Dietary Supplement Health and Education Act (DSHEA) requires manufacturers and distributors who wish to market a dietary supplement containing a new dietary ingredient (NDI) to notify the FDA before marketing, unless a legal exception applies. The notification must contain the safety information that a manufacturer relied upon to conclude the dietary supplement containing the NDI is reasonably expected to be safe.
There are no FDA-approved drugs containing delta-8 tetrahydrocannabinol (delta-8 THC). Any delta-8 THC product claiming to diagnose, cure, mitigate, treat, or prevent diseases is considered an unapproved new drug. The FDA has not evaluated whether these unapproved drug products are effective for the uses manufacturers claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products, or whether they have dangerous side effects or other safety concerns.
FDA is not precluded from taking action against any dietary supplement containing new dietary ingredient if it is found to be unsafe, adulterated, or misbranded.